Telix Pharm Ltd

Good morning and good evening everybody. My name is Kyahn Williamson, SVP of Investor Relations and Corporate Communications at Telex and it's my pleasure to welcome you today to our H1 2026 interim results presentation and call. You'll have seen our documents lodged on the ASX earlier this morning. Next slide please. Today on our call we'll be joined by Dr. Christian Behrenbruch, Managing Director and Group CEO, Darren Smith, our Group Chief Financial Officer, Kevin Richardson, CEO of the Telex Precision Medicine business, and Dr. David Cade, Chief Medical Officer. Following prepared remarks, we will open up the call to Q&A, starting with calls on the conference line. If we don't get to your questions during the call, we'll respond to you after the call is finished. Just move to the next slide, please. Brief notice that please note that today's presentation includes forward-looking statements including within the meaning of the US Private Securities Litigation Reform Act of 1995 that relate to, among other things, anticipated future events, financial performance, plans, strategies and business developments. These forward-looking statements are based on current information, assumption and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those containing forward-looking statements. These and other risks are described in our filings with the ASX and SEC, including our half-year and annual reports. You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. Please refer to the disclaimer slide included in the presentation accompanying this webcast for further information. With that, I'd now like to hand over to Chris.

Thank you very much, Kai. Good morning and good evening, everyone. Before I go into our strategic priorities for this year, let me take a moment to remind everyone about our competitive advantages and what it takes to lead this field. We are a pure play radiopharmaceutical firm and our strength is based on five core pillars of activity. Firstly, our therapeutic pipeline is highly differentiated and built around significant unmet medical need. We're advancing innovative therapies in areas that have seen little to no innovation for decades with either first-in-class or best-in-class candidates. Our portfolio is diversified with multiple shots on goal, further de-risking commercial success. We've also built in-house R&D capabilities that enable us to develop and optimize both targeting agents and their radioactive radioisotope payload, tailored to the specific biology of each disease. As we've said many times before, we are agnostic to the targeting agent and radioisotope. We let science guide these decisions. We are not wed to a narrative around a specific platform or approach. Earlier this year, we announced a collaboration with Regeneron that combines our expertise in radiopharma with Regeneron's leadership in biologics and antibody engineering. This highly complementary partnership positions us to accelerate the development of next-generation candidates and really puts us in a good place to lead in the therapeutic space in the future. Our precision medicine business is our third core pillar that's generating close to a billion dollars in revenue and enables us to reinvest this significant capital into the business to continue this growth trajectory. The precision medicine business has enabled us to establish a presence across global markets where we continue to strengthen and guide our clinical activity. We've built a specialist commercial organization, a team that represents some of the strongest talent in the industry and is our fourth core pillar in differentiating us from competition. We've invested and continue to invest in our manufacturing and supply chain capabilities. The RLS transaction last year has significantly strengthened our control over the entire value chain from production and quality assurance to the final dose delivery. It's brought us closer to the customer, enabled us to meet growing demand, and positioned us well to deliver therapeutic solutions down the road. Earlier this year, we shared three areas of focus and I wanted to show the progress we're making against them. On the commercial front, we delivered approximately $390 million in precision medicine sales, up 27% year on year. This is driven by the successful launch of Gazelix and continued growth of Ellucix. We are now tracking towards the upper end of our guidance Very close to a billion dollars in revenue. On the regulatory front, we've completed the submissions for PixClara and PixLumi in both the U.S. and Europe, with a PDUFA date now assigned in the U.S. of the 11th of September. In terms of zircaics, we received a corrected complete response letter from the FDA, and the resubmission process is tracking against agreed timelines with the agency. We're putting the final touches on the package and ensuring that the resubmission fully addresses all outstanding items before filing, particularly third-party manufacturing deficiencies. And this, of course, remains one of our top priorities for the year. On the therapeutics front, we've advanced three phase three candidates with full alignment with the FDA on part two for TLX591, our prostate cancer therapeutic, and started dosing patients for the other programs. And David will go into this in more detail later in the presentation. The bypass biopsy phase three study is close to completing the targeted enrollment. The study has the potential to significantly increase the market and change the treatment paradigm in prostate cancer. And Kevin will share more on this game-changing program later in the presentation. Next slide, please. This slide illustrates our growth since 2024. As you can see, we've continued to develop the business, doubling the revenue since the first half of 2024. and delivered approximately 22% year-on-year growth, really eclipsing the growth of peer firms and recent financial results. We've demonstrated market leadership with two approved and reimbursed products, strong market penetration and continued commercial execution. This really shows that our strategy works. The strategic transactions and R&D investments we've made are starting to pay off. The acquisition of RLS has also, as I've mentioned, further diversified our revenue streams and allowed us to maintain a stable third-party revenue stream since the acquisition of last year. We are committed to building out full product suite capability of RLS as an independent pharmacy network, including third-party product solutions that benefit from one of the most capable distribution networks in North America. As our global footprint has grown, so has our manufacturing and distribution network. This is particularly important in the field of radiopharma where the half-lives and shelf-lives products require just-in-time manufacturing and a highly specialized supply chain to avoid disruptions or delays to patients. Last year we expanded manufacturing and distribution capabilities in the U.S. and Japan, and these are investments that are critical to establish the foundation for a scalable infrastructure in the future. This year we also opened up our new translational research site in Melbourne. The site offers an integrated platform housing R&D and patient care under one roof and is designed to accelerate the development and delivery of Theranostics through rapid de-risking and proof-of-concept development. And this is really a capability that's unlike any other found elsewhere. We continue to make CapEx investments at various sites including CNEF, Yokohama, and at RLS. where we're building out the manufacturing capabilities for therapeutics delivery, very important clearly to our next phase of growth. This includes increasing cleanroom capacity, installing cyclotrons, and making sure that the RLS network is equipped and licensed to do things like dispense lutetium therapeutics drugs. With that, I'll hand over to our CFO, Darren Smith, who will provide an update on the financials. Over to you, Darren.

