Telix Pharmaceuticals Limited (NASDAQ:TLX) Q1 2025 Earnings Call Transcript

Telix Pharmaceuticals Limited (NASDAQ:TLX) Q1 2025 Earnings Call Transcript August 21, 2025

Telix Pharmaceuticals Limited misses on earnings expectations. Reported EPS is $-0.0068 EPS, expectations were $0.214.

Operator: Thank you for standing by, and welcome to the Telix Half Quarter 2025 Results and Investor Webcast. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.

Kyahn Williamson: Thank you and everybody, for joining us this morning and this evening for those joining from overseas. My name is Kyahn Williamson. I’m the SVP of Investor Relations and Corporate Communications at Telix. You can see there our disclaimer. Just moving forward to Slide 4. I’d like to introduce today’s speakers that are on the line with me. We have Chris Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group Chief Financial Officer; Kevin Richardson, CEO of Telix Precision Medicine; and Richard Valeix, CEO of Telix 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 1 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 5, 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, Illuccix, which was commercial in just a handful of companies. Today, we have multiple approved products.

We are preparing to roll out Illuccix across Europe and are preparing for launch of Zircaix and Pixclara. 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 4 pillars on the left-hand side of the slide and the achievements we have delivered against each one 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 finally, the 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.

Darren Smith: Thanks, Kyahn, 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 Illuccix and the addition of third-party revenue from RLS. Our precision medicine revenues were up 30% year-on-year with EBITDA improving 24%. Gross margins in our Precision Medicine business remained stable at 64%, reflecting efficient manufacturing of Illuccix. 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 flow and finished the half year with a healthy $207 million cash on hand. Now moving to the next slide and our group revenues. Telix 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. Illuccix 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 on the group P&L. As stated previously, the group P&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 revenue from 10% last year as we prepared for the 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 COGS increased to 5% of revenue from 4% last year, driven by investment in our manufacturing and distribution infrastructure in ARTMS, Iso Therapeutics and multiple TMS facilities. General and 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 investments. 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 Illuccix, enhancing our ability to reinvest in growth. As planned, we prepared for new product launches and geographic expansion, increasing selling and marketing 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 spend 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 TMS 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 RLS, 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 Telix. In the next 5 months — sorry, in the 5 months since acquisition, RLS EBITDA was close to breakeven. The addition of further volumes of Telix’s products through RLS will improve the contribution.

RLS currently processes 1/3 of Telix’s group revenue with total network revenues for the 5 months being $110 million. This includes $79 million of third-party products and $31 million of intersegment revenues related to Illuccix. Gross 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 5 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 TMS business also includes various subsidiaries such as Iso Therapeutics, ARTMS and TMS Brussels, Melbourne, Oklahoma, Sacramento, where we increased our investment to advance operational activities 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, Telix has 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 and funding preparations for market and product expansion. As previously mentioned, Telix utilized cash on hand to make a number of strategic acquisitions. The largest of this was RLS. Cash on 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. Telix is focused on 4 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 4 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 and geography. In terms of M&A, we invested in 3 strategic assets in the first half of 2025. They were RLS Radiopharmacies, ImaginAb and a FAP 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 Illuccix and RLS to be in the range of $770 million 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 3 years, we will grow revenues by advancing assets from clinical development to commercialization, expanding indications and geographic expansion. We will reinvest the earnings into our portfolio and ensure that we have the capabilities, 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 be troughed from the strategic investments needed to unlock the full potential of our pipeline. I’ll now hand you over to Chris Behrenbruch, Managing Director and Group CEO. Thank you.

Christian P. Behrenbruch: Thanks very much, Darren, and good day to everybody online. So I’d like to start by taking a moment, if you could advance on to the next slide, please, to talk about why Telix 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 towards 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 multiproduct 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 Illuccix 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 Telix as we transition from effectively a single product, single market company to a multiproduct, 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 multiproduct 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 Illuccix, but we are leading our new strategy through a life cycle 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 BiPASS study, a groundbreaking Phase III study that’s aimed at expanding the label to use Illuccix and Gozellix right to the front of the patient journey with the potential to disrupt current diagnostic pathways and significantly expand the total addressable market.

