Good morning. Thanks, Ashley, thank you everyone for joining our investor call today to discuss the Appendix 4C, the cash flow statement activities report, which we lodged with the ASX just at market close yesterday. As mentioned, I'm Kyahn Williamson, SVP of Investor Relations and Corporate Communication. I'm joined today by Dr. Christian Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group CFO; and Colin Hayward, our Group Chief Medical Officer. Today, we'll be taking you through the presentation that was lodged on the ASX. It's also displayed on the webcast for those joining by that forum. For those by phone, we'll give a verbal cue for each slide change. We'll go to Q&A at the end of the call. Just advancing through the disclaimer and to slide three. Slide three.
By way of summary, the milestones and achievements of Q1 2023 really demonstrate how we are delivering against our growth strategy and delivering on our mission of global leadership within the growing radiopharmaceutical sector. We've had another excellent quarter of Illuccix sales in the U.S. and advancing our global rollout. We've got 27% growth Q-on-Q. Chris will take you through these results in more detail. We're in high gear in preparing to file for regulatory approval and commercialize two additional imaging agents in brain cancer and kidney cancer, which will ultimately layer in new revenue streams. We're making good progress across all of the clinical trials in our core therapy programs of prostate, kidney, and brain cancer. Colin will talk to these in more detail.
We also announced yesterday the olaratumab antibody, which we in-licensed, has established a proof of concept as a radiopharmaceutical and will move into clinical trials. Chris will talk to you a bit more about the importance of this research and innovation that builds on our track record of identifying and successfully developing promising assets and expanding our pipeline. Finally, the transition to a cash flow positive business has continued. Importantly, we've again demonstrated that with growing revenue and expenditure control, we can fund the pipeline while also improving the financial position of the company. Next slide, please. This slide just takes you through the key financial metrics, and Darren will walk you through this in more detail shortly.
To note the key headlines, we've reported AUD 100.1 million in total revenue, which includes our US commercial sales and rest of world sales, including pre-commercial and commercial sales of Illuccix. Net operating cash flow has improved again, despite some one-off costs impacting the quarter. Our growth margin remains stable at 63%, following a period of steady improvement over the previous half. Customer seats are growing in line with commercial sales. The closing cash balance is AUD 121.4 million, an increase from AUD 5.1 million compared to the closing balance as of December 31, 2022. I'll now hand over to Chris to talk about the Illuccix commercial update.
Thanks very much, Ki, thank you for the opportunity to give you this update today. As Ki said, my name is Chris Behrenbruch . I'm the Group CEO. Moving over to slide six. I mean, I think, you know, the numbers are fairly self-evident in terms of the trajectory of our sales. We've had a strong and consistent quarter of growth. As we have seen since reimbursement began in, you know, middle of 2022, it's been a very stable growth pattern. This growth comes across all segments and includes a mixture of new customer acquisition and conversion, as well as procedure growth overall. This is clearly a market opportunity and a clinical opportunity that's growing very rapidly.
You know, this is a combination of managing our existing customer base and driving procedure volume, as well as acquiring new customers. It's a great result that reflects the maturation of the US sales and marketing team under our US CEO, Kevin Richardson, and we've invested pretty significantly in building that commercial team. This result is really reflective of the success in building and mobilizing that team. We expect to see this growth to continue. We are actively working on label expansions as well for Illuccix that will continue to help develop this exciting and dynamic market. It's, as we said, it's a really consistent performance quarter- on- quarter, and we expect to see this trajectory to continue. Moving on to the next slide seven.
Clearly, the majority of our revenue is still focused on the U.S. today, but geographic diversification is an important objective. You know, we, as Telix, almost uniquely in this space, remain committed to the global development of these products, and we continue to make significant progress. We launched Illuccix in Canada this last quarter. As we previously disclosed, we've refiled our submission in the U.K. and Europe, and have made significant strides in progressing Illuccix in APAC and Latin America. For the EU resubmission, we chose to continue and complete the decentralized procedure that we began. We've taken on board some lessons and some lessons learned and have elected to... Well, how do I say this? Work with a bigger league competent authority in the form of BfArM, which is the German competent authority.
