Telix Pharm Ltd

Thank you for standing by and welcome to the TELEX half quarter 2025 results and investor webcast. All participants are in a listen only mode. There will be a presentation followed by a question and answer session. If you would like to ask a question, you will need to press the star key followed by the number one on your telephone keypad. I would now like to hand the conference over to Ms. Kionne Williamson. Please go ahead.

Thank you and everybody for joining us this morning and this evening for those joining from overseas. My name is Kyanne Williamson. I'm the SEP of Investor Relations and Corporate Communication at Tealix. You can see there our disclaimer. Just moving forward to slide four, I'd like to introduce today's speakers that are on the line with me. We have Chris Barenbrook, our Group CEO and Managing Director. Darren Smith, our Group Chief Financial Officer. Kevin Richardson, CEO of the Tealix Precision Medicine. and Richard Vallex, CEO of Telex Therapeutics. Today we'll be taking you through the H1 2025 financial results presentation lodged earlier today on the ASX and our operational achievements for the half. This call is scheduled to run for one hour and following the presentation, we'll take questions firstly from analysts on the phone and request that you ask one question at a time and hop back in the queue if you have further questions. If we do not get to your questions on the webcast, we will reply to you directly. Moving on to slide five, please. In today's presentation, our business leaders will be talking to the investments we have made in the business to set it up for long-term value creation. This slide illustrates the scale of our business today, spanning development, commercialization, and global production and manufacturing. It's been a rapid transformation. This time last year, we had one approved product, Ellusix, which was commercially just a handful of companies. Today, we have multiple approved products. We are preparing to roll out Ellusix across Europe and are preparing for launches at Cakes and Six Clara. The acquisitions we have made have seen our manufacturing and distribution sites grow to 38, and our workforce has more than doubled, with now over 1,000 employees globally. Next slide, please. We've previously presented our growth strategy that is in place to drive value creation for the long term. You can see the four pillars on the left-hand side of the slide and the achievements we have delivered against each one of this half. These pillars are to grow our precision medicine or commercial stage imaging business and the achievements this half are focused on the goal to grow our share in the PSMA market and bring new products to patients. Kevin will discuss this further. Delivering on our late stage therapeutics pipeline and building our next generation pipeline including alpha therapy candidates. This half we have made solid progress across an array of programs which Richard will take you through in more detail. And finalizing expansion of our global delivery infrastructure, a key highlight this half has been the integration of the RLS business. Chris will take you through this and the key value drivers aligned to our strategy. Firstly, however, Darren will talk you through the financial results for H1 2025 in more detail. So I'll hand over to you, Darren.

Okay, thanks, Kai. And welcome, everyone. From a financial perspective, the first half of 2025 was characterized by strong commercial growth in our precision medicine business and continued investment into building our business for the future. We delivered strong revenue growth in the first half of 2025 with group revenues improving 63% year-on-year and driven by growth in the LUSIC in the addition of third-party revenue from RLS. Our precision medicine revenues were up 30% year-on-year with EBITDA increasing 24%. Gross margins in our precision medicine business remained stable at 64%, reflecting efficient manufacturing of elutics. The group's gross margin was 53%, reflecting the addition of RLS third-party product mix and the associated manufacturing and distribution costs. In this half, we have made a significant investment into our global manufacturing infrastructure to ensure that we are well positioned for long-term growth, and we continue to invest in our R&D pipeline with investment up 47% year-on-year. Following these investments, we generated $18 million in operational cash flows and finished the half year with a healthy $207 million cash on hand. Now moving to the next slide and our group revenues. Felix generated revenues of $390 million. This consisted of $79 million in revenues from RLS third-party sales and $311 million mainly from our precision medicine business. This represents an increase of 63% year-on-year and 41% compared to the second half of 2024. Ellucid continues to deliver strong growth, especially as it relates to volume doses. Kevin will provide more detail later in the presentation. Now moving on to the next slide in the group P&L. As stated previously, The group T&L represents a period of solid growth and strategic investment into preparation for delivering future long-term growth. Group gross margin landed at 53% following the addition of RLS third-party products and RLS associated manufacturing and distribution expenditure. R&D increased 47% to $82 million. As planned, we increased our investment into our therapeutic pipeline to be 54% of our overall investment in R&D from 43% last year. Richard will talk to our therapeutic portfolio later in the presentation. Selling and marketing expenses increased to 13% of revenues from 10% last year as we prepared for product and geographic expansion of our precision medicine business and the addition of $7 million in selling and marketing expenses from RLS. Manufacturing and distribution expenditure, excluding RLS COG, increased to 5% of revenue from 4% last year. driven by investment in our manufacturing and distribution infrastructure in Artemis, isotherapeutics, and multiple TMS facilities. General administration expenses decreased to 12% of revenue from 16% of revenues last year. As a result, adjusted EBITDA declined to $21 million, driven by our investment. Now moving on to the next slide. This slide represents the income statement of our precision medicine business. As you can see, gross margin is steady at 64%. This indicates that we have maintained our operational efficiency of Elusix, enhancing our abilities to reinvest in growth. As planned, we're prepared for new product launches and geographic expansion increase in selling and market expenses to 12% of revenue, facilitating the build-out of our commercial infrastructure ahead of the expected revenue growth. This increase was offset by reductions in percentage of revenue spent on R&D and general and administration. As a result, the precision medicine EBITDA improved $20 million year-on-year, driven by 29% revenue growth. Moving to the next slide of our CMS business.

Moving on to the next slide.

