Earnings Labs

Telix Pharmaceuticals Limited (TLX)

Q4 2024 Earnings Call· Thu, Feb 20, 2025

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Transcript

Operator

Operator

Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited FY 2024 Results Call. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to Ms. Kyahn Williamson, SVP of Investor Relations and Corporate Communications. Please go ahead.

Kyahn Williamson

Analyst

Thank you, Ashley, and thank you, everybody, for joining us morning Australian time. We're pleased to share with you our full year results for 2024, which we lodged with the ASX yesterday afternoon Australian time after market close, just looking through our standard disclaimer. I am joined today by Chris Behrenbruch, our Managing Director and Group CEO; Darren Smith, our Group CFO; Kevin Richardson, our CEO of the Telix Precision Medicine business; and Richard Valeix, the CEO of Telix Therapeutics. Together we will be taking you through our performance, financial results and focus for 2025. If we could move to Slide 5, please. Just by way of some introductory remarks, 2024 has once again been an extraordinary year for Telix. We are delivering against all aspects of our growth strategy and some of these operational highlights include the continued strong commercial performance driven by sales of Illuccix and the creation of a platform for further growth as we prepare to launch three new products in the U.S. next year and roll out Illuccix globally into Europe and UK specifically. We're making great progress across our therapeutic pipeline, notably in the late-stage assets being brain, kidney and, of course, our prostate cancer program which is now in Phase 3. And we've had some really exciting developments across the next generation pipeline including delivery of a clinical proof-of-concept for our prostate cancer alpha candidate. It's been a year of many acquisitions and these are supporting the strategic expansion of our pipeline and the build out of our global product delivery or manufacturing infrastructure. So in short, the business looks very different to what it did a year ago and at the end of 2025 it will look very different again as a result of this great progress. If we could move to Slide 6, please. This is also reflected in the financial performance, which Darren will take you through today. Our commercial performance has underpinned delivery of our second consecutive year of profit and growth in a year that saw us increase our investment in R&D and this which we expect will translate into near-term value creation for shareholders and strategic transactions that have assisted in the transformation of Telix and set us up for ongoing leadership in this rapidly growing market. Today's presentation outlines these key developments and the step change in our operations as a result of the acquisitions we've made. With that, I'd like to hand over to Chris to talk further about the strategy and our performance over the past year.

Chris Behrenbruch

Analyst

Thanks very much Ky and good morning everybody and we could move to Slide 8 please. Although Ky has somewhat introduced the strategy outline in a prior slide, this is a nutshell summary of how we see the Telix growth strategy over the next three to five years or so. It's focused on four priority areas of business activity. Firstly, our R&D investment, which will be well covered in this presentation both financially and operationally. It's really about delivering long-term shareholder value and patient outcomes through our therapeutics pipeline. At the end of the day, that's what the core mission of Telix is and as I'll show you in a minute, represents a step change for the company when we achieve it. Richard Valeix, who leads this business unit, will go through the details shortly. Within this effort, we are building the strongest portfolio in the industry of next generation radiopharma products with a focus on novel targets and alpha-emitting radionuclides. We've made several transactions and licensing deals that support this and in some respects it represents a pivot towards a more internally sourced innovation model and this is reflected in our R&D growth. The engine room of the business today is our precision medicine business led by Kevin Richardson, which encompasses our diagnostic imaging products but also has the mandate to ensure that we have well thought out patient selection strategies for our therapeutics program and strategically designed clinical trials that have a high degree of certainty of success because we're utilizing the whole theranostic power radiopharma. That's why we call that business unit precision medicine and not diagnostic Imaging. And lastly infrastructure. This has been a big focus for Telix over the last couple of years with some significant investments such as our state-of-the-art European manufacturing footprint in…