I think we have a clear pathway forward. We understood very clearly some of the pitfalls of our prior submission, and I think the resubmission is in very nice shape. I also note that after a bit of a soft launch, we are making solid inroads for Illuccix in the home turf of Australia and New Zealand, and it's great to see local customers starting to clearly understand the differentiation and ease of use of our product. That's very gratifying. Just to summarize, progress on all fronts, in terms of global rollout of Illuccix and getting traction in other key markets. I'll now hand over to Darren Smith, Chief Financial Officer, for an update on how this commercial and operational progress has translated into our financial trajectories.
Yeah. Thank you, Chris. Turning to slide nine.
This quarter one full sleep presents Telix's second consecutive quarter of positive cash flow. It clearly demonstrates that Telix has transformed to a cash-generative business following growing a commercial revenue base while controlling investment into operations. The continual growth in sales of Illuccix drove customer receipts higher by AUD 11 million- AUD 83.2 million, a 15% increase on the prior quarter. These additional funds were invested back into the business to, one, build out Telix's commercial capability to support further revenue growth. two, make an annual payment of AUD 4.3 million for last year's short-term incentives to staff. three, to fund the investment into the development of Telix's product pipeline, including delayed payments from 2022. Turning to slide 10. Here we provide insight into Telix's financial performance in terms of sales and expenditure items.
As previously discussed, revenue from Illuccix continues to grow through the acquisition of new customers and improving volumes through existing sites. Gross margin as a percentage of sales during the first quarter has remained consistent with the prior quarter at 63%. This reflects stable distribution costs and normalized manufacturing activity. Telix continues to invest in its commercial infrastructure and resources to ensure it has the capacity to manage future growth and maximize the Illuccix opportunity and to prepare for the launch of the two diagnostic products. As a result, operational investment during Q1 in absolute terms has increased. However, as a percentage of sales, this expenditure when compared to the prior quarter has reduced thus improving profitability. Investment into R&D has been funded through our commercial performance.
This investment has been focused on to our late-stage diagnostic assets to bring them to market and the priority therapeutic programs such as the ProstACT group of studies. Turning to slide 11. This clearly shows that 2023 is off to a great financial start for Telix. This is evidenced by, one, that the total revenue in quarter one improved 27% on the prior quarter to be Telix's first quarter over $100 million. Obviously, four quarters at this level would annualize to over $400 million. two, operational cash flow was positive for the second consecutive quarter, demonstrating Telix can fund its product development activities through its commercial operation. three, the adjusted EBITDA for the third consecutive quarter is positive and growing, having improved 66% to $36.7 million compared to the previous quarter of $22 million.
This has been driven by continual growth, growing sales and costs being controlled as a percentage of revenue. Finally, Telix maintained a healthy cash balance of AUD 121 million, up AUD 5.1 million from December 31 balance. Together, these financial metrics place Telix in a sound financial position to take advantage of the opportunities that lie ahead. I will now hand you over to our Chief Medical Officer, Dr. Colin Hayward, to take you through these product development opportunities.
Thank you, Darren. Moving on from slide 12 to slide 13 now. This is our core pipeline, which you are very familiar with. It's deep and unparalleled in urological oncology as well as in brain cancer and in hematological malignancies in the rare disease space. I'll go into some of this a little bit more depth to show our clear progress in diagnostics and progress in our therapeutics as well. If we go to the next slide 14, this also shows you our research pipeline.