As we have made significant investments into TMS, I thought it was important to provide details, in particular, the contribution of RLF which we are reporting for the first time. RLS is the largest component of the TMS business, employing over 500 people across more than 30 locations, integrating last mile delivery capabilities for Tealix. In the next five months, sorry, in the five months since acquisition, RLS EBITDA was close to break even. The addition of a further volumes of Tealix products through RLS will improve the contribution. RLS currently processes one-third of Tealix's group revenue, with total network revenues for the five months being $110 million. This includes $79 million of third-party products and $31 million of inter-segment revenues related to Elucid. Growth margins for RLS were 7%. which is typical for this type of business and includes manufacturing and distribution costs from the radiopharmacies. RLS operating expenditure excluding COGS for the five months since acquisition totaled $15 million. We expect these costs for the second half of 2025 to remain at a similar percentage of revenue. Our T&S business also includes various subsidiaries such as Isotherapeutics, Artemis, and TMS Brussels, Melbourne, Oklahoma, Sacramento, where we increased our investment to advance operational activity at each of these sites. Chris will expand on the TMS strategy later in the presentation. Now moving on to the group's cash flow. In the first half of 2025, Telex is again achieved a positive operating cash flow totaling $18 million, demonstrating the ability of the commercial business to fund the development of our R&D pipeline in funding preparation for market and product expansion. As previously mentioned, Helix utilised cash on hand to make a number of strategic acquisitions. The largest of this was RLS. Cash from hand at the end of June was a healthy $207 million. Now moving on to the next slide. I'd like to take a moment to go over our capital allocation priorities. Tealix is focused on four areas. Firstly, R&D development. Secondly, optimizing our commercial performance. Third, strategic growth opportunities through M&A. and fourth, supply chain resilience and production capacity. We believe these four areas of focus will enable us to deliver long-term growth. Within R&D, we are advancing several late-stage clinical programs, and we are optimizing our commercial infrastructure to advance our commercial assets and expand into new areas of focus in geography. In terms of M&A, we invested in three strategic assets in the first half of 2025. They were RLS Radio Pharmacy, Imaginab, and AFAP Candidate. We continue to invest strategically into our manufacturing and supply chain infrastructure to preserve our competitive edge and to ensure we are in a position to scale efficiently as demand grows. We do all of this in a disciplined way by ensuring that we have a prudent cash buffer on our balance sheet. Now moving to my final slide. As stated on this slide, we are reaffirming our full year revenue and R&D guidance. We expect our revenue from the LUSIX and RLF to be in the range of $770 to $800 million. Our R&D investments, we expect to fall in the range of 20% to 25% increase on last year. Finally, I'd like to take the opportunity to reiterate our investment strategy. For the next three years, we will grow revenues by advancing assets from clinical development to commercialisation, expanding indications and geographic expansions. We will reinvest the earnings into our portfolio and ensure that we have the capability, infrastructure, and readiness to deliver on our therapeutic programs. At this stage of our development, our priority is building long-term asset value rather than optimizing near-term EPS growth. We believe that focus on earnings too early can detract from the strategic investments needed to unlock the full potential of our pipeline. I'll now hand you over to Chris Barron-Brooke, Managing Director in Group CEO. Thank you.

