Good afternoon, everyone. Welcome back to the afternoon session of Oppenheimer's Annual Healthcare Conference. I'm Jeff Jones, one of the analysts on the biotech team here. I am delighted to be joined by Christian Behrenbruch, CEO of Telix Pharmaceuticals. Chris, thank you very much for joining me this afternoon, or what time is it in Australia right now?
Don't worry, it's civilized. I'm home on a rare mission to see my kids for a little bit, but normally we'd be doing this, obviously, on a more favorable time zone. Over to you.
Well, thank you for taking the time to join us, and really look forward to checking in on the Telix story. For those less familiar with the story, Telix is one of the largest independent, call it, non-pharma players in the targeted radiopharm space. Chris, would you mind giving us just sort of a high-level overview on the company, and then we could dive into really the two main product businesses that the company has, the diagnostics and the therapeutics?
Yeah, thanks, Jeff. We're a dual-listed ASX, NASDAQ-listed company. We'll do about just under $1 billion in revenue this year, mostly in what we call our precision medicine business, which is our imaging business, which we'll, I'm sure, touch on a little bit today. That's a multi-product, multi-jurisdictional business. We're commercially active in 26 countries around the globe. Very international workforce. Our R&D pipeline, which is a self-funded R&D pipeline this year, to the tune of about $300 million, between R&D and infrastructure development, is focused on a pretty diverse pipeline of assets in therapeutic oncology. We are also a fairly vertically integrated company. We have our own commercial team in major markets.
We are also a manufacturer for most of our own products as well. For example, in the U.S., we run our own nuclear pharmacy network to deliver our products. Quite an unusual company, I think, under the radar of most U.S. investors, but certainly that's changing. We've had a lot of inbound interest over the last 12 months.
Yeah. As you know, a lot of Your biggest business right now is the precision medicines business or really imaging. Traditionally, most biotech and a lot of the biotech investors interested in the targeted radiopharm business have been more therapeutics-focused, myself included. You guys have a very deep pipeline. Let's spend a little bit of time on precision medicine-
Sure.
Then transfer over to therapeutics. As you mentioned, you guys are doing close to $1 billion in revenue, $600 million or so on the diagnostics precision medicine business for last year. You have sort of two leading products there, in Illuccix and Gozellix.
Mm.
Both approved on the prostate side. Could you maybe distinguish those two products for us and how they fit into the market?
Yeah, sure. Well, they're really about scale and clinical activity. Illuccix was our flagship product. We launched it in 2021. It was a, it's a PSMA-targeting agent. You know, our major competitor in that space is Lantheus, who put out their results earlier today. We came second to market behind Lantheus very shortly, but obviously, they had a first-mover advantage. I think over the last few years, we've done a very solid job of taking our market, our fair share of that market. Illuccix came off transitional pass-through last year at the end of Q2. Gozellix is a lifecycle management product for Illuccix. It is reimbursed.
We got pass-through in October of last year, which gives us a three-year run at the HOPPS, CMS HOPPS segment, you know, which is clearly from a market share perspective, a very important place to be. We have now three years of clear run at reimbursement with Gozellix. There are some clinical advantages. It's not a me-too product or just kind of a reframe of Illuccix. It uses cyclotron-based solid targetry and higher activity generators to produce larger quantities. It has a very different formulation than Illuccix does. It allows us to transport the product with a longer shelf life, a three-times longer shelf life, which means that from a nuclear pharmacy dispensing perspective, we get deeper into the woods in that last mile of patient delivery.
It also means that for the academic centers, you know, we were always kind of begrudgingly impressed by how Lantheus framed our business in the early days. We were the morning espresso shot, and then Lantheus would come in with a big Starbucks container at about 11:00 A.M., and academic centers really loved that. Gozellix enables us to do exactly the same thing, so it really has a dual purpose. It's really about servicing volume accounts that want to have a lot of activity delivered all at once, as well as the ability to really go to that last mile and fill some of the radiopharma deserts that are out there. That's how the two products work.