Kevin is 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 AlFluor chemistry program. This first application — the first application is the 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 in 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 multiproduct, multi-region commercial organization actually means. It takes a highly complex global manufacturing and 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 — global footprint reflects our commitment to leadership in radiopharma. 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 5 short months, the integration is going very well, and I have been personally extensively involved in the process alongside Darren Patti, Telix’s Group COO. RLS can deliver value in the following ways. Firstly, we are already seeing the synergies of having 2 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 Illuccix sales through the RLS network has increased by 50% on a dose volume basis in the first 6 months since the acquisition. This is not at the expense of our key partners, rather it demonstrates the synergies between the 2 commercial organizations and our ability to capture commercial white space and optimize our competitiveness. PET agents like Illuccix and Gozellix 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 radio metal 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 6 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 part — third pillar of value creation that I want 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 ImaginAb, 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. So the next slide, please. So just to wrap up in terms of expectations around top line and bottom line growth and reiterating some of the messages that Darren has given you, I’ve been showing this chart in our investor presentation 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 derisking 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 without 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 disappointed to be in the 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’re 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.

Kevin Richardson: 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 3 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 Gozellix, further strengthening our position in the PSMA space. And looking ahead, we have 2 near-term regulatory milestones with Zircaix and Pixclara. These assets will build on our strong commercial foundation established by Illuccix. Moving on to our second pillar. The global rollout of Illuccix 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 3 strategic pillars, driving the expansion of our global Precision Medicine business and paving the road for our Therapeutics business. Next slide, please. Illuccix continues to deliver strong growth in the high single digits. In the second quarter, Illuccix 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 5 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 agreement than F-18 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 Illuccix. As you can see, we’ve established a strong commercial footprint across key markets, including the U.S., Canada, Australia, Brazil, the U.K. and Europe with marketing authorizations now secured in 23 countries.

In the second quarter, we successfully launched Illuccix in the U.K. 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 Illuccix. While in Japan, we are just initiating our Phase III study for Illuccix, 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 Illuccix, supported by strong execution in the U.S. Next slide, please.

We launched Gozellix 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. Telix is the first company to bring 2 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 pillar 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 BiPASS 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. BiPASS 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 Pixclara Orphan Drug and Fast Track designation, an acknowledgment of the drug candidate’s importance in addressing a significant unmet medical need. Turning to Zircaix. Our PDUFA date is approaching next week. We view this as a transformative opportunity targeting an area with no approved therapies. If approved, Zircaix will be first to market, positioning us to lead in the 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 Illuccix in the U.S. We’ve secured marketing authorizations in 23 countries and successfully launched in the U.K. Gozellix, 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 BiPASS 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.

Richard Valeix: Thank you, Kevin. So let me present to you today the update of our Therapeutic business unit. 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 this slide, our strategic focus is centered around 3 therapeutic pillars: first, urology oncology; second, neurology oncology; and third, solid tumors and hematology. So within urology, 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 ccRCC indication for clear cell renal cell carcinoma. But we have also a therapeutic agent such as TLX090 for metastatic bone pain deviation, which is frequent in the prostate cancer late stage.

Within neuro-oncology, we have a pipeline asset for glioblastoma. And I’m happy to share that we are also adding a new indication for leptomeningeal disease with the alpha version of the TLX102 compound. Within our third pillar regarding solid tumors and hematology, we have the TLX400, our FAP-targeting asset that we closed 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 agent 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, 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 v beta 6 coming from the ImaginAb acquisitions. We are exploring the best combination with isotopes for these targets. Our diagnostic strategy includes having a companion diagnostic 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. TLX591 is our Phase III asset for mCRPC. And let me remind you that ProstACT 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 2-part study where the primary readout from the Part 1 will be safety and dosimetry. And I’m pleased to disclose that we have reached target enrollment of 30 patients in the Part 1 and we’ll 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 ProstACT 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 the Part 1 to complete the dosimetry data. Let’s move on to TLX592, 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 level imaging version. This was essentially a proof of concept of this asset and we are really looking forward to moving into Phase I. 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, TLX090, our Samarium 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 regimens 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’s 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. TLX250 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 submission 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 level girentuximab scan. You can see intense activity in the sacrum where there was a metastatic lesion. And after 3 cycles of therapy with lutetium girentuximab, 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 girentuximab compound, let’s have a look to the TLX252, our CA9-targeting alpha therapy for pan-tumor approach, including ccRCC. When patients have high expression of CA9, they often face resistance to chemotherapy, immunotherapy and with time also radiotherapy.