Thank you, Chris, and hello, everyone. Moving to the financials for the first half of this year, We reported revenue of $477 million, up 22% compared to the first half of 25. This was achieved through robust commercial execution that delivered strong demand on our precision medicine products. Kevin will speak to this later in the presentation. EBITDA improved 146% year-on-year to $52 million, and net profit after tax was up to $38 million, reflecting strong business performance in continued control of operating expenditure. Our R&D investments represented 26% of our revenue, focused on accelerating near-term growth opportunities and developing our late-stage assets. Gross margin for our precision medicine business was 65%, an improvement of 1% year on year. We also successfully increased our cash balance to $252 million for the refinance of our convertible bonds, a successful transaction with better terms. We are well-placed with the financial capacity to accelerate growth. Next slide, please, and turning to our income statement. As previously mentioned, we delivered double-digit growth both on the top line and the bottom line of our group P&L. Gross margins for the consolidated group improved 2% to 55%. This was supported by our strong growth on the top line and we continued our healthy investment into our product development pipeline with a focus on near-term commercial opportunities and phase three clinical studies for a number of our therapeutic candidates. At the same time, we have maintained a disciplined approach to managing our operating expenditure, reducing it by 1% as a percentage of sales. Next slide, please. Moving to our thank you diagram, this clearly illustrates how we generate our funds and how they flow through the business. On the left side of the chart, it shows that in the first half of 2026, Telex generated revenue and income of $523 million from our precision medicine business, CMS, and Regeneron Collaboration. The middle sections of the chart show that after covering cost of sales, OPEX, and finance costs, Tealix reported a commercial profit of $153 million, a 29% return on revenue and income generated, demonstrating the strength of the business. I want to reiterate that we have a highly profitable business with strong cash generating capabilities. But as we have said many times, rather than maximising near term earnings, we are reinvesting capital into growth opportunities that will drive long term shareholder value. We continue investing our earnings into the business for the remainder of this year and the next year. From this financial position, and as illustrated on the right side of this thank you graph, we have made a decision on how much we invest into our R&D development and how much we bank as profit. Again, I cannot overstate the importance of the investment we are making today and the significant value that will drive in the long term. Next slide, please. A precision medicine business continues to deliver double-digit growth, up 27% year-on-year from our differentiated products. Both Ellucix and Gazelix continue to drive strong demand across all market segments. Kevin will comment on this later. Gross margins of 65% improved 1% year-on-year, driven by a disciplined pricing and manufacturing and distribution efficiencies. R&D investment increased year on year driven by PixClara, Zikaix and Bypass investments that will drive meaningful commercial uptake near term. As Chris mentioned, we are significantly expanding our market across our portfolio, including prostate cancer imaging with Bypass, brain metastases imaging from PixClara and Renal Mass Imaging with Sakaics. Overall, that is in excess of one million scans that our customers will meaningfully benefit from. EBITDA grew 26% year on year to $132 million. While we expect healthy EBITDA growth to remain, we remain committed to reinvesting the capital into the business in our pipeline, as I've mentioned earlier. Now moving to TMS. CMS generated third party revenues of $89 million, up 10% year on year by RLS. Since the acquisition of RLS, we have maintained a stable base of third party revenue, further diversifying our revenue streams. We have also successfully been driving manufacturing and supply chain efficiencies for RLS by selling a higher proportion of our own assets through them. Internal revenues of $57 million improved 70% year-on-year, representing the Lucex and Gazellex distributed for RLS. This means RLS is now our second largest distributor of our products. We also continue to invest in our manufacturing sites at CNEF, Yokohama, and selected RLS sites to ensure the global readiness to deliver our precision medicine and therapeutic candidates. Next slide, please. Our full-year revenue guidance of between $950 and $970 million is maintained for 2026. We do, however, expect that to land at the upper end of the range. And we expect continued growth in excess of 20% year-on-year of our precision medicine business. Please note, our full-time guidance does not reflect unapproved products, providing the potential for upside. We updated our R&D guidance to a range of $230 to $270 million, primarily reflecting new investment across the development program discussed today, as well as our collaboration with Regeneron. Given the strength of our commercial business, we believe that we are well positioned to support and accelerate near-term growth. I'll now hand you over to Kevin Richardson, Precision Medicine CEO.