From a reimbursement perspective, obviously, Illuccix allows us to compete in the commercial segment in a very assertive way without putting price erosion into the, into the reimbursed part of the market. So that two track of reimbursement or two-payer track really allows us to control pricing and what has become, as you know, a pretty commercial, mainstream, contracted market now. It's heavily driven by, you know, GPO and IDN network contracts. So that dual-track product pathway really gives us an excellent selling advantage. We have vision, of course, beyond Gozellix. We want to be the leader in prostate imaging and urologic imaging for the long term, today that's our strategy.
Okay. And that's a great sort of framing of it and highlighting how you're thinking about the prostate market, potentially being much larger. It's worth talking about your BiPASS trial.
Yeah. Absolutely. Yeah, I mean, PSMA is growing generally. You know, you'd be amazed how many urologists still need to be educated about PSMA. You know, we believe there's still merit in selling the clinical value proposition of our product, so our sales force is very active in doing that. Fortunately, because we have a multi-product strategy in urology, we see a depth of relationship there that we can build. You know, first of all, the urologist is a surgical specialist, so we have, we have surgical tools, and we meet the urologist in the OR. We have a kidney cancer product that's, you know, very close to being available as well.
Again, it's about, you know, coming in with a full suite of products: prostate, renal, bladder, you know, really to have that one-stop-shop relationship with urology. By the way, urologists are buying PET scanners as well. They want to be owners in that patient journey. They want to own the patient much more carefully, so our pharmacy network is also an important part of that story. We're in there providing service directly to the urologist, in a, in a much closer working relationship. That's kind of all of that piece. The market will continue to grow. PSMA is continuing to grow. I think some of the analyst estimates of 3%, 2%-3% a year, I think that's frankly a little underbaked.
I think, you know, when you have a large player like Lantheus in the market that's losing market share, you sort of tend to get a bit of distortion effect there. I think the market's growing more like 5%-7% a year. On top of that, there's opportunities for label expansion for PSMA. As you note, we have the BiPASS biopsy study, which is recruiting extremely fast. It's about halfway through recruitment already. We expect it to finish recruitment in the sort of May, June timeline. This is a study that is designed to address the fact that we give 1.2 million biopsies a year in the United States, but only about 800,000 are not additive to patient management.
The BiPASS study, which, you know, is a very, I think, effective working relationship with the FDA, is really around how do you triage a patient with PET to decide whether taking tissue is the right thing for that patient? We're not trying to eliminate biopsy, because actually there's no clinical or business case to eliminate biopsy in patients that need it. You know, the tissue is very important, a lot of patients don't need a biopsy based on the combination of MRI and PET. We're excited about this trial. Currently today, the TAM is about 650,000-700,000 scans in the U.S. BiPASS has the potential to add another 800,000 scans, really double the size of the market.
There's a big prize there, but it's also strategically a big prize because we believe that whoever scans the patient first is also going to be with that patient on their prostate cancer journey long term, that longitudinal comparison of data. We think it's not just a market-sizing event, but we also think it's a market-shifting event as well, a market share shifting event. Yeah, we're super excited about it. The KOL engagement, I mean, everybody knows, everybody knows we've got to do better at how we biopsy and manage that early, you know, that early diagnosis piece.
Then maybe the last question on prostate imaging, and just, I mean, if you're adding potentially 800,000 scans to this market, as you noted, urologists buying PET scanners, what does PET capacity look like today, and when does that start becoming a bottleneck?
Yeah, look, I think, I think it's a really serious question for the industry. You know, they, there's no doubt that, between prostate market growing, new indications, new disease areas like FAP, growth in neuroendocrine, got dementia, cardiology now is demanding more of PET. There's clearly we're gonna need more scanners, and we are. The capacity is growing. The backlog on scanner volume is certainly there, so there's a lot of new installations going in. The other thing as well is we're in an era now of much more sensitive scanner designs, that are, you know, able to have higher patient throughput. You know, in some cases, we're talking about an order of magnitude, greater sensitivity.
AI is also playing a role, you know, in terms of compressing scan times and requiring, you know, fewer counts to get a reconstructed image. I think that there's a lot of tech that's coming in behind, and what it does is, the whole landscape, it reinforces the idea that a PET scan. You know, most people in America don't get paid to take a day off work to go get a PET scan. All right? It's about getting the patient in, hopefully having the patient scanned in their community, right? Again, that idea of bringing the dose deeply into the patient experience as we can is a super important part of our commercial strategy.