We think this is a good target for radioligand 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 I trial once we receive ethics approval. Let’s move to the next slide and moving to the neuro-oncology portfolio. I will start with the good news of receiving full ethics approval in Australia to start the IPAX-BrIGHT. IPAX-BrIGHT 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 Orphan Drug designation, both in U.S. and Europe for treatment of glioma.

Our initial focus with PDX101 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 U.S., it tells you that the clinical trial [indiscernible] is option for treating second-line patients with recurrent disease. Also, I just wanted to summarize data that we disclosed previously this year. IPAX-1 and IPAX-Linz 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. It’s a 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 this 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-211. We are currently in the process of preparing regulatory filing for submission for leptomeningeal disease and conducting a collaborative initiated — investigator-initiated trial in glioblastoma. Let’s move to the next slide, please. And focusing on the other solid tumors and hematology disease.

Let’s start with the TLX400, our FAPi, which stands for fibroblast activation protein inhibitor, an antigen expressed on the tumor microenvironment. 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 I pan-cancer Basket study starting — will start in 2026. The other 2 molecules we have are TLX300 in licenses from Lilly, PDGFR alpha for advanced metastatic soft tissue sarcoma. We have initiated a Phase I ZOLAR imaging trial that is recruiting patients in New Zealand and Australia. We also have the TLX66 for bone marrow conditioning for allogeneic stem cell transplantation, more specifically in myelodysplastic 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 portfolio with 10 pipeline assets and even a few more if I add some the research stage with ImaginAb recent acquisition. Within urology and neuro-oncology, we are progressing, initiating 3 pivotal trials. First, advancing the pivotal trial with ProstACT GLOBAL; second, preparing the pivotal trial LUTEON for the 250 compound and starting the pivotal trial IPAX-BrIGHT. We are also starting the clinical trial with the TLX090, which is the perfect companion product for our ProstACT portfolio. And I don’t forget that we are entering first-in-human trials with our 2 alpha emitters, TLX592 and TLX252. Thank you for your attention.

Christian P. Behrenbruch: Thanks very much, Richard. Great rundown and really conveys the depth of the pipeline and development activity and progress over the last 6 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, Telix 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.

Operator: [Operator Instructions] Today’s first question comes from David Low with JPMorgan.

Q&A Session

David A. Low: If we could start with just the outlook for gross margins. I mean I think it was very useful to get all the update on RMS (sic) [ RLS ] 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.

Christian P. Behrenbruch: Well, Darren, why don’t you — it sounds like 3 questions, not one, but why don’t you go ahead, Darren, and start off with the gross margin.

Darren Smith: Yes, sure. Thanks, David. Obviously, this half year has been quite a change for the organization where we’ve compared to the prior year where we’re only selling Illuccix. And I think the first key point is that the Illuccix 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 Illuccix in the market from the gross margin. Then when we look at RLS, we see there the addition of those third-party products and also the kind of internal contribution that it received by selling our Illuccix product 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 cost of goods.

The interesting thing we have done a little bit of benchmarking and what we found is the industry that’s similar, some of our partners/ competitors are doing a very similar gross margin in that kind of low to mid-range single-digit yield. So gross margin is obviously a result of those 2 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 Illuccix and the higher contribution that it provides to the RLS business that, that should help grow the 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 Illuccix and potentially the future products that we’re looking to bring to market in Gozellix, Pixclara and Zircaix, that will continue to assist that business to make a better contribution to the organization.

Hopefully, that kind of answers your question, David.

Christian P. Behrenbruch: Yes. I think I don’t have anything to add except for that, obviously, we didn’t acquire RLS for its commodity radiopharmaceutical 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 prefilled syringe to a customer, which is the name of the game, you got to have a pharmacy network to do that. So this is not about like what’s going to happen this quarter. It is what’s going to happen in the next quarter and the quarter after that and 3 years from now. So let’s move on to the next question.

Operator: The next question comes from Tara Bancroft with TD Cowen.

Nicholas Lorusso: This is Nick on for Tara. I have one on the guidance and the continued growth of Illuccix 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 Illuccix 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 Illuccix net sales? Also, could Gozellix need to return to growth once it does have pass-through status?

