Wait. I like this song, but I'd prefer not to talk over it. Okay. Hi, everyone. I'm Tara Bancroft, one of the senior analysts here, and thank you for coming to TD Cowen's 46th Annual Healthcare Conference. For our next session, we have a presentation followed by some Q&A with Telix. From Telix, we have the Group CEO, Christian Behrenbruch here. Thank you for joining us. I'll let you go ahead with the presentation before we get started on the Q&A. Go ahead.
All right. Well, thank you very much, Tara. I'll just step aside so you can actually see the.
Yeah.
The screen. Just the usual preemptive statement. I think most of you looking around the room, I think, recognize just about everybody. I think you understand the company, but just to give a sort of potted summary, you know, 2026 is really about investing in developing our therapeutics pipeline, which is very strong. We have three programs now that are in late-stage clinical trials. That's where the majority of our investment from cash generation comes from. We have looking at the purchase price of innovation at the moment in the radiopharma space, we've decided that sort of contrary to the early days of the company, that there is some value in in-house innovation.
You know, when Novartis pays $1 billion for an asset that's been in three mice, you've got to sort of pay attention to that, I suppose. I'm joined here at the conference by Kevin Richardson, who leads our precision medicine business. We've had a great year, frankly, in 2025. A lot of exciting things happening in 2026 on the commercial front, both with PSMA and beyond. We do expect this year to refile Zircaix and Pixclara, which are significant additional revenue streams for the company, as well as our international expansion as well. The commercial organization continues to be something that we grow in. We see that as an asset, not as SG&A. We see that as really building a leveraged capability for multi-product delivery in the future.
As you know, we've invested a huge amount, more than half a billion dollars in the last couple of years in supply chain and manufacturing verticalization. I think it's a theme of the mature end of the radiopharma market. You've gotta have the infrastructure to do patient delivery. Yeah, company in a nutshell. Took longer to talk through than I thought it would, I don't need to spend too much time on this. We've just put out our numbers. We had a great year, record year last year of AUD 804 million top line, up 56% year-on-year. We're obviously trying to, as a company, overall diversify our revenue streams.
Part of that comes through from the acquisition of RLS, which is proving to be a very successful acquisition for the company. Our guidance for 2026 is $950-$970 range. That doesn't include any unapproved products. That's only based on things that we have baked today that we're selling that's reimbursed today. I think, you know, a very positive outlook for 2026. I'm sure Tara will grill me on that in due course.
Sometimes people tell me that Telix is a complicated company to understand, and I really I can see how that would be the case perceptually, but really this year, we have three simple things to do: to grow our core business, to launch a couple additional products that we expect to get approved this year, and then really to put a spotlight back onto our therapy programs. We're getting some really exciting patient data out of our therapy programs, but they somewhat stay out of the spotlight because we have so much analyst and investor focus on our commercial business. We really hope to change that this year. We got very close last year, and then when we got a couple of CRLs, that tended to pivot the conversation back to the diagnostic imaging side of the business.
It's clearly not really what we get out of bed every day for. We finally bit the bullet in our in our year-end results and put a Sankey diagram together that shows, like, where does the cash go in the company. You can see we throw off a lot of cash that we invest, hopefully for a very bright future in terms of what the therapeutics portfolio can offer. That's it in a nutshell for for 2026. I don't think I've got much more to add, just a reminder, really deep pipeline on the therapeutic side. For every target that we develop, we develop a companion or, you know, corresponding precision medicine agent. You can see they're mostly baked. We have a couple that are in the R&D stage.
That sort of really speaks to the commercial strategy, overall for the business. I think I'll pause there, 'cause I wanna have time for Q&A, and I've got a couple of extra slides if we wanna talk about any of the therapy programs, but open it to you, Tara, and to the floor, I suppose.
Okay, great. I guess we can sit here. You're right, I do wanna grill you on guidance and a little bit on the commercial pipeline, but I also wanna spend the majority of the time that we have on the therapeutics pipeline.
Mm-hmm.
B ecause, you know, especially with, changing dynamics among, competitor companies.
Yes.