Darren Smith

Analyst

Thanks Chris. And hello everyone. Today it gives me great pleasure to talk to Telix strong financial achievements and progress during 2024. So let’s now turn to Slide 12 and Telix’s key financial metrics. It’s been an excellent year for Telix with all six of these metrics improving dramatically compared to the prior year. Just listen to the headline numbers. Revenue improved 56%, beating guidance; adjusted EBITDA improved 70% to $99 million; operating cash inflow improved 80%; profit after tax improved 860% and the end of year cash position finished at a solid $710 million on the back of a convertible bond placement. I will now go into some detail on these metrics on the following slides. But now let’s turn to Slide 13 and review the Group’s operating profit. As can be seen in this simplified P&L on the slide, operating profit and similar metrics all improved significantly year-on-year. The headline drivers of the results were firstly, that we achieved excellent commercial growth by Illuccix in the U.S. accounting for 97% of our revenue. Kevin Richardson, our CEO of Precision Medicine, will talk later in the presentation on how this has been achieved. Secondly, we improved gross margin through efficiencies and stable pricing across key market segments. And thirdly, we are effectively managing expenditure as a percentage of revenue. Now turning to Slide 14 in the Group’s adjusted EBITDA. As can be seen on the bubble on the right side of the slide, the adjusted EBITDA improved 70% on the prior year and this is a testament to the strong underlying performance of the Telix business model. The graph on the slide shows the bridge from operating profit to the $99 million adjusted EBITDA, highlighting the impact of the main non-reoccurring corporate initiatives that is impacting operated profit in…

Kevin Richardson

Analyst

Thank you, Darren. Slide 21 please. To help define the precision medicine business, please see the slide on our expanding commercial portfolio. We will go over in more detail our prostate imaging asset as well as our kidney and brain over the next few slides. But I did want to make note of a recent announcement that we intend to bring into our precision medicine business unit and further develop Scintimun as a companion patient selection and safety assessment tool for TLX66, its therapeutic bone marrow conditioning candidate. The plan is to increase sales for its current indication by improving product availability worldwide with commercial consistency. Slide 22, Telix continues to strengthen its position in the PSMA market with Illuccix, our first commercial product, driving revenue growth for the 10th consecutive quarter since launching in April of 2022. Q4 2024 saw a 55% increase over Q4 2023 while achieving over $500 million in U.S. sales for full year 2024 reflecting our strong market momentum. Our commitment to clinical accuracy, reliable delivery and exceptional customer service attracts and retains our customers. What we mean by that is that our Illuccix product has the highest interrater agreement of the currently marketed PSMAs delivering an accurate diagnosis, while our 245 points of distribution puts our PSMA within minutes of our customer at dispensing. We are your friendly neighborhood pharmacy. We like to say it's locally farmed to scanner and our customers say that our multifunctional approach to the customer experience let the customer hit the Telix easy button when they begin using our products. Our performance is driven by executing our commercial strategy with consistency, expanding our market reach and capturing more share. With CMS reform providing a tailwind, Illuccix retains pass through status through June 30, 2025 with CMS reform as a…

Richard Valeix

Analyst

Thank you, Kevin. Hello, I’m pleased to be able to speak to you today about the strategy of Telix Therapeutics business. Telix has built a pipeline of highly differentiated therapeutic candidates based on validated targets and clinical data. Our focus is twofold. First, in the short-term, our priority is on the delivery of three main late-stages assets for prostate, kidney and brain cancer. Our lead asset TLX591 is already in Phase 3 and our goal this year is to advance the kidney and brain cancer therapies to pivotal trials. I will talk more to that shortly. The second part of our strategy is building our pipeline of next generation assets. Telix has one of the deepest alpha pipeline in the industry. Now we are transitioning these programs which have been stage gated through our internal R&D and based on excellent preclinical data into clinic. The TLX592 and TLX102 compounds are the natural evolutions of our portfolio lifecycle management with alpha radioisotopes in order to extend indication. While TLX090, the bone seeking assets we acquired last year from QSAM is being developed initially for treatment of pain from bone metastases, that gives us the potential to treat prostate cancer patients right across their disease journey. This is also building on our strong urology footprint established with precision medicine. Finally, we have a unique opportunity to explore multi-indication or pan-cancer asset strategy. Let me explain. The CA-NINE and FAP are both validated as pan-tumor targets. Pursuing this strategy can add value to these assets, generating first-in-human data in multiple indications in a limited time frame. Next slide, please. In the next two slides, you can see our pipeline. The first slide is presenting our late-stage assets with our pivotal trial ProstACT GLOBAL that supports TLX591 compound data generation and our two additional…

