Telix Pharmaceuticals H1 2026 Earnings Call Transcript

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Provided by Quartr
August 19, 2026

Key Takeaways

  • Positive Sentiment: Telix reported strong H1 performance, with revenue up 22% year over year to AUD 477 million, EBITDA up 146% to AUD 52 million, and net profit after tax of AUD 38 million. Precision medicine sales rose 27%, driven by continued Illuccix growth and the successful Gozellix launch.
  • Positive Sentiment: The company maintained its FY2026 revenue guidance of AUD 950–970 million but expects to finish near the upper end, with precision medicine growth expected to exceed 20%. Cash increased to AUD 252 million following a convertible-bond refinancing, supporting further investment.
  • Positive Sentiment: Telix highlighted multiple near-term catalysts, including a September 11 U.S. PDUFA date for Pixclara, an expected Zircaix resubmission within one to two months, and continued progress toward launches in Europe and other international markets.
  • Positive Sentiment: The BiPASS phase III study has nearly completed enrollment after rapid recruitment, and management believes a positive result could approximately double the PSMA imaging market by moving scans into the pre-biopsy setting and reducing unnecessary prostate biopsies.
  • Neutral Sentiment: Telix is advancing three pivotal therapeutic programs, including ProstACT Global/TLX591, TLX101 for glioblastoma, and TLX250 for renal cell carcinoma, while increasing FY2026 R&D guidance to AUD 230–270 million. Management emphasized substantial reinvestment today rather than maximizing near-term earnings, leaving execution and clinical outcomes as key risks.
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Earnings Conference Call
Telix Pharmaceuticals H1 2026
00:00 / 00:00

Transcript Sections

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Kyahn Williamson
Senior VP of Investor Relations and Corporate Communications at Telix

Good morning and good evening, everybody. My name is Kyahn Williamson, SVP of Investor Relations and Corporate Communications at Telix, and it is my pleasure to welcome you today to our H1 2026 interim results presentation and call. You will have seen our documents lodged on the ASX earlier this morning. Next slide, please. Today on our call, we will be joined by Dr. Christian Behrenbruch, Managing Director and Group CEO, Darren Smith, our Group Chief Financial Officer, Kevin Richardson, CEO of the Telix Precision Medicine business, and Dr. David Cade, Chief Medical Officer. Following prepared remarks, we will open up the call to Q and A, starting with calls on the conference line. If we do not get to your questions during the call, we will respond to you after the call is finished. Just as we move to the next slide, please.

Kyahn Williamson
Senior VP of Investor Relations and Corporate Communications at Telix

Just a brief notice that please note that 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, assumption, and expectations of future events that are subject to change and involve risks and uncertainties that may cause the actual results to differ materially from those contained in forward-looking statements. These and other risks are described in our filings with the ASX and SEC, including our half year and annual reports. You are cautioned not to rely on these forward-looking statements, which are made only as of today's date, and the company disclaims any obligation to update such statements. Please refer to the disclaimer slide included in the presentation accompanying this webcast for further information.

Kyahn Williamson
Senior VP of Investor Relations and Corporate Communications at Telix

With that, I would now like to hand over to Christian.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Thank you very much, Ky. Good morning and good evening, everyone. Before I go into our strategic priorities for this year, let me take a moment to remind everyone about our competitive advantages and what it takes to lead this field. We are a pure-play radiopharmaceutical firm, and our strength is based on five core pillars of activity. Firstly, our therapeutic pipeline is highly differentiated and built around significant unmet medical need. We are advancing innovative therapies in areas that have seen little to no innovation for decades with either first-in-class or best-in-class candidates. Our portfolio is diversified with multiple shots on goal, further de-risking commercial success. We have also built in-house R&D capabilities that enable us to develop and optimize both targeting agents and their radioactive radioisotope payload tailored to the specific biology of each disease.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

As we have said many times before, we are agnostic to the targeting agent and radioisotope. We let science guide these decisions. We are not wed to a narrative around a specific platform or approach. Earlier this year, we announced a collaboration with Regeneron that combines our expertise in radiopharma with Regeneron's leadership in biologics and antibody engineering. This highly complementary partnership positions us to accelerate the development of next-generation candidates and really puts us in a good place to lead in the therapeutic space in the future. Our precision medicine business is our third core pillar that is generating close to AUD 1 billion in revenue and enables us to reinvest this significant capital into the business to continue this growth trajectory. The precision medicine business has enabled us to establish a presence across global markets, where we continue to strengthen and guide our clinical activity.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

We have built a specialist commercial organization, a team that represents some of the strongest talent in the industry and is our fourth core pillar in differentiating us from competition. We have invested and continue to invest in our manufacturing and supply chain capabilities. The RLS transaction last year has significantly strengthened our control over the entire value chain, from production and quality assurance to the final dose delivery. It has brought us closer to the customer, enabled us to meet growing demand, and positioned us well to deliver therapeutic solutions down the road. Earlier this year, we shared three areas of focus, and I wanted to share the progress we are making against them. On the commercial front, we delivered approximately AUD 390 million in precision medicine sales, up 27% year-on-year. This is driven by the successful launch of Gozellix and continued growth of Illuccix.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

