Operator
Operator
Thank you for standing by, and welcome to the Telix Half Quarter 2025 Results and Investor Webcast. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.
Telix Pharmaceuticals Limited (TLX)
Q2 2025 Earnings Call· Fri, Aug 22, 2025
$10.49
+0.48%
Same-Day
-2.24%
1 Week
-23.48%
1 Month
-18.19%
vs S&P
-20.64%
Operator
Operator
Thank you for standing by, and welcome to the Telix Half Quarter 2025 Results and Investor Webcast. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson. Please go ahead.
Kyahn Williamson
Analyst
Thank you and everybody, for joining us this morning and this evening for those joining from overseas. My name is Kyahn Williamson. I'm the SVP of Investor Relations and Corporate Communications at Telix. You can see there our disclaimer. Just moving forward to Slide 4. I'd like to introduce today's speakers that are on the line with me. We have Chris Behrenbruch, our Group CEO and Managing Director; Darren Smith, our Group Chief Financial Officer; Kevin Richardson, CEO of Telix Precision Medicine; and Richard Valeix, CEO of Telix Therapeutics. Today, we'll be taking you through the H1 2025 financial results presentation lodged earlier today on the ASX and our operational achievements for the half. This call is scheduled to run for 1 hour. And following the presentation, we'll take questions firstly from analysts on the phone and request that you ask one question at a time and hop back in the queue if you have further questions. If we do not get to your questions on the webcast, we will reply to you directly. Moving on to Slide 5, please. In today's presentation, our business leaders will be talking to the investments we have made in the business to set it up for long-term value creation. This slide illustrates the scale of our business today, spanning development, commercialization and global production and manufacturing. It's been a rapid transformation. This time last year, we had one approved product, Illuccix, which was commercial in just a handful of companies. Today, we have multiple approved products. We are preparing to roll out Illuccix across Europe and are preparing for launch of Zircaix and Pixclara. The acquisitions we have made have seen our manufacturing and distribution sites grow to 38 and our workforce has more than doubled with now over 1,000 employees globally. Next slide, please. We've previously presented our growth strategy that is in place to drive value creation for the long term. You can see the 4 pillars on the left-hand side of the slide and the achievements we have delivered against each one this half. These pillars are to grow our precision medicine or commercial stage imaging business and the achievements this half are focused on the goal to grow our share in the PSMA market and bring new products to patients. Kevin will discuss this further. Delivering on our late-stage therapeutics pipeline and building our next-generation pipeline, including alpha therapy candidates. This half, we have made solid progress across an array of programs, which Richard will take you through in more detail. And finally, the expansion of our global delivery infrastructure, a key highlight this half has been the integration of the RLS business. Chris will take you through this and the key value drivers aligned to our strategy. Firstly, however, Darren will talk you through the financial results for H1 2025 in more detail. So I'll hand over to you, Darren.
Darren Smith
Analyst
Thanks, Kyahn, and welcome, everyone. From a financial perspective, the first half of 2025 was characterized by strong commercial growth in our Precision Medicine business and continued investment into building our business for the future. We delivered strong revenue growth in the first half of 2025 with group revenues improving 63% year-on-year and driven by growth in Illuccix and the addition of third-party revenue from RLS. Our precision medicine revenues were up 30% year-on-year with EBITDA improving 24%. Gross margins in our Precision Medicine business remained stable at 64%, reflecting efficient manufacturing of Illuccix. The group's gross margin was 53%, reflecting the addition of RLS third-party product mix and the associated manufacturing and distribution costs. In this half, we have made a significant investment into our global manufacturing infrastructure to ensure that we are well positioned for long-term growth and we continue to invest in our R&D pipeline with investment up 47% year-on-year. Following these investments, we generated $18 million in operational cash flow and finished the half year with a healthy $207 million cash on hand. Now moving to the next slide and our group revenues. Telix generated revenues of $390 million. This consisted of $79 million in revenues from RLS third-party sales and $311 million mainly from our Precision Medicine business. This represents an increase of 63% year-on-year and 41% compared to the second half of 2024. Illuccix continues to deliver strong growth, especially as it relates to volume doses. Kevin will provide more detail later in the presentation. Now moving on to the next slide on the group P&L. As stated previously, the group P&L represents a period of solid growth and strategic investment into preparation for delivering future long-term growth. Group gross margin landed at 53% following the addition of RLS third-party products and RLS associated…
