Good day, and thank you for standing by. Welcome to Telix H1 2023 financial results and business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press Star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.
Thank you, Maggie, and thank you everyone for joining us today. We're here to discuss the half-year results that were lodged with the ASX yesterday evening, yesterday evening, Australian time. As mentioned, I'm Kyahn Williamson, and I'm joined today by Christian Behrenbruch, our Group CEO and Managing Director, Dr. Colin Hayward, our Group Chief Medical Officer, and Darren Smith, our Group Chief Financial Officer. Today, as usual, we'll be taking you through the presentation that was lodged on the ASX, and which you can see on the webcast display here. For those joining by phone, we'll give a verbal cue for each slide change and then open the call up to, to Q&A. Just move to the next slide, please. I just want to start by making a note, Slide 4, of the remarkable journey we've been on over the past 12 months.
You know, at the first half last year, we just launched our product, Illuccix. Following this very successful launch, we are making progress across our therapeutic programs in the clinic. We're really making a meaningful difference in the lives of thousands of patients every week and bringing to fruition our vision to be a global leader in theranostics and precision medicine. It's this strong sense of purpose and patient impact that drives all of us at Telix, it's also underpinned our very rapid transition to a sustainable revenue-generating business. Next slide, please. The results we present today really show strong improvement across all of our key metrics and importantly, show the underlying profitability of the business.
We're demonstrating a commitment to cost control while funding the development of our late-stage programs, including regulatory filings and scale up to support the launch of two new diagnostic imaging agents. The significant improvement in our overall net loss position does include a non-cash adjustment to provision for future payments based on Illuccix sales, again, reflecting that really strong performance. Darren will talk through that further. Next slide, please. The operational highlights for the half demonstrate that not only are we delivering to the growth strategy that we have laid out for our investors before, but we're laying a foundation for future value creation. Chris and Colin will talk to our outlook for the PSMA PET imaging market and our lead product, Illuccix. The progress we're making on regulatory filings for our brain cancer and renal cancer imaging agents.
We've also made some excellent progress across our core therapeutic programs, including ProstACT, with Global now open for enrollment at our first APAC sites and the readout from the ProstACT SELECT study fast approaching. We continue to drive innovation, and we've added some exciting new aspects to the portfolio through acquisitions during the half. I'd now like to hand over to Darren to talk you through the financial commentary and key results.
Thanks, Kyahn. Telix's June 2023 first-half financial results present a sound financial position. Following the commercial launch of Illuccix in April 2022 and receiving reimbursement in July 2022, Illuccix revenue has had sustained growth over the 15-month period since launch. In the US, which represents 95% of Telix's global revenue, Telix's commercial team, with the assistance of our distribution network, has driven revenue growth by acquiring new sites and focusing on improving volumes through existing sites. This has been the key driver to increasing global sales to $220 million for this first half of the year. This is an 820% improvement from the first half of 2022, in which the launch of Illuccix occurred, and a very respectable 62% improvement from the prior half.
It's also pleasing to note that the rest of world revenue improved 50% compared to the first half last year. In Europe, we have seen increased kit sales ahead of market approvals. Following regulatory approvals of Illuccix in Australia and Canada, we are seeing the early stages of growing acceptance and use of Illuccix in these markets. Telix will continue to pursue opportunities to expand our geographic footprint to assist with the growing the top line. Turning to Slide 9. Here we provide a comparison of the last three consecutive halves, outlining Telix's improving financial performance over a significant revenue growth period of 15 months following the launch of Illuccix. This has culminated in Telix delivering its first positive half-year adjusted EBITDA of AUD 34.7 million, being a AUD 41.7 million improvement on the prior half.
On the prior slide, I talked to Telix's revenue performance. Obviously, this has been the key driver to significantly improving the gross margin. It is worth noting that this increasing sales volume is assisting Telix to realize manufacturing efficiencies, improving gross margin as a percentage of revenue from 50%, from 66% in the launch half to now be 64% this half. Telix manufacturing team will continue to implement incremental improvements in the production of Illuccix. Look, looking to the expenditure categories of the income statement, it is evident that Telix is actively driving growth on the top line by continuing to invest in building out the infrastructure of the organization. This investment across people, general selling and operational expenditure, and the provision of resources and services supporting our current product development activities.