Thanks very much, Darren, and good day to everybody online. So I'd like to start by taking a moment, if you could advance onto the next slide, please, to talk about why TLIX is highly differentiated and built for long-term success. Starting with our therapeutics pipeline, our pipeline is built around areas of high unmet medical need, with a diversified portfolio strategy that gives us multiple shots on goal, even in some cases concentrated in the same disease area. Our R&D efforts remain sharply focused on advancing next-generation assets, whether that's in the alpha or beta therapies, novel isotopes, or innovative targeting agents. As a data-driven organization, our decisions are grounded in rigorous scientific and clinical evidence, ensuring that we prioritize our limited resources toward the most promising opportunities. Turning to manufacturing and supply chain excellence, I want to emphasize that radiopharmaceutical manufacturing and distribution is an extremely complex business from an operational quality and regulatory perspective. A robust, reliable supply chain is critical to long-term success, especially for a multi-product portfolio like ours that's also going to one day deliver therapeutic outcomes. This is why we've made strategic investments in selective aspects of vertical integration over the past couple of years, alongside deepening relationships with key strategic partners that we think are best aligned with our long-term commercial strategy. Our investment in commercial infrastructure is starting to deliver real operational and financial returns, including with continued volume growth for LUSIX in a maturing market landscape. This performance reflects our proven track record in commercial execution And I think it positions us very well for future product launches. This year also marks a major inflection point for Tealix as we transition from effectively a single product, single market company to a multi-product, multi-region commercial organization. And we've done it pretty cost effectively. With this global infrastructure in place, our precision medicine assets are laying the operational and financial foundation for the rollout of our future therapeutic pipeline, which as a reminder is really not that far away. Next slide, please. So, within prostate cancer, our multi-product strategy, supported by next-generation follow-on assets, is designed to drive sustained revenue growth. This approach strengthens our market position while expanding our commercial runway. We may have been second to market with Illucix, but we are leading our new strategy through a lifecycle management initiative that will enable us to continue to capture market share and to compete on the merits of our product portfolio to dramatically reduce the impact and viability of new entrants. We'll continue to expand the market. We'll continue to expand the market through new indications and indication expansion, notably our bypass study, a groundbreaking phase three study that's aimed at expanding the label to use Eleusis and Gozelex right to the front of the patient journey with the potential to disrupt current diagnostic pathways and significantly expand the total addressable market. Kevin's going to talk more about this exciting near-term opportunity during his part of the presentation. Finally, we continue to focus on product innovation, leveraging the strength of our distribution model, customer service, and innovation focus to maximize product choice to the benefit of physicians and patients. For example, we recently unveiled the outfloor chemistry program This first application, the first application is a development of a PSMA targeting agent that enables us to combine the imaging benefits of Fluorine 18 with the convenience of Gallium Kit-based workflows the market has already come to appreciate. We have an extensive clinical data package to support this, including a Phase III study and a significant number of patients. Following a helpful consultation with the FDA, we are now planning a registration-enabling study to take this forward to a new drug application. Next slide, please. Let's take a moment to understand what transitioning from a single product, single market company to a multi-product, multi-region commercial organization actually means. It takes a highly complex global manufacturing distribution infrastructure to deliver our precision medicine assets and obviously future therapeutics that are coming down the pathway to patients. Due to the relatively short half-lives of isotopes and the need for just-in-time manufacturing, Highly specialized facilities and logistics are required to avoid factors throughout the journey that can lead to disruption and delays. We have continued investing in our manufacturing infrastructure globally to have greater control throughout the process and significantly reduce quality and delivery risk. We see this as a crucial point of competitive advantage because without reliability, there is no commercial traction in this industry. Our global footprint Our global footprint reflects our commitment to leadership in Radio Pharma. We believe a truly global presence is critical to becoming and maintaining market leadership in this space. Next slide, please. On the topic of RLS integration, the RLS acquisition was a highly strategic investment enhancing our U.S. presence, which is a critical market with a production and distribution network that covers over 85% of the U.S. and provides last-mile delivery and a footprint to expand our manufacturing capability in the U.S. Darren has already talked to the financial contribution of RLS. I want to touch on the value drivers and integration progress to date. In just five short months, integration is going very well, and I have been personally extensively involved in the process alongside Darren Paddy, Telex's Group COO. RLS can deliver value in the following ways. Firstly, we are already seeing the synergies of having two distinct commercial teams that complement each other in terms of the way that they view and engage with the market. Having a nuclear pharmacy network provides a new entry point and insights, bringing us closer to the customer and enabling us to identify significant new opportunities. To be clear, our team manages everything from producing the end dose, quality controlling it, to walking it into the clinical site. This business is all about service to the end customer. Second is a pathway to margin improvement. The volume of Ellucix sales through the RLS network has increased by 50% on a dose volume basis in the first six months since the acquisition. This is not at the expense of our key partners. Rather, it demonstrates the synergies between the two commercial organizations and our ability to capture commercial white space and optimize our competitiveness. Pet agents like Ellucix and Gozelex reflect higher margin, higher value products for nuclear pharmacies to distribute. As we increase product distribution of our own products through RLS, we expect to see long-term improvement in gross margins and the ability to mitigate competitive and distributor risk. Finally, our goal with RLS is to build a radiometal production network to meet future demand for imaging and therapeutic radiopharmaceuticals, to grow the RLS business, but also to reduce our own reliance on third parties for supply chain in the U.S. Again, with this investment, we will be focusing on high-margin products, not historical commoditized products. We are currently in facilities planning and development for six cyclotrons across the RLS network initially, with the facilities upgrade process to commence in the second half, and will be complemented by in-house capabilities to produce select therapeutic products alongside our pharmacy production function for dose drawing and dispensing. So this will support both commercial activity and clinical activity. Next slide, please. So the third pillar of value creation that I wanted to touch on is our therapeutics pipeline and platform. We are deeply committed to bringing our therapeutics to the market, and this ambition remains a central focus of our investment strategy. As you heard from Darren, it's a growing proportion of our R&D expenditure. We are making meaningful progress across the entire pipeline, and the momentum we're building reflects the strength of our execution. I'm going to let Richard speak more about our progress generally across the pipeline. With the acquisition of Los Angeles-based Imaginev, we acquired a biologics and drug development platform that's really well-optimized for targeted alpha therapies. This is an incredibly talented team of people with a huge amount of experience, backed by key opinion leaders that have a great vision for what the future targeting platform will look like in radiopharma. The acquired platform uses small engineered biologics or antibodies that enable highly specific cancer targeting combined with fast tumor uptake and blood clearance. With our capabilities in antibody engineering, linker and chelator optimization, and isotope selection, we're really well positioned to develop highly potent and targeted radiopharmaceuticals that range from small molecules all the way to advanced biotherapeutic products. We believe these specialist in-house R&D capabilities are fundamental for long-term success of the company. Next slide, please. Just to wrap up in terms of expectations around top line and bottom line growth and reiterating some of the messages that Darren's given you, I've been showing this chart in our investor presentations since the start of the year. And there are some important signaling aspects to this graphic. We are now in the middle stage of our trajectory where we're diversifying our revenue streams, expanding globally, and de-risking the business. If you recall, our midterm strategy has been to reinvest our revenues into the business to fuel long-term growth. We're making very targeted investments today to position the company for long-term growth, both in top-line expansion and bottom-line performance. But right now, it's about putting every last dollar into that growth and infrastructure that when we hit our pre-commercial launch year for the therapeutics business, we are really ready to go. I want to give a little final comment before I hand over to Kevin and take a moment to address the information request from the SEC. I know many people have had questions about it. I'm personally, you know, disappointed to be in this situation as I really don't believe it reflects the quality of our organization or our commitment to excellence. The subpoena was a request for documents primarily relating to our disclosure activity related to the development of our prostate cancer therapeutic candidates. We are in the process of responding to the SEC to resolve this as soon as possible. I want to make clear that there have been no allegations or charges leveled at the company or any individuals. We do not know what or who triggered this. Let me be clear. This has no impact on our commercial portfolio or the momentum of our pipeline development. In fact, we are operating with more urgency and focus than ever before to bring these breakthrough assets to patients. I believe you can see evidence of this progress in today's presentation. So with that, I'd like to transition over to Kevin, our CEO of Precision Medicine, for a commercial update. Thanks, Kevin.