Thank you, Darren. First slide, please. As we've talked about before, we've continued to grow our PSMA business through a very pragmatic strategy focused on clinical differentiation and customer economics. We launched our two-product strategy to address the different needs of our two major customer segments, and that's proven to be the right approach. As a result, we've now delivered growth every quarter, with our strongest growth rates coming in the two quarters following the launch of Gozelex. That performance has enabled us to increase both unit share and revenue share for the 16th consecutive quarter. In the second quarter, we delivered $202 million in revenue, up 9% quarter over quarter, following $186 million in the first quarter, which was up 16% quarter over quarter. Those results reflect not only our continued market demand, but also strong execution by our commercial, operational, and customer-facing teams. The launch of Gozelex has been very successful. Demand was strong from day one, and the adoption we've seen reinforces that our two-product strategy is delivering exactly what we've intended. More importantly, it positions us well to continue innovating in the PSMA market with programs such as Bypass and Outfloor as we expand our ability to meet the evolving needs of physicians and patients. At the end of the day, demand for our products comes down to a few things that we work on every day. We meet customers where they are. We provide a high level of service and reliability. We clinically differentiate our products. We make them easy to order. We deliver on time, every time. We maintain a consistent pricing strategy and we invest heavily in education around both the science and the reimbursement of PSMA imaging. That combination continues to matter. Our PSMA imaging agents have demonstrated fewer indeterminate bone lesions and higher intra-rheator agreement compared with F18-based agents, giving physicians greater confidence in clinical decision making. When you combine that with the clinical performance and operational reliability and strong customer support, it continues to drive adoption across the market. Next slide, please. Moving on to global expansion. We continue to execute well internationally with our PSMA portfolio now launched or initiated across 24 countries. At the same time, we are making progress in two of the most important pharmaceutical markets in the world, China and Japan. In China, we submitted our NDA earlier this year and are awaiting review by the NMPA. In Japan, we've completed enrollment in our registration enabling study. One of the fastest recruiting studies of its kind with more than 100 patients enrolled. We are now preparing our NDA submission while also awaiting feedback on conditional approval, which could support an accelerated path to market. These are important milestones because China and Japan represent two of the largest pharmaceutical markets globally and significant opportunities for T-Lix over the long term. More broadly, Our international expansion strategy is about much more than near-term diagnostic revenue. Every market that we enter allows us to build relationships with regulators, payers, physicians, and health systems while establishing the commercial and operational infrastructure we need for future therapeutic launches. In many ways, the precision medicine business is creating the foundation that will support the broader T-Lix portfolio for years to come. Next slide, please. Moving on to PixClara and Xercaix, our two most important near-term launches. Starting with PixClara, we've made significant progress over the last several months. As you've heard, we've been assigned September the 11th PDUFA date in the United States and have also submitted PixLumi in Europe. In addition, PixClara has now been included in both NCCN and international clinical guidelines, further validating the importance of this imaging agent and the needed addresses. With the regulatory submissions behind us, our commercial, medical affairs, market access, and supply teams are launch ready and positioned to move quickly upon approval. What's particularly encouraging is the feedback we're receiving from the market. Our research continues to indicate strong physician interest and a high level of awareness of the unmet need. We're also in continuing to expand the opportunity for PixGlera. Earlier this year, we announced an IND submission in brain metastasis an indication with a substantially larger addressable patient population than our initial target indication and one that further demonstrates the platform potential of these assets. Now turning to Xerkaix. As a potentially first-in-class radiolabeled biologic to reach the market, it underscores both the significance of this imaging agent and the substantial unmet need in clear cell renal cell carcinoma. Importantly, our confidence in the opportunity remains unchanged. Zyrkaix has received breakthrough therapy designation and fast track designation. It's supported by strong Zircon clinical data package and is increasingly recognized within major international clinical guidelines. As a result, Zyrkaix remains one of our highest strategic priorities for 2026 and we remain fully committed to bringing this product to patients. So when you step back, Both PixClara and Xerkaix are first-in-class imaging agents addressing areas of significant unmet clinical need and further strengthening T-Lix leadership in precision medicine imaging. Xerkaix is particularly important as the first radiobiologic imaging agent to help establish a regulatory pathway for this emerging class of products, creating opportunities not only for T-Lix, but the future of molecular imaging more broadly. Next slide. Moving on to the current state of the PSMA market. Today, the PSMA imaging market is over 600,000 annual scans and is estimated to be approaching two-thirds penetrated. The majority of scan volume is concentrated in biochemical recurrence, with initial staging represent the second largest indication. We also have approval for patient selection for patients receiving radioligand therapy, although this remains a relatively small contributor to the overall scan volumes. and we've discussed previously there are opportunities to continue expanding utilization through guideline updates, increased physician adoption and additional clinical evidence and treatment response or monitoring indications. However, those opportunities are largely incremental and not expected to fundamentally change the size of the market. So while we continue to see growth and market expansion, the current PSMA market remains primarily driven by biochemical recurrence and staging. which together account for the majority of scans performed today. Moving on to bypass. Bypass has the potential to fundamentally change where PSMA imaging is used in prostate cancer journey. Today, most PSMA imaging is performed at initial staging following biochemical recurrence. Bypass could move PSMA imaging to diagnosis bringing it to the very beginning of prostate cancer diagnosis, which has the largest patient population. And if successful, we believe bypass could approximately double the existing PSMA imaging market by creating a new pre-biopsy market segment for T-Lix PSMA. As we've discussed before, approximately 800,000 prostate biopsies are performed annually in the U.S. with roughly 75% proving negative. Bypass has the potential to reduce unnecessary biopsies while improving confidence in patients who ultimately proceed to biopsy. In addition, up to 200,000 patients delay or decline core needle biopsy each year because of its invasive nature. We believe patients are increasingly seeking less invasive approaches to prostate cancer diagnosis when supported by strong clinical evidence. But importantly, our confidence in bypass is supported by primary and primary two studies, which demonstrated that PSMA PET combined with MRI improved prostate cancer detection and showed the potential to reduce unnecessary biopsies. Strategically, bypass is important because it has the potential to anchor T-Lex PSMA at the beginning of the patient's prostate cancer diagnosis. If a physician adopts Bypass, we believe they will increasingly prefer to use the same PSMA imaging agent throughout the patient's cancer journey, from diagnosis through staging, reoccurrence, and ongoing monitoring. Consistency of imaging and interpretation becomes increasingly important as a patient's move through the continuum of cancer care. That's what makes this opportunity so compelling. Bypass doesn't simply expand the market, it has the potential to redefine and redistribute it. Through scientific innovation and clinical evidence, TELIX has the opportunity to create and lead a new category of PSMA imaging in the pre-biopsy setting, possibly displacing the existing indications over time. Advancing science that reduces unnecessary procedures, reduces risk, and increases patient outcomes is true market leadership. And with that, I'll hand it over to our Chief Medical Officer, Dr. David Kage.