Currently, Telix's R&D investment is predominantly focused on delivering two new revenue streams by progressing the activities that support the filing of a BLA for the renal cancer diagnostic and the NDA for our brain cancer diagnostic. Looking to the bottom line of the income statement, Telix did report a statutory loss before tax of $12.3 million, being a $58.4 million improvement on the first half of 2022. It is important to note that this statutory loss for the first half includes a $36.6 million non-cash remeasurement of provisions. For details of this remeasurement, I would refer you to note 12 in the interim accounts. In short, this adjustment reflects a significantly improved performance and outlook for the sales of Illuccix, thus requiring a larger projected burnout of the acquisition of the product.
If not for this adjustment, Telix would have been reporting its first statutory profit before tax of approximately AUD 24 million for the half year. Turning to Slide 10. Telix continues to demonstrate improving financial metrics, having built out a sustainable business. As it can easily be seen in the graphs on the right-hand side of the slide, that gross margin has improved significantly since the commercial launch, being 64% for the first half of 2023, reflecting the normalized operating conditions.
Despite increased investment into SG&A to build out our commercial infrastructure and capabilities, as a percentage of revenue, it has reduced dramatically from 120%, 166% in the launch half at the beginning of 2022, then reducing to 36% in the second half of 2022, to now be 26% of revenue in the first half of 2023. This, coupled with the improved gross margin, has enabled Telix to self-fund its current research and development pipeline. Now turning to slide 11, and the adjusted financial metrics of EBITDA and EBITDA. For these two financial measures, I refer you to note 3 of the interim financial reports released last night. Basically, the adjusted EBITDAR graph reflects the operational profit performance of the commercial Illuccix business over the last three half periods.
Clearly, the strong growth in revenue and improved gross margin, a focus on controlling and reducing expenditure as a percentage of sales, has delivered half on half improvements of 128% to $82.4 million, representing a 37% return on revenue. The adjusted EBITDA graph simply reflects the Illuccix business performance, less the investment into the development of Telix's pipeline. Again, this measure demonstrates improved earnings performance and the fact that Telix is able to fund its current research and development pipeline through its commercial Illuccix operations. In summary, Telix is financially sound with an improving commercial performance, a growing revenue line, and a respectable cash on hand balance. This will ensure that we can fund the activities to deliver two new revenue streams and progress our ongoing clinical development program. Chris, I'll hand over to you.
Thanks very much, Kyahn and Darren, good evening everyone from Telix's U.S. headquarters in Indianapolis. If we can move to Slide 13, please. I'm I'm reliably of shareholders that play drinking games every time I use the word excited to describe our work at Telix, I know perhaps that explains our share, share price volatility over the last quarter. However, it's fair to say that we're delighted with our half year results and the really stellar progress the company has made year to date. I think that's very much reflected in the financial summary that Darren has just presented. This slide, this slide summarizes the mission for 2023.
As you've just heard from Darren Smith, we had a strong first half of sales, there's clear evidence that this growth and performance will continue into the second half of the year. I will talk about Illuccix more specifically in a minute. In terms of preparing for the company's future, we set down really fundamental groundwork this past six months or so on our two follow-on product submissions, which we are on track to file in the United States in Q4 of this year. We've had really good interactions with the regulator, we believe that we have a clear pathway forward for those two products, revenue streams to significantly diversify in terms of not only the follow-on geographies for Illuccix, I'll talk a bit more about that in a second, but truly delivering a de-risked multi-product company.