It's why we own a nuclear pharmacy network, and why we work very closely with some of the big nuclear pharmacy networks, like Cardinal Health, to get that penetration out there. You know, you wanna have the patient be able to go in, get scanned, you know, 20 minutes, 30 minutes later, quick scan and out. The throughput demand on a PET scanner is massive, and it's only growing, right? That workflow and speed of activity, I think in the competitive end of the market that we are today with ourselves, certainly Lantheus, I think we understand that patient throughput, that patient workflow is super important.
Another really important indication for you guys in terms of the scanning is your Zircaix product for renal cell filed the BLA. I know you've got some CMC work to do. I guess any update on the CMC side with the FDA? That's a really exciting product to come forward on the renal cell side.
Yeah. Well, look, I mean, I'm very front-faced about it. You know, we had two setbacks last year. We had two CRLs for our glio and our renal products, very novel products, and in some cases, novel clinical development strategy. Pixclara will be submitted, you know, in the next few days, resubmitted in the next few days. We've actually just filed our European submission. We decided to take the opportunity to harmonize the EU and the US submission so that, you know, we have one CMC package, you know, one, you know, consistent clinical data references, and so forth. Pixclara is nearly remediated, and Zircaix will follow a couple of months behind. We've had two Type A meetings with the FDA to review the CMC deficiencies that they outlined in the CRL.
You know, I think that, you know, speaking candidly, we feel that Pixclara should have been approved. We view that as more of a change in goalposts type of environment with, you know, where we're at with the FDA right now. That said, they've been very collaborative in addressing the statistical changes that they wanted to see in the analysis of the Pixclara data. I'd say that the Zircaix CRL was more, you know, we approached the problem as a PET drug, you know, a PET imaging drug with the dosing and the risk profile that a PET drug has. I think the FDA viewed it more as a biologic drug conjugate. You know, we've had a learning curve. I'd say that, you know, frankly, that we and the FDA are learning side by side.
It's the first time anybody submitted a PET biologic to the FDA. We learned a lot from it. It was a very collegial conversation, and in my view, the agency is highly supportive of the product getting approval. You know, we've had a learning curve on it. You know, that unfortunately came at the expense of the momentum around that asset. I still expect that we will launch that asset this year. You know, the submission is not, you know, a distant activity. You know, it's still targeted for this half. You know, we're working very hard to make that happen.
Fantastic. All right, I know I really wanted to spend some real time on the therapeutics, so let's move over there. You have a really extensive portfolio on the therapeutic side. I think you've got about 10 disclosed programs, three of which are in advanced clinical studies. Maybe starting off with TLX591, which is the antibody linked to lutetium-177. You're in a pivotal study at this point in prostate cancer. Maybe take us through where you are today. I know there's a run-in there, and sort of updates around the run-in patients and where you are in enrollment.
Well, I mean, just from a high level, before I launch into 591, I just wanna sort of comment a little bit at a high level on the pipeline, you know. For every target we go after, we develop both an imaging agent and therapeutics. We feel that the imaging validates our target choices on the therapy side of things. There is a strong nexus between the two. Obviously, patient selection and target validation and target expression is something that we get from the imaging piece. When we go after a target on the therapy side of things, usually we have a lot of data to support that from a dosimetry and targeting perspective.
591, as you note, it's in a phase III trial, ex U.S., in Australia and Canada and places like that. It's already in the randomized part of the study, it passed. There was a seamless transition between what we call the part one and the part two. The part one was a run-in study that we agreed with the agency. When we went to the FDA with the protocol for the phase III trial, we didn't have, from the agency's perspective, satisfactory data around the different RP combinations that we were looking to put into the study. We had treated enzalutamide and abiraterone as kind of a class effect. We had some clinical data on enzalutamide. We had some preclinical data showing that, you know, they were much of a muchness.
I think that the FDA was fairly dogmatic about it, and said, "Look, we'd like to see a comparative safety study, particularly between the two different RPs." As you know, RP switch is a cornerstone of that patient population in the United States. It is not a cornerstone in that patient population, ex-US. In Europe, for example, the ESMO guidelines discourage RP switch in that patient population. It's more likely that we're going