Earnings Call Transcript - TLX Q4 2025

Operator, Operator

Good day, and thank you for standing by. Welcome to the Telix Full Year 2025 Results and Investor Webcast. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.

Kyahn Williamson, SVP of Investor Relations

Thank you, and thank you to everybody for joining us on this call this morning, this evening, wherever you are in the world. We launched our annual report and full year results on the ASX about 30 minutes ago. We also have the slides on the screen via webcast for you to see today. I'm just going to take you through a brief introduction and some disclaimer statements before handing over. If you just move to Slide 2. Very pleased to have on the call with us today, Chris Behrenbruch, our CEO and Managing Director; Darren Smith, our CFO; and Kevin Richardson, our CEO of the Precision Medicine business. I should also mention that we have Dr. David Cade, our Chief Medical Officer, on the line for the Q&A session. We'll be running through today our strategy, financial results, and update on our Precision Medicine and Therapeutics business. If you can move to the next slide, please. I am required just to give you an excerpt from our forward-looking statement disclaimer statement. So please note that on today's presentation includes forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that relate to, among other things, anticipated future events, financial performance, plans, strategies, and business developments. These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our filings with the ASX and SEC, including on our half-year annual report. You are cautioned not to rely on forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. Please refer to the disclaimer slide in the presentation for further information. With that, I'm very pleased to hand over to Chris to kick off the call.

Chris Behrenbruch, CEO and Managing Director

Thanks very much, Kyahn, and I hope that my audio is nice and clear, and I certainly appreciate the introduction. Before Darren Smith, our Chief Financial Officer, goes into the numbers, I thought a bit of strategic framing would be useful for investors to understand where the company is heading and, of course, our key accomplishments in 2025. Next slide, please, Slide 5. Over the last 12 months, we started to put the depth and execution around what has been a multiyear corporate development strategy. It's useful to think of Telix as a platform with these five major segments, as illustrated on this slide. Moving from left to right, first up of key focus is our therapeutics pipeline, which has grown significantly and now features three programs in pivotal studies, as well as several high potential earlier-stage programs in rare diseases. I'm going to come back a little bit towards the end of the presentation on this topic. Because of the explosive growth of activity in the radiopharma landscape, we have also pivoted to some extent to an internal innovation model alongside our business development activities. Clearly, when big pharma is willing to pay $1 billion for an asset that has been in a few mice, there's clearly an incentive to do in-house innovation. And so we now have a significant set of technical and clinical capabilities around fundamental R&D and discovery technologies. In the middle of this vision and the engine room of the commercial business today is what we call the Precision Medicine business. This is far more than just an ATM machine that throws off a couple of hundred million of cash each year. It's a strategic validation of the targets we develop our therapeutic drugs for. It is more robust and streamlined clinical trials because we can see where our drug goes, and it's an early opportunity to build deep relationships with the physician stakeholders that underpin the future of the business. Fourth, one can obviously look at sales and a commercial team simply as SG&A. We view it as building a specialty sales organization that very few companies have. Selling nuclear medicine is not selling a vial or a blister pack. It involves selling complex clinical workflows. And as our product portfolio expands, this is a strategic differentiator because it enables us to build depth with key referral physicians and drive preference towards our product. It's also fair to note that in the major markets, this is a significant financial investment that most of our competition, both present and emerging, cannot afford to undertake. Lastly, you can develop all the great ideas you want and convince people to buy them, but if you can't deliver them reliably every single day, you aren't going to succeed. In most industries, vertical integration is probably wasteful and doesn't offer much of a moat. In radiopharmaceuticals, where you are dealing with