Our research pipeline, which really focuses in these core areas of immuno-oncology, targeted alpha therapy, the tumor microenvironment, which includes that olaratumab data that Chris is gonna touch on a little bit more later on in this presentation, also integrating with existing oncology pathways such as surgery, including technician PSMA to expand the life cycle of our PSMA portfolio as well. If we move on to the next slide 15, I want to talk about some of those milestones that we've had recently, notably renal cancer imaging with the continuation and the high momentum of the ZIRCON study going into high gear for the BLA submission.
The IND has been approved for one of the studies that's gonna look at expanding the indication both in the diagnostic setting but also potentially in the therapeutic setting as we look to see how CA-nine is expressed in other cancers. One of the combination studies, STARLITE 2, in combination with nivolumab in the second-line setting of renal cancer is recruiting nicely. If we look at prostate cancer therapy, then it's the ProstACT program of studies. ProstACT SELECT, which is this study in radiomics, is going well with completion of the initial cohorts. ProstACT Global preparing to recruit in the U.S. ProstACT TARGET is this early therapy study looking at this early biochemical recurrence. In combination with external radiation, that continues to recruit in Australia.
If we go into glioma and both imaging and therapy, and we've had a recent positive consultation with the FDA highlighting a pathway forwards for FET PET, which I'll talk about in more detail. In addition, we have the therapeutic and the IPAX-2 study moving TLX101 into that frontline, newly diagnosed, newly operated setting. We also have approval to commence the phase I therapy study in China. Rare disease, as I mentioned, olaratumab, the PDGFRα therapy, and TLX66 with manufacturing scale up so we can get ready to support a clinical trial in a bone marrow transplant indication. Next slide. On slide 16, I just want to spend a little bit more time talking about the ZIRCON results. These have been featured in a lot of medical congresses as we really drill down into the data.
The data really is spectacular in terms of a very high sensitivity and a very high specificity. What does that mean? That really means that people can use this to identify that clear cell renal cancer in a non-invasive way. As the data sinks in, we're really seeing the urologist and nuclear medicine community understanding the vast clinical utility of this agent in terms of planning for surgery, for example, diagnosing whether patients have clear cell renal cancer or not, and looking at the extent and location of that cancer. As I mentioned before, the BLA submission is progressing well, and we have an expanded access program being rolled out, firstly in the U.S. and then into other countries and regions as well.
I just wanna go into slide 17 and just talk about a little bit more, the TLX101-CDx or fluoroethyltyrosine, which is our diagnostic for glioma. Clearly, there is a high unmet need for further imaging of glioma like we're seeing now with prostate cancer, we're seeing with clear cell renal cancer with the TLX250-CDx. Here, there's a number of opportunities for FET in terms of demarcating tumor margins, for understanding grade better to help guide biopsies. Really the initial indication we're going to pursue is that in terms of the recurrence, looking for diagnosing treatment-related change. Here, MRI doesn't do a great job in terms of understanding whether a patient has true progression or what we call pseudoprogression.
We understand this is a market of around about 40,000 patients who are diagnosed with glioma every year in the U.S. that we feel is gonna be around $90 million. That is, of course, an orphan indication and, you know, a potential another orphan indication would be with PDGFR alpha, which I'll hand over to Chris to just talk about the olaratumab data.
Thanks very much, Colin. Look, just to pick up on the 101 program. You know, clearly the initial indication that, you know, we're pursuing is a modest number of patients, but there's a huge opportunity to expand the label. I think that that's a reoccurring theme across the pipeline. Colin's team is very much working on label expansion for Lu6. We see other, really important and unmet medical needs on the carbonic anhydrase nine, 250 space. Clearly there's scope to expand into other CNS malignancy applications for the brain imaging program. Just lots of room to grow across all those programs.
Turning to the next slide, you know, I just wanna have a brief conversation about the olaratumab program. As Kai noted yesterday, we put out a progress update on this program. We have now managed to transition that asset into a or completed the preclinical development and transitioned that asset into a clinical stage program. Really, this now denoted TLX300 program. When it gets to a certain level of development inside the company, it gets a TLX number. This program reflects really the kind of pipeline expansion activity that we'd like to do a lot more of.