Christian P. Behrenbruch
Analyst
Thanks very much, Darren, and good day to everybody online. So I'd like to start by taking a moment, if you could advance on to the next slide, please, to talk about why Telix is highly differentiated and built for long-term success. Starting with our therapeutics pipeline. Our pipeline is built around areas of high unmet medical need with a diversified portfolio strategy that gives us multiple shots on goal, even in some cases, concentrated in the same disease area. Our R&D efforts remain sharply focused on advancing next-generation assets, whether that's in the alpha or beta therapies, novel isotopes or innovative targeting agents. As a data-driven organization, our decisions are grounded in rigorous scientific and clinical evidence, ensuring that we prioritize our limited resources towards the most promising opportunities. Turning to manufacturing and supply chain excellence. I want to emphasize that radiopharmaceutical manufacturing and distribution is an extremely complex business from an operational quality and regulatory perspective. A robust, reliable supply chain is critical to long-term success, especially for a multiproduct portfolio like ours that's also going to one day deliver therapeutic outcomes. This is why we've made strategic investments in selective aspects of vertical integration over the past couple of years, alongside deepening relationships with key strategic partners that we think are best aligned with our long-term commercial strategy. Our investment in commercial infrastructure is starting to deliver real operational and financial returns, including with continued volume growth for Illuccix in a maturing market landscape. This performance reflects our proven track record in commercial execution and I think it positions us very well for future product launches. This year also marks a major inflection point for Telix as we transition from effectively a single product, single market company to a multiproduct, multi-region commercial organization. And we've done it…
Kevin Richardson
Analyst
Sure. Thank you, Chris. And for my first slide, I would like to start with our precision medicine growth strategy. Our growth strategy is based on 3 pillars: expand product offerings, expand geographies and then expand indications on those products. In terms of our first pillar, expanding our product offerings, we have now launched Gozellix, further strengthening our position in the PSMA space. And looking ahead, we have 2 near-term regulatory milestones with Zircaix and Pixclara. These assets will build on our strong commercial foundation established by Illuccix. Moving on to our second pillar. The global rollout of Illuccix continues to progress well with marketing authorizations now secured in over 23 countries. Turning to our third strategic pillar. We are actively exploring new indications for our existing assets, particularly indications where we believe we can deliver meaningful impact for patients. We remain laser-focused on the execution of these 3 strategic pillars, driving the expansion of our global Precision Medicine business and paving the road for our Therapeutics business. Next slide, please. Illuccix continues to deliver strong growth in the high single digits. In the second quarter, Illuccix revenues were up 2% quarter-over-quarter or 25% year-over-year with dose volumes up 7%. Q2 represents the highest unit volume growth we've seen in the last 5 quarters. And despite competitive pricing pressures, we continue to manage the impact to our average selling price. To do so, we continue to drive share growth in clinical accuracy and reliability of dose delivery. Our clinical message is Telix PSMA gallium agents have fewer indeterminate bone lesions and higher inter-reader agreement than F-18 assets. We couple the clinical message with a highly specialized sales force and customer-facing teams that differentiate Telix with our customers every day. We've developed a reputation in the marketplace as an innovator, paving…
Richard Valeix
Analyst
Thank you, Kevin. So let me present to you today the update of our Therapeutic business unit. And you will see that during the first half of this year, 2025, we were moving the needle on all our therapeutic areas. You can see on this slide, our strategic focus is centered around 3 therapeutic pillars: first, urology oncology; second, neurology oncology; and third, solid tumors and hematology. So within urology, we have a pipeline asset for prostate cancer and more specifically targeting the mCRPC standing for metastatic castrate-resistant prostate cancer. And also kidney cancer, we're targeting the ccRCC indication for clear cell renal cell carcinoma. But we have also a therapeutic agent such as TLX090 for metastatic bone pain deviation, which is frequent in the prostate cancer late stage. Within neuro-oncology, we have a pipeline asset for glioblastoma. And I'm happy to share that we are also adding a new