products that have shelf life of hours to days at most, there's a huge amount of market share ownership dynamic, intellectual property, and customer differentiation in how you deliver. This is why we have invested over $0.5 billion in the last years to better control our destiny and pave the way for high-value therapeutic products. Next slide, please. To do all these things, you need cash, and we have a very high-growth business that made a step change this year, both through organic growth of our Precision Medicine business and through acquisition. We expect all of our revenue streams to continue to diversify and grow in 2026 and beyond, and Darren will cover this off on guidance later in this presentation. Kevin is also going to frame this in terms of the core growth of the Precision Medicine portfolio, which is extremely exciting. The key point is we have a hyper-growth business, and it generates the cash we need to aggressively expand, further diversify our revenue and dominate the field. Slide 7, please. This slide puts the whole strategy into perspective. As I've already said, to deliver on our bold vision for being the dominant player in radiopharma, we need a cash-generative business. We have one, and we grew it significantly this year with revenues exceeding USD 800 million or over AUD 1.2 billion for anyone that prefers their greenback served with shrimp on the barbie. Our margins have remained extremely stable despite competition, and this excellent commercial performance enabled us to invest $0.5 billion into growing our product pipeline, funding the best commercial team in the industry, and building our infrastructure and supply chain. Think about that. $0.5 billion to grow the future value of the company from earnings without shareholder dilution. Telix is a very unique and valuable story. Moving on to Slide 8, please. Before handing over to Darren, I thought it would be useful to give you a condensed view of our priorities for 2026. I get a lot of feedback that Telix is complicated, but it really isn't. This year is about doing three things and hopefully doing them better than we did last year. One, we are going to continue to grow our core business around our approved products. We actually did get a new and innovative product approved by the FDA last year in Gozellix that also leverages the ARTMS isotope production acquisition. The launch of Gozellix has been successful and is not only growing our ASP and market share, it will pave the way for many future products through both the RLS network and partner distributors with Zircaix being the next prime example of this technology platform. Two, we have two new products to launch, Pixclara, which is known as Pixlumi in Europe. This is for glioblastoma and Zircaix for renal cancer. We understand the disappointment that these did not get approved last year, but this is the price of being at the forefront of innovation in new technology areas. While people are well aware, it has been a tumultuous period within the FDA itself, we also made certain we took valuable learnings from the experience. We have made extensive changes to the management team. We boosted our regulatory affairs capabilities, and these programs are in good shape for resubmission and approval this year. They are highly anticipated products and will become significant revenue streams, and we have not taken our foot off the gas pedal in terms of market readiness for these products. We are preparing to launch, and I want to make that very clear. Last of all, we have several very high-value clinical programs. This is not an exhaustive list. In fact, we have over 30 sponsored and collaborative studies running from early stage to pivotal trials. But these are the ones that are going to generate the greatest commercial and financial inflection points this year and are the priority in terms of our resources and R&D investment. I note that four out of five of these studies are pivotal or Phase III studies. We have imminent data point coming out on ProstACT Global, which we will take to the FDA to gain clearance to commence Part 2 in the United States. I remind you that the study has already progressed to randomizing patients ex-U.S. for Part 2 of the study and talk a little bit about this later in the presentation. Our BiPASS biopsy study will complete enrollment this year, and we expect to generate significantly enhanced revenue in 2027 as a consequence of this Phase III study. Our current late-stage clinical studies pave the way to our first therapeutic commercial inflection point likely in 2028. So these are not distant thoughts. They are all near-term catalysts. And I will come back at the end of the presentation to some of the broader sets of upcoming catalysts. Now, Darren, over to you for the numbers.