Sure. Thank you, Chris. And for my first slide, I would like to start with our Precision Medicine growth strategy. Our growth strategy is based on three pillars, expand product offerings, expand geographies, and then expand indications on those products. In terms of our first pillar, expanding our product offerings, we have now launched Gozelex, further strengthening our position in the PSMA space. And looking ahead, we have two near-term regulatory milestones with Zerkayx and Pixclara. These assets will build on our strong commercial foundation established by Ellucix. Moving on to our second pillar, the global rollout of Ellucix continues to progress well. with marketing authorizations now secured in over 23 countries. Turning to our third strategic pillar, we are actively exploring new indications for our existing assets, particularly indications where we believe we can deliver meaningful impact for patients. We remain laser focused on the execution of these three strategic pillars, driving the expansion of our global precision medicine business and paving the road for our therapeutics business.

Next slide, please.

Ellucix continues to deliver strong growth in the high single digits. In the second quarter, Ellucix revenues were up 2% quarter over quarter, or 25% year over year, with dose volumes up 7%. Q2 represents the highest unit volume growth we've seen in the last five quarters. And despite competitive pricing pressures, we continue to manage the impact to our average selling price. To do so, we continue to drive share growth in clinical accuracy and reliability of dose delivery. Our clinical message is TELIX PSMA gallium agents have fewer indeterminate bone lesions and higher inter-reader agreements than F18 assets. We couple the clinical message with a highly specialized sales force and customer-facing teams that differentiate TELIX with our customers every day. We've developed a reputation in the marketplace as an innovator, paving the way for successful launch of our follow-on products. Next slide, please. Moving on to geographic expansion and the global rollout of Elucyx. As you can see, we've established a strong commercial footprint across key markets, including the US, Canada, Australia, Brazil, the UK, and Europe, with marketing authorizations now secured in 23 countries. In the second quarter, we successfully launched Elucyx in the UK and see encouraging uptake. In the next wave of launches, we are focused on key markets like France, Germany, Italy, and Spain. And as you move further east, we're focused on China and Japan, where in China, we have completed our registration study and are preparing an NDA for Eleusis. While in Japan, we are just initiating our phase three study for Eleusis, and we are happy with the progress thus far. Now, on to Latin America, where we have the first approved product for PSMA PET, and we have commenced commercial operations there with our partner on the ground. Overall, we remain on track with the global rollout of Ellucix, supported by strong execution in the US. Next slide, please. We launched Gozelex earlier this year and successfully delivered our first commercial doses in June. The launch is progressing well through our comprehensive network of distribution partners, Cardinal Health, Pharmalogic, Jubilant, and RLS. Telex is the first company to bring two PSMA-targeted agents to the market, a differentiated strategy that we believe is central to our competitive advantage. This dual-product approach gives customers meaningful choice, whether in terms of economic value or scheduling flexibility, and it reinforces our commitment to meeting diverse clinical and operational needs. Now, from a reimbursement point of view, We are pleased with the recent HCPCS code we received from CMS, a major reimbursement milestone, and look forward to getting an update on the decision around transitional pass-through status in the near future. The HCPCS code will be effective October 1, 2025, streamlining the billing and reimbursement in the hospital outpatient setting for Medicare eligible patients. Next slide, please. Moving on to our third color of growth strategy, label expansion. I wanted to talk about a study that we think has the potential to become the future of prostate cancer diagnosis. Our bypass biopsy study or biopsy of the prostate avoidance stratification study. Biopsy are highly invasive and carry risk. And there are more than 1 million patients getting a biopsy every year with up to 75% of them being negative. When you think about it, what it takes to really be disruptive in this space and be innovative, we think it's minimizing patient trauma, reducing risk and recovery time, and lowering cost while improving patient outcomes. Next slide, please. Bypass is the first registrational study combining MRI and PSMA PET in diagnosing prostate cancer. Patients are categorized into high, medium, and low risk categories for prostate cancer. And for high-risk category, an image-guided biopsy would be recommended. For the intermediate or an indeterminate category, a precision biopsy would be recommended since PSMA is much more sensitive in the detection of prostate cancer, and we can perform one and done. For the low-risk category, if there is no uptake of PSMA in the scan, we can conclude that no biopsy is needed, none and done. So with this study, we aim to improve the predictive accuracy of prostate cancer while reducing the number of biopsies. This study has the potential to significantly broaden our market opportunity, potentially doubling it. We see significant value in moving earlier in the care pathway by positioning our scan at the front of the patient journey. Next slide, please. Moving on to PixClara. We've engaged with the FDA and agreed on a pathway forward and plan to resubmit the NDA. Recall that the FDA has granted Pixcara orphan drug and fast track designation and acknowledgement of the drug candidate's importance in addressing a significant unmet medical need. Turning to Xerkayx, our PDUFA date is approaching next week. We view this as a transformative opportunity targeting an area with no approved therapies. If approved, Xerkayx would be first to market positioning us to lead in a space with significant unmet need for patients and commercial potential. So to summarize, we've built a robust commercial infrastructure that continues to deliver, highlighted by high single-digit growth for Ellucix in the U.S. We've secured marketing authorizations in 23 countries and successfully launched in the U.K. Gozelex, our next-generation PSMA agent, is now on the market with HCPCS reimbursement starting in October. Looking ahead, we have several near-term regulatory milestones, and then we believe our bypass study has the potential to redefine the diagnostic pathway in prostate cancer. So with that, I'd like to introduce you to Richard, who will provide you an overview of the therapeutic assets.