We are now tracking towards the upper end of our guidance, very close to AUD 1 billion in revenue. On the regulatory front, we have completed the submissions for Pixclara and Pixlumi in both the U.S. and Europe, with a PDUFA date now assigned in the U.S. of September 11. In terms of Zircaix, we received a corrected Complete Response Letter from the FDA, and the resubmission process is tracking against agreed timelines with the agency. We are putting the final touches on the package and ensuring that the resubmission fully addresses all outstanding items before filing, particularly third-party manufacturing deficiencies. This, of course, remains one of our top priorities for the year. On the therapeutics front, we have advanced three phase III candidates with full alignment with the FDA on part two for TLX591, our prostate cancer therapeutic, and started dosing patients for the other programs.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

David will go into this in more detail later in the presentation. The BiPASS biopsy phase III study is close to completing the targeted enrollment. The study has the potential to significantly increase the market and change the treatment paradigm in prostate cancer, and Kevin will share more on this game-changing program later in the presentation. Next slide, please. This slide illustrates our growth since 2024. As you can see, we have continued to develop the business, doubling the revenue since the first half of 2024. We delivered approximately 22% year-on-year growth, really eclipsing the growth of peer firms in recent financial results. We have demonstrated market leadership with two approved and reimbursed products, strong market penetration, and continued commercial execution. This really shows that our strategy works. The strategic transactions and R&D investments we have made are starting to pay off.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

The acquisition of RLS has also, as I've mentioned, further diversified our revenue streams and allowed us to maintain a stable third-party revenue stream since the acquisition of last year. We are committed to building out full product suite capability of RLS as an independent pharmacy network, including third-party product solutions that benefit from one of the most capable distribution networks in North America. As our global footprint has grown, so has our manufacturing and distribution network. This is particularly important in the field of radiopharma, where the half-lives and shelf-lives products require just-in-time manufacturing and a highly specialized supply chain to avoid disruptions or delays to patients. Last year, we expanded manufacturing and distribution capabilities in the U.S. and Japan, and these are investments that are critical to establish the foundation for a scalable infrastructure in the future.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

This year, we also opened up our new translational research site in Melbourne. This site offers an integrated platform housing R&D and patient care under one roof, and is designed to accelerate the development and delivery of theranostics through rapid de-risking and proof of concept development. This is really a capability that's unlike any other found elsewhere. We continue to make CapEx investments at various sites, including Seneffe, Yokohama, and at RLS, where we're building out the manufacturing capabilities for therapeutics delivery, very important, clearly, to our next phase of growth. This includes increasing clean room capacity, installing cyclotrons, and making sure that the RLS network is equipped and licensed to do things like dispense lutetium therapeutics drugs. With that, I'll hand over to our CFO, Darren Smith, who will provide an update on the financials. Over to you, Darren.

Darren Smith
Group CFO at Telix

Thank you, Chris, and hello, everyone. Moving to the financials for the first half of this year. We reported revenue of $477 million, up 22% compared to the first half of 2025. This was achieved through robust commercial execution that delivered strong demand on our precision medicine products. Kevin will speak to this later in the presentation. EBITDA improved 146% year-on-year to $52 million, and net profit after tax was up to $38 million, reflecting strong business performance and continued control of operating expenditure. Our R&D investments represented 26% of our revenue, focused on accelerating near-term growth opportunities and developing our late-stage assets. Gross margin for our precision medicine business was 65%, an improvement of 1% year-on-year. We also successfully increased our cash balance to $252 million through the refinance of our convertible bonds, a successful transaction with better terms. We are well-placed with the financial capacity to accelerate growth.

Darren Smith
Group CFO at Telix

Turning to our income statement. As previously mentioned, we delivered double-digit growth both on the top line and the bottom line of our group P&L. Gross margins for the consolidated group improved 2% to 55%. This was supported by our strong growth on the top line, and we continued our healthy investment into our product development pipeline with a focus on near-term commercial opportunities and phase III clinical studies for a number of our therapeutic candidates. At the same time, we have maintained a disciplined approach to managing our operating expenditure, reducing it by 1% as a percentage of sales. Moving to our Sankey diagram. This clearly illustrates how we generate our funds and how they flow through the business.

Darren Smith
Group CFO at Telix

On the left side of the chart, it shows that in the first half of 2026, Telix generated revenue and income of AUD 523 million from our precision medicine business, CMS, Regeneron collaboration. The middle sections of the chart show that after covering cost of sales, OpEx, and finance costs, Telix reported a commercial profit of AUD 153 million, a 29% return on revenue and income generated, demonstrating the strength of the business. I want to reiterate that we have a highly profitable business with strong cash-generating capabilities. But as we have said many times, rather than maximizing near-term earnings, we are reinvesting capital into growth opportunities that will drive long-term shareholder value. We continue investing our earnings into the business for the remainder of this year and the next year.