I n the therapeutic space. Okay, on diagnostics first, I was hoping maybe you could tell us a little bit more about what you're seeing with this two-product strategy, because 25% year-over-year growth guidance is actually it's substantial. Maybe just a little bit more on feedback and how that's resonating in the commercial setting.
Sure. The Gozellix launch, you know, Q4 was really our kind of the administrative transition to Gozellix. Typically, when you launch a new product, you're looking at, you know. We saw most of our customers didn't do anything until they saw TPT in hand. You know, it's a six to eight-week timeline to go through the purchasing committees and getting all the paperwork done in place. Really last quarter, even though we had an uplift in the quarter, I would say it was very preliminary on Gozellix. You're gonna see much more the impact of Q1 and Q2 this year. I think Q1 will be very interesting for investors to see just how much impact Gozellix has in terms of ASP.
I think one of the things that's not really fully understood that Gozellix is not just a rinse and repeat of Illuccix. It has new clinical utility, it has different distribution profile. It obviously has a different reimbursement profile as well. One of the things that enables us to defend a higher price point on Gozellix is the clinical experience that we had in injecting 200,000 patients with Illuccix. We really learned that a six millicurie dose is better than a five millicurie dose. It gives you higher scanner throughput, which is super important in the current demand for PET scanning. It also gives you slightly better image quality. What we're really asking for people to pay for is the extra millicurie.
It's part of the transition of Gozellix is selling a five millicurie to a six millicurie dose. Still puts us under the imparted radiation dose of our competitor, it does speak to, you know, improved clinical utility or enhanced clinical utility. It's a really easy sell to make when you combine that with the reimbursement change. That's why you'll see the Gozellix impact really drive the average ASP of the business. It already has. You know, you could see that a little bit in last last quarter's results, but you'll see the impact more this year as we go into full-fledged availability of that product. The other thing is that when we launched in the U.S. market behind Lantheus, we chose to focus more on the IDTF space.
We wanted to hammer out a space where we didn't have so much competition. You know, they tended to focus on the large academia accounts that were low-hanging fruit. Now with Gozellix, we really have the opportunity to address the fact that, you know, historically, a relatively lower proportion of our business has been HOPS accounts. Now we have the ability to change that. That will also have an impact on share capture for this year.
Okay, great. you know, understood about this year, I kinda wanna ask about longer term strategy. This is a question that I get from investors a lot. once Gozellix got TPT and, you know, others are cycling through, you know, POSLUMA is losing, you know, PYLARIFY 2.0 might get it. what is the long-term goal here? Is it a new product every three years? how does that look three years from now and further than that?
I think that, I mean, we are not the only area of pharma where you need to do product lifecycle management, so I think that that's not an unheard-of concept. I do think we expect that continued innovation and bringing new capabilities, new clinical capabilities to the table is an important part of market leadership. You know, we see market leadership through selling clinical differentiation, through pricing discipline, and through innovation. All of those things are, I think are really important. Yes, it will continue to be the case. I think what it'll also do is it'll put pressure on to hunt for new targets.
Mm-hmm.
You know, we are doing it. You know, we've got a couple of things that are just about to go into humans that are, you know, novel target, non-PSMA targets. I think everybody understands what impact PSMA has had on prostate cancer, but PSMA is not the end of the journey.
Of these new targets, which one would you say is your favorite?
I could tell you, but then I'd have to kill you afterwards. You seem like a nice person, so.
It's okay. This conference might do it for you.
Yeah.
Okay. All right. Let's stay on the topic of guidance, before we move on. One of the things that you highlighted in your opening was how important RLS is, to the bottom line. I'm curious what your expectations are for RLS revenue this year and, you know, is it something that you expect to be relatively stable? Are you bringing in new third-party contracts or not? What's under those expectations?
We definitely, you know, we have a multi-channel strategy in the U.S. market. You know, we, you know, particularly our partner in Cardinal Health is a super important long-term, you know, relationship, and we see ourselves as an innovation complement to their market strength, and I don't see that ever going away. RLS was really about tidying up the splashy end of the pool in terms of pricing and price discipline. We wanna be able to have a bit more control over the segmentation of the market. We don't report RLS revenues segmentally, so all the precision medicine revenue is banked on one side, so we don't report it. We are growing the SPECT business. It's not as high a growth opportunity. It's a mature, very mature space.