The other significant inflection point that's coming is the formal launch of the ProstACT Global phase III trial, as Kyahn mentioned in her opening comments, patients into the study any day now, and the IND package to expand the study into the U.S. is in good shape, with Europe and possibly a few other jurisdictions to follow on next year. We're certainly committed to running that trial as expeditiously as possible. Illuccix has drawn the majority of the attention from investors to date, but the big value creation and valuation uplift, we think, has yet to come and will be the result of becoming a validated multi-product diagnostic and therapeutic company. As I always like to say, Illuccix is just the beginning. It's the launch pad of the company.
The big value, we believe, is in our therapeutic pipeline, and Colin Hayward will discuss our progress in more detail a little bit later in this presentation. If you can move to the next slide, please, Slide 14. Back to Illuccix. You've already had the financial snapshot from Kyahn and Darren that captures most of the high-level information. However, we wanted to elucidate a bit more detail and help you with the really spectacular growth in this business. As you can see, the revenues have grown very rapidly since we got reimbursement in July of last year. The second half of last year was our first full reimbursed half, and we are, we are up over 60% for the first half of this year. That is serious growth market share. Our growth has come from both new accounts and deeper penetration into existing accounts.
We've had very little customer attrition and a whole lot of wins, including some real success stories of capturing major customers from our competition. We believe that the market is buying into our positioning around both supply chain superiority as well as clinical differentiation, which I will talk a bit more about in a moment. The best evidence that I can offer of this is that our customer mix has considerably matured and evolved as we have picked up larger luminary hospital accounts. We've had a notable uplift in the percentage of doses that are servicing government payers. That's really part of that maturation of, and, you know, clearly, government payers have a different pricing structure than commercial payers, but noting that pricing has overall been very stable in the last six months. There are different contracting pricing tiers between government and commercial payers.
The reason why I outline this is because notwithstanding the very, you know, top line, very strong top-line financial growth, revenue top line doesn't actually tell the whole story of just how well we've done. In dose volume terms, the growth has actually been quite a bit higher. Slide 15. Next slide, please. When we launched Illuccix a little over a year ago, we launched with the messaging that our last mile strategy of nuclear pharmacy-enabled delivery would result in superior uptime and more reliable and flexible scheduling. We've certainly delivered this, with a 99%+ customer delivery track record. It's a differentiation that our customers really believe in and they value, and it's an important competitive differentiation going forward as we see other entrants into the PSMA imaging space. You know, we feel very much that we are unique in this differentiation.
However, as the market for PSMA imaging matures for the current set of indications, noting that guidelines continue to evolve, and Colin Hayward and I are going to discuss this a little bit more later in the presentation, our competitive marketing strategy is pivoted to focusing on our clinical differentiation. This is not only a message that many of our customers believe in from actual firsthand experience, but is backed up by peer-reviewed science and changes in practice guidelines that increasingly spell out this differentiation very unambiguously. There's simply no confusion about this. Our message is simple: Gallium gives more reliable and accurate results than F18. This is a statement that, based on scientific literature and our own clinical experience, we believe is applicable to the entire class of F18-based agents.
This is an important development for the field, it's an appropriate development, and the patients are not overtreated on the basis of false positives. It's a good development for patients. Moving on to the next slide, please, Slide 16. The evolution of Illuccix and its message of clinical superiority comes at an important time. We are focused on expanding the global reach of the product beyond Australia, New Zealand, Canada, and the United States. We currently have filings in progress in 29 European countries, the U.K., Korea, and Brazil, with Japan and China in progress, including a launch of a phase III bridging study in China. It was a bit surprising that we needed to do that, we think it's a market worth prosecuting. You know, we're with our partners, Grand Pharma, we're prosecuting that very aggressively.
We believe that this will not only help us to diversify our revenue stream for Illuccix, but also there is a significant financial and strategic reward in supporting global pharmaceutical companies that are running urology trials using PSMA, an increasingly common, commonplace practice. We really feel that our mission to delivering our products globally is something that differentiates us from our competition and puts us really in the front line of relationship preference with big pharma. Moving on to Slide 17, please. The Illuccix story doesn't end with the current three indications for high-risk men, biochemical recurrence and patient selection for radionuclide therapy. As we rapidly gain clinical experience through a mixture of routine use, investigator-led research, and company-sponsored trials, we are also seeing significant guideline evolution happen in parallel.