Darren Smith, CFO

Thank you very much, Chris. We have reported a 56% growth in revenue to $804 million, which aligns with our revenue guidance. Importantly, this marks our third consecutive year of double-digit revenue growth. Revenue from the Precision Medicine business has increased year-over-year.

Operator, Operator

Please check your mute button.

Darren Smith, CFO

This year, can people hear me now?

Operator, Operator

Yes, we can hear you.

Darren Smith, CFO

This aligns with our upgraded full-year guidance. Additionally, we are pleased to report our third consecutive year of double-digit revenue growth. Revenue from our Precision Medicine business rose by 22% year-over-year, with EBITDA increasing by 25% to $216 million, fueled by strong demand for Illuccix and the launch of Gozellix. The performance of our Precision Medicine division allowed us to self-fund and mitigate risks associated with our investments in research and development and commercial infrastructure for future growth. Although 2025 involved significant investment, we maintained a solid cash balance of $142 million through disciplined cost management. We have included a slide for our non-account investors that outlines the strength of our business model. It shows our revenue sources and their significance, as well as highlights our gross margin, with 94% originating from our Precision Medicine segment, totaling approximately $400 million. We allocate about half of the gross margin towards our commercial sales and marketing efforts, global supply chain, and corporate functions. Importantly, around $200 million, which is 25% of revenue, is available for either reinvestment in our development pipeline or recognition as operating profit. This business model, which delivers a quarter of revenue as operating profit for reinvestment or cash reserves, is quite appealing. In our traditional P&L, while I have discussed most financial highlights earlier, I want to emphasize some additional points. The group's gross margin stood at 53%, consistent with our earlier performance. We invested $157 million into product development, adhering to our 2025 guidance and focusing on our late-stage pipeline. General and administrative expenses fell from 17% of revenue last year to 12%, reflecting operational efficiencies achieved during our growth. Consequently, we recorded an adjusted EBITDA of $39.5 million, aligning with market expectations. Moving on to our Precision Medicine business, its financial performance is robust. It contributed an additional $113 million in revenue, indicating a year-on-year growth of 22%, alongside a 28% rise in operating profit and a 25% increase in EBITDA. This illustrates a high-growth segment capable of generating substantial funds for long-term value creation. Our sales and marketing expenditures facilitated the launch of Gozellix, the geographic expansion of Illuccix, and preparatory activities for Pixclara and Zircaix. If this were a standalone business growing at over 20% annually, its extrinsic value could reach up to eight times its revenue, representing significant value creation for shareholders. Regarding Telix Manufacturing Solutions, we've shared detailed insights on TMS in our half-year results for two reasons: to clarify the financial impact of the RLS acquisition and to offer transparency into the cost structure of the remaining TMS operations. RLS contributed positive EBITDA for the first 11 months after acquisition. At the remaining TMS facility, we increased our investments compared to last year to enhance operational activities for clinical and commercial supply. As we conclude a full year with RLS integrated, we plan to revert to reporting TMS as a single segment for commercial and competitive purposes. In terms of cash flow, we've consistently generated strong operational cash flows, which we reinvested in our pipeline. In 2025, our operational generation reached $206 million, enabling continued R&D investment. Excluding the contingent consideration payment of $52 million for Illuccix, we reported a net positive operating cash flow of $35 million. Our R&D investments are discretionary and can be adjusted based on commercial performance, allowing for effective cash management. Furthermore, we utilized available cash for targeted strategic investments like RLS, ImaginAb, and our FAP asset, resulting in a sound cash position of $142 million at year-end. As we look to our next growth phase, we are redirecting R&D investments towards our therapeutic pipeline, with plans for 2026 allocations between $200 million and $240 million, focusing on therapeutic development. Over the next 2 to 3 years, we aim to boost revenues by advancing assets from clinical development to commercialization and expanding our geographic reach and indications. We intend to reinvest profits back into the business over the next few years instead of prioritizing short-term earnings per share, emphasizing the building of long-term value. We recognize that rushing to optimize earnings may hinder essential strategic investments needed to realize our pipeline's full potential. Moving forward, our disciplined capital allocation approach, aligned with our corporate strategy, has evolved significantly in the past year. We maintain focus on four core areas: investing in R&D, optimizing commercial performance, pursuing strategic growth through M&A, and ensuring supply chain resilience and production capacity. These pillars will support our long-term growth. We have adhered to our strategy judiciously, ensuring our balance sheet maintains a solid cash buffer. Looking ahead, we are optimistic about momentum leading into 2026, expecting another year of over 20% revenue growth. Our full-year revenue guidance for 2026 is set at $950 million to $970 million, based on currently approved products in approved markets. This forecast excludes potential revenue from pending product approvals. This growth suggests up to 25% growth in our Precision Medicine business and a full year of RLS revenue. Our R&D investment is projected to be between $200 million and $240 million, contingent on achieving specific clinical outcomes and development milestones. In summary, we achieved another year of double-digit revenue growth, made strategic investments across the business, and maintained a prudent cash position. The year 2026 is poised to be pivotal, with numerous key milestones ahead. Our revenue guidance reflects our confidence in the business, and we commit to disciplined financial management throughout 2026. I will now pass it over to Kevin Richardson, CEO of Precision Medicine. Thank you.