The principal idea of the RLS infrastructure is actually not about the precision medicine business. We acquired RLS because we believe that in the medium term, that the radioligand therapy space will transition to a individually patient-calibrated dose. You know, if anyone knows anything about GMP manufacturing of radiopharmaceuticals in the room, you don't wanna spit out a custom dose for every patient. You wanna produce a unit dose or a bulk vial, and then when you ask how you're going to dose calibrate that's where that gets done in practice of pharmacy. That's the place where it happens. So we really acquired RLS with the pipeline of therapeutics that we have in mind. Today, RLS, you know, washes its face.
It's amazing to have, you know, almost a $200 million operating cost kind of covers itself through third-party revenue. We see that growing and the interest and the range of products, third-party products, will continue to grow. We have a vendor-agnostic view on the RLS side of the fence, the investment in RLS is really for the future. We are making those infrastructure improvements. We are putting Part 211 manufacturing into that network on the other side of the pharmacy wall. We're installing a bunch of cyclotrons this year. We're gearing up to be some impact of that this year. Obviously, the European pricing strategy is a little bit different. Also the cost of doing business in Europe is not the same. Oops, I just lost my microphone. Maybe it died. Testing. There we go.
The pricing model is different because we don't typically deliver hot dose business in Europe like we do. The top line is lower, but the cost of doing business is lower as well, and the distribution costs are lower. There's still good cash to be made in Europe, I would say. You know, we just announced that we have filed, for example, Pixclara in Europe, or Pixlumi, it's called in Europe. We definitely have the commitment to making sure that the whole product portfolio is available. We have filed an NDA in China. We are completing the phase III bridging study in Japan this year. Japanese market's a really healthy market for nuclear medicine. It's probably the second-largest homogenous market after the U.S.
I think that there's a good opportunity there as well with a nice advanced PET procedure, code reimbursement level. There's a bunch of things on the international that we continue to look at. On the indication expansion, We have multiple indication label expanding studies planned, but I think the notable one is our Bypass Biopsy Study. We really believe Excuse me, I'm a bit snuffly. Have the opportunity to double the size of the market for prostate cancer in the U.S. for imaging. I think it's an important label for patients. It's not about eliminating biopsy, it's about making sure that he who needs a biopsy gets one. I think, yeah, really important study.
That trial is recruiting really well. It's just about halfway recruited. It should be done by the middle of the year. You know, that is a label producing study. Yeah, we're excited about that potential.
Okay, great. I guess maybe I really wanna move on to TLX591, but since you mentioned Pixclara and the filing with the EMA, maybe you could just level set with us what's left to do for both Zircaix and Pixclara to be filed.
We're just finishing the resubmission package for Pixclara. There's nothing else to be done. It's When I say imminent.
Mm-hmm.
D ays to weeks, not weeks and months. Pixclara is imminent. Zircaix will be two months behind Pixclara. It's all manufacturing related stuff. As you recall, the CRL for Pixclara was a clinical statistical analysis CRL, which we remedied. Zircaix, clinical data fine, the manufacturing package is really complicated. You know, there's a price you pay, I think, for being an innovator, it was the first time that we put a PET biologic in front of the FDA, I think that we learned some hard lessons from that. I think, frankly, we learned together. It just came at the expense of time. Both of those packages are in good shape.
We actually had two Type A meetings with the FDA on the CMC and clinical comparability piece. We believe that we have fully agreed with the agency on what needs to be remedied, and I'm confident that we'll get those packages in. You know, we're still even shooting for this half for Zircaix.
Mm-hmm.
Yeah, these are not like distant catalysts. These are near-term.
Okay, great.
Yeah.
All right. Now on to TLX591. The Part A data, can you just update us again? What should we expect to see in that update? Really, how soon can you take it to the FDA to start U.S. enrollment?