Thanks, Kevin. What a great opportunity. Next slide, please. Well, this is our pipeline slide. And as you can see, our two primary areas of focus are within urologic and neurologic oncology. Within urologic oncology, we have our two late stage programs in prostate and kidney cancer, but also follow on alpha therapy candidates in earlier stages of development. Looking at neuro-oncology, which is our other key area of focus, this is a field in which new drug innovation has really largely been stagnant over the past couple of decades. Here, against that background, we have a Phase III candidate, TLX101, that's shown promising data to date, as well as an alpha therapy candidate utilizing astatine, also in early development. Within our other tumors domain, we're exploring different targets, including our TLX400 candidate, targeting fibroblast activation protein, or FAP, that's expressed within the tumor microenvironment across a very broad range of tumors. And therefore, this asset has pan-cancer potential. I'd like to also briefly mention the imaging agents and how we think about these. So for every therapeutic candidate, we develop and Imaging Agent. And in many cases, these are true theranostic pairs. With imaging agents developed at the forefront, we generate significant clinical data before making additional investment decisions in the corresponding therapeutic program. So by the time we advance a therapeutic candidate, we've already developed a strong understanding of its bio-distribution and its selectivity for the intended target. which significantly addresses the level of risk in the therapeutic development pathway. Let's go to the next slide, please. On this slide, I wanted to highlight a few programs that we're focused on and where we've made significant progress through the first half of this year. Starting with Prostate Global, this is our phase three candidate for metastatic castrate resistant prostate cancer. We recently announced that the FDA had completed its review of the safety data from part one of the study and that we've also fully aligned with the FDA on the protocol design for part two of the study. So essentially our next step is to amend the IND that we have and align the regulatory submissions for the US with the European Medicines Agency. Outside of the United States, we're also pleased with the progress we're seeing in part two of Prostac Global. We're currently enrolling patients in seven countries and we look forward to providing an update on the pre-planned interim analysis of radiographic progression-free survival, which is the primary endpoint, when that becomes available. Remembering that this is a milestone, it's event-driven, in other words needing 81 disease progression events to trigger this first analysis. Now before I move away from prostate cancer, I'd also like to highlight TLIX597, our next generation small molecule candidate that's shown some promising early data. We presented some of that data earlier this year, demonstrating a very low radiation dose to the salivary glands and the kidneys, while at the same time delivering a high dose to the tumor. So this favorable dosimetry profile, high to tumors and low to normal tissues, makes it an ideal candidate in the early metastatic hormone sensitive prostate cancer setting. There are currently two Phase II studies ongoing where enrolment is completed in optimal PSMA in metastatic castrate-resistant prostate cancer and we've now also started dosing patients in optimal E in metastatic hormone-sensitive prostate cancer. We're also advancing TLIX90 in a Phase I study for the palliation of bone pain from skeletal metastases that occurs in patients with very advanced disease. TILIX-90 I think fits very well within our urology domain given that most patients with metastatic prostate cancer will ultimately develop bony metastases. Now moving on to IPEX BRIGHT, this is our phase three study in glioblastoma. This study is evaluating TILIX-101 in combination with the chemotherapy agent Lomustin and it continues to progress well. We're currently dosing patients in the first cohort which commenced at the highest If the combination demonstrates an acceptable tolerability profile, we'll advance into the expansion cohort to further characterize the safety of this combination. Now moving on to Luteon, this is our monotherapy study for renal cell carcinoma using a CA9 or carbonic anhydrase 9 targeting antibodies. Luteon is being run under a phase three protocol in Australia and it forms part of our global development program for T-Lex 250, which also includes the phase two Luteon Atlas study in the United States and Europe. We've advanced this study through its site activation and it's begun dosing patients. and lastly I wanted to highlight the collaboration we entered into earlier this year with Regeneron. Now this partnership builds on our well established expertise across radiopharmaceutical development and it reflects our shared commitment to advance the next generation of candidates with a focus on alpha therapies. We believe that we're uniquely positioned to drive innovation in this emerging field, that's alpha therapies, and to have the opportunity to play a leading role in the future of precision oncology. Let's move to the next slide, please. Now, this is a slide you may have seen before, but I believe it's valuable to describe how we are thinking about the therapeutic cascade across the continuum of prostate cancer care. 2x591, as I mentioned, uses a radio antibody drug conjugate to deliver the therapeutic payload. It has a long tumor retention with limited radiation exposure to healthy organs, as well as a convenient two-dose regimen that really facilitates its combination together with a backbone of standard of care. This candidate is well-suited for the first-line and second-line metastatic castrate-resistant prostate cancer settings. which is a more advanced disease state that may benefit from a therapy with a more convenient dosing regimen that better enables it to be layered on top of the ongoing use of a standard of care backbone of therapy. Now moving to TLIS597, our small molecule candidate. This is a highly targeted next generation small molecule radioligand therapy which has demonstrated the highly favorable dosimetry profile I talked about earlier, which really makes it uniquely positioned for use in earlier metastatic hormone sensitive prostate cancer where efficacy while maintaining quality of life in that early stage of disease is of utter paramount importance. We believe the preliminary data are compelling and we look forward to providing an update on the various trials once their data are sufficiently mature. As patients' disease will almost always progress, we're studying the use of an actinium-based alpha therapy, TLX592, in the later line setting, as we view that alpha therapies are sequential to beta therapies at this point in their development, so after beta therapies. Now, finally, our portfolio approach also captures our bone pain palliation candidate, TLX90. As I mentioned earlier, when cancer is metastasized to the bony skeleton, in most cases, it results in pain and a significant degradation in quality of life. We see pain palliation as an equally critical component in late cancer care. And with that, I'll hand back to you, Chris, for some final remarks.