The consequence of this guideline-driven use of PSMA imaging for repeat imaging, patient follow-up, and longitudinal assessment of disease progression is that there's a really big explosion in the use of PSMA that we believe will have a pretty nice impact in the relatively near- term on the potential addressable market. Moving on to the next slide. Elaborating this a little bit further, you can see on this slide the sort of generally accepted addressable market that is associated with the current product label scope. The guideline evolution, largely related to, you know, fairly sensible patient management and well-established clinical use, significantly extends the potential market from about $1.5 billion-$1.6 billion to well over $2.3 billion for the U.S. market, I think with a similar growth and opportunity on a scaled basis globally.
This bodes well for the continued growth of our business over the next couple of years. There's a lot more happening clinically down the road. I will now hand over to Colin Hayward, Telix's Chief Medical Officer, to give you some key insights. Colin, over to you.
Thanks, Chris. If we could go to Slide 19, then, you know, beyond those areas where we've just highlighted that Illuccix has been used, and the guidelines, which are rapidly moving, have been shown to use, there's a large number of other areas for potential for Illuccix and PSMA imaging. If we look right at the beginning of that patient journey, for patients who have a potential diagnosis of prostate cancer, monitoring those patients and having a virtual biopsy by imaging, and I'll go into some of the data that shows this, and potentially opening up the active surveillance population to benefit from Illuccix. Surgical planning, we've already seen data published on this in terms of, you know, being able to minimize the surgery and maximize the side effect profile so that patients really can preserve their neurovascular bundles post-surgery.
Talking of treatment planning, it's not just surgery, it also goes into some of those bigger studies from the early to late disease studies, where PSMA PET is being used not only to detect and part of the entry of those studies, a bit like the ARISTOTLE study, but also continuing to monitor their response and progression at regular intervals after they are being entered into the study. In fact, in that study, PSMA PET imaging is the primary endpoint. In addition to therapeutic surgery, we also have radiation therapy, and PET, PSMA PET imaging is being used to guide radiation therapy in a number of areas, including our collaboration with RefleXion. Of course, PSMA isn't just prostate specific.
There is expression in the neovasculature of other tumors as well, there is potential to extend into non-prostatic disease, such as hepatocellular carcinoma, for example. If we go to Slide 20, people are seeing the application in their daily management of patients. People are really seeing this, urologists, oncologists, that's why we're seeing this rapid transition, this rapid uptake in guidelines and expansion in guidelines. If we see this, this PSA graph that we like to show as part of the prostate journey, those dark blue indications are there, are our current indications. We can see where going from the very beginning of a diagnosis for monitoring active surveillance, all the way to monitoring response to radioligand therapy, there's potential to be used all the way through that patient journey, and the data's there.
If we go to Slide 21, we can see this 291 patient study, the PRIMARY study out of Australia, leading to a second PRIMARY 2 study. Really, these are patients who are planned for a biopsy. They haven't yet had a biopsy, but they're imaged with gallium PSMA, and then they have a biopsy, and we can see how well that image correlates to the presence of disease. Being able to identify patients who have clinically significant disease or not, is a real, real opportunity to not only add information to existing MRIs, but potentially to avoid biopsies for patients in the future. If we go to Slide 22, we know that working with leading-edge technology providers like uEXPLORER, we can see that we can image very quickly, but also image very small disease.
Not only are we detecting disease with a very high sensitivity, we're able to increase the number of patients that are going through the scanner as well. If we go to Slide 23, we can see our holistic overview in urologic oncology, which I'll just turn over to Chris again, just to comment on.