Darren Smith
Group CFO at Telix

From this financial position, and as illustrated on the right side of the Sankey graph, we have made a decision on how much we invest into our R&D development and how much we bank as profit. Again, I cannot overstate the importance of the investment we are making today and the significant value that will drive in the long term. Next slide, please. Our precision medicine business continues to deliver double-digit growth, up 27% year-on-year from our differentiated products. Both Illuccix and Gozellix continue to drive strong demand across all market segments. Kevin will comment on this later. Gross margins are 65%, improved 1% year-on-year, driven by a disciplined pricing in manufacturing and distribution efficiencies. R&D investment increased year-on-year, driven by Pixclara, Zircaix, and BiPASS investments that will drive meaningful commercial uptake near-term.

Darren Smith
Group CFO at Telix

As Chris mentioned, we are significantly expanding our market across our portfolio, including prostate cancer imaging with BiPASS, brain metastases imaging from Pixclara, and renal mass imaging with Zircaix. Overall, that is in excess of 1 million scans that our customers will meaningfully benefit from. EBITDA grew 26% year-on-year to AUD 132 million. While we expect healthy EBITDA growth to remain, we remain committed to reinvesting the capital into the business in our pipeline, as I've mentioned earlier. Now moving to TMS. TMS generated third-party revenues of AUD 89 million, up 10% year-on-year by RLS. Since the acquisition of RLS, we have maintained a stable base of third-party revenue, further diversifying our revenue streams. We have also successfully been driving manufacturing and supply chain efficiencies for RLS by selling a higher proportion of our own assets through them.

Darren Smith
Group CFO at Telix

Internal revenues of AUD 57 million improved 70% year-on-year, representing Illuccix and Gozellix distributed through RLS. This means RLS is now our second-largest distributor of our products. We also continue to invest in our manufacturing sites at Seneffe, Yokohama, and selected RLS sites to ensure the global readiness to deliver our precision medicine and therapeutic candidates. Next slide, please. Our full-year revenue guidance of between AUD 950 million and AUD 970 million is maintained for 2026. We do, however, expect that to land at the upper end of the range, and we expect continued growth in excess of 20% year-on-year of our precision medicine business. Please note our full-time guidance does not reflect unapproved products, providing the potential for upside.

Darren Smith
Group CFO at Telix

We updated our R&D guidance to a range of AUD 230 million-AUD 270 million, primarily reflecting new investment across the development program discussed today, as well as our collaboration with Regeneron. Given the strength of our commercial business, we believe that we are well-positioned to support and accelerate near-term growth. I will now hand you over to Kevin Richardson, our Precision Medicine CEO.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

Thank you, Darren. First slide, please. As we have talked about before, we have continued to grow our PSMA business through a very pragmatic strategy focused on clinical differentiation and customer economics. We launched our two-product strategy to address the different needs of our two major customer segments, and that has proven to be the right approach. As a result, we have now delivered growth every quarter, with our strongest growth rates coming in the two quarters following the launch of Gozellix. That performance has enabled us to increase both unit share and revenue share for the 16th consecutive quarter. In the second quarter, we delivered $202 million in revenue, up 9% quarter-over-quarter, following $186 million in the first quarter, which was up 16% quarter-over-quarter. Those results reflect not only our continued market demand but also strong execution by our commercial, operational, and customer-facing teams.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

The launch of Gozellix has been very successful. Demand was strong from day one, and the adoption we have seen reinforces that our two-product strategy is delivering exactly what we have intended. More importantly, it positions us well to continue innovating in the PSMA market with programs such as BiPASS and Outfloor as we expand our ability to meet the evolving needs of physicians and patients. At the end of the day, demand for our products comes down to a few things that we work on every day. We meet customers where they are. We provide a high level of service and reliability. We clinically differentiate our products. We make them easy to order. We deliver on time, every time. We maintain a consistent pricing strategy, and we invest heavily in education around both the science and the reimbursement of PSMA imaging. That combination continues to matter.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

Our PSMA imaging agents have demonstrated fewer indeterminate bone lesions and higher inter-reader agreement compared with F-18-based agents, giving physicians greater confidence in clinical decision-making. When you combine that with the clinical performance and operational reliability and strong customer support, it continues to drive adoption across the market. Next slide, please. Moving on to global expansion. We continue to execute well internationally with our PSMA portfolio now launched or initiated across 24 countries. At the same time, we are making progress in two of the most important pharmaceutical markets in the world, China and Japan. In China, we submitted our NDA earlier this year and are awaiting review by the NMPA. In Japan, we have completed enrollment in our registration-enabling study, one of the fastest recruiting studies of its kind, with more than 100 patients enrolled.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