Thanks very much, David. So to conclude, we entered the year with a strong line of catalysts. and at the halfway point, the list has expanded quite a bit. This is a significant and impactful year for the company for sure. We continue to successfully navigate the regulatory processes and advance our programs with two near-term launches. And as I said earlier, Zyrkaix is a top priority to us and will be refiled very soon. We have three pivotal therapeutic trials that have generated readouts and continue to advance towards important upcoming clinical and regulatory milestones. and you can expect plenty of clinical touch points in the coming months. We have a strong pipeline of new assets advancing behind. These are assets that have generated some very compelling data as David has outlined. Our international expansion is progressing well and remains a critical component of our strategy to establish the needed infrastructure for future therapeutic launches and overall I believe that we're in a strong position with positive momentum across the business and multiple important catalysts ahead in the second half of the year. I also wanted to note that we'll be hosting an R&D day in New York on September 22nd, where we'll provide an overview of our pipeline assets and go into a bit more detail around the data. In addition to having our management there, you'll get an opportunity to hear perspectives from leading key opinion leaders in the space. So we're really excited to showcase all the progress we've made over the last 12 months, and I'd very much like to acknowledge the efforts of my executive team who internalized some of the setbacks we've had last year and really rewired the way in which we approach our developments and clinical activities. Before we move to Q&A, I'd like to take a moment to thank my colleagues and all of our employees. Their dedication, hard work, and commitment every day are what enables us to advance our mission of delivering life-changing treatments to patients. And so with that, I'll hand it over to the operator for Q&A.