Yeah, thanks, Colin. I appreciate it. great summary and also a nice reminder, really, of how aligned and integrated, you know, our, our products are from a, from a, a continuum perspective. This, this is really nicely illustrated in this, in this graphic, showing our end-to-end commitment from initial diagnosis and staging through intervention and into providing decision support for metastatic disease. We believe with our product portfolio and key bolt-on acquisitions, acquisition for AI and Lightpoint for intraoperative solutions, Telix can become a one, one-stop shop for urology and, and really claim our market share. This commitment to urology is well recognized by our customer base, who value this vision as much as we believe in it. Colin, back to the data around the development programs.
Perfect. Let's skip Slide 24, that's an introduction, and go to Slide 25. It's the product line overview, which you're all familiar with, but I want to just reinforce not only that commitment to GU oncology, and the rare disease, the orphan indications in terms of glioblastoma, glioblastoma and bone marrow conditioning, but also just to emphasize for each of those diagnostics, there's a therapeutic that's advancing, and we have some real significant and tangible advancement in each one of those therapies and seeing ourselves as a therapeutics company now. If we go to Slide 26, I'll talk you through some of the clinical development highlights within there. Let's talk about the CA9 program, obviously, with girentuximab, based on the excellent results of the ZIRCON study. Well, we have some imaging studies with the ZIRCON, so expanding the regional application, of zirconium girentuximab.
Also the OPALESCENCE and STARBURST studies, which are imaging studies, but will show the expansion of CA9 as a potential therapeutic target in multiple indications. The OPALESCENCE study is in triple-negative breast cancer study. The data for this has been submitted to the next San Antonio Breast Cancer conference. Looking forward to hear whether that is accepted or not. The therapeutic ones that are ongoing here, the STARSTRUCK study, the first patient in has occurred there. This is a combination with pepasertib, the Merck KGaA agent, a DNA damage repair inhibitor, in both a renal cancer and a pan-tumor CA9 expressing set. The STARLITE study, STARLITE-2, is recruiting, it's in its final dose escalation cohort. The STARLITE-1 study is, you know, really exciting.
It's in that, it's in that first-line renal cancer in combination with the checkpoint inhibitor nivolumab, but also with cabozantinib as well. Let's talk about prostate cancer therapy and where we've advanced there. We have the ProstACT SELECT study. 30 patients have been dosed fully there now, we're having a readout of that in the last quarter of this year. As Kyahn touched on, the ProstACT phase III study will be open, is open, in fact, and is dosing imminently in Australia and New Zealand with progress to the global U.S. IND. Glioma, mainly in terms of the therapeutic studies here, get moving forwards. We have the IPAX-2. Patients have been recruited for this in this second dose escalation phase I. Reminder that this is in earlier disease stage in the original IPAX study.
It's in that post-surgical population. They're following up with the IPAX-LINS investigator study, which is recruiting extremely well, is in the recurrent setting. The IPAX China, again, is another therapeutic study in startup as we speak, and looking forward to announcing the first patient very soon. Just to touch on some of that bone marrow conditioning with TLX66, and other rare disease, where we have the uliratuximab. This is the acquisition from Lilly. The proof of concept study, looking to progress to the first-in-human studies later this year. We're making good progress there. Also preparing our Australia site for a phase II study of TLX66 in AML, as well as launching the investigator study in pediatric leukemias in the UK. If we go to Slide 27, I just wanna go back.
I, I did briefly mention the ZIRCON study and the fantastic, and unprecedented results, really, in terms of sensitivity, specificity, and a reminder in terms of the consistency of that reading. We're making progress there with the regulators, having had that initial meeting with the FDA and, you know, continuing to, based on their feedback, progress with the regulatory submission. Part of our pre-launch tactics is the expanded access program, making headway in Europe and the U.S. Most recent data, I wouldn't be the Chief Medical Officer if I couldn't just present the data, that was at the most recent Congress, right?