We are now preparing our NDA submission while also awaiting feedback on conditional approval, which could support an accelerated path to market. These are important milestones because China and Japan represent two of the largest pharmaceutical markets globally and significant opportunities for Telix over the long term. More broadly, our international expansion strategy is about much more than near-term diagnostic revenue. Every market that we enter allows us to build relationships with regulators, payers, physicians, and health systems while establishing the commercial and operational infrastructure we need for future therapeutic launches. In many ways, the precision medicine business is creating the foundation that will support the broader Telix portfolio for years to come. Next slide, please. Moving on to Pixclara and Zircaix, our two most important near-term launches. Starting with Pixclara, we have made significant progress over the last several months.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

As you have heard, we have been assigned September 11th PDUFA date in the U.S. and have also submitted Pixlumi in Europe. In addition, Pixclara has now been included in both NCCN and international clinical guidelines, further validating the importance of this imaging agent and the need it addresses. With the regulatory submissions behind us, our commercial, medical affairs, market access, and supply teams are launch-ready and positioned to move quickly upon approval. What is particularly encouraging is the feedback we are receiving from the market. Our research continues to indicate strong physician interest and a high level of awareness of the unmet need. We are also continuing to expand the opportunity for Pixclara. Earlier this year, we announced an IND submission in brain metastasis, an indication with a substantially larger addressable patient population than our initial target indication, and one that further demonstrates the platform potential of this asset.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

Now turning to Zircaix. As a potentially first-in-class radiolabeled biologic to reach the market, it underscores both the significance of this imaging agent and the substantial unmet need in clear cell renal cell carcinoma. Importantly, our confidence in the opportunity remains unchanged. Zircaix has received Breakthrough Therapy designation and Fast Track designation. It is supported by strong ZIRCON clinical data package and is increasingly recognized within major international clinical guidelines. As a result, Zircaix remains one of our highest strategic priorities for 2026, and we remain fully committed to bringing this product to patients. So when you step back, both Pixclara and Zircaix are first-in-class imaging agents addressing areas of significant unmet clinical need and further strengthening Telix leadership in precision medicine imaging.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

Zircaix is particularly important as the first radiobiologic imaging agent to help establish a regulatory pathway for this emerging class of products, creating opportunities not only for Telix, but the future of molecular imaging more broadly. Next slide. Moving on to the current state of the PSMA market. Today, the PSMA imaging market is over 600,000 annual scans and is estimated to be approaching 2/3 penetrated. The majority of scan volume is concentrated in biochemical recurrence, with initial staging representing the second-largest indication. We also have approval for patient selection for patients receiving radioligand therapy, although this remains a relatively small contributor to the overall scan volumes. And we have discussed previously, there are opportunities to continue expanding utilization through guideline updates, increased physician adoption, and additional clinical evidence, and treatment response or monitoring indications.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

However, those opportunities are largely incremental and not expected to fundamentally change the size of the market. So while we continue to see growth and market expansion, the current PSMA market remains primarily driven by biochemical recurrence and staging, which together account for the majority of scans performed today. Next slide, please. Moving on to BiPASS. BiPASS has the potential to fundamentally change where PSMA imaging is used in the prostate cancer journey. Today, most PSMA imaging is performed at initial staging following biochemical recurrence. BiPASS could move PSMA imaging to diagnosis, bringing it to the very beginning of prostate cancer diagnosis, which has the largest patient population. If successful, we believe BiPASS could approximately double the existing PSMA imaging market by creating a new pre-biopsy market segment for Telix PSMA.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

As we've discussed before, approximately 800,000 prostate biopsies are performed annually in the U.S., with roughly 75% proving negative. BiPASS has the potential to reduce unnecessary biopsies while improving confidence in patients who ultimately proceed to biopsy. In addition, up to 200,000 patients delay or decline core needle biopsy each year because of its invasive nature. We believe patients are increasingly seeking less invasive approaches to prostate cancer diagnosis when supported by strong clinical evidence. Importantly, our confidence in BiPASS is supported by PRIMARY and PRIMARY 2 studies, which demonstrated that PSMA PET combined with MRI improved prostate cancer detection and showed the potential to reduce unnecessary biopsies. Strategically, BiPASS is important because it has the potential to anchor Telix PSMA at the beginning of the patient's prostate cancer diagnosis.

Kevin Richardson
CEO of Telix Precision Medicine at Telix

If a physician adopts BiPASS, we believe they will increasingly prefer to use the same PSMA imaging agent throughout the patient's cancer journey, from diagnosis through staging, reoccurrence, and ongoing monitoring. Consistency of imaging and interpretation becomes increasingly important as the patients move through the continuum of cancer care. That's what makes this opportunity so compelling. BiPASS doesn't simply expand the market, it has the potential to redefine and redistribute it. Through scientific innovation and clinical evidence, Telix has the opportunity to create and lead a new category of PSMA imaging in the pre-biopsy setting, possibly displacing the existing indications over time. Advancing science that reduces unnecessary procedures, reduces risk, and increase in patient outcomes is true market leadership. With that, I'll hand it over to our Chief Medical Officer, Dr. David Cade.