This program is based on a drug and a target that showed a lot of potential in another form as a naked antibody, and has some really promising biology behind it for a range of cancers, particularly soft tissue sarcoma. There's a little bit of a summary here, in terms of the opportunity for STS and why it's important. I'm not gonna go through this opportunity line by line, but as an orphan disease indication, there's just a lot of potential in the radiopharmaceutical approach. I think the other thing that's important to note is the target PDGFR alpha is, you know, it's a target that's expressed in the tumor microenvironment. It has a lot of interesting biological applications, but it's also fundamentally a fibroblast target.
This is a target space, is generating a lot of interest in radiopharmaceuticals right now, particularly through the development of agents, targeting FAP. What we see is relatively little therapeutic index in targeting FAP with radiation, at least to date. A lot of potential with this particular target as an alternative approach. It's just really a very topical area right now of research, and that's why we were so keen to pursue this asset as a development prospect. Just to kind of give you a sense of what this looks like if you move on to the next slide. You can see this is slide 19. You can see some beautiful examples.
These are PET scans of a mouse model with an STS xenograft. We have now a radiopharmaceutical candidate that looks very promising, and we are progressing this to early clinical studies in the form of imaging and dosimetry in humans, and that's planned for the second part of this year. It is already factored into our budgetary expenditure for the year, so this is not an incremental, out of budget expense. This is a planned investment. You can see these images are really gorgeous and they show how well the asset localizes a radioactive payload. We are obviously exploring a number of different therapeutic radionuclides in this application 'cause the biology of sarcoma is quite complicated.
Like the rest of our antibody-based therapy candidates, an antibody-based approach delivers really excellent localization, selectivity and retention of the radiation. We're optimistic that this approach, including in combination with other therapeutic modalities, can lead to new patient outcomes in this very difficult to treat cancer. This is a target and an asset that's, you know, generating a lot of interest in the community, and it's great to be able to transition it now to clinical stage activity. Colin's team's got another really interesting clinical candidate to work with. Maybe I'll just wrap up now with the last slide 20. You know, I regularly re-refer back to the four key catalysts of the company for the year, which as you can see is that top line of balloons there.
I'd like to reiterate the key objectives for the year, that we are making great progress on. As is demonstrated by our growth in revenue and geographic diversification, we continue to march forward with Illuccix, with a lot of positive outcomes for shareholders and patients. We continue to make great progress on our key therapy program. You know, I wanna emphasize that getting the prostate global study moving into high gear this year, as well as some of the ancillary studies around it, is really the key investment priority for the team and Colin's key focus. We are making excellent progress towards our BLA submission in terms of formalized meetings established with the FDA for the pre-BLA meeting. Those are already locked and loaded.
We've had an excellent pre-NDA meeting with the FDA to review our total submission strategy for the brain cancer asset. We remain, at this point in time, confident that we can submit those two assets to the FDA this year, with a launch of those products in 2024. You know, that will of course significantly diversify our revenue stream beyond Illuccix.
Of course, the geographic expansion of Illuccix will continue to be an important part of the strategy, bringing on follow-on assets that have significant revenue potential, you know, frankly, between renal and brain cancer, we should be able to more than mirror the revenue streams that we see coming from Illuccix, and we have some significant competitive advantages that I think we can take advantage of in the launch of those products. In terms of additional milestones, whilst the smaller balloons are not the priority areas, we continue to tick them off. These do represent important milestones, in terms of patient information and patient application development, it also gives us an opportunity to more round out the pipeline and expand the core capabilities of the business.
You know, we are ticking those off as well. An exciting year ahead. I think at that point in time, I'll just summarize by saying we continue to make great progress. We're kicking goals on all of our clinical and development activities around the globe, including, I'll note, with our partners such as Grand Pharma. If you didn't see it, we have a joint upcoming investor webinar with Grand Pharma to really provide some insights into that partnership and the great progress we're making in China. You know, superb progress across the bat. I'm now happy to open it up to questions from the floor.