Kevin Richardson, CEO of Precision Medicine

Thank you, Darren. My first slide, please. Last year, our Precision Medicine portfolio delivered $622 million in revenue, up 22% year-over-year. Importantly, we delivered sequential growth every single quarter. That includes Q3, our most challenging quarter, which was the first full quarter following the expiration of Illuccix transitional pass-through status and the transition to MUC, mean unit cost reimbursement for a subset of Medicare patients. Q3 allowed us to see the full impact of that change on the business. Even in that environment and despite ongoing competitive pressure, we still delivered 3% quarter-over-quarter dose growth and 1% sales growth. That performance speaks to our disciplined approach to business fundamentals and the strength of our customer-facing team. We continue to gain share based on clinical differentiation and operational reliability, our PSMA agents demonstrate fewer indeterminate bone lesions and higher inter-reader agreement compared to F-18 assets, driving confidence in clinical decision-making. We pair that clinical value with a highly specialized commercial organization that engages customers every day and consistently differentiates Telix in the market. Our reputation as an innovator also positioned us for a successful launch of Gozellix. Gozellix was FDA approved in April of 2025, and transitional pass-through status became effective in October, enabling a transitional pass-through supported full launch in Q4 of 2025. We are very pleased with the early uptake and our 2026 full year guidance underscores our strong conviction in the growth outlook for our Precision Medicine portfolio. Today, we are the only company with two PSMA agents on the market. This dual product strategy is a competitive advantage, offering different types of customers meaningful choice across economics and scheduling flexibility while reinforcing our commitment to meeting diverse clinical and operational needs. In short, resilient growth, clinical differentiation, disciplined execution, and a platform built for sustained growth. What does it take to win in a maturing PSMA market? Winning in a mature PSMA market is no longer about being first. It's about executing at scale. Clinical credibility is nonnegotiable. Products must deliver consistently high image quality, strong inter-reader agreement, and reliable detection at low PSA levels across all patient types. Incremental claims aren't enough. Confidence in clinical decision-making is what sustains adoption. Workflow integration matters. In a high-volume market, solutions must fit seamlessly into established clinical pathways, enable same-day imaging, and support high patient throughput without disrupting nuclear medicine operations. Reimbursement sophistication is a competitive advantage. Success requires multiple product strategies that give customers economic flexibility while navigating complex and evolving reimbursement frameworks over extended periods of time. Commercial infrastructure is a must. This is a contract-driven market that demands experienced field teams, market access expertise, compliance rigor, and long-standing customer relationships. These capabilities take a large investment in years, not quarters to build. Supply chain excellence separates winners from participants. Reliable, flexible dose production and delivery at scale, supported by high service nuclear pharmacy last mile experts is critical. There is no proven shortcut to mass market large volume coverage. Sustained investment fuels durability, indication expansion, lifecycle management, and camera technology advances all require ongoing clinical and operational investment to maintain leadership. In short, leadership in PSMA is earned through clinical trust, operational reliability, commercial scale, and disciplined investment, not novelty. We continue to execute our strategic plan to grow the Precision Medicine business by expanding our product offering, expanding our indications on those products, and expanding the geographies where we market those products. Global expansion is a priority for Precision Medicine here at Telix. Illuccix is now available in 17 countries with reimbursement secured, and we hold marketing authorizations in more than 24 markets. In 2025, we focus on country-by-country access. In '26, we pivot to driving uptake, particularly across key markets, including the U.K., France, Germany, Italy, and Spain. In China, we delivered strong Phase III results with 94.8% positive predictive value, including patients with very low PSA levels. We submitted the NDA to the regulators with our partner, Grand Pharma. And with prostate cancer incidence rising and PET/CT infrastructure expanding rapidly, China represents a significant growth opportunity. While in Japan, our 105-patient Phase III study is progressing well with the first patient dose. This positions us well in the world's second-largest pharmaceutical market where prostate cancer remains a leading cause of mortality. New products and new indications enhance our ability to take share and grow the market and Gozellix is off to a strong start, and we are focused on accelerating commercial momentum in 2026, and you can see that is reflected in our 2026 guidance. BiPASS is a Phase III study that represents the next wave of innovation, combining PSMA imaging, Illuccix or Gozellix, with MRI to improve diagnostic accuracy and potentially reduce or eliminate invasive biopsies. This is about moving earlier in the care pathway, reducing patient risk, lowering system costs, and expanding the total addressable market to include frontline biopsy candidates. We believe moving to the front line where patients are diagnosed will give us a competitive advantage, both as the lead PSMA in diagnosis but also in sequential scans that happen later on in the patient journey as physicians want to see consistency scan to scan. For Zircaix, we've completed two Type A meetings with the FDA and believe we have full alignment on key resubmission requirements. We are now focused on completing the agreed deliverables and documentation required for the resubmission. With breakthrough therapy designation, supportive ZIRCON-X data, and inclusion in major international guidelines, this remains a top priority for approval and launch this year. This is a really exciting and highly anticipated product. Moving on to our neuro platform. We are pursuing complementary submissions in both the EU and the U.S. TLX101-Tx was filed with the European regulators recently, and the U.S. submission will follow closely. As a reminder, the FDA has granted both orphan drug and fast track designation for Pixclara. Our commercial, medical, and supply chain teams are launch ready. Our expanded access programs serve patients and our customers very well, and they anticipate commercial use of Pixclara. In short, we built a global commercial platform, delivered successful launches, taken share, penetrated the available market, and advanced multiple late-stage assets in high unmet needs markets. We are entering our next phase of growth with momentum and discipline. So what does this strategy mean in terms of financial impact? Our current baseline business with some further lifecycle management, which we've talked about, should be able to sustain a 15% to 20% annualized growth. This partially reflects the growth of the field overall, as well as our ability to continue to capture market share as the size of the market expands. The recent addition of Gozellix certainly derisked this. With indication expansion in prostate cancer alone, particularly a major opportunity in the BiPASS study, this growth over the five years can be closer to a 30% CAGR. And then when you add in Pixclara and Zircaix, this growth rate defensively looks more like 40% compounded annual growth, especially with metastatic indication expansions that further drive procedural volume. In short, our current product strategy, which is fully baked from a clinical perspective, just needs to clear a few more regulatory hurdles as it represents future upside for the company. It is a direct consequence of the market presence we are building, the depth of our pipeline, and the quality of service we are able to deliver to the patients. This is really an exciting business with a bright future. The growth in Precision Medicine gives us the ability to finance the growth potential of our Therapeutics business. On that note, I'll hand it back over to Chris, to give you a bit of perspective on that.