David Cade
Chief Medical Officer at Telix

Thanks, Kevin. What a great opportunity. Next slide, please. This is our pipeline slide, and as you can see, our two primary areas of focus are within urologic and neurologic oncology. Within urologic oncology, we have our two late-stage programs in prostate and kidney cancer, but also follow on alpha therapy candidates in earlier stages of development. Looking at neuro-oncology, which is our other key area of focus, this is a field in which new drug innovation has really largely been stagnant over the past couple of decades. Here, against that background, we have a phase III candidate, TLX101, that's shown promising data to date, as well as an alpha therapy candidate utilizing astatine, also in early development.

David Cade
Chief Medical Officer at Telix

Within our other tumors domain, we are exploring different targets, including our TLX400 candidate, targeting fibroblast activation protein, or FAP, that is expressed within the tumor microenvironment across a very broad range of tumors. Therefore, this asset has pan-cancer potential. I would like to also briefly mention the imaging agents and how we think about these. For every therapeutic candidate, we develop an imaging agent, and in many cases, these are true theranostic pairs. With imaging agents developed at the forefront, we generate significant clinical data before making additional investment decisions in the corresponding therapeutic program. By the time we advance a therapeutic candidate, we have already developed a strong understanding of its biodistribution and its selectivity for the intended target, which significantly addresses the level of risk in the therapeutic development pathway. Let us go to the next slide, please.

David Cade
Chief Medical Officer at Telix

On this slide, I wanted to highlight a few programs that we are focused on and where we have made significant progress through the first half of this year. Starting with ProstACT Global, this is our phase III candidate for metastatic castrate-resistant prostate cancer. We recently announced that the FDA had completed its review of the safety data from part one of the study, and that we have also fully aligned with the FDA on the protocol design for part two of the study. Essentially our next step is to amend the IND that we have and align the regulatory submissions for the U.S. with the European Medicines Agency. Outside of the United States, we are also pleased with the progress we are seeing in part two of ProstACT Global.

David Cade
Chief Medical Officer at Telix

We are currently enrolling patients in seven countries, and we look forward to providing an update on the pre-planned interim analysis of radiographic progression-free survival, which is the primary endpoint, when that becomes available. Remembering that this is a milestone that is event-driven, in other words, needing 81 disease progression events to trigger this first analysis. Before I move away from prostate cancer, I would also like to highlight TLX597, our next-generation small molecule candidate that has shown some promising early data. We presented some of that data earlier this year, demonstrating a very low radiation dose to the salivary glands and the kidneys, while at the same time delivering a high dose to the tumor. This favorable dosimetry profile, high to tumors and low to normal tissues, makes it an ideal candidate in the early metastatic hormone-sensitive prostate cancer setting.

David Cade
Chief Medical Officer at Telix

There are currently two phase II studies ongoing where enrollment is completed in OPTIMAL-PSMA in metastatic castrate-resistant prostate cancer. We have now also started dosing patients in OPTIMAL-e in metastatic hormone-sensitive prostate cancer. We are also advancing TLX090 in a phase I study for the palliation of bone pain from skeletal metastases that occurs in patients with very advanced disease. TLX090, I think, fits very well within our urology domain, given that most patients with metastatic prostate cancer will ultimately develop bony metastases. Moving on to IPAX-BrIGHT, this is our phase III study in glioblastoma. This study is evaluating TLX101 in combination with the chemotherapy agent lomustine, and it continues to progress well. We are currently dosing patients in the first cohort, which commenced at the highest planned dose levels.

David Cade
Chief Medical Officer at Telix

Now, if the combination demonstrates an acceptable tolerability profile, we will advance into the expansion cohort to further characterize the safety of this combination of TLX101 plus chemotherapy. Moving on to Lutetium. This is our monotherapy study for renal cell carcinoma using a CAIX or carbonic anhydrase IX targeting antibody. Lutetium is being run under a phase III protocol in Australia, and it forms part of our global development program for TLX250, which also includes the phase II LUTEON ATLAS study in the U.S. and Europe. We have advanced this study through its site activation, and it has begun dosing patients. Lastly, I wanted to highlight the collaboration we entered into earlier this year with Regeneron. This partnership builds on our well-established expertise across radiopharmaceutical development, and it reflects our shared commitment to advance the next generation of candidates with a focus on alpha therapies.

David Cade
Chief Medical Officer at Telix

We believe that we are uniquely positioned to drive innovation in this emerging field, that is alpha therapies, and to have the opportunity to play a leading role in the future of precision oncology. Let us move to the next slide, please. This is a slide you may have seen before, but I believe it is valuable to describe how we are thinking about the therapeutic cascade across the continuum of prostate cancer care. TLX591, as I mentioned, uses a radio antibody-drug conjugate to deliver the therapeutic payload. It has a long tumor retention with limited radiation exposure to healthy organs, as well as a convenient two-dose regimen that really facilitates its combination together with a backbone of standard of care.