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. If you wish to ask a question via the webcast, please type it into the Ask a Question box and click Submit. Your first question comes from Shane Storey with Wilsons. Please go ahead.
Good morning, Shane. Thanks for taking my question. Chris, I'm gonna start with you, please. It looks like, just on Illuccix, my only question on Illuccix will be. It looks like, average scans a week probably increased from the 900- 1,200 when we sort of look at the two last sequential quarters. You mentioned an idea that the trajectory might continue. I guess anything you can help to help us disaggregate between, you know, what's happening organically with prescribers being activated and market share opportunities, that would be, that'd be, I guess, the start. Thank you.
Well, I mean, obviously, we're reporting our numbers and the competition is as well. I think you can sort of glean what the current active market share is from that. I mean, we're picking up roughly 1/3 of the market at the moment. If you consider that we launched the product middle of last year from a reimbursement perspective, it's been a pretty quick launch. The market opportunity continues to grow in terms of the number of scans on an incidence basis. Part of that is based on broader use application, you know, beyond just the kind of narrow initial, you know, indications for Illuccix that also relates to prescriber behavior. We're seeing some repeat imaging as patients go from, say, being scanned in the community setting to going to a tertiary referral environment to have an intervention.
Yeah, there's lots of places where the utilization of Illuccix is growing. As we've talked about in the past, there's that patient reservoir of proximal to biochemical recurrence where, you know, arguably a patient gets a lot of benefit from localizing disease. These are all tailwinds to procedure growth volume. We still see white space in the market. You know, there's a well-quantified number of accounts still to pick up. We are also successfully making some account conversions. You know, label expansion has helped with that. Also, the fact that the company's overall profile in urology is, you know, it's very visible right now. We've got between our clinical and our commercial team, we've got a lot of opportunities to engage with the industry.
I think, you know, our activity around key conferences has been really, you know, really supportive of that trajectory. Yeah, there's a lot of momentum. I think that it's fair to say that overall, the PSMA imaging opportunity was probably underestimated. It's gonna continue to grow, and clearly label expansion is a key focus to continue to expand it into other new indications.
That's helpful, Chris. Thank you. I'm gonna move on now. Second question is to Dan. Look, I guess given the way things are developing and starting to invest tax planning and effective tax rates as Telix moves into positive impact, Dan, just any tips and tricks you can offer to help us get that right, and our forecast would be very helpful. Thank you.
Thanks, Shane. I think from a tax issue. Sorry. From a tax perspective, obviously Telix is still in a growth and development stage. We've brought one asset to market, and it's predominantly being sold in the U.S. That product was originally, well, sorry, it was developed in Europe. There will be some balancing of, you know, where the money deserves to belong. Through that process, there are opportunities around, let's call them patent box type arrangements, that we will conform with. That's probably where we're at. We have worked with our advisors to put in a structure that's appropriate for the organization. We'll replicate that as we bring new assets to market to balance off the global position for the organization. Sorry, I'm not giving you a defined number, but I think that's probably.
No, no.
Close Monday.
No, you've told me where to look, which is, which is enough.
Okay.
My last question is really for Colin. We noticed that the U.S. component of Global is in the second half of this year now. Just wondered if you could please just run us through what's left to do there before filing an IND. As part of that, I'm wondering whether there's any intention to include the SELECT data in that filing, please.
Yeah, just to get the question, is there intent to include the SELECT data in terms of the filing? Well, you know, all information that we've got in terms of our PSMA program and our PSMA antibody is gonna go into our IND to show that. For sure. Yeah, I mean, the IND includes all the normal components of the IND, including all of that clinical data that we have that will inform the FDA so we can move forward.
The rate determining step here is then?
Sorry, the rate determining step.
Oh.
Getting the sites up and running.
Okay. Right. That's all I had. Thanks. Bye.