Thank you, Kevin. So let me present to you today the update of our therapeutic business units. And you will see that during the first half of this year, 2025, we were moving the needle on all our therapeutic areas. You can see on these slides our strategic focus is centered around three therapeutic PRs. First, urologic oncology. Second, neurologic oncology. And third, the solid tumors and hematologies. So within neurology, we have a pipeline asset for prostate cancer, and more specifically targeting the MCRPC, standing for metastatic castrate-resistant prostate cancer. And also kidney cancer, we're targeting the RCC indication for clear cell renal cell carcinoma. But we have also a therapeutic agent, such as the TX90, for metastatic bone pain palliation, which is frequently in the prostate cancer late stage. Within neuro-oncology, we have pipeline assets for glioblastoma, and I'm happy to share that we are also adding a new indication for leptomeningeumal disease with the alpha version of the TELIX-102 compound. Within our third pillar, regarding solid tumors and hematology, we have the TELIX-400, our targeting asset that will close the acquisition during the Q1 2025. This asset has the pan-cancer potential and we are exploring various indications. We also have molecules for soft tissue sarcoma and bone marrow conditioning agents for pediatric high-risk leukemia patients. I will come back on that in a minute. In summary, you can see that we have 10 early and late stage assets. Late stage assets are primarily focused on beta therapies, followed by earlier stage assets exploring alpha therapies. In addition to these 10 assets, we also have preclinical compounds targeting for the most well-known DLL3 and alpha-D beta-6, coming from the imaginal acquisitions. We are exploring the best combination with isotopes for these targets. Our diagnostic strategy includes having companion diagnostics for all our disease area of focus, and we are working in close collaboration with Kevin and the Precision Medicine colleagues.

Next slide, please.

Let's talk about prostate as the first pillar of our urology strategy. Stelix 591 is our phase three asset for NCRPC. And let me remind you that PROSTA Global is a combination trial with Standard of Care. Namely, we are associating the product with abiraterone, enzalutamide, and docetaxel, with 10 patients in each arm. This is a two-part study where the primary redout from the part one will be safety and dosimetry. And I'm pleased to disclose that we have reached target enrollment of 30 patients in the part one. and will provide an update once the data analysis is complete. Part 2 of the study is a randomized treatment expansion including 490 patients. In order to accelerate PROSTA Global Part 2, firstly, we are currently in the process of getting the required regulatory approvals in various countries in order to expand the number of sites. Secondly, the protocol in Part 2 is more patient-friendly. In that, the patients will not need to come back to the hospital for multiple scans, which were required in part one to complete the dosimetry data. Let's move on to TELIX 592, which is our next generation PSMA targeting alpha therapy using actinium in development. Earlier this year, we presented data at ASCO-GU from our clinical study evaluating the biodistribution and the dose to the organs of the copper 64 label imaging version. This was essentially a proof of concept of this asset, and we are really looking forward to moving into phase one. I'm pleased to say that we have now received the Human Research Ethics Committee approval in Australia for first in human study with this 592 asset. Let's move forward. TELIX-90, our Samarian agent, this is being developed to treat the pain palliation in patients that have osteoblastic metastatic disease. It fits nicely and perfectly with our urologic platform because frequently the patients that have osteoblastic metastatic disease have prostate cancer. Currently, we are developing this as a single-dose agent for pain palliation, but there is potential in the future for multiple-dose regimen as well. And I'm pleased to announce that we just received the FDA approval for Phase I study and look forward to start. It is another great milestone for this first half of the year 2025. I'm sure you can agree with me. Moving to the next slide. Our second pillar of the urology strategy is focused on kidney cancer. TELIX 250 is our CA9 targeting agent. We know that CA9 is expressed in greater than 90% of clear cell renal cell carcinoma. It's also being expressed in a number of solid tumors. We have a few ongoing studies exploring mono and combination therapy. We are focusing on monotherapy for advanced third and fourth line patients with CCRCC. And I'm pleased to announce again that we are moving forward a pivotal trial named Luteon, with the submissions completed to the Human Research Ethics Committee in Australia. On the right-hand side, you can see images. This is a patient with metastatic advanced renal cell carcinoma. On the top, you can see the initial images that have been performed with zirconium label gerantuximab scan. You can see intense activity in the sacrum where there was a metastatic lesion. And after three cycles of therapy with lutetium gerantuximab, you can see on the bottom row that the amount of activity in the sacral lesion has significantly decreased, again giving us confidence that the injected therapy has made its way to the bone lesion. Now, if we consider the life cycle of geriatric CMAP compound, let's have a look to the Pelix 252, our CNI targeting alpha therapy for pan-tumor approach, including CCRCC. When patients have high expression of CNI, they often face resistance to chemotherapy, immunotherapy, and with time also radiotherapy. We think this is a good target for radioligant therapy. because with an alpha isotope, we can use the increased activity directly targeting the tumor cells. We have submitted to the Human Research Ethics Committee application in Australia in late Q2 and look forward to start our phase one trial once we receive ethics approval. Let's move to the next slide. I'm moving to the neuro-oncology portfolio. I will start with the good news of receiving full ethics approval in Australia to start the IPAX-BRITE. IPAX-BRITE is a pivotal registration enabling study in recurrent glioblastoma. Given the absence of effective options for glioblastoma, we are very pleased that this agent has been granted an orthodontic designation both in US and Europe for treatment of gliomas. Our initial focus with TELIX 101 is going to be in glioblastoma, the most common and aggressive form of primary brain cancer. There is no established second-line treatment at this point. And if we look at the NCCN guidelines in the US, it tells you that the clinical trial is a recommended option for treating second-line patients with recurrent disease. Also, I just wanted to summarize data that we discussed previously this year. IPACS-1 and IPACS-LINS in the recurrent setting demonstrated an acceptable safety profile as well as encouraging overall survival duration, both from the time of recurrent diagnosis ranging from 12 to 13 months and time from initiation of treatment from 23 to 32 months. great achievement when we know the average life expectation, which is extremely reduced in this debilitating disease. On the right part of the slide, you can see a patient case coming from a compassionate use program in Europe. In this patient, the scans describe a stable disease for 18 months, very encouraging when you know the severity of the disease. Turning to our targeted alpha therapy approach in neuro-oncology, utilizing astatine isotope. We believe patients with smaller, more diffuse disease may be well-suited with the mechanism of action and the higher energy deposition of astatine 3-11. We are currently in the process of preparing regulatory filing for submission for leptomeningemal disease and conducting a collaborative investigator-initiated trial in glioblastoma. Let's move to the next slide, please. I'm focusing on the other three tumors and hematology disease. Let's start with the TELIX-400, our FAPI, which stands for fibroblast activation protein inhibitor, an antigen expressed on the tumor macroenvironment. The diagnostic piece has been confirmed in patients, and we have several publications on the topic. we are looking forward to bringing this molecule to the clinic. The phase one pan-cancer basket study will start in 2026. The other two molecules we have are TELIX-300 in licenses from Lilly, PDGFR-alpha for advanced metastatic soft tissue sarcoma. We have initiated a phase one ZOLAR imaging trial that is recruiting patients in New Zealand and Australia. We also have the TELIX66 for bone narrow conditioning for allogenic stem cell transplantation, more specifically in myelodysplasic syndrome and acute myeloid leukemia. Let's move to the next slide. In conclusion, it is an extremely busy first part of the year. TELIX has one of the most complete therapeutic portfolios with 10 pipeline assets and even a few more if I add the research stage with IMAGINAB recent acquisition. Within urology and neuro-oncology, we are progressing, initiating three pivotal trials. First, advancing the pivotal trial with Prostac Global. Second, preparing the pivotal trial Luteon for the 250 compound, and starting the pivotal trial IPEX Bright. We are also starting the clinical trial with the Telix 90, which is the perfect companion product for a pro-site portfolio. And I don't forget that we are entering first in human trials with our two alpha emitters, Telix 5.2 and Telix 2.52. Thank you for your attention.