Christian P. Behrenbruch: Yes. I mean, obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. So you’re absolutely correct. 1st of July, we came off pass-through. We actually reported 7% growth quarter-on-quarter, which is, I think, exceptional — 7% growth in volume quarter-on-quarter, which is really exceptional performance if you — 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?

Kevin Richardson: 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.

Christian P. Behrenbruch: Yes. And I think you’d be mistaken in thinking that this is just a pricing game. It’s not. I think there’s 4 pieces to commercial success in the market dynamic today, as Kevin said, selling on clinical value proposition, which we have 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. 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 smaller customers. And I think the last thing is clearly reimbursement status. And again, to reiterate, we go into Q4 with a very strong and differentiated commercial strategy with Gozellix. And we’re excited about that. We’re looking forward to it. Sales team is pumped.

Operator: Our next question comes from David Dai with UBS.

Xiaochuan Dai: Congrats on the quarter. I’m just curious about the Zircaix launch readiness. Maybe you can highlight some of the things you’ve been doing for Zircaix and how should we think about the launch in the first and the second quarter after approval on August 27?

Christian P. Behrenbruch: There’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, same referral physician base as Illuccix. So it’s a very straightforward pathway to the customer. We’re clearly focused on using our Illuccix customer base to seed that product launch. And I would say commercial team is ready to rock and roll on Zircaix. I don’t know if you want to add anything to that, Kev?

Kevin Richardson: 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 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.

Christian P. Behrenbruch: Yes. I mean we’ve had a lot — the expanded access program, the EAP has been a huge success. We’ve done a very, I think, well- orchestrated unbranded physician education campaign. So as far as we’re concerned, the market is ready for this product.

Operator: The next question is from Andy Hsieh with William Blair.

Tsan-Yu Hsieh: Congratulations on the performance. So for the BiPASS 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 outcomes, longer-term outcomes for patients pertaining to survival or treatment steps that you can really, really convey the value of taking this agent upfront?

Christian P. Behrenbruch: Yes. 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, 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 1 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 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 is 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 stay tuned, Andy, we’ve got more updates on that trial design coming down the pathway.

Operator: The next question comes from David Nierengarten with Wedbush Securities.

David Matthew Nierengarten: I just had one on the ProstACT study. Just around the parameters, you’ve recruited the patients. Kind of what are you looking for on the dosimetry and safety side? And when you think about the movement into the Part 2 of the study, is it still the plan to carry forward all 3 combinations? Or could that change in the future when you talk about the results from these first 30 patients?

Christian P. Behrenbruch: Well, things can always change based on data. But we — 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 specto dosimetry, a lot of patient visits involved, 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.

And the 3 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 1 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 3 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.

Operator: The next question comes from John Hester with Bell Potter.

John Hester: I want to just come back to the situation with PSMA pricing. I’m sure everyone on the call heard the comments from Lantheus 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?

Christian P. Behrenbruch: 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 is 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 life cycle management product. which, by the way, has innovative aspects in its own right.

Like 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 that — 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 life cycle management strategy to address it.

Operator: Today’s last question will come from Andy Hsieh with William Blair.

Tsan-Yu Hsieh: 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 ARTMS platforms?

Christian P. Behrenbruch: Well, on the node, 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 aluminum and fluorine together, it’s pretty violent coupling. And what you end up with is a metallized version of F-18. And it turns out that, that metallized version of F-18 is a drop-in replacement for gallium. So what it means is that you have the same targeting agent with the same chelator and you can interchangeably substitute either gallium or F-18. 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 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 gallium and F-18 and of course, continue that life cycle management. And PSMA-11is 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 F-18. And still, by the way, utilizing our well-trodden and well- understood distribution model.

Maybe, Kevin, you want to comment on physician preference?

Kevin Richardson: Sure. So as you know, we launched Illuccix 3 years ago and we’ve successfully taken over 1/3 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 Illuccix and our Gozellix plan through the marketplace. But what we do see is some stalwarts that have used F-18 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 from — in our life cycle management from Gozellix 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 product to do it through our distribution and commercial network.

Christian P. Behrenbruch: Yes. 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 F-18. Some guys drive the beamer, some guys drive the 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 Yes, I think we’re at the end of time anyway. Well, thanks — I just want to say thanks very much to everybody for your time today and I appreciate the opportunity to give you an update. Thanks very much.

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