David Cade
Chief Medical Officer at Telix

This candidate is well-suited for the first-line and second-line metastatic castrate-resistant prostate cancer setting, which is a more advanced disease state that may benefit from a therapy with a more convenient dosing regimen that better enables it to be layered on top of the ongoing use of a standard of care backbone of therapy. Moving to TLX597, our small molecule candidate. This is a highly targeted next-generation small molecule radioligand therapy, which has demonstrated the highly favorable dosimetry profile I talked about earlier. Which really makes it uniquely positioned for use in earlier metastatic hormone-sensitive prostate cancer, where efficacy, while maintaining quality of life in that early stage of disease, is of utter paramount importance. We believe the preliminary data are compelling, and we look forward to providing an update on the various trials once their data are sufficiently mature.

David Cade
Chief Medical Officer at Telix

As patients' disease will almost always progress, we are studying the use of an actinium-based alpha therapy, TLX592, in the later line setting, as we view that alpha therapies are sequential to beta therapies at this point in their development, so after beta therapies. Finally, our portfolio approach also captures our bone pain palliation candidate, TLX090. As I mentioned earlier, when cancers metastasize to the bony skeleton, in most cases, it results in pain and a significant degradation in quality of life. We see pain palliation as an equally critical component in late cancer care. With that, I will hand back to you, Chris, for some final remarks.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Thanks. Thanks very much, David. To conclude, we entered the year with a strong line of catalysts. At the halfway point, the list has expanded quite a bit. This is a significant and impactful year for the company for sure. We continue to successfully navigate the regulatory processes and advance our programs with two near-term launches. As I said earlier, Zircaix is a top priority to us and will be refiled very soon. We have three pivotal therapeutic trials that have generated readouts and continue to advance towards important upcoming clinical and regulatory milestones, and you can expect plenty of clinical touch points in the coming months. We have a strong pipeline of new assets advancing behind. These are assets that have generated some very compelling data, as David has outlined.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Our international expansion is progressing well and remains a critical component of our strategy to establish the needed infrastructure for future therapeutic launches. Overall, I believe that we are in a strong position with positive momentum across the business and multiple important catalysts ahead in the second half of the year. I also wanted to note that we will be hosting an R&D Day in New York on September 22nd, where we will provide an overview of our pipeline assets and go into a bit more detail around the data. In addition to having our management there, you will get an opportunity to hear perspectives from leading key opinion leaders in the space.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

We are really excited to showcase all the progress we have made over the last 12 months. I would very much like to acknowledge the efforts of my executive team who internalized some of the setbacks we have had last year and really rewired the way in which we approach our developments and clinical activities. Before we move to Q and A, I would like to take a moment to thank my colleagues and all of our employees. Their dedication, hard work, and commitment every day are what enables us to advance our mission of delivering life-changing treatments to patients. With that, I will hand it over to the operator for Q and A.

Operator

Thank you. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. If you wish to cancel your request, please press star two. If you are on a speakerphone, please pick up the handset to ask your question. As stated previously, if management do not have the chance to answer your question today, they will endeavor to do so after the call. Your first question comes from Chris Cooper from JPMorgan. Please go ahead.

Chris Cooper
Chris Cooper
Analyst at JPMorgan

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

Kevin Richardson
CEO of Telix Precision Medicine at Telix

I would just add that we see it as a similar product, and our approach to the market has been very pragmatic and we manage that across all segments, and we believe that the two-product strategy was the right one and it's proven to be very successful for us. We will continue that.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Yeah. Thanks, Chris.

Chris Cooper
Chris Cooper
Analyst at JPMorgan

Thank you. Second one, please, just on the Zircaix. Good to see the extension was granted, although probably a bit disappointing it was necessary. You say you are making good progress, and I think you just said there, Chris, the resubmission is going to happen very soon. I presume that means now the next couple of months, but we have also been assuming that for a while. How much of that is within your own control at this stage?

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

All of it.

Chris Cooper
Chris Cooper
Analyst at JPMorgan

Okay. So it is correct to assume the resubmission should occur in the next month or two?

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

That would be a reasonable assumption.

Chris Cooper
Chris Cooper
Analyst at JPMorgan

Thanks for taking the questions.

Operator

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

Laura Sutcliffe
Laura Sutcliffe
Analyst at Citi

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

David Cade
Chief Medical Officer at Telix

Just really, all I would add, Laura, is that, it was a very close and I think collaborative dialogue with the FDA. The FDA understands the background of the PRIMARY and the PRIMARY 2 studies that came from Australia, and they were large multicenter, but investigator-initiated trials, generating data not ultimately fit for an FDA filing. So the FDA really understands that background, and BiPASS is an industry-sponsored study that builds on those studies, with agreed endpoints, an agreed statistical analysis plan, intended to support a regulatory filing as Kevin has so nicely articulated.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Yeah. Hopefully that answers your question, Laura.