Thank you. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. and 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. As stated previously, if management do not have the chance to answer your question today, they will endeavour to do so after the call. Your first question comes from Chris Cooper from JP Morgan. Please go ahead.

Chris Cooper, JP Morgan Good morning, Chris and team. Thanks for taking the questions. I guess market share has been an important factor for you this year with the PSMA imaging portfolio. We now know that TrueView has the reimbursement code coming into effect on the 1st of October. Just your latest thinking on how you expect that market share development to progress through the balance of the year, please, given that.

Well, we don't really see, we don't really expect a huge amount of impact, unlike Gazellix and Ellucix, which are really a, you know, these are two very different products that are delivered simultaneously to the market. Based on the information that's been put out into the public domain, TrueView's really been positioned more as a manufacturing improvement, and as a consequence, it'll be a product that will have to get rolled out across all segments of the market. rather than be a market segmentation strategy that we've undertaken with our two-product strategy. So we haven't modified our guidance. Our guidance bakes in what we think is going to be the realistic outcome for the year, and really nothing has changed from our perspective. I don't know, Kevin, if you want to add anything.

I would just add that we see it as a similar product, and our approach to the market has been very pragmatic, and we manage that. across kind of all segments. And we believe that the two product strategy was the right one and has proven to be very successful for us. And so we'll continue that. Thanks, Chris.

Thank you. And second one, please, just on the ZOKEX, I guess. I mean, good to see the extension was granted, although probably a bit disappointing it was necessary. You say you're making good progress, and I think you just said there, Chris, the resubmission is going to happen very soon. I presume that means now the next couple of months, but we've also been assuming that for a while. How much of that is within your own control at this stage? All of it. Okay. And so it's correct to assume the resubmission should occur in the next month or two?

That would be a reasonable assumption.

Thanks for taking the questions.

Thank you. Your next question comes from Laura Sutcliffe from Citi. Please go ahead.

Hello, thank you for taking my question. I have one on the bypass trial, please. I think target recruitment was increased for a second time earlier this year, which we understand is because there was a need to increase the statistical powering of the trial. Is that right? And if so, could you tell us a bit more about what motivated the need for the increased powering?

I think there's been a lot of chatter about statistical powering, and it's not something that we've spoken really openly about. When we started the trial, there were a number of design assumptions, and as the trials matured, so too has our approach been to recruitment. Actually, the most interesting dynamic of the study was that we had a huge amount of uptake. We rapidly onboarded A lot of sites, and in fact, the trial essentially recruited in five months, which I think is about the fastest study. And so because of the backlog of patients that we had in the study, we actually elected to fulfill the backlog. So it's not as simplistic as a statistical plan or a statistical analysis. It's more about the dynamic of the study itself. I don't know, Dave, if you want to add anything to that.

Just really all I would add Laura is that it was a very close and I think collaborative dialogue with the FDA. The FDA understands the background of the primary and the primary two studies that came from Australia and they were large multi-center but investigator initiated trials generating data not ultimately fit for an FDA filing So the FDA really understands that background, and BYPASS is an industry-sponsored study that builds on those studies with agreed endpoints, an agreed statistical analysis plan intended to support a regulatory filing, as Kevin has so nicely articulated. Yeah.

Hopefully that answers your question, Laura.

Thank you. And then just to come back to the KX, I heard the comment you made in response to Chris's question just now about resubmitting in the next one to two months. Does the extension that you have from FDA come with any specific timeframes or deadlines? And is its existence a consequence in any way of the corrected CRL that you received, which seems to say that the regulator failed to consider some CMC data that you submitted a year or so ago? Or are they unconnected?

They're unconnected. There wasn't any additional actions that came out of the delayed CRL. That was an administrative matter on the FDA side. So from our perspective, nothing really changed. And just to be clear, there's been a lot of chatter about deadlines and dates or something, but we're not quite sure where this really comes from. There's nothing that's restricted us from, you know, for being flexible on the date of resubmission.

Okay, thank you.

Thank you. Your next question comes from Andy Shea from William Blair. Please go ahead.