Maybe if I could just make a note, Shane, we're not talking. I mean, it's not a material delay. It is a small delay.
Your next question comes from David Stanton with Jefferies. Please go ahead.
Good morning, team. Thanks very much for taking my questions. I guess, you know, we've seen a very strong growth trajectory in the U.S. for Illuccix in this quarter. Sorry to start with an Illuccix question, but, you know, can you give us sort of an idea of, you know, just broad brush this kind of level of trajectory in terms of volume for the rest of calendar 2023? Is that what What should we be thinking for the U.S. for 2023, please?
I mean, we haven't given forecasts yet, I mean, I suppose every quarter we end up reiterating that. There will become a point later in the year, David, where we'll go into more of a forecast mode, but obviously it's the early stage launch of a product. I think we'd like to get a couple of more quarters of sales under our belt. I think the cleanest and most appropriate way for me to answer is we don't see any abatement of opportunity. You know, we are, you know, we're picking up a lot of new customers every month. We are making some customer conversions. We are working with customers to look at how we drive volume. We're clearly engaging with referral physician base as well.
I think, you know, over the course of the year, the impact of our, of our marketing strategy will really become apparent. I think that the strong quarter that we've just had, does reflect that. That's really a pivot towards articulating our clinical differentiation. When we launched Illuccix, you know, we were second to market, and so we had to focus really on product availability and guideline equivalency. Over the last 12 months, we've sculpted, you know, a very compelling clinical differentiation, approach, which is, you know, gallium PSMA. You know, there's significant evidence to support the statement that gallium PSMA has the best sensitivity and specificity, particularly at low PSA levels, has a significantly lower false positive rate than competing fluorinated products.
You know, we are able to explain with reference to the clinical literature, that you know that there is a difference between the two. You know, we don't have to go out and explicitly make that education. There's a wealth of literature out there, and our customer base is well-versed. You know, they approach us to discuss, you know, why gallium PSMA-11 has advantages for them, and we're pleased to be able to provide that product. I think it's, I think that, you know, talking about clinical differentiation is obviously, you know, a positive direction for the company in terms of, of how we, how we position Illuccix in the field.
Understood. If I could change tack to TLX250-CDx. You mentioned you've got, you know, an upcoming meeting with the FDA, and you talked to revenues. You just talked to revenues in calendar 2024, potentially from that product in the U.S. Would it be fair to say that, you know, it's gonna probably take about six months to get reimbursement approval as it did with Illuccix? Therefore, we should be thinking probably, you know, third or fourth quarter calendar 2024 before we see significant revenues out of that product in the U.S.?
Well, I think there's a lot of understanding now in the urology community of what PET imaging, what molecular imaging can do for urology. We you know, the pharmacoeconomic benefit of the 250, of the renal imaging program is really even more profound than that of the prostate cancer program. I mean, it addresses a much more immediate and pressing medical need. I think we've done, through the clinical trials and the outreach and the conferences and the patient advocacy groups, I think we've done a good job of educating the customer base or potential customer base about what the prospects are. I mean, I think we've gotten great coverage in key academic environments.
You know, one from a launch perspective, you know, the customer, the referral customer for the 250 program is very much overlapping with Illuccix. The investment that we've made in the sales team is an investment we expect to be able to repurpose once the renal cancer program launches. I think the ramp-up can be quite fast. Obviously, yes, to your point, reimbursement makes a difference, but, you know, there's a great opportunity to start generating revenue coming out of the gate. The reimbursement process, you may or may not recall, but it's actually quite compact. There's clear entry points four times a year for pass-through approval. You know, the approval process takes roughly a quarter. There's not a huge...
You know, assuming that we meet all the criteria for reimbursement, which, you know, based on the clinical data we would expect to, there's not a great impediment to the reimbursement process moving ahead. It's a pathway we've gone down before. We have a fairly good understanding of it. We think that we're engaging effectively from a guidelines perspective, starting to build that clinical case of why it should be included in practice guidelines. There's a lot of momentum for that. I don't think we need to be too pessimistic about the proximity to reimbursement once the product has a license.