Laura Sutcliffe
Laura Sutcliffe
Analyst at Citi

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

Laura Sutcliffe
Laura Sutcliffe
Analyst at Citi

Okay. Thank you.

Operator

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

Andy Hsieh
Andy Hsieh
Analyst at William Blair

Thanks for taking our questions, and congratulations on continued solid commercial execution. Two macro questions, if you don't mind. One, maybe against the backdrop of your comment on being modality agnostic and the Regeneron collaboration. There's a pretty animated, I would say, discussion at the ASCO radiopharma session about antibody modality, mostly on a negative perspective. I'm curious, Christian, if you can opine on that or rebut against that. Secondarily, Lantheus is, I guess, in the process of being merged with Curium, and I'm curious, just against that backdrop, do you see a difference in terms of your strategy or kind of continue everything as planned? Thank you.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

I think for the first question, data always speaks for itself, and I think that the rebuttal, since you were there at the ASCO session, you know that the rebuttal from the floor was actually pretty vibrant as well. I think nuclear medicine has a history of being developed on budget-conscious academic environments where there's no ability to even consider experimenting with a biologic. There's a lot of prejudice there that isn't driven by data, it's really driven by capability. I think that exists to the present day. At the end of the day, what we care about is what's the pharmacology of the drug? How does it interact with the target? How does it deliver a payload? We obviously wouldn't be investing money into programs when we have an agnostic approach if we didn't feel that there was a merit to doing so.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

I would encourage anyone that is interested in debating that further, come to our R&D Day, and that would be the place certainly where we can go and do a deep dive on that, perhaps rather than an investor half year results call. I think regarding the second question, it will be disappointing not to have a competitor reminding us of their 2% growth compared to our 22% growth on their earnings calls. I am not sure that that is something that we will miss as a comparison and contrast. It sort of mystifies us a bit why you would bother acquiring a company with such a flat growth outlook. Apparently, maybe it is a European mentality or something, I do not know. Nonetheless, we kind of see it as business as usual for us, and it will be interesting to see what happens in the future in the space.

Andy Hsieh
Andy Hsieh
Analyst at William Blair

That is very helpful. Thanks, Chris.

Operator

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

David Dai
David Dai
Analyst at UBS

Great, thanks for taking my questions. Also, congrats on the quarter. A couple of questions, actually, on BiPASS studies. It seems like enrollment is going very fast. If you could just provide some early feedback from physicians' enthusiasm on the study so far, and what successful outcomes would look like for that study?

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

David Cade
Chief Medical Officer at Telix

Yeah. Look, we were pleasantly surprised. This study, multi-center international trial, but essentially international means U.S. and Australia. Multiple sites across both of those countries. The first site was a site in Melbourne. It kicked the study off. That's where we got the ethics committee approval first before we got the IND and the IRB approvals to open other sites, starting in Texas and then expanding in the U.S. from there. What pleasantly surprised us was the site in Melbourne almost had the study done and dusted by itself.

David Cade
Chief Medical Officer at Telix

They enrolled a very significant proportion of patients, and we didn't tell them to slow down, but what that showed was that there's clearly a very significant physician desire to add the benefits of gallium PSMA PET imaging on top of MRI imaging because they believe, from their experience on study, that it furnishes the clinician with more useful information about whether to biopsy or not. If to biopsy, what type of biopsy to do, a template biopsy or an image-directed biopsy. The treatment planning can be done with a lot more certainty for the patient. So that early experience and that rapid enrollment rate classically will tell you something about the investigators' feelings towards the clinical performance of the asset under study.

David Cade
Chief Medical Officer at Telix

That then propagated when we were able to open the study at the sites in the U.S., and as Chris said, it enrolled within about five months, for the total sample size of sort of 350-odd patients.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Yeah.

David Cade
Chief Medical Officer at Telix

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

I think that hopefully that answers your question. Yeah. Thank you.

Operator

Thank you.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Next question.

Operator

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

David Stanton
David Stanton
Analyst at Jefferies

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

We'll certainly be keeping you updated on timelines. Do you have another question, David?

David Stanton
David Stanton
Analyst at Jefferies

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Thank you.

Operator

Thank you. Your next question comes from Melissa Benson, from Barrenjoey. Please go ahead.

Melissa Benson
Analyst at Barrenjoey

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

I can answer that very quickly. The review of the part one data from ProstACT Global was treated as an end of part one meeting rather than a pre-phase III meeting. We have one more engagement coming up with the FDA in a couple of weeks' time, and then we will be filing the IND on the back of that. That is just a standard process as we go into part two, just to finalize the full scope of the IND amendment that we plan to submit to the agency, and it is just courtesy to have that pre-submission meeting. We consider that to be fairly much part and parcel from a regulator engagement perspective. Regarding the European submission, our priority really has been to get U.S. patients into the study this year.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Once we are over the hump with that on the U.S. side, then we will turn to a broader focus. I do know we have Eurosphere jurisdictions already in the study, U.K., Turkey, but we will add some other European countries that are keen to be involved in the study once the FDA submission is in.