Chris Behrenbruch, CEO and Managing Director

Thanks, Kevin, for the update, and congratulations on your team's success this year. It’s been a remarkable year of achievements. Moving on to Slide 25, this slide simplifies my opening remarks about a highly profitable and cash-generative business that, as Darren mentioned, would receive a very healthy revenue multiple. It operates as a stand-alone business, but it serves as our engine room. The future growth of the business will depend on how that cash is invested. Kevin has clearly demonstrated how the Precision Medicine business can expand significantly over the next five years through clinical, regulatory, and commercial milestones we anticipate achieving this year. I want to highlight that the growth trajectory Kevin discussed is tied to events being completed this year. It’s also vital to stress our commitment to manufacturing and supply chain. In the context of our Therapeutics business, this means more than just reliable and timely delivery. It involves R&D cost efficiency and, importantly, capturing intellectual property. Over the last decade, we’ve realized that using contract manufacturing organizations for product scale-up educates the ecosystem in a way that can empower competition, which we want to avoid. Therefore, particularly as our therapeutics advance to late-stage trials, this has become a strategic objective for the company. To clarify, while we do still utilize CMOs, we're increasingly addressing key intellectual property related to platforms, targeting agents, and specific isotopes in-house or with select partners. Moving to the next slide, this shows why this is the case. Kevin has already outlined the share of the Precision Medicine sector we believe we can address in the coming five years, and on a total addressable market basis, it's quite conservative. However, the therapeutics opportunity is estimated to be three to four times larger for the targets and indications we are already exploring. This doesn't even take into account the potential for indication expansion into new disease areas, such as those we are developing with pan-cancer targets like carbonic anhydrase IX and FAP. Therefore, the future of our theranostics strategy looks very promising. Moving to Slide 27, over the past five years, we have developed a robust pipeline focusing on key disease areas, which you will hear us refer to as multi-product concentration areas, similar to what we have done with Gozellix and Illuccix in Precision Medicine. Addressing major unmet clinical needs may require a multi-asset approach at different phases of clinical development or patient care, as well as well-planned combination therapies with standard medical oncology. This is already evident in the design of the ProstACT GLOBAL and IPAX-BrIGHT studies. There are three specific aspects of our pipeline I'd like to highlight. First, our theranostic approach has allowed us to establish deep relationships with referring and prescribing physicians in these disease areas, which is a competitive advantage. This depth of relationship has already started with our existing commercial products and will intensify in the coming year. Investors often see the Precision Medicine and Therapeutics sectors as adjacent, but they are quite distinct. Second, while we have several high-potential early-stage programs, we also have three late-stage programs in prostate, renal, and glioblastoma that are expected to generate significant data in the next 12 months. Given the company's current valuation, these programs essentially serve as a free option, but we believe the data and clinical foundation behind them are compelling. Most importantly, while the 2026 and 2027 financials will reflect the commercial growth of the Precision Medicine business, 2028 is when we anticipate launching our Therapeutics business. This is not far off. This highlights our focus on the targets, learning more about disease extent, exploring new patient populations, and ultimately expanding market size and share. For therapeutics, when they become available, the Precision Medicine business will provide a pathway. Despite some challenging but educational regulatory hurdles we've faced, our commercial imaging experience gives us the confidence that we can deliver on therapeutic programs moving forward. We've gained valuable insights this year, especially last year. Can you hear me okay? Moving to the next slide, as I mentioned earlier, we have multiple clinical studies in progress, both company-sponsored and in collaboration with key opinion leaders worldwide. The four major trials to monitor this year are outlined here. I won’t detail each one since this is an earnings call, but it’s important for shareholders to understand our research priorities and the associated development goals and catalysts. We are gathering a substantial amount of patient data this year, which is exciting given that we have three programs in pivotal studies. This is significant for both patients and shareholders, and it has required a great deal of work and investment to reach this point. Moving to Slide 29, a primary focus for both patients and shareholders is the ProstACT GLOBAL study. Recruitment for Part 2 of the study is moving forward nicely outside the U.S. Part 2 is streamlined compared to Part 1, which was a safety dosimetry run-in study required by the FDA for including U.S. patients in the randomized segment. Part 2 began last year after an independent data safety review confirmed that Part 1 data met safety criteria for progression. We will soon share the details of Part 1 alongside our FDA submission to request approval for adding U.S. patients to the study. We are eager to release these results and demonstrate the significant progress we are making, especially given the unique combination therapy design of the ProstACT GLOBAL study. Just to remind you, we will be releasing safety data from Part 1 on three standard of care combinations in the global study, along with comparative dosimetry data, which will be very interesting, particularly regarding the two androgen deprivation therapies used in the study. So this information is coming soon. Moving to Slide 30, before I summarize the upcoming catalysts, I’d like to show a montage of patient case studies that connects the company's strategy and demonstrates how integrated our Precision Medicine, Therapeutics, and Manufacturing operations are. This slide features four patients with advanced and challenging cancers. Daily, we witness how our development and commercial pipeline positively impacts lives. Sometimes this means gaining a better understanding of disease extent. Other times, it results in significant disease modification, as seen in the metastatic prostate and breast cancer cases on this slide. Additionally, there are glioblastoma or kidney cancer patients who experience disease stabilization or pain reduction, allowing them to resume work. These are the genuine outcomes of our research, delivering significant, life-changing results for patients. This motivates us and reinforces the importance of investing our resources into this future. The technology is effective and will continue to improve as we accumulate more clinical experience. I must also mention that, for the most part, the images you see here come from the companion diagnostic imaging agents we are developing, emphasizing that imaging technology is critical not only for diagnosing and staging patients but also in predicting and measuring disease control. Moving to the final slide, to conclude, this slide summarizes the upcoming year. It will be a significant year with numerous inflection points across our business. I won’t go through it point by point, but we have much to discuss in 2026, with the next major catalysts being the resubmission of Pixclara and Zircaix, along with the release of Part 1 global data. We are excited to work towards these important milestones for both patients and shareholders in the coming year. With that, I will pause and open the floor for questions.

Operator, Operator

Our first question comes from Laura Sutcliffe with Citi.

Laura Sutcliffe, Analyst

At the risk of potentially making myself a bit unpopular, I think we'd like to understand a bit more about when we might see some data for 591, the safety data. And perhaps given that you said you will disclose at the same time that you go to the FDA, whether the next steps are things that you need to do at Telix or whether you're waiting for the FDA to do something on their end to be able to get to that point?

Chris Behrenbruch, CEO and Managing Director

Thank you for your question, Laura. It's a valid inquiry. We have had an independent data safety review board evaluate the data under the clinical charter of the study and progress to randomization outside the U.S. However, to send the information to the FDA and make it public, we need to complete the clinical case report forms and finalize, control, and validate the data, as that's what the FDA requires. Once we have that data, which I have not seen yet, we will disclose it and submit it to the FDA simultaneously. We are not waiting on the FDA for anything; the remaining steps are on our end, and you won't have to wait long for the information.

Operator, Operator

Our next question comes from Tara Bancroft with TD Cowen.