At the SNMMI, very pleased to see that some of this data on extrarenal lesions, some patients, at the option of the investigator, are allowed to have full body scans, and a number of those were detected to have extrarenal lesions, even in this very early renal mass disease. That certainly supports the feedback that we're hearing and the potential clinical utility in terms of monitoring patients with high-risk disease, all the way, like PSMA, to detecting metastatic disease in the long term and potentially response to therapies. If we go to Slide 28, I touched on the ProstACT SELECT study. What was this all about? Well, look, it's a study really looking at the tumor targeting of Gallium PSMA to Lutetium PSMA, Gallium PSMA being a small molecule, our Lutetium rosopatamab, TLX591, an antibody.
Showing that we can utilize the pair, the theranostic pair for patient selection, as well as determining that whole body dosimetry for TLX591. Really showing that tumor targeting of the antibody, because if we go to Slide 29, we know that small molecules leave the body very quickly. We know with small molecule therapeutics, something like 70% of the activity is lost within that first 12 hours. Here, you can see that Gallium PSMA image on the far left and on the far right, or even the, the, the 5 images after that, are all SPECT images of a patient who's been dosed with the TLX591 Lutetium PSMA antibody. You can see that there's very good correlation on those tumors. Those little black dots all over that patient's skeletal system in particular, are tumors from the prostate cancer.
You can see that even two weeks out, there's still activity within each of those tumor sites, and that's what makes, you know, using this as an antibody approach very exciting for me. You can also see, if you're really good at analyzing images, that there's no salivary gland uptake of the antibody as well. That's gonna get over that salivary gland toxicity that we see potentially. On that, with that exciting data, I'll hand back to Chris to summarize.
Thanks, Colin. Hopefully, that overview gives shareholders a perspective on the depth of our clinical activity. We are making excellent progress, and we're very fortunate to enjoy a high degree of opinion leader engagement around our programs as, as Colin has suggested. We're also grateful to the amazing patients that have supported these programs to generate this exciting, impressive data. To summarize where we're at in the year and to provide insights into upcoming, this slide provides a comprehensive snapshot of what 2023 is about. It's gratifying to see that at halfway through the year, we're also about halfway through our goals for the year, including some pretty big accomplishments in terms of core objectives, but also some, you know, pretty important deliverables as well.
The second half of the year, we'll continue to see revenue growth through a deep new customer pipeline, as well as both the continued operationalization of our clinical trials and the two new drug approvals that are pending. I look for- or two new drug submissions that are pending. I'm looking forward to coming back to you in six months' time and showing a full set of deliverables. On that basis, I will now hand it over to questions.
Thank you. We will now conduct the question-and-answer session. As a reminder, to ask a question, please press Star one one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one one again. Please stand by as we compile the Q&A roster. Our first question is from David Stanton from Jefferies. Please go ahead.
Good morning and good evening, team, and thanks very much for taking my questions. Greatly appreciated. Look, mine are basically for Darren, if that's okay. I wonder if he could give us an update on, you know, expected R&D spending in F 2023, in F 2024 as a first question, please.
Oh, hi, David. I think it, as we reported back in, Q, sorry, Appendix 4C, we reported that.
Darren, you're breaking up. your, your audio is not very clear. David, I'm not sure what's happened to Darren's audio.
No worries. No worries.
Maybe while he's working out his head... Items on 2024 yet, although we've always said that, our R&D expenditure will be consistent and in line with our ability to grow the business.
Sure.
I think the, the expenditure in the first half is in line with our prior guidance of around AUD 100 million of R&D.
Great.
We have incurred a bit more expense, as Darren said in his comments, around manufacturing scale-up and readiness for the BLA and the NDA submission, but we see that as commercial pre-launch expense. We don't see that as R&D. In terms of real R&D expenditure, you know, that means clinical trials and outsourced R&D, it's in line with prior guidance.
Understood. Thank you. Second and last question, again, if Darren's there, that'd be great, but if he's not, we can take it offline.
Sorry.
second half, management and admin expenses, you know, should we think that, that that's basically in line with, with first half? If that's the case, we're gonna see some decent operating leverage in the second half if growth continues. Thank you.
Are you there, Darren?
I am back online. Sorry about that.
Good man.