Yeah. Part One of the ProstACT Global Trial was a U.S. requirement. It wasn't a rest of world requirement.
Mm-hmm.
The clinical development of that asset has now progressed to randomization ex-U.S. We had a clinical. I'm not across the details of it, so I'm not in the clinical charter, but the independent data safety review committee agreed that Part One met its pre-specified safety and proceeded to randomization ex-U.S. It's only the FDA's blessing that we're waiting on here. My view is, if I could say kind of informally, there's sort of a disproportionate focus on this as a catalyst. Like I don't think it's really a main. It's not a huge event for the company.
Mm-hmm.
We did have to close out a study and fully produce a CSR, which just takes time.
Mm-hmm.
It's always hard to do that over a Christmas, New Year period, so it's just taken a little bit longer to get it done. We're just waiting on final CRO stuff now. Again, that's an imminent outcome, like days and weeks, not weeks and months. I think the data that we'll be putting out for Part One will be safety and dosimetry and done in a comparative way across the different standard of care arms of the study. I think in talking to analysts, what's going to be of interest is the comparison between the two different RPs. It's the first time that we've seen a combo RP comparison. That was really why the FDA was interested for us to do that Part One study, aside from the fact that it's a manufacturing run-in.
You know, when we went to the agency, we had combo with docetaxel data, we had some combo enzalutamide data, but we didn't have abiraterone data. We felt it was a drug class. We felt that some of the non-clinical data that we had supported that as a drug class. The agency was much more prescriptive about it, and that's why the Part One came up as a gating requirement. So I think the scientifically and I guess commercially interesting thing is there any difference between those combos? I guess you'll know when I know. According to the fact that we are randomizing ex-U.S.-.
Mm-hmm.
Already, it does mean that pre-specified safety was already met. I think it's just about elucidating the data.
Okay, great.
Yeah.
Now that you have started globally the second half, could you maybe tell us a little bit about how enrollment is going in that and what you're taking from that pace of enrollment to maybe extrapolate how you expect it to go in the U.S. once it starts?
A huge amount of interest in this study. It's a very differentiated asset. It has a completely different dosing profile. It has a completely different safe patient side effect profile. Yeah, really good investigator engagement on it. I would say that the uptake of the main event has been so much faster because we're not dealing with, you know, multi-time point dosimetry for every patient. You know, the part one is I think it was four repeat visits for scanning, and it's just a lot of work. It's a lot of work for the site, which is why we kept part one to a lower number of sites. I think in hindsight, if you'll pardon the alliteration there.
In hindsight, it would've been nicer if we'd actually just, you know, increased the number of sites. It would've been faster and easier. The other thing that we weren't expecting really was the geographic mix of RP Switch versus docetaxel, so we had some preconceived ideas about how that would play out. I think we did learn a lot from part one, and the result is at part two, it's just a lot more efficient. Yeah, the pace of recruitment is really what we would expect and what we're aiming for, we think on an event-driven basis that we should be able to have a futility analysis in place by the end of this year. It's based on 25% of the trial events.
It was something that we had agreed with the FDA and made it into the global protocol or the international protocol. I think that's based on, I'll probably get it wrong, but it's like 86 events or something like that.
Mm-hmm.
Yeah, roughly that should be in Q4 this year. Yeah.
You'll present that? I mean, is it gonna be data or just the announcement of the futility or not?
No. We'll report on it.
Yeah.
We'll report on futility.
Okay.
I guess there'll have to be some color 'cause that'll be based on progression data.
Mm-hmm. Yep. Okay. Got it.
If we, yeah, if we had a futility, if we didn't achieve, if it was futile, then.
Yeah.
E xplain why.
Yep.
Um...
Okay.
I mean, based on the historical data that we've seen with this asset, you know, it's a really exciting asset.
Mm-hmm.
Yeah, we're looking forward to getting that data out.
I agree. Okay. What would be the bar that you would want to beat? Not necessarily for futility.
No, for sure.
Even though that actually would be helpful to know too. You know, what does good data look like?