Understood. Final question from me, for Darren actually. I know, Darren, that the company's starting to talk about adjusted EBITDA, and it's, you know, got a very impressive trajectory as we can see on slide 11 there. I'd just like to sort of understand a little bit more about potential costs or expenses for F-23 in terms of what should we be thinking. Should we be thinking that, you know, it's basically a reasonably fixed cost in terms of management and admin and employment costs and potentially for R&D costs for the rest of calendar 2023? Should it increase in line with revenue growth, or is it reasonably fixed? Thanks.
It's a good question, David. It probably depends on the category that we're talking about. So just taking R&D, like obviously we've got a plan there that we're progressing towards in the amount of work that we need to do over the coming 12 months. You could probably almost put that in that relatively fixed basis. Obviously there's some discretion around timeframes and what we progress at what point. Obviously there's a focus on the core group of activities which we've already spoken about in that last slide.
Mm-hmm.
That's R&D. In regards to admin and sales, typically you'd say that it was more of a fixed level, and you build that to manage your organization at a certain level. Obviously, when you have a reasonably rapid trajectory, there is a need to be constantly reviewing that and building to ensure that you don't disadvantage that growth trajectory. I think the other item that you need to overlay on that is the fact that we've got two diagnostic assets that we're in the process of going to the regulatory authorities or the FDA to get approval for, and we need to start to prepare to have the capacity within the business to be able to manage that commercial launch and be successful with that. There's no point gimping on your costs to...
at the risk of damaging your future revenue streams. Having said that, obviously we're still focused on making sure that we can continue to fund the business sustainably and we'll invest in an appropriate level to achieve all the objectives that we have.
Under-understood. Just to paraphrase quickly before I jump off. Management admin reasonably fixed, R&D reasonably fixed, but employee costs in line with, you know, a new, a potential new drug coming to market, maybe somewhat more variable.
Yeah. Some of those costs in admin are not so much admin, but from a sales marketing perspective, we still need to invest into to get that traction in the market. It's not just employment costs. Yeah.
It is. I mean, it is incremental expenditure, David.
Yeah.
It's not, you know, it's not doubling the cost of.
Yeah.
of our SG&A. It is incremental.
Understood. Thank you very much, team.
Your next question comes from Yuan Zhi with B. Riley. Please go ahead.
Hi, this is Brandon Carney on for Yuan. Congratulations on a successful quarter, and thanks for taking our question. Just one from us. Just to kinda expand on some of the things you mentioned already, with answering the first question, we're just wondering if you could give us any more color on the breakdown of different types of patients currently getting scanned with Illuccix, and if you see that changing as sales continue to ramp. Basically, how many are initial staging versus recurrence versus patient selection for radioligand therapy. Thanks.
Yeah. We haven't given that breakdown. Probably at this point in time, there isn't a ton of value in putting that information out there 'cause obviously it defines the competitive segments that we operate in. You know, there's a pretty good delineation between the different hospital segments and those different indications, or at least on a sort of predominance basis. The radioligand therapy I can comment on. You know, we were pleased to have the label expansion and, you know, to be able to support Pluvicto patients to the extent that gallium PSMA is required. You'd be aware that there are some supply chain limitations right now.
I think that that's an indication that we'll likely ramp up over the latter part of the year. Doesn't represent a major component of sales at the moment, but we certainly see that there's some momentum that's starting to build there. It'll have a more meaningful impact towards the back end of the year.
Okay. Thanks for the call and thanks for taking our question.
Pleasure. Thanks for joining.
Your next question comes from Dennis Hulme with Taylor Collison. Please go ahead.
Good morning, Chris. Congratulations on the result. Just one question from me. You've previously commented that you expect to see the PSMA PET mark in the U.S. largely fully penetrated by the end of the year.