indication for leptomeningeal disease with the alpha version of the TLX102 compound. Within our third pillar regarding solid tumors and hematology, we have the TLX400, our FAP-targeting asset that we closed the acquisition during the Q1 2025. This asset has the pan-cancer potential and we are exploring various indications. We also have molecules for soft tissue sarcoma and bone marrow conditioning agent for pediatric high-risk leukemia patients. I will come back on that in a minute. In summary, you can see that we have 10 early and late-stage assets. Late-stage assets, primarily focused on beta therapies, followed by earlier-stage assets exploring alpha therapies. In addition to these 10 assets, we also have preclinical compounds targeting for the most well-known DLL3 and alpha v beta 6 coming from the ImaginAb acquisitions. We are exploring the best combination with isotopes for these targets. Our diagnostic strategy includes having a companion diagnostic for…
Christian P. Behrenbruch
Analyst
Thanks very much, Richard. Great rundown and really conveys the depth of the pipeline and development activity and progress over the last 6 months. So as is typical, I get to end the presentation with a summary of our upcoming catalysts and key objectives. This is by no means an exhaustive list but captures some of the key value creation events that are on the near-term horizon. Many of these catalysts are new commercial opportunities that will add to our revenue and earnings growth and will support our expansion and transition into a fully-fledged theranostics company. Some of these catalysts relate to new clinical data points that I believe will reinforce our leadership position as an innovative player in the radiopharma space with pipeline of either best-in-class or first-in-class assets. Expanding our capabilities is a key driver of near-term value creation as we work to deliver our products into major global markets. Our investments are focused on building the operational strength needed to unlock these markets and then, of course, to scale sustainably. In closing, Telix continues to demonstrate strong growth and operational improvement. We've never been more focused or committed to delivering value for our shareholders, our clinical partners and most importantly, the patients we serve. Thank you for your attention. I hope you found this presentation interesting and informative, and I now open it up for questions.
Operator
Operator
[Operator Instructions] Today's first question comes from David Low with JPMorgan.
David A. Low
Analyst
If we could start with just the outlook for gross margins. I mean I think it was very useful to get all the update on RMS (sic) [ RLS ] and understand exactly where the contribution is, but I heard the message that you think it can improve. And then, of course, we've seen some fairly significant changes in PSMA pricing in the last quarter, particularly the back end. I'm just wondering how that's going to play out and of course, trying to understand how Gozellix fits into that mix as well. So if I could have someone have a go at answering some of those facets, please.
Christian P. Behrenbruch
Analyst
Well, Darren, why don't you -- it sounds like 3 questions, not one, but why don't you go ahead, Darren, and start off with the gross margin.
Darren Smith
Analyst
Yes, sure. Thanks, David. Obviously, this half year has been quite a change for the organization where we've compared to the prior year where we're only selling Illuccix. And I think the first key point is that the Illuccix gross margin is -- and you can see this by looking at that precision medicine slide has remained fairly consistent. I think we reported 65% last year and 64% this year. So obviously, no real change in the gross margin perspective for Illuccix in the market from the gross margin. Then when we look at RLS, we see there the addition of those third-party products and also the kind of internal contribution that it received by selling our Illuccix product into the market that they're able to achieve a 7% gross margin once you've included the radiopharmaceutical -- sorry, the radiopharmacy cost into the cost of goods. The interesting thing we have done a little bit of benchmarking and what we found is the industry that's similar, some of our partners/ competitors are doing a very similar gross margin in that kind of low to mid-range single-digit yield. So gross margin is obviously a result of those 2 businesses brought together. So the 53% is the average based on the load of business. I think the important thing to remember, though, with RLS is that as we start to push a product like Illuccix and the higher contribution that it provides to the RLS business that, that should help grow the dollar gross margin for that business with little or minimal cost impact on being able to deliver that to patients. So what we would potentially see is as we add the more Illuccix and potentially the future products that we're looking to bring to market in Gozellix, Pixclara and Zircaix, that will continue to assist that business to make a better contribution to the organization. Hopefully, that kind of answers your question, David.