Thanks very much, Richard. Great rundown, and it really conveys the depth of the pipeline and development activity and progress over the last six months So as is typical, I get to end the presentation with a summary of our upcoming catalysts and key objectives. This is by no means an exhaustive list, but captures some of the key value creation events that are on the near-term horizon. Many of these catalysts are new commercial opportunities that will add to our revenue and earnings growth and will support our expansion and transition into a fully-fledged theranostics company. Some of these catalysts relate to new clinical data points, that I believe will reinforce our leadership position as an innovative player in the radiopharma space with pipeline of either best-in-class or first-in-class assets. Expanding our capabilities is a key driver of near-term value creation as we work to deliver our products into major global markets. Our investments are focused on building the operational strength needed to unlock these markets and then, of course, to scale sustainably. In closing, TOX continues to demonstrate strong growth and operational improvement We've never been more focused or committed to delivering value for our shareholders, our clinical partners, and most importantly, the patients we serve. Thank you for your attention. I hope you found this presentation interesting and informative, and I now open it up for questions.

Thank you. If you wish to ask a question, please press star 1 on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star 2. If you are on a speakerphone, please pick up the handset before you ask your question. Today's first question comes from David Lowe with JP Morgan. Please go ahead.

David Lowe Great. Thank you for taking my question.

If we could start with just the outlook for gross margins. I think it was very useful to get all the update on RMS and understand exactly where the contribution is, but I heard the message that you think it can improve. And then, of course, we've seen some fairly significant changes in PSMA pricing in the last quarter, particularly the back end. I'm just wondering how that's going to play out. And, of course, trying to understand how Gozellix fits into that mix as well. So if I could have someone have a go at answering some of those facets, please.

Well, Darren, why don't you – it sounds like three questions, not one. But why don't you go ahead, Darren, and start off with the gross margins.

Yeah, sure. And thanks, David. Obviously, this past year has been quite a change for the organisation where we've, you know, compared to the prior year where we were only selling the roofing, And I think the first key point is that the illusix gross margin is, and you can see this by looking at that precision medicine slide, has remained fairly consistent. I think we reported 65% last year and 64% this year. So obviously no real change in the gross margin perspective for illusix in the market from the gross margin. Then when we look at RLS, we see the addition of those third-party products and also the kind of internal contribution that it receives by selling our elusive products into the market, that they're able to achieve a 7% gross margin once you've included the radiopharmaceutical, sorry, the radiopharmacy cost into the gross, which are cost of goods, the interesting things we have done a little bit of benchmarking and what we found is the industry that's similar you know some of our partners slash competitors are doing a very similar growth margin in that kind of low to mid range single ginger yield so growth margin is obviously um a result of those two businesses brought together. So the 53% is the average based on the load of business. I think the important thing to remember though with RLS is that as we start to push a product like Elucid and the higher contribution that it provides to the RLS business, that that should help grow just dollar gross margin for that business with little or minimal cost impact on being able to deliver that to patients. So what we would potentially see is as we add the more elucidated and potentially the future products that we're looking to bring to market in Gozellix, Six Clara and Cacate, that that will continue to assist that business to make a better contribution to the organization. Hopefully that kind of answers your question, David.

Yeah, I think I don't have anything to add except for that obviously we didn't acquire RLS for its commodity pharmaceutical business. We acquired it to put a larger proportion of our own products through and to prepare for when we have to distribute therapeutic unit doses, which you can't do that without a nuclear pharmacy dose dispensing. If you want to deliver a pre-filled syringe to a customer, which is the name of the game, you've got to have a pharmacy network to do that. So this is not about what's going to happen this quarter. It's what's going to happen in the next quarter and the quarter after that and three years from now. So let's move on to the next question.