Nicholas Lorusso, Analyst

This is Nick on for Tara. Congrats on the progress and the strong guidance for 2026. We were hoping that you can dive in a little more on what you've seen in the early innings of the two-product strategy for Illuccix and Gozellix and how you anticipate that will evolve this year to reach the 25% growth in the precision medicine revenue?

Chris Behrenbruch, CEO and Managing Director

Yes. Thanks very much for the question. Kevin, do you want to pick this one up for your wheelhouse?

Kevin Richardson, CEO of Precision Medicine

Thank you for the question. The two-product strategy allows us to effectively address the economic needs of HOPPS accounts and their preference for a reimbursed product compared to a non-reimbursed one. The changes brought by MUC, or Main Unit Cost, have impacted the reimbursement landscape and pricing within HOPPS accounts. By having a two-product company, we can better manage this customer type and the IDTF group, catering to their preferences for reimbursement pricing or more price-sensitive options. Additionally, we have a long-term perspective on the precision medicine business and specifically PSMA, considering how CMS may evolve and adjust reimbursement in the future. This approach provides us flexibility with ASP management as CMS potentially shifts towards the ASP reimbursement model, allowing us options without committing to a single product.

Operator, Operator

Our next question comes from Shane Storey with Canaccord Genuity.

Shane Storey, Analyst

Kevin, I'm going to stick with you, if that's okay. Question on Pixclara. Just maybe some descriptive piece, I guess, around the customer channel there. It's quite different from your PSMA urology presence. Is that potentially a first work example for how the Varian relationship might evolve? Just some thoughts on that, please.

Chris Behrenbruch, CEO and Managing Director

Kevin, are you there?

Kevin Richardson, CEO of Precision Medicine

Yes, I'll take that first, then, Chris. We're really excited about the opportunities with Varian, particularly focused on PSMA, Illuccix, and Gozellix. From a commercial standpoint, we have a specialized team dedicated to managing referrals from neurologists, as there are fewer sites performing PSMA prostate scans compared to those conducting neuro scans. This smaller team leverages existing relationships at the nuclear medicine level to drive patients toward the scanners. We also have a team that maintains connections on the reading end. The plan is to create a referral pathway into our established relationships within nuclear medicine. If a site does not offer Illuccix or Gozellix, having access to these sites still provides us a competitive advantage, allowing us to introduce more specialized drug technologies. Does that answer your question, Shane? Chris, do you have anything to add?

Operator, Operator

Our next question comes from David Stanton with Jefferies.

David Stanton, Analyst

I might be following a dead horse here, but I just want to make it clear and help you to make it clear. You'll be reinvesting earnings to get close to zero NPAT for F '26, F '27 and F '28. Is that what the market should be thinking going forward, please? I ask because it's a question I get asked the most.

Chris Behrenbruch, CEO and Managing Director

Yes, that's fine. No concerns, David. I'm glad you asked the question. While we aren't providing guidance beyond 2026, it's reasonable to expect that in 2026 and 2027, we will be reinvesting most of our earnings back into the company, aside from what’s necessary for risk management and maintaining a healthy balance sheet. This investment will be in various areas, including research and development, as well as expanding our commercial team. Additionally, we will continue to invest in infrastructure and capital projects to support the business. Therefore, achieving a profit this year and next is not our main focus.

Operator, Operator

Our next question comes from David...

David Bailey, Analyst

It's a follow-on from Dr. Stanton's question. Just from Darren, there was a clear comment there that I think that the investment in growth will consider the commercial performance. I think that was interesting from our perspective. Just as we look at the sales guidance for '26 and the R&D guidance for '26, should we think that if the commercial performance is at the upper and lower end of those ranges, the R&D will follow? As an extension of that, within the R&D spend, are the earlier stage clinical trials, are they the ones that would potentially be put on hold for a little bit to the extent that the commercial performance doesn't meet expectations?

Chris Behrenbruch, CEO and Managing Director

I can start, Darren, and then you can add anything if you’d like. We’ve chosen in this presentation to highlight the clinical studies that are the real priorities for the company, which include the five studies, one of which is the BiPASS study. We will also be investing in other clinical studies this year. If adjustments are necessary, they will be made outside of the five prioritized studies, which include the four therapeutic studies and the BiPASS study. We clearly expect that 2026 will be a strong year and do not anticipate any challenges in financing our R&D pipeline. However, as you have mentioned and as Darren has made clear, we generally view our R&D investment as discretionary and can make adjustments as needed. Darren, do you want to add anything? Okay, I’ll take that as a no.

Operator, Operator

Our next question comes from Craig Wong-Pan with RBC.

Craig Wong-Pan, Analyst

Just a question on the 25% growth in Precision Medicine. I was wondering how much growth was coming from markets outside of the U.S.

Chris Behrenbruch, CEO and Managing Director

Sure. I'll address that question first, and then maybe Darren can add anything I might have overlooked. Currently, since we only received our European reimbursements towards the end of last year, a very small percentage of our revenue comes from outside the U.S. In fact, 95% of our revenue is U.S.-based. We anticipate that this mix will change throughout this year as we expand into other markets, like Japan, which has a valuable advanced PET procedure code that is quite competitive internationally. However, for now, the vast majority of our revenue is generated in the U.S.