Thanks for taking our questions and congratulations on continued solid commercial execution. Two macro questions, if you don't mind. One, maybe against the backdrop of your comment on being modality agnostic and the Regeneron collaboration. There's a pretty animated, I would say, discussion at the ASCO radiopharma session about antibody modality, mostly on a negative perspective. So I'm curious, Chris, if you can kind of opine on, you know, that or rebut against that. Secondarily, Lanthea is, I guess, in the process of being merged with Curium.

and I'm curious just against that backdrop do you see a difference in terms of your strategy or kind of continue you know everything as planned thank you I think for the first question data always speaks for itself and I think that the rebuttal I mean since you were there at the ASCO session you know that the rebuttal from the floor was actually pretty vibrant as well so I think Nuclear medicine has a history of being developed on budget-conscious academic environments where there's no ability to even consider experimenting with a biologic. And so there's a lot of prejudice there that isn't driven by data. It's really driven by capability. And I think that exists to the present day. At the end of the day, what we care about is what's the pharmacology of the drug, how does it interact with the target, how does it deliver a payload, and we obviously wouldn't be investing money into programs when we have an agnostic approach if we didn't feel that there was a merit to doing so. So I would encourage anyone that's interested in debating that further, come to our R&D day, and that would be the That would be the place certainly where we can go and do a deep dive on that, perhaps rather than an investor half-year results call. I think regarding the second question, it'll be disappointing not to have a competitor reminding us of their 2% growth compared to our 22% growth on their earnings calls. But I'm not sure that that's something that we'll miss as a comparison and contrast. It sort of mystifies us a bit why you would bother acquiring a company with such a flat growth outlook. But apparently, maybe it's a European mentality or something. I don't know. But nonetheless, we kind of see it as business as usual for us. And it'll be interesting to see what happens in the future, you know, in the space.

That's very helpful. Thanks Chris.

Thank you. Your next question comes from David Dai from UBS. Please go ahead.

Great. Thanks for taking my questions. Also congrats on the quarter. I just want a couple of questions actually on bypass studies. Seems like enrollment is going very fast. Could you provide some early feedback from physicians, enthusiasts, some of the studies so far? and what successful outcomes would look like for that study.

Dave, that's your wheelhouse. You want to pick that one up?

Yeah. We were pleasantly surprised, you know, this study, multicenter international trial, but essentially international means United States and Australia, multiple sites across both of those countries. The first site was a site in Melbourne. It kicked the study off. That's where we got the Ethics Committee approval first before we got the IND and the IRB approvals to open the sites starting in Texas and then expanding in the US from there. But what pleasantly surprised us was the site in Melbourne almost had the study done and dusted by itself. They enrolled a very significant proportion of patients and we didn't tell them to slow down but What that showed was that there's clearly a very significant physician desire to add the benefits of gallium PSMA PET imaging on top of MRI imaging because they believe from their experience on study that it furnishes the clinician with more useful information about whether to biopsy or not if to biopsy, what type of biopsy to do, a template biopsy or an image-directed biopsy. And so the treatment planning can be done with a lot more certainty for the patient. So that early experience and that rapid enrollment rate typically, classically, will tell you something about the investigator's feelings towards the clinical performance of the asset under study. and that then propagated when we were able to open the study at the sites in the U.S. and as Chris said it enrolled within about five months for the total sample size of sort of 350 odd patients.

I would just add that our lead investigator for the U.S. is going to be at the R&D day as well to talk through that so it would be a good time to hear his opinion about your question.

I think that answers your question. Thank you.

Thank you.

Next question.

Your next question comes from David Stanton from Jefferies. Please go ahead.

Morning team and thanks very much for taking my question. Just one from me. Can you give us sort of an update in terms of potential timelines for PixLumi in terms of the marketing authorization application has been accepted? When might we hear a decision on that, please?

Look, we haven't really given updated timelines because there's some early review of the package that can lead to clock stops and stuff like that that we haven't sort of crystallized. So I think that's more of a watch and wait at this point in time. If you follow the review timeline to the letter from submission, it's around an 18-month process. It can go a little bit faster, a little bit slower, depending on clock stops and review times. But that's sort of the standardized approach. I don't think there's anything in our submission that's particularly controversial, and we're not expecting any major issues. I think when we submitted the PixLumi package, we had the benefit of having had it reviewed by a major regulator already. And so when we submitted it, it was with a high degree of confidence in the package that we were putting forward. So we'll certainly be keeping you updated on timelines. Do you have another question, David?

No, that's it. Thank you very much.

Thank you.

Thank you. Your next question comes from Melissa Benson from Barron Joey. Please go ahead.

Morning team, thank you for taking questions. I just had two. The first one is just to clarify something on David's comments around Prostact Global and the progress there. So you had the successful June FDA meeting we heard back there around part two. Have you now filed, I guess, the formality of the IND amendment paperwork? So we're kind of on track for US sites this half. And then similarly, you mentioned European progress. Last year you talked about a clinical trial application over there, the European regulator to review that for the same thing for European sites. So just any update on whether you've submitted kind of a CTA for them to review?