The next question comes from Tara Bancroft with TD Cohen. Please go ahead.

Great. Thanks for taking our question. This is Nick on for Tara. I have one on the guidance and the continued growth of Ellucix moving forward. So to reach the 2025 guidance with assuming stable RLS revenue, obviously it's a little bit difficult to say that right now, but it appears like Ellucix sales growth may be slowing a little bit. Is this due to the loss of pass-through status and what impact could this have on Ellucix net sales? Also, could Gozelex lead to return to growth once it does have pass-through status?

Thanks. I mean, obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. So you're absolutely correct. First of July, we came off pass-through. We actually reported 7% growth quarter-on-quarter, which is, I think, exceptional. So 7% growth in volume quarter-on-quarter, which is really exceptional performance, particularly if you take some of our competitors' financial results into consideration. So What we did is we made a decision that we were going to stabilize our customer book going into the third quarter. We have the situation where we have one product coming off pass-through and then another product getting reimbursement effective 1st of October. And we've got to bridge that gap, and we chose to take certain commercial actions to do that. And we still had growth in revenue quarter on quarter, again, where our competition didn't. And so I think we have a nice stabilization strategy for Q3, and then Q4 continues with the advantage that we uniquely have of a second product introduction. I don't know, Kevin, if you want to add anything to that.

I would just add that we just continue to take the market pragmatically and continue to sell clinically on our accuracy, as we spoke of earlier in my presentation, and then continue to drive that message with reliability. And again, we have a strategic pillar and our customer-facing team that really represents well and is able to really manage that ASP and volume mix that we work on with that piece of the business and the strategic accounts.

Yeah, and I think you'd be mistaken in thinking that this is just a pricing game. It's not. I think there's four pieces to commercial success in the market dynamic today. It's, as Kevin said, selling on clinical value proposition, which we have you know, demonstrably the strongest clinical value proposition. It's selling on service and service quality. Then there is, of course, pricing and pricing structure, particularly for large volume customers. You know, unlike our competition, we don't throw it all at the same price to everybody. We give benefits to our customers that are more loyal than, you know, smaller customers. And I think the last thing is clearly reimbursement status. And again, to reiterate, we go into Q4 and with a very strong and differentiated commercial strategy with Gazellex. And we're excited about that. We're looking forward to it.

Sales team's pumped.

Next question. The next question comes from David Dye with UBS. Please go ahead.

Thanks for taking my question. I'm just curious about the Zerkayex launch readiness strategy. maybe you can highlight some of the things you've been doing for Zerkayx, and how should we think about the launch in the first and the second quarter after approval on August 27th?

Well, it's probably not too much to really kind of openly discuss. I mean, the commercial team, it's not their first rodeo. We're selling into the same customer base, the same referral position base as LUSIC, so it's a It's a very straightforward pathway to the customer. We're clearly focused on using our Lucix customer base to seed that product launch. And I would say commercial team is ready to rock and roll on Zerkay. Do you want to add anything to that, Kip?

No, I think the combination of a urological call point with a nuclear med physician base that's reading that is really the key to success there. And, you know, we've had an expanded access program going for a while that's demonstrated exactly what we saw in the Zircon study. So we're excited about the launch and just haven't given guidance for 2026 yet.

Yeah, I mean, we've had a lot, you know, the expanded access program, the EAP, has been a huge success. We've done a You know a very I think well orchestrated unbranded, you know physician education campaign So as far as we're concerned the the markets ready for this product Thanks for the question The next question is from handy say with William Blair, please go ahead Thanks for taking our questions and congratulations on the on the performance of

So for the bypass study, obviously very provocative in terms of the disruptive potential. I'm curious. The trial is posted on clinicaltrials.gov. You have some primary endpoints. Just curious about some secondary endpoints that you're contemplating on and how you think about some of the, you know, outcomes, you know, longer-term outcomes for patients pertaining to survival or treatment steps that you can really, really convey the value of taking this agent upfront. Thank you.

Yeah, so this study was really born out of and driven by KOL engagement around where is PSMA going to really go as we move up the treatment cascade. And to be quite honest with you, you know, on the front line of patient management, not a lot has really changed in the last sort of 15 years. It's pretty archaic. And whilst MRI, of course, gets better and better, we're still doing well over a million biopsies a year. And a good proportion of those biopsies aren't adding any value to the patient journey. So just to be clear, our goal is not to eliminate biopsy. I mean, that's a nonsensical clinical objective. a biopsy is super important. What our goal is is to make biopsy count and to use it where, you know, it's absolutely essential and to use the scope of biopsy where it absolutely makes sense to do that. In terms of the, we will, of course, be putting out the trial design on clinicaltrials.gov. It's only just, that study's just launching, so clearly we want everybody to understand the endpoints. But to the implied part of your question, yes, there will be a monitoring period. It won't be a very long monitoring period, but there's definitely a follow-up period that's part of the evaluation of the utility of prostate imaging in that patient segment. So, you know, stay tuned, Andy. We've got, you know, more updates on that trial design coming down the pathway.

The next question comes from David Mirengarden with Wedbush Securities. Please go ahead.

Hi, thanks for taking the question. I just had one on the prostate study. Just around the parameters, you've recruited the patients. What are you looking for on the dosimetry and safety side? And when you think about the movement into the part two of the study, is it still the plan to carry forward all three combinations or Could that change in the future when you talk about the results from these first 30 patients? Thanks.