Operator, Operator

Our next question is coming from Andy Hsieh with William Blair.

Tsan-Yu Hsieh, Analyst

Chris, I want to ask you about the recent collaboration with Atley and Stanford, focusing on astatine-211. So in your pipeline, you have three alpha emitters: Actinium-225, you have lead generator that's in progress, and then now astatine having a California supply chain. So I'm curious about your view on this isotope, another short half-life. Just wondering about how it fits into your product portfolio.

Chris Behrenbruch, CEO and Managing Director

Yes. It's a bit of sort of outside of the major sort of activity area. But essentially, we do see value in alpha emitters. The majority of our late-stage programs, as you know, are beta-emitting isotopes. We think that they're going to be a workhorse for the foreseeable future, but we can see ALPHIX coming over the horizon. As you know, most of our clinical stage programs are with actinium. It's probably from a supply chain perspective, the lowest hanging fruit. We have one program, TLX102, which is with astatine that's in early clinical translation. We think that for applications where a targeting agent needs to cross the blood-brain barrier that radiohalogens are a better, perhaps a more practical pathway than a radio metal with a chelator. So we are exploring astatine mostly in the CNS setting. Then we do, as you know, have a lead generator that we've developed. It's a very novel and very compelling generator design that we think can be rolled out for large-scale lead production. We currently today do not have any clinical programs using Lead-212, but we have a number of preclinical programs that we expect to take into patients by the end of this year that are not currently disclosed, and they have the potential to use Lead-212. We are exploring several different isotopes. But I think as a company, we've elected to put a modest proportion of our R&D expenditure into understanding the future landscape of alpha because we think it has some potential. I hope that answers your question.

Operator, Operator

Our next question comes from David Dai with UBS.

Xiaochuan Dai, Analyst

Just on the gross margin for the business, it seems like it's remaining stable at 53%. But then the RLS business, the gross margin has been quite poor. So just thinking about the gross margin for RLS business moving forward, what are some of the key drivers of gross margin expansion for the RLS business that you can provide?

Chris Behrenbruch, CEO and Managing Director

I want to clarify that when we report the RLS segment, it strictly pertains to third-party products, which are mostly general nuclear medicine products, not Telix products. The operating costs for RLS are primarily covered by these third-party products, making it a subsidized manufacturing infrastructure. Telix products that pass through the RLS network are included in the reporting for precision medicine. Therefore, the RLS gross margins being low is unrelated to Telix's product portfolio. RLS margins are lower because they deal with standard, commoditized nuclear medicine products. Last year, we reported an average margin that surprised many, as it dropped from mid-60s to mid-50s or low-50s margins across all products, including RLS products. Does that make sense?

Xiaochuan Dai, Analyst

Yes, that makes sense. Yes.

Chris Behrenbruch, CEO and Managing Director

Don't be sidetracked by RLS. The most important thing is that when we put our products through RLS, the gross margin number we report for the Precision Medicine business is around mid-60%. That above-the-line cost is our distributor margin, which is different when we run a product through our own pharmacy network. It's crucial for us to maintain key distribution partnerships in important markets, so we do incur that above-the-line cost. However, when we produce a product that goes through our nuclear pharmacy network, the gross margin changes significantly. You should expect to see that as a larger share of our product volume goes through our in-house pharmacy network, the gross margin has the potential to improve and approach 70%.

Operator, Operator

Our next question comes from Andrew Paine with CLSA.

Andrew Paine, Analyst

You mentioned that success in the PSMA market relies on executing at scale, and we've observed your growth and the challenges you've faced there. Can you clarify how strong your competitive advantage is, especially with potential competitors emerging? Furthermore, could you elaborate on the advancements in camera technology and their impact on the sensitivity of PSMA imaging, which may not be fully recognized?

Chris Behrenbruch, CEO and Managing Director

Well, I think Kevin has done a great job of running through what the competitive barriers to entry, and there are multiple. I mean it's not just product, it's also clinical, it's also manufacturing, and supply chain. So I'm not sure what competitor you're talking about that's coming immediately on the horizon. But nonetheless, we see those as, I mean, pretty well enumerated sort of barriers to entry for competition. On the topic of camera technology, generally speaking, we've seen a step change in sensitivity on PET cameras over the last three to five years because of the demand for PET imaging, not just in prostate cancer, but across a whole lot of indications, including neuro-oncology, neurodegeneration, cardiovascular disease. We're seeing a lot of camera installation going in, and the next generation of scanners are in order of magnitude more sensitive. And so that just means that we have to keep abreast of it. We need to make sure that we're running clinical trials and clinical studies that demonstrate the improved utility. We are clearly detecting disease early and earlier. I mean, we have our most recent studies that were done in China, for example, with absolutely state-of-the-art scanners because they're brand-new scanners. We're seeing PSA levels down to fractions of a nanogram per ml. And so the camera technology is part of the complementary story to tracer development that should not be forgotten about. I think I'll pause there in terms of that particular topic. There isn't too much more else to say. Is there another question?

Operator, Operator

Our next question comes from Melissa Benson with Barrenjoey.

Melissa Benson, Analyst

So Kevin mentioned you had a full alignment on the agreed deliverables with the FDA for the...