Had a little bit-
All right, well, then I'll let you answer that one.
What we are expecting, obviously, we still need to continue to progress the development of the organization, so we will have further expenditure. We also do need to prepare for, you know, the launch of 250-CDx and 101 as we progress with those regulatory approvals. We need to be ready for that, so we will continue to invest, let's say, before the, before the curve. However, I still believe that there is leverage within the balance sheet, but at this point in time, given the development activity we need to do, say, if you focus more on the percentage of revenue as opposed to the actual absolute dollar, that would be more appropriate.
Yeah, I mean-
Understood. Thank you very much.
Maybe, maybe if I could add to that, I mean, I think, yes, so we will continue to pre-prepare for market launch, but that's a, as we've talked about in the past, that's a, maybe that's a 10%-15% increase in cost. That's not a, not a doubling down of costs, so it is incremental. Also, you know, we have, we've, we've got this, you know, one-time effect, that we've, we talked about and, and that, you know, impacted our, our profitability in this quarter. You know, clearly going forward, we've got a much better understanding of what the growth curve looks like.
Thank you very much.
Thank you. Just a reminder, to ask a question, please press Star one one on your telephone keypad. I will now hand back to Kyahn. Thank you.
Thanks. We just have a couple of final questions coming through. A question for Chris or Colin: Why have you commenced enrollment of the ProstACT global study before finalizing the protocol with the FDA?
I mean, I, you know, I don't know if you wanna take that, Colin. We have actually had multiple interactions with the FDA, we are working on the basis of a single harmonized protocol. I'm not quite sure I fully understand the question, but just to be clear, we do have a finalized protocol. It's the same protocol that's being used in all jurisdictions. Colin, do you want to add anything to that?
No, I think, I think we've been pretty clear in our pathway for the protocol. It mirrors very much, the ProstACT SELECT protocol in terms of that. You know, it's, it's clear in terms of the patient population we're going. There's clear precedent in other Lutetium PSMA agents, but also in other, therapeutics as well, coming into this area. I, I think we're fairly clear and have got some great feedback over the, last, you know, months and, and years from the FDA.
Yeah.
Just one more question. With the, with the data on Slide 21, are there any plans to use this to expand indication for Illuccix? Question for Colin.
Let Se just... Yeah, the Slide 21 is the primary data. This is, you know, generated not from our research, but there's certainly a group that we would love to collaborate with and expand. You know, this is clearly indicative data that we can use Illuccix as PSMA imaging in the active surveillance setting.
Kyahn, do we have any other questions online?
One final question. Is there any update on the launch date for Illuccix in Europe?
Yeah, I'm happy to answer that question. You know, all of our, our submissions have been received and validated by the European competent authorities that we've submitted to on the decentralized submissions. That's 19 countries. We're just doing the Q&A backwards and forwards on the package. Obviously, most of those regulators have seen the package before, so I think that, you know, we, we feel that we've got a pretty good handle on, on where things lie. That Q&A will go backwards and forwards on various clock stops between now and the end of the year and, and into the early part, but right now, it's, it's really, that submission is just progressing as expected.
you know, we've indicated that we're, we're expecting to get approval in Europe towards the back end of the first half of next year, and that, that remains on track as, as far as we can see today. It's, it's been quite a straightforward process so far.
Thank you. We have no more further questions. I'll hand back over to you, Chris, for some closing remarks.
Well, great. I, I think, you know, just to keep it succinct, we appreciate everybody's time. A lot of new data presented in this in this half-year update. Hopefully, the progress that's being made clinically is very evident. The expansion and the opportunity for Illuccix continues to grow, so this is something that we're focused on in terms of in terms of label expansion and the opportunity to develop new indications for the product. You know, and overall, the field is really going gangbusters at the moment. It's a very interesting time to be involved in the theranostics space, and clearly, a lot of commercial potential for our pipeline. You know, very delighted with the results, and thank you for your time and attention today.
Thank you. This concludes today's conference call. Thank you all for participating. You may now disconnect.