Christian P. Behrenbruch
Analyst
Yes. I think I don't have anything to add except for that, obviously, we didn't acquire RLS for its commodity radiopharmaceutical business. We acquired it to put a larger proportion of our own products through and to prepare for when we have to distribute therapeutic unit doses, which you can't do that without a nuclear pharmacy dose dispensing. If you want to deliver a prefilled syringe to a customer, which is the name of the game, you got to have a pharmacy network to do that. So this is not about like what's going to happen this quarter. It is what's going to happen in the next quarter and the quarter after that and 3 years from now. So let's move on to the next question.
Operator
Operator
The next question comes from Tara Bancroft with TD Cowen.
Nicholas Lorusso
Analyst · TD Cowen.
This is Nick on for Tara. I have one on the guidance and the continued growth of Illuccix moving forward. So to reach the 2025 guidance with assuming stable RLS revenue, obviously, it's a little bit difficult to say that right now. But it appears like Illuccix sales growth may be slowing a little bit. Is this due to the loss of pass-through status? And what impact could this have on Illuccix net sales? Also, could Gozellix need to return to growth once it does have pass-through status?
Christian P. Behrenbruch
Analyst · TD Cowen.
Yes. I mean, obviously, we give guidance on an annualized basis, not on a quarter-by-quarter blow. So you're absolutely correct. 1st of July, we came off pass-through. We actually reported 7% growth quarter-on-quarter, which is, I think, exceptional -- 7% growth in volume quarter-on-quarter, which is really exceptional performance if you -- particularly if you take some of our competitors' financial results into consideration. So what we did is we made a decision that we were going to stabilize our customer book going into the third quarter. We have the situation where we have one product coming off pass-through and then another product getting reimbursement effective 1st of October. And we've got to bridge that gap and we chose to take certain commercial actions to do that. And we still had growth in revenue quarter-on-quarter, again, where our competition didn't. And so I think we have a nice stabilization strategy for Q3 and then Q4 continues with the advantage that we uniquely have of a second product introduction. I don't know, Kevin, if you want to add anything to that?
Kevin Richardson
Analyst · TD Cowen.
I would just add that we just continue to take the market pragmatically and continue to sell clinically on our accuracy as we spoke of earlier in my presentation and then continue to drive that message with reliability. And again, we have a strategic pillar and our customer-facing team that really represents well and is able to really manage that ASP and volume mix that we work on with that piece of the business and the strategic accounts.
Christian P. Behrenbruch
Analyst · TD Cowen.
Yes. And I think you'd be mistaken in thinking that this is just a pricing game. It's not. I think there's 4 pieces to commercial success in the market dynamic today, as Kevin said, selling on clinical value proposition, which we have demonstrably the strongest clinical value proposition. It's selling on service and service quality. Then there is, of course, pricing and pricing structure, particularly for large volume customers. Unlike our competition, we don't throw it all at the same price to everybody. We give benefits to our customers that are more loyal than smaller customers. And I think the last thing is clearly reimbursement status. And again, to reiterate, we go into Q4 with a very strong and differentiated commercial strategy with Gozellix. And we're excited about that. We're looking forward to it. Sales team is pumped.
Operator
Operator
Our next question comes from David Dai with UBS.
Xiaochuan Dai
Analyst · UBS.
Congrats on the quarter. I'm just curious about the Zircaix launch readiness. Maybe you can highlight some of the things you've been doing for Zircaix and how should we think about the launch in the first and the second quarter after approval on August 27?
Christian P. Behrenbruch
Analyst · UBS.
There's probably not too much to really kind of openly discuss. I mean the commercial team, it's not their first rodeo. We're selling into the same customer base, same referral physician base as Illuccix. So it's a very straightforward pathway to the customer. We're clearly focused on using our Illuccix customer base to seed that product launch. And I would say commercial team is ready to rock and roll on Zircaix. I don't know if you want to add anything to that, Kev?
Kevin Richardson
Analyst · UBS.
No, I think the combination of a urological call point with a nuclear med physician base that's reading that is really the key to success there. And we've had an expanded access program going for a while that's demonstrated exactly what we saw in the ZIRCON study. So we're excited about the launch and just haven't given guidance for 2026 yet.
Christian P. Behrenbruch
Analyst · UBS.