Chris Behrenbruch, CEO and Managing Director

Melissa, I'm sorry, I can't hear you. Now I can hear you. Go on.

Melissa Benson, Analyst

I'm sorry. So I think Kevin was mentioning there was alignment on the agreed deliverables with FDA, per the K. So I was just wondering if there's anything you can share regarding what those agreed deliverables are, but specifically, if there's any new clinical data required or if it's more preclinical analytical data only?

Chris Behrenbruch, CEO and Managing Director

Yes. Most of the CMC remediation topics are around laboratory documentation, manufacturing documentation, and process documentation. We do have a deliverable to the FDA around comparability between the research grade material that we used in the Phase III trial and the commercial scale-up material. But we have that data set well in hand, and it's not a material time delay to the resubmission.

Operator, Operator

Our next question comes from Steve Wheen with Jarden.

Steven Wheen, Analyst

It's Steve here. So my question was just a bit of an extension of some of the others. But I guess for Kevin, I'm just trying to understand the European market with regards to Illuccix and Gozellix, I guess. Just they've been approved for some time. The launch in the U.S., obviously was incredibly rapid. And just trying to understand what's holding it back or slowing it to not really be much of a feature for your growth in the next 12 months?

Chris Behrenbruch, CEO and Managing Director

Kevin, I can start and then maybe you can finish. It's not that it's not a feature, but the European market has a very different reimbursement landscape. In the U.S., there is a much quicker process between product approval and reimbursement, whereas in Europe, there can be delays of nine to twelve months between approval and reimbursement. Material product sales cannot occur until reimbursement is in place. Also, reimbursement is typically at the individual product level in most countries rather than across a class. Therefore, without reimbursement, there are no significant sales. Regarding the traditional EU five countries, we have only recently obtained reimbursement in some of them. Kevin, would you like to add anything?

Kevin Richardson, CEO of Precision Medicine

Yes, there's very little other color to add in my prepared remarks, which was really 2025, the international team under that direction was really focused on gaining market access through reimbursement. And now we in that EU five, the plans now are to execute those market launches. And so you'll see that as we continue to grow in 2026 as we execute against that launch. But Chris is right, each country is different, each product is different. So it takes a bit to get that approved in the system and then begin the launch. So we're in the midst of that right now.

Steven Wheen, Analyst

Can I just ask an unrelated question just with regards to your R&D, the expensing of Zircaix through the R&D line, is there a shelf life for that particular inventory just with regards to just noticed your comment that there is the potential once it's approved by the FDA that, that could then come back and be backed out of the P&L?

Kevin Richardson, CEO of Precision Medicine

Yes, that's right. That's our expectation. And the shelf life goes far beyond the launch time of the product.

Operator, Operator

Our next question is a follow-up from Shane Storey with Canaccord Genuity.

Shane Storey, Analyst

Sorry for extending the time, everyone. My question was going to come off the back of Melissa's question actually on Zircaix and except everything you've just said there. But just as far as how we should think about the FDA's review phase once the resubmitted BLA is accepted, we've been sort of assuming six months. I just unsure how the breakthrough status and priority review might influence that, if at all?

Chris Behrenbruch, CEO and Managing Director

Yes. We don't know yet for Zircaix. For Pixclara, we have a reasonable idea that it's going to be a rapid review also because it's a single issue CRL. We could imagine for the Zircaix review because there are a number of issues that it may take longer, but we haven't received guidance yet from the FDA on this topic. We will be engaging with the agency shortly on this topic as we are preparing to resubmit, but we won't know that information for a little bit when it comes to Zircaix. No worries. But I do note that it has a breakthrough designation. And I actually want to compliment the agency. They've been highly engaged, very helpful, very proactive. They gave us a lot of extra time around the Type A meeting that they really didn't need to do. So we feel like it's a pretty good collaboration, and we're working with the agency towards the drug approval and nothing less than that. Okay. I think I have a feeling that we're wrapping it up there. I don't know if there's any more questions coming through.

Operator, Operator

We do have a final question, a follow-up from David Stanton with Jefferies.

David Stanton, Analyst

Saving the best for last. Chris, just I note that you've talked to a Part 2 interim analysis in calendar '26. I wonder if you could sort of give us any kind of timeline as to when that might be? Is it the third quarter? Is it the fourth quarter? What should we be thinking there?

Chris Behrenbruch, CEO and Managing Director

Yes. Obviously, I get increasingly reluctant to estimate timelines on clinical trials because I like to be precise to the day or to the week rather than to the quarter. But right now, the Part 2 study is recruiting really nicely. We're seeing good site expansion and getting plenty of patients consented into the study. That interim analysis is based on about 80 or 90 events, I don't know the exact number, somewhere around that. And we would expect that, that should lead based on the current recruitment trajectory for some time in Q4 of this year for that futility analysis to read out. So that's the reason why we have it sitting there in the calendar for this year. Well, I think that was the last question. I just want to apologize profusely to all the attendees for the audio challenges we've had today. It's a new conference provider. I'm not sure we'll be using it again in the future. But I just wanted to thank you for your questions and for your attention. Obviously, if there are follow-up questions, we'll be happy to receive them directly and follow up in due course. Thank you for your time today.

Operator, Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.