Melissa Benson
Analyst at Barrenjoey

Great.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Do you have another question?

Melissa Benson
Analyst at Barrenjoey

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

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

Melissa Benson
Analyst at Barrenjoey

Okay. Thanks.

Operator

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

Dennis Hulme
Analyst at Taylor Collison

Thank you. I've also got a question about BiPASS. If we assume if the trial results are positive, two questions. Can you talk about the label claim that you expect to ask for BiPASS? Secondly, if it is approved, how do you see it being used? We saw in the PRIMARY 2 trial that there's definitely a strong benefit in patients who have a PI-RADS score of three or less. Do you think that's use is likely to be targeted in that patient population, at least initially, or do you see a scope that would be used more broadly, including in patients who have higher PI-RADS scores?

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Yeah. I will let Dave comment on the clinical utility. We do not typically give label guidance until we have negotiated a label with a regulator. But obviously, the spirit of the study is to help guide decision-making around biopsy utilization, and so that will be the context of the label. I think there is a lot of misunderstanding, and the goal of the study is really to make sure that the right patient gets a biopsy.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

It is not about eliminating tissue, it is not about taking away the value of pathology in cancer diagnosis, but it is really about making sure that that very large proportion of patients that do have a biopsy, the ones that are not going to benefit from it, the ones that come back with unequivocal or negative findings, that those are the ones that are not being subjected to a fairly unpleasant and expensive procedure. Dave, do you want to add anything in terms of the PI-RADS question?

David Cade
Chief Medical Officer at Telix

Yeah, I will. Yeah, thanks, Dennis. Good question. So like I talked earlier about the agreement that we came to with the U.S. FDA in terms of the design of the study and the patients who would be enrolled. We agreed with the FDA that it would enroll PI-RADS 1, 2, 3, and 4, but not 5. PI-RADS is the 1 through 5 scoring system that a radiologist uses to score the MRI scan. So the PI-RADS 1 is not commonly seen in a 65-year-old man. A PI-RADS 1 is typically a younger adult male, 20s, that has an absolutely normal prostate, and PI-RADS 5 is prostate cancer. Now, what we did agree with the FDA was even though we do not need to enroll PI-RADS 5, the FDA would consider the totality of the data and would consider that it covers all of those PI-RADS scores.

David Cade
Chief Medical Officer at Telix

But just at a high level, what the study is going to enable in terms of clinical implementation post-approval is the objective of halving the number of prostate biopsies that need to be done or that are required to be done. So halving the number of biopsies while not missing patients with clinically significant prostate cancer that then need to have a biopsy done. So obviating the need for biopsy in half the population of patients that currently get biopsy. Then in the patients that do require biopsy, taking it from a template biopsy, which is between 12 and 20 needles, placed transperineally, through a very sensitive piece of real estate, to one targeted biopsy. So we say none and done, obviating the need for a biopsy in half the population that today would get biopsy, or one and done, shifting template to a single targeted image-guided biopsy.

David Cade
Chief Medical Officer at Telix

That is the purpose of BiPASS. In doing so, we believe that there will be very significant clinical uptake, that it will become standard that PSMA PET scan is done as well as an MRI scan before anyone has a biopsy. Did that help, Dennis?

Dennis Hulme
Analyst at Taylor Collison

Yes. Thank you. That is very helpful. If I can ask just quickly on TLX597, can you just talk about what you think the next step will be for TLX597 after the OPTIMAL-PSMA and OPTIMAL-e trials?

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Yeah, we are waiting for really the first chunk of data to read out. Our priority right now from a prostate trial perspective is clearly to complete the recruitment of TLX591. It is our major program and our flagship program. We have some data to read out from the first phase II trial, and we are really looking forward to reading that data out. Then once we have got that in hand, that will be the catalyst to inform the market about what our plans are longer term for that asset.

Dennis Hulme
Analyst at Taylor Collison

Thank you very much. That is all from me.

Operator

Thank you.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

Thanks, Dennis.

Operator

That does conclude our time for questions. I will now hand back to Dr. Christian Behrenbruch for any closing remarks.

Christian Behrenbruch
Christian Behrenbruch
Managing Director and Group CEO at Telix

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

Operator

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

Executives
Analysts
    • Kyahn Williamson
      Senior VP of Investor Relations and Corporate Communications at Telix
    • Darren Smith
      Group CFO at Telix
    • Kevin Richardson
      CEO of Telix Precision Medicine at Telix
    • David Cade
      Chief Medical Officer at Telix
    • Chris Cooper
      Analyst at JPMorgan
    • Laura Sutcliffe
      Analyst at Citi
    • Andy Hsieh
      Analyst at William Blair
    • David Dai
      Analyst at UBS
    • David Stanton
      Analyst at Jefferies
    • Melissa Benson
      Analyst at Barrenjoey
    • Dennis Hulme
      Analyst at Taylor Collison
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