Yes. I mean we've had a lot -- the expanded access program, the EAP has been a huge success. We've done a very, I think, well- orchestrated unbranded physician education campaign. So as far as we're concerned, the market is ready for this product.
Operator
Operator
The next question is from Andy Hsieh with William Blair.
Tsan-Yu Hsieh
Analyst
Congratulations on the performance. So for the BiPASS study, obviously, very provocative in terms of the disruptive potential. I'm curious, the trial is posted on ClinicalTrials.gov. You have some primary endpoints. Just curious about some secondary endpoints that you're contemplating on and how you think about some of the outcomes, longer-term outcomes for patients pertaining to survival or treatment steps that you can really, really convey the value of taking this agent upfront?
Christian P. Behrenbruch
Analyst
Yes. So this study was really born out of and driven by KOL engagement around where is PSMA going to really go as we move up the treatment cascade. And to be quite honest with you, on the front line of patient management, not a lot has really changed in the last sort of 15 years. It's pretty archaic. And whilst MRI, of course, gets better and better, we're still doing well over 1 million biopsies a year and a good proportion of those biopsies aren't adding any value to the patient journey. So just to be clear, our goal is not to eliminate biopsy. I mean that's a nonsensical clinical objective. A biopsy is super important. What our goal is, is to make biopsy count and to use it where it's absolutely essential and to use the scope of biopsy where it absolutely makes sense to do that. In terms of the -- we will, of course, be putting out the trial design on ClinicalTrials.gov. It's only just -- that study is just launching. So clearly, we want everybody to understand the endpoints. But to the implied part of your question, yes, there will be a monitoring period. It won't be a very long monitoring period, but there's definitely a follow-up period that's part of the evaluation of the utility of prostate imaging in that patient segment. So stay tuned, Andy, we've got more updates on that trial design coming down the pathway.
Operator
Operator
The next question comes from David Nierengarten with Wedbush Securities.
David Matthew Nierengarten
Analyst · Wedbush Securities.
I just had one on the ProstACT study. Just around the parameters, you've recruited the patients. Kind of what are you looking for on the dosimetry and safety side? And when you think about the movement into the Part 2 of the study, is it still the plan to carry forward all 3 combinations? Or could that change in the future when you talk about the results from these first 30 patients?
Christian P. Behrenbruch
Analyst · Wedbush Securities.
Well, things can always change based on data. But we -- at present, our plan remains as stated. The real purpose of the Part 1 study and frankly, the reason why it took a while to accrue is because it's a multi-time point specto dosimetry, a lot of patient visits involved, typically requires specialist centers. So it's really a subset of departments that are really suitable for running that study. And it is, as I said, it's a demanding study on patients. We know that when we move into the second part of the study, which in some countries is a seamless transition. So that's already in play. It's a very straightforward transition and a much more straightforward study protocol from a patient perspective. And the 3 different arms were because we had the aspiration in this study to have flexibility on the choice of RP. We think that, that's an important thing. And so really, what we're looking to get out of Part 1 is confirmation of our understanding of the safety profile in combination with both RPs, different RPs and Taxanes. We fully expect that, that's what's going to progress into the second part of the study. We think that there's a compelling clinical use case for all 3 of those combos and our mission is to really demonstrate to the agency that, that safety profile is consistent across -- really across different RPs. So I hope that answers your question, but we're really excited to have that first run-in part done. It was a pretty painful study protocol. The rest of the study now is going to pick up at a much greater pace.
Operator
Operator
The next question comes from John Hester with Bell Potter.
John Hester
Analyst · Bell Potter.
I want to just come back to the situation with PSMA pricing. I'm sure everyone on the call heard the comments from Lantheus a few weeks ago regarding the competitive situation and also Kevin referred to competitive pricing pressures in the market in his prepared comments. So the question is this, are you worried about that pricing pressure contagion spreading to your own market? And can you also sort of update perhaps on what you've seen on those pricing pressures in this current quarter?
Christian P. Behrenbruch
Analyst · Bell Potter.