Well, things can always change based on data, but at present, our plan remains as stated. The real purpose of the Part 1 study, and frankly, the reason why it took a while to accrue, is because It's a multi-time point spectrosymmetry. There's a lot of patient visits involved. It typically requires specialist centers. So it's really a subset of departments that are really suitable for running that study. And it is, as I said, it's a demanding study on patients. We know that when we move into the second part of the study, which in some countries is a seamless transition, so that's already in play. it's a very straightforward transition and a much more straightforward study protocol from a patient perspective. The three different arms were because we had the aspiration in this study to have flexibility on the choice of RP. We think that that's an important thing. And so really what we're looking to get out of part one is confirmation of our understanding of the safety profile in combination with both RPs, different RPs and taxanes. We fully expect that that's what's going to progress into the second part of the study. We think that there's a compelling clinical use case for all three of those combos, and our mission is to really demonstrate to the agency that that safety profile is consistent across, really across different RPs. So I hope that answers your question, but We're really excited to have that first run-in part done. It was a pretty painful study protocol. The rest of the study now is going to pick up at a much greater pace.

Thanks very much for your question, David.

The next question comes from John Hester with Bell Potter. Please go ahead.

Yes, good morning, Chris. I want to just come back to the situation with PSMA pricing. I'm sure everyone on the call heard the comments from Lanthus a few weeks ago regarding the competitive situation, and also Kevin referred to competitive pricing pressures in the market in his prepared comments. So the question is this. Are you worried about that pricing pressure contagion spreading to your own market, and can you also sort of update... perhaps on what you've seen on those pricing pressures in this current quarter? Thank you.

Well, I think we've reported all the numbers, so the numbers are the numbers. I think that pricing is a direct function of both competitive dynamics and clearly reimbursement status. The market's complicated, as you know. There are multiple customer segments in the market that have different competitive dynamics and different pricing dynamics. What we do know is that customers prefer, understandably, to use a reimbursed product. Lantheus came off reimbursement, and that certainly puts pressure on their business. We've now come off reimbursement, albeit for a very transient period of time. because we have been granted a HCPCS code for our lifecycle management product, which, by the way, has innovative aspects in its own right. It's not just a direct follow-on. There's some genuine clinical and clinical workflow benefits that comes from that product. So the way that we manage pricing and pricing consistency is by ongoing innovation and capability delivery to our customers and differentiating ourselves in both the clinical use case for the product and the reimbursement profile of the product. And so, and I don't want to sound facetious, but no, pricing pressure is not what we worry about because we have a lifecycle management strategy to address it. Next question, please.

Thank you. Today's last question will come from Andy Say with William Blair. Please go ahead.

Thanks for squeezing me in for one more. So, Chris, I'm just curious if you can comment a little bit more about the aluminum fluorine technology that you mentioned that kind of allows you to traverse between the gallium-68 and fluorine-18 isotopes. Can you speak to maybe the commercial implication, i.e., what is the next steps in terms of potential regulatory pathway and then supply chain? How does that kind of fit into your goal of being a vertically integrated company, leveraging the RLS and Artemis platforms?

Yeah. Well, I'm the nerd, so I'll start off with the science lesson, and then I'll hand it over to Kevin to talk about the commercial implications and the physician preference. But essentially, when you react to aluminum and flaring together, it's a pretty violent coupling process. And what you end up with is a metallized version of F18. And it turns out that that metallized version of F18 is a drop-in replacement for gallium. So what it means is that you can have the same targeting agent with the same chelator, and you can interchangeably substitute either gallium or F18. And the beautiful thing about aluminum fluoride is that you make it in extremely large quantities at a cyclotron facility. It's not a drug per se. It's essentially an API, a hot API. and you can drop that activity then into a nuclear pharmacy, and using all of the benefits and the production workflow advantages that we have of the kit-based approach, we can essentially, particularly in high-density areas or where we want to service large academic customers that really are enamored by F-18, and I'll get Kevin to characterize the customer base a bit more, but it enables us to seamlessly transition between galleon products and F18, and of course, continue that lifecycle management. PSMA 11 is really well demonstrated in terms of its sensitivity and specificity as a targeting agent, and now we get to marry that kind of superior pharmacology of PSMA 11 with the utility of F18, and still, by the way, utilizing our well-trodden and well-understood distribution model. Maybe, Kevin, you want to comment on physician preference?

Sure. So as you know, we launched Illusix three years ago, and we've successfully taken over a third of the market, pushing 40% of the market with Gallium. And we believe that Gallium is a fantastic product, and we're going to continue to execute on our Illusix and our Gozelex plan through the marketplace. But what we do see is some stalwarts that have used F18 for many other products through the years and tend to favor that more. The reality is that we believe our reliability story, along with our commercial customer-facing team, can support that in the next couple of years as we move in our lifecycle management from Gozelex and continue to maximize gallium cells and then find, if you will, the corners of the canvas, if you will, to paint with ALF. And we believe that's a great way to do it through our distribution and commercial network.

Yeah, so maybe just to wrap up, because it's a super great question. And by the way, you're the first analyst that's ever asked a question about it. So that's why I'm grateful to elaborate a bit more. But going forward, I think what you're going to really see is we have a whole pile of imaging products coming down the pike, including, for example, there's a gallium FAP agent there. As we develop that agent, we'll think about how this time do we avoid having to participate in a physician preference discussion, right? Some folks like Gallium, some folks like F18. Some guys drive a Beamer, some guys drive a Mercedes. And we're going to set up shops so we can make both available depending on what the preference is.

All right, well, look, I think we're at the end of time anyway.

Well, I just want to say thanks very much to everybody for your time today and appreciate the opportunity to give you an update. Thanks very much.

That does conclude our conference for today. Thank you for participating. You may now disconnect your lines.