Chris Behrenbruch

Analyst

Thanks very much, Richard. Great summary. And just to reiterate, we’ll have three programs in pivotal studies by the end of this year, which I think is a really good testament to Richard’s team and the great effort that’s underpinned our R&D this year. I’m going to talk now a little bit about our manufacturing solutions activity. Darren Patti, our Chief Operating Officer is on the road at the moment, but I’m going to step in and give a little bit of an update here. If you can move to Slide 34. So this is a summary slide of really why we think this is so important. Radiopharma is about whether it’s a diagnostic or a therapeutic product is really about proximal manufacturing and just in time manufacturing. As Kevin noted for the Illuccix product, we’re distributing that product now out of about 240 points of distribution in the United States. To deliver these products globally, you need to have infrastructure to really be able to go that last mile and make the product available with a high degree of confidence for patients. We’ve been focusing on building that infrastructure, scaling it to meet the demand both today and the expected demand for our products. And this is really a two-part model for success. We are heavily dependent on key partnerships. Our goal is not to go at the task of manufacturing alone. And in almost every market we operate in, we have key supply chain, manufacturing, distribution and even sales and marketing partnerships. But we also have a certain amount of facilitative infrastructure ourselves. And the wheel diagram on the right hand side shows how the acquisitions that we’ve made over the last few years map onto that or the investments that we’ve made really map onto that activity.…

Kyahn Williamson

Analyst

Thank you. We will now move into question-and-answer. So Ashley, you can take questions from the phone, please.

Operator

Operator

Thank you. [Operator Instructions] Your first question comes from David Stanton with Jefferies. Please go ahead.

David Stanton

Analyst

Good morning team and thanks very much for taking my questions. If we could start with the revenue guidance, please. You've talked to 11 months of RLS Radiopharma. I note that in 2023 when you bought it, you noted that they did $158 million worth of revenue. What should we be broad brush, what should we be thinking about revenue growth for 2025 in that division and or a number for that division, please? That's my first question.

Chris Behrenbruch

Analyst

Yes, that number we put out was all inclusive number. We obviously don't double count the Illuccix revenue in that number. Going forward and generally across the U.S. business inclusive of Illuccix and RLS, we'd be looking at high-single-digit, low-double-digit growth. And our viewpoint and we've outlined it, if you have a look at my CEO letter in the annual report, we think that this guidance is a reflection of a continuing growth in our business, continuing expansion of opportunity for PSMA, but it also considers some of the headwinds that we have this year in terms of uncertainties in the U.S. healthcare system. Obviously, we are facing a government environment perhaps with more challenging resourcing from an FDA and a CMS perspective. And so we think that that sort of guidance is a good balance of the risk and opportunities that we see in the market this year. Obviously, David, we haven't yet included substantive European revenues in that forecast. So you should think of that as a primarily a U.S. centric forecast. Is that useful?

David Stanton

Analyst

Understood. Very useful. So on that basis then, second question, just for the market in general, would you be able to sort of help us understand what you think market growth might be for U.S. Illuccix sales in 2025? Will it slow from frankly, very good growth in 2024?

Chris Behrenbruch

Analyst

I'll start and maybe I'll ask Kevin to chime in since he's a little more call face on that. But I think we continue to see the expansion of the PSMA opportunity. It's one of those things where new indications and new opportunities still have the potential to cause step change in growth in the market. We also think that as we start to roll out Gozellix, which you have to remember, it has a PDUFA goal date next month, but that means that the CMS reimbursement will be sort of more around mid-year. So the impact of Gozellix will start to really come in the second half of the year. We see that as also expanding our reach and our percentage of the market in an accelerating fashion. So the second half of the year can certainly see good acceleration. I think one of the things that we're dealing with right now, and maybe I'll get Kevin to expand on it, is just all the changes in the reimbursement landscape have made the near-term customer interaction, it’s pretty complicated. There's a lot for customers to digest. There's obviously differing commercial behaviors in the marketplace. We have succeeded against that backdrop of very stable pricing. We've continued to take market share. So we feel that our commercial team is doing a good job. But I don't know, Kevin, if you want to add anything to that.