Yeah, I can answer that very quickly. We had a, the review of the Part 1 data from Prostac Global was sort of treated as an end of Part 1 meeting rather than a pre-Phase 3 meeting. So we have one more engagement coming up with the FDA in a couple of weeks time and then we'll be filing the IND on the back of that. That's just a standard process as we go into part two just to finalize the full scope of the IND amendment that we plan to submit to the agency and it's just courtesy to have that pre-submission meeting. So we consider that to be sort of fairly much part and parcel from a regulator engagement perspective. Regarding the European submission, our priority really has been to get U.S. patients into the study this year, and once we're over the hump with that on the U.S. side, then we'll turn to a broader focus. I do note we have EuroSphere jurisdictions already in the study, U.K., Turkey, but we'll add some other European countries that are keen to be involved in the study once the FDA submission is in. Do you have another question?

I did have one other, and this was actually on revenue guidance. So you've kind of maintained the 950 to 970, but noted that you're on track for the top end. I guess the question just being like, there was a lot of strength in the second quarter, particularly in the Pearson APET franchise. And if we infer that into the second half, it kind of It suggests that you should already be, you're definitely on track, albeit above and I think consensus is now sitting above. So is that conservatism on your end to kind of not upgrade and move the guidance range or are you kind of factoring in anything in the second half or that we should be kind of aware of dynamically around seasonality or even like the Lantheus TrueView launch?

We've given guidance and we're maintaining our guidance.

Okay, thanks. Thank you. Your next question comes from Dennis Hulme from Taylor Collison. Please go ahead.

Thank you. I've also got a question about bypass. If we assume if the trial results are positive, two questions. Can you talk about the label claim that you expect to ask for bypass? And secondly, if it is approved, how do you see it being used? We saw in the primary two trial that There's definitely a strong benefit in patients who have a PI-RADS score of 3 or less. Do you think that use is likely to be targeted in that patient population at least initially or do you see a scope for it to be used more broadly including in patients who have higher PI-RADS scores?

I'll let Dave comment on the clinical utility. We don't typically give label guidance until we've negotiated a label with a regulator. but obviously the spirit of the the spirit of the study is to help guide decision making around biopsy utilization and so that will be the sort of context of the label and I think there's a lot of misunderstanding the goal of the study is really to make sure that the right patient gets a biopsy it's not about eliminating tissue it's not about taking away the value of pathology in cancer diagnosis but it's really about making sure that very large proportion of patients that do have a biopsy, the ones that aren't going to benefit from it, the ones that come back with unequivocal or negative findings, that those are the ones that are not being subjected to a fairly unpleasant and expensive procedure. And Dave, do you want to add anything in terms of the PI-RADS question?

Yeah, I will. Yeah, thanks, Dennis. Good question. So like I talked earlier about the agreement that we came to with the US FDA in terms of the Design of the study and the patients who would be enrolled. So we agreed with the FDA that it would enroll PI-RADS 1, 2, 3, and 4, but not 5. PI-RADS is the 1 through 5 scoring system that a radiologist uses to score the MRI scan. So the PI-RADS 1 is not commonly seen in a 65-year-old man. A PI-RADS 1 is typically a A younger adult male, you know, 20s, that has an absolutely normal prostate. And PI-RADS 5 is prostate cancer. Now, what we did agree with the FDA was even though we don't need to enroll PI-RADS 5, you know, the FDA would consider the totality of the data and would consider that it covers all of those PI-RADS scores. Just at a high level, what the study is going to enable in terms of clinical implementation post-approval is the objective of halving the number of prostate biopsies that need to be done or that are required to be done. So halving the number of biopsies while not missing patients with clinically significant prostate cancer that then need to have a biopsy done. So obviating the need for biopsy in half the population of patients that currently get biopsy and then In the patients that do require biopsy, taking it from a template biopsy which is between 12 and 20 needles placed transperineally through a very sensitive piece of real estate to one targeted biopsy. We say none and done, you know, obviating the need for a biopsy in half the population that today would get biopsy, or one and done, shifting template to a single targeted image-guided biopsy. That's the purpose of bypass. And in doing so, we believe that there'll be very significant clinical uptake, that it will become standard that PSMA PET scan is done as well as an MRI scan before anyone has a biopsy. Does that help, Dennis?

Yes, thank you. That's very helpful. And if I can ask just quickly on TLX597, can you just talk about what you think the next step will be for 597 after the Optimal PSMA and Optimal E trials?

Yeah, we're waiting for really the first chunk of data to read out. I mean, our priority right now from a prostate trial perspective is clearly to complete the recruitment of 591. It's our major program and our flagship program. So, you know, we've got some data to read out from the first phase two trial. And we're, you know, we're really looking forward to reading that data out. And then once we've got that in hand, that'll inform That'll be the catalyst to inform the market about what our plans are longer term for that asset.

Thank you very much. That's all from me.

Thank you. That does conclude our time for questions. I'll now hand back to Dr Christian Behrenbruch for any closing remarks.

Well thank you very much everyone. Hopefully that was a useful update and again a very strong quarter from a commercial perspective and lots of great clinical outcomes. We look forward to seeing you at the R&D day in New York in a few weeks time. And as for this call, I'll leave it there and wish you all a good day. Thank you.