Mm-hmm.
Can you give us a little color around that? Does that have implications for potential sales growth over the next two years, next couple of years after you get to the end of this year?
I think we've, I mean, we've talked about the sort of the three major, kinda commercial, you know, inflection points that we have coming up. Clearly, on a growth trajectory that we and others have, at some point in time, we're gonna hit that kind of theoretical market size and, you know, clearly, patient referral patterns and some off-label use and some clinical trial uses is obviously driving volumes beyond that. At some point in time, it's gonna taper off. That's just on a strict account-by-account basis. The sort a phase II that we see coming in now is more around national accounts and group purchasing organizations where there's some opportunities there to move larger amounts of customer around.
That's kind of gonna be a phase II and it absolutely represents, you know, if we execute on that well, that represents a growth strategy, and that's clearly something that we and others are focused on making happen. The third, the third stage is really the label expansion going into the end of pass-through. You know, the two or in our case, three indications that we have for Illuccix is not the end of the story. As you know, we see that there's value in PSMA imaging along the entire continuum of patient care. On a, on a strict incidence basis right now, we're somewhere between I don't know, 1.3 and 1.5 scans per patient.
There's the clear potential, there's clear clinical rationale for that to go up to five, six, seven scans per patient over the life of the journey, and that's gonna drive volume. You know, one can see the potential for, you know, even a multiple of scans of where we're at right now in terms of the current label scope. The flip side to that is that the economics of the imaging agent will have to change to accommodate that. You know, at the end of 25, we're gonna have, you know, in the current regulatory legislative environment, we're gonna have the end of pass-through, which means that it goes away from being reimbursed as a standalone radiopharmaceutical to a bundled procedure.
We've seen in cases where there's solid clinical evidence that the price erosion that results is modest. We've seen in cases where there isn't a great deal of clinical evidence that, you know, that has been a deeper price erosion. Fundamentally, there'll be a trade-off at that point in time between procedure volume and product economics. I think it's gonna be, you know, broadly positive. It's interesting to me how misconstrued pass-through is. Pass-through is not the business case for an imaging agent. Pass-through is an accelerant or a buffer from an NPV perspective to make the investment case easier for a diagnostic imaging agent, because it enables us to recoup some of the investment costs up front. Obviously, the investment cost in Illuccix was very modest.
I mean, the ROI on Illuccix is a spectacular ROI. Clearly for some of the follow-on products like the TLX250 program, where there's a higher investment because we've had to do things like run a phase III trial, you know, pass-through is a great tool for accelerating the IRR on that investment. I'm very optimistic about where the field is gonna go. There's plenty of scope for expansion. What it's gonna come down to is, you know, an ongoing commitment to customers, making sure that we're servicing our customer base flawlessly. I think Telix has a massive advantage there through our partner pharmacy networks in terms of product availability. We continue to co-collect excellent clinical data that shows our differentiation and the utility of the product in all kinds of new application areas.
You know, the third is really that long-term understanding of how will Illuccix align with that continuum of cancer care beyond just these very early in the disease journey, utilization. I think there's plenty of room to grow and maneuver. You know, As this becomes a mainstream modality and gets entrenched into clinical care, we're gonna see lots of new opportunities.
Great. Thanks for that. Thanks very much for taking my question.
Thanks, Dennis. I see that cleans off the list of questions online, unless the moderator has some other questions that have come in.
No, we're right, Chris.
Okay.
People to ask.
Well, look, I think I'll just wrap up then and just to say thanks very much for the attendance. As said, with the 4C, the focus is primarily on the financial results, we'll continue to provide shareholder updates on our progress for the programs. It's really an exciting year for the company, and it's great to be able to show the progress. I'd like to thank my colleagues for joining me and wish everybody a terrific remainder of their day in the U.S. and the beginning of their day here in the Southern Hemisphere. Thank you.