Kevin Richardson

Analyst

Yes, I would just answer specifically on the market in general and all the changes and things that are happening right now that may affect the customer that we sell to doesn't really affect the patients that we scan. So, we still see good growth in the scanning side of that and the patients that are still coming in to get scanned. The growing confidence in PSMA scans by urology physicians and really beginning – continuing to utilize it at the same rate. So we don't see that trajectory changing.

Chris Behrenbruch

Analyst

Yes, that's right.

David Stanton

Analyst

And final one for me, thank you. That's very clear. Final one from me. In terms of the PDUFA dates, we have noted that, some other pharma companies who had a PDUFA date in February have had [ph] delayed. I note that you've got your PDUFA date, as you say, in February coming up reasonably soon for a number of different products. Given the change in regulatory environment in the U.S. what would you say, is the risk around those dates being delayed or postponed? Thank you.

Chris Behrenbruch

Analyst

So we have contemplated that risk management in our guidance and clearly that, that we haven't got Illuccix, Gozellix and Pixclara yet in our guidance for the year. So I suppose that somewhat disintermediates it. I would say without sounding overconfident about something that I don't personally control, I think that Gozellix is in fine shape to meet its goal date. We have not had any guidance from the FDA on change in PDUFA date for Pixclara. And we've had clinical site inspections and stuff like that scheduled on time. So we're feeling very good about that. We've already got clinical site inspections happening for Zircaix as well. So the FDA appears to be highly engaged. I think not all divisions of the FDA are going to be impacted equally, but there's no doubt, I would say not making a Telix specific concern, but as an industry wide phenomenon, I think there's a lot of concern about the structure and nature of the U.S. government going forward in the FDA, in CMS, in the NIH. I think it's a Richter scale shift and I think we're all dealing with what the potential consequences of that will be.

Kevin Richardson

Analyst

I would just add that, we continue to have good communication as of today. And as Chris mentioned, our visits are scheduled and we're moving forward in the process. So that really hasn't changed.

Chris Behrenbruch

Analyst

Yes. Thank you, David. Much appreciated.

David Stanton

Analyst

Very clear. Thank you. I'll get back in the queue. Thank you.

Chris Behrenbruch

Analyst

Good question. Thanks.

Operator

Operator

Your next question comes from Laura Sutcliffe with UBS. Please go ahead.

Laura Sutcliffe

Analyst · UBS. Please go ahead.

Hello. Thank you for taking my questions. Could we look at Slide 10, which is like you said, a new slide, I think for us this time around. It looks as though your first therapeutic product to market will be hitting around 2028. Which of your pipeline assets do you think will make it first?

Chris Behrenbruch

Analyst · UBS. Please go ahead.

Yes, look. We haven't sort of given specific guidance on that. I mean, actually what I said was that 2027 is our pre commercial year. So what that means is that in 2027 we expect to have regulatory filings in place. I think that at the rate that we're going with ProstACT GLOBAL, I would expect in 2027 that we are having those filing discussions. Of course, subject to the clinical data being what we hope certainly based on PFS data. In 2027, we would also expect to be on the cusp of pivotal trial data readouts potentially for 101 and 250, because those two assets will go into pivotal trials this year. And we think that based on the clinical trial strategy that we have, those can be fairly streamlined trials. So I think that there's a lot of momentum in the therapeutics program in the second half of 2027 as we get ready to launch those products in 2028.

Laura Sutcliffe

Analyst · UBS. Please go ahead.

Okay. Thank you. And could I ask about the 591 interim? Obviously, you've been pretty clear that the data will be from the safety run in phase from part one. Do you expect to be able to give any insights on efficacy? Or should we purely expect safety and dosimetry data?

Chris Behrenbruch

Analyst · UBS. Please go ahead.

We spoke as an immediate effect of completing the enrollment of part one. It will be safety and dosimetry, although it will be very interesting because it will be comparative information across enzalutamide, abiraterone, and docetaxel combinations. But the intention is still to provide interim PFS data. It will be event driven, obviously. So I can't give exact guidance of when that's going to be, but there will certainly be ongoing reporting on that study as it progresses. I don't know, Richard, if you want to add anything to that.

Richard Valeix

Analyst · UBS. Please go ahead.