Well, good data, I mean, from the market research that we've done and from a KOL perspective, what people are excited about is that it's a much more concentrated dosing regimen. It's much less lutetium. It doesn't have some of the traditional patient side effect issues of the current standard of care. You know, what I would like to see is that we have, you know, that we're at least as good as the current product, I think. Based on the PFS data that we have, that seems to be the case. We have OS data now in a much more heterogeneous patient population and with very different treatment histories, so it's hard to extract from it. It also looks like, you know, the OS data is really compelling.
You know, the OS for standard of care is, you know, a bit over three months in the patient population that we're looking at. If we can do better than that's gonna be a very successful product. Yeah, we'll have to wait and see.
Okay. How about similar question for TLX250? What's the bar to beat for that?
The bar to beat for that is really belzutifan. you know, this, the LUTEON trial, it is an end line therapy study. I'd say it's very much analogous to the VISION trial RLT study that was done in prostate cancer. It's that sort of last line, advanced metastatic patient population. We've seen good disease control in those patients and responses. It's really. That is a, that is a patient population where controlling progression really does make a difference. Belzutifan is the bar. We think that the trial can potentially position two fifty as an alternative to that.
Okay. Let's go down the line. TLX101, when could be a data update that we see from that, and what are you looking for?
Yeah. I think the plan is around the middle of next year, there'll be an interim analysis, based on the first cohorts of the study. The idea there is really, yeah, whether we have the opportunity to perhaps talk to regulators about an early approval or a conditional approval process.
Mm-hmm.
We've seen some really amazing patient responses as a monotherapy. We've seen almost all patients that have ever received at above a four gigabecquerel dosing level have not required steroids anymore. Really strong disease control, clinical data, you know, clinical evidence. Yeah, that's the sort of aspiration, sort of middle of next year that we would have something to point to in terms of data readout.
Okay. I know we're coming up on time here.
Mm-hmm.
I'm gonna group the rest together and ask, of the remaining pipeline opportunities, which ones are you most excited about or represent the largest opportunity that we should be focusing on?
Well, I think when we put out our year-end results, there were four trials that we focused on. Obviously, ProstACT Global is a current active phase III that we are keen to show that we've turned the corner on from a recruitment perspective. LUTEON and IPAX-BrIGHT, those are new advanced metastatic studies which can generate data really quickly. You know, I expect both of those studies will yield some data outcome, output towards the middle of next year. Then we have the - I trial for TLX090, which is our bone palliation product.
This is actually a really strategic product, and if this trial runs, you know, produces the sort of data that we expect, that has a very fast pathway to a regulatory approval, because it's a comparable product to an existing product that has already been approved in the past. We think that there's a faster regulatory strategy there. That is a really unmet medical need, particularly as the whole radioligand therapy space expands in prostate and breast cancer and a few other areas. The need for effective palliation is actually an art that we've lost.
With the current sort of price of opioid compliance, cost of opioid compliance, and the challenge of opioid compliance, it's a real new opportunity, a new old opportunity, I would say, if that makes sense. Yeah, I'm really passionate about that. We've seen patients, in early development to that asset that have been, you know, bedridden on a multi-narcotic regimen and go to having really quite high functioning quality of life. Yeah, it's a, it's a, it's a big opportunity.
Okay, great. I know, we're up on time, but we talked about a lot of things here. I'd like to ask you, what do you think is most underappreciated about Telix?
Well, just really how much great data we're generating on the therapy side of the business. You know, notwithstanding some regulatory and commercial speed bumps, you know, our precision medicine business does really well. It's a very rational portfolio. We have things that will continue to come in down the pathway. We have still future life cycle management. Really, it's a baked business now. It's a mature business. We're commercially escalating. You know, right now our therapy pipeline is just kind of a free option. The goal for this year is to really turn it into something that's valued, and that doesn't happen if we don't get to talk about it.
Yeah, right now we're just basically viewed as a pro rata of Lantheus somehow, I don't really know how that could be the case, that seems to be the case.
All right.
We have to fix that, I suppose.
I believe in you.
Thank you.
All right.
Thank you, Tara.
Well, thank you so much for your time, insight.