Well, I think we've reported all the numbers. So the numbers are the numbers. I think that pricing is a direct function of both competitive dynamics and clearly, reimbursement status. The market is complicated. As you know, there are multiple customer segments in the market that have different competitive dynamics and different pricing dynamics. What we do know is that customers prefer understandably to use a reimbursed product. Lantheus came off reimbursement, and that certainly puts pressure on their business. We've now come off reimbursement, albeit for a very transient period of time because we have been granted a HCPCS code for our life cycle management product. which, by the way, has innovative aspects in its own right. Like it's not just a direct follow-on. There's some genuine clinical and clinical workflow benefits that comes from that product. So the way that we manage pricing and pricing consistency is by ongoing innovation and capability delivery to our customers and differentiating ourselves in that -- in both the clinical use case for the product and the reimbursement profile of the product. And so -- and I don't want to sound facetious, but no, pricing pressure is not what we worry about because we have a life cycle management strategy to address it.
Operator
Operator
Today's last question will come from Andy Hsieh with William Blair.
Tsan-Yu Hsieh
Analyst
So Chris, I'm just curious if you can comment a little bit more about the aluminum fluorine technology that you mentioned that kind of allows you to traverse between the gallium-68 and fluorine-18 isotopes. Can you speak to maybe the commercial implication, i.e., what is the next steps in terms of potential regulatory pathway and then supply chain, how does that kind of fit into your goal of being a vertically integrated company, leveraging the RLS and ARTMS platforms?
Christian P. Behrenbruch
Analyst
Well, on the node, so I'll start off with the science lesson, and then I'll hand it over to Kevin to talk about the commercial implications and the physician preference. But essentially, when you react aluminum and fluorine together, it's pretty violent coupling. And what you end up with is a metallized version of F-18. And it turns out that, that metallized version of F-18 is a drop-in replacement for gallium. So what it means is that you have the same targeting agent with the same chelator and you can interchangeably substitute either gallium or F-18. And the beautiful thing about aluminum fluoride is that you make it in extremely large quantities at a cyclotron facility. It's not a drug per se. It's essentially an API, a hot API. And you can drop that activity then into nuclear pharmacy and using all of the benefits and the production workflow advantages that we have of the kit-based approach we can essentially, particularly in high-density areas or where we want to service large academic customers that really are enamored by F-18, and I'll get Kevin to characterize the customer base a bit more, but it enables us to seamlessly transition between gallium and F-18 and of course, continue that life cycle management. And PSMA-11is really well demonstrated in terms of its sensitivity and specificity as a targeting agent. And now we get to marry that kind of superior pharmacology of PSMA-11 with the utility of F-18. And still, by the way, utilizing our well-trodden and well- understood distribution model. Maybe, Kevin, you want to comment on physician preference?
Kevin Richardson
Analyst
Sure. So as you know, we launched Illuccix 3 years ago and we've successfully taken over 1/3 of the market, pushing 40% of the market with gallium. And we believe that gallium is a fantastic product and we're going to continue to execute on our Illuccix and our Gozellix plan through the marketplace. But what we do see is some stalwarts that have used F-18 for many other products through the years and tend to favor that more. The reality is that we believe our reliability story, along with our commercial customer-facing team can support that in the next couple of years as we move from -- in our life cycle management from Gozellix and continue to maximize gallium cells and then find, if you will, the corners of the canvas, if you will, to paint with AlF, and we believe that's a great product to do it through our distribution and commercial network.
Christian P. Behrenbruch
Analyst
Yes. So maybe just to wrap up because it's a super great question. And by the way, you're the first analyst that's ever asked a question about it. So that's why I'm grateful to elaborate a bit more. But going forward, I think what you're going to really see is we have a whole pile of imaging products coming down the pike, including, for example, there's a gallium FAP agent there. As we develop that agent, we'll think about how this time do we avoid having to participate in a physician preference discussion, right? Some folks like gallium, some folks like F-18. Some guys drive the beamer, some guys drive the Mercedes. And we're going to set up shops so we can make both available depending on what the preference is. All right. Well, look, I think Yes, I think we're at the end of time anyway. Well, thanks -- I just want to say thanks very much to everybody for your time today and I appreciate the opportunity to give you an update. Thanks very much.
Operator
Operator
That does conclude our conference for today. Thank you for participating. You may now disconnect your lines.