Yes. As you said, so the primary focus will be the safety and dosimetry, which are already very interesting data for the development of this compound in association with the classical treatments. So the RPFS will come perhaps a little bit later, but we are monitoring that and we will be keen to disclose that without penalizing the clinical trial.

Chris Behrenbruch

Analyst · UBS. Please go ahead.

Yes. Thank you, Richard. What else have you got, Laura?

Laura Sutcliffe

Analyst · UBS. Please go ahead.

I'll just go with one more. For your bone palliation agents, 090, what is the pathway to approval for something like that look like? Do you need one or more full Phase 3s? How big do they need to be? And what does the FDA think is the right comparator in this situation?

Chris Behrenbruch

Analyst · UBS. Please go ahead.

Yes, we've actually had a pre-IND consultation with the FDA to talk about our current state of data. The predicate product for that is there is in fact a predicate product for that. That gives us quite a bit of guidance on how a product like that would be developed. We do have really nice data, including repeat dosing data that shows the utility – clinical utility of the product. The study that we would expect to run is not a classical therapeutic treatment response study. Our first indication is focused on pain management, and that results in a very compact trial design. So historically, and we haven't put a trial protocol in front of the FDA, we've been invited to do so. But historically, a trial like that has been in the vicinity of 150 to 200 patients, with a primary endpoint being pain scoring for a period of time, typically 12 weeks to 16 weeks of pain scoring. And that results in a very tractable trial design that can recruit and complete very quickly. So the attractiveness of that agent is really that we are doing some bridging and comparative dosimetry work right now to the predicate product. Once we have that data to present to the FDA, then we will go back with a trial design that is along the lines of what I just outlined.

Laura Sutcliffe

Analyst · UBS. Please go ahead.

Super. Thank you.

Operator

Operator

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

Andy Hsieh

Analyst · William Blair. Please go ahead.

Oh, great. Thanks for taking our questions. A couple from us if you don't mind. So, one, I want to go back to the ProstACT GLOBAL study, especially with the dosimetry portion of the interim analysis. I'm curious if you will be able to detect what Dr. Louise Emmett had shown in the ENZA-p Study where enzalutamide could upregulate PSMA expression. Just from that dose symmetry portion of your trial, as a way to kind of amplify the response? So that's question number one. Question number two has to do with the DA9 franchise. I'm curious if you could comment on the labeling efficiency of Zircaix, since you're doing – you're using a different key laser for this one. Obviously, you have gross margin implications here? And related to that also STARLITE-2 really curious about when the results will come in. So I'm just curious if you can comment on kind of the timing to what type of data in combination with nivolumab we can expect? Thank you so much.

Chris Behrenbruch

Analyst · William Blair. Please go ahead.

Yes. So I think it's kind of three questions there. The first one is very straightforward. I mean, we obviously wouldn't estimate what we might see in clinical data that we haven't yet got in our hands. But you are right certainly the – part of the basis for the trial design is that there is a synergistic effect for both the RPs and in fact the taxanes, and up regulation of PSMA is one of them. Those patients are scanned serially in the study. The dosimetry is a multi-time point dosimetry study. So if there is an effect around PSMA expression levels, then we may well see it from the data. And that's exactly Richard commented and I won't ask him to repeat it, but that's why Richard commented having the comparative data between the three different standard of cares is going to be really interesting. And we'll certainly put that commentary out there when it's available. Regarding the second question, which was radio labeling efficiency, so generally, I mean, as a general statement across the antibody drug conjugates, one of the consequences of the type of chelators that we use and the radiochemistry that we use is very high radio labeling efficiency. Typically, because of the slightly higher cost of goods of a biologic compared to a small molecule, we don't have a tolerance for poor radio labeling efficiency. But typically radio labeling efficiency, we shoot for 85% to 90% radio labeling efficiency. I am bound to tell you though; it does not have a profound consequence on cost of goods. And the reason is that the production efficiency of zirconium and gallium with the ARTMS target system that we have is extremely high. We produce multi-Curie quantities of radionuclides. So, if the efficiency is plus or minus 5%, it's in the rounding noise of the economics for the product. And then the third question relates to STARLITE-2. So on the back end of ASCO, where we obviously wanted to give our KOLs the chance to have some podium and poster time, we actually will be shortly running an update on the STARSTRUCK-I, STARSTRUCK-2 sorry, STARLITE-1, STARLITE-2 and STARSTRUCK studies. So, yes, that will be the subject of some further data released quite shortly.

Andy Hsieh

Analyst · William Blair. Please go ahead.

That's super helpful. Thank you so much and congratulations on all the progress.

Chris Behrenbruch

Analyst · William Blair. Please go ahead.

Thanks. Thanks very much, Andy.

Operator

Operator

Your next question comes from Tara Bancroft with TD Cowen. Please go ahead.

Tara Bancroft

Analyst · TD Cowen. Please go ahead.

Hi, good evening or I guess good morning for you. But I'm hoping you could help us better understand what the implied impact in the second half for pass through expiry is for Illuccix in your 2025 revenue guidance. So I mean, I guess specifically upon that expiry, do you have an idea of what the average MUC base pricing would be for fee for service patients based on historicals? And also how many of treated patients would this impact? Like how many now are CMS patients and specifically fee for service?

Chris Behrenbruch

Analyst · TD Cowen. Please go ahead.

I'll start and then I'll hand over to Kevin. I mean, we don't give guidance on what we think our MUC pricing will be since that's obviously a future event that will depend on a number of other pricing parameters at the time that that comes into effect. And clearly, I think as a general statement, the HOPs [ph] impacted segment of the market is roughly half of the market. I think that's generally known, it's a similar phenomenon for [indiscernible]. So that's the impacted patient population. Although there are obviously subcategories of patients within that segment. So that's my initial sort of answer – high level even answer to your question. Kevin, if you want to chime in on add anything?

Kevin Richardson

Analyst · TD Cowen. Please go ahead.

I think I would just add that that's why we have a two product strategy. The CMS pass through expiration is a known event and we plan for that known event with Gozellix launch and we're timing that up very nicely and we'll manage smoothly through that transition. So I think the larger answer to your question is based on our guidance and you'll be able to look at that and see what we're think, and what we're going to be able to do in terms of product mix. Remember, we'll be the only company out there with a two product strategy in PSMA to manage that situation.

Chris Behrenbruch

Analyst · TD Cowen. Please go ahead.

Yes. And just to reiterate earlier that our guidance, as it stands, does not include the impact of Gozellix in the marketplace. So it's Illuccix only guidance.

Tara Bancroft

Analyst · TD Cowen. Please go ahead.

Okay, got it. And so just to be clear, so your commercial strategy for Gozellix is almost that it will cannibalize the Illuccix revenue after the pass through expiry or will it also – do you plan for it to take from competitors or do you plan for it to grow the market? Maybe just a little more detail on that?

Chris Behrenbruch

Analyst · TD Cowen. Please go ahead.

Well, I don't think cannibalization is quite what we expect. We genuinely expect the two products to exist side by side. Commercial payers have a different dynamic than Medicare and government payers like FFS and 340B and stuff like that. So what we see is that there are some markets where there's an advantage to having a reimbursed product and we would like to competitively service that advantage. So that's really about taking market share and we are consistently taking market share even in this current backdrop. We expect that market share acquisition to accelerate with Gozellix. Again, that's not in our guidance at the moment. So that's an update for later in the year. But it really is about a two tier. As Kevin said in his presentation, it's really about having a two-tier strategy that can deal with different price sensitivity and different reimbursement dynamics. And we think that's very powerful.

Tara Bancroft

Analyst · TD Cowen. Please go ahead.

Okay, great. Yes, thank you for that. And so I guess, one last question. So I guess at peak, what do you expect? The Gozellix and Illuccix franchise, what market share are you expecting to achieve?

Chris Behrenbruch

Analyst · TD Cowen. Please go ahead.

All of it. No, I'm just joking. I don't think we really put out an aspirational number. I mean, our goal, we chip away, we take, 2%, 3% market share every quarter. We continue to expect to do that. Obviously, again, because Gozellix isn't in our guidance, we haven't given an updated TAM with what we think Gozellix will do. I think currently our competition and ourselves have a very similar viewpoint, around what the size of the market is. It's around maybe the 600,000 scan level. We do see some opportunities to increase that market size. You should remember that probably 15% to 20% of the U.S. market still not reached in terms of scanner footprint and patient footprint. We expect to change that with Gozellix. The key attribute of Gozellix being a six hour shelf life instead of a two hour shelf life, which really gives us enormous reach out of nuclear pharmacies. You have to remember that the advantage of the nuclear pharmacy model is, as Kevin said in his Texas Twang, it's locally farmed to bedside or locally farm to scanner. What that means is that, when we compound that product or when we produce that product out of a nuclear pharmacy, there's nowhere where we can't go with Gozellix. And so we really get to pick up that patient population. And it's been well studied. You know, it's been well reported in our field that we have significant patient deserts. Patients travel two, three hours to the big smoke to get a PSMA scan. And, we can, if we can bring that to the patient, that gives us an enormous competitive advantage.

Tara Bancroft

Analyst · TD Cowen. Please go ahead.

Okay, great. Yes, thank you so much for all that detail.

Operator

Operator

Your next question comes from Steven Wheen with Jarden. Please, go ahead.

Steven Wheen

Analyst · Jarden. Please, go ahead.

Yes, thanks very much. I just wanted to go back to the guidance slide. I'm just wondering if you might be able to help us understand in the RLS revenue, what amount has been removed for double counting purposes. Giving the starting point for RLS revenues about US$158 million.

Chris Behrenbruch

Analyst · Jarden. Please, go ahead.

We haven't non-material. The RLS Illuccix component is non-material at this stage, so there isn't much to account for.

Steven Wheen

Analyst · Jarden. Please, go ahead.

Okay, great. And so then the balance of the RLS revenue, just trying to understand the cost structure of that business that you've acquired. How would we think about the cost and sort of the profitability of that revenue? Obviously, it would look quite different to sort of just straight out Illuccix profitability.

Chris Behrenbruch

Analyst · Jarden. Please, go ahead.

Yes. So we're going to start reporting RLS as you have to remember that our acquisition has just completed. So we're going to start reporting RLS as part of the breakdown for Telix Manufacturing Solutions. I think for simplicity, if you exclude the impact of our product, you can assume that the RLS cost basis is neutral to Telix.

Steven Wheen

Analyst · Jarden. Please, go ahead.

Okay, got it. And then just the final question I had just to help with some of the modelling. You've obviously been so busy with a lot of acquisitions. When we look at the cost structure, I'm just talking about G&A and sales and marketing lines. When we look at that for FY 2024, can we divide the second half of 2024 up and say that's a lot of those costs from those acquisitions are fully baked into those lines? Or is there further annualization of those costs that we need to be accounting for in FY 2025?

Chris Behrenbruch

Analyst · Jarden. Please, go ahead.

No, those costs are baked in. I mean there is some headcount growth in line with our general R&D and commercial plans. I think we've given guidance to the market previously on what we think that SG&A increase will look like. But again, I mean, I know, Steve, I know you're so focused on earnings and bottom line and everything, but it's just not our focus. Our focus is to reinvest everything we can back into our R&D platform, barring some reasonable risk management and balance sheet prudence. Right. So you should expect. And I think the numbers are there. Darren's gone through them. I think, it's going to be a continued trajectory from where we were last year.

Steven Wheen

Analyst · Jarden. Please, go ahead.

Okay. I mean, I'm not that focused on it. I'm focused on the top line, but I just kind of. We've got to produce a whole P&L. So that's just helpful on that basis. Thank you. All right, thanks.

Chris Behrenbruch

Analyst · Jarden. Please, go ahead.

I think we're past the end of the hour, so I think if there are some remaining questions or some online questions, we had sort of a bumper attendance in this call, so we'll do a follow up separately. But maybe Kyahn, if I could hand back to you.

Kyahn Williamson

Analyst · Jarden. Please, go ahead.

Yes, absolutely. Look, thank you very much. We have run over time. I will respond to the webcast questions and Darren and I are available today. But thanks for your attention and for tuning in.

Chris Behrenbruch

Analyst · Jarden. Please, go ahead.

Thanks very much, everyone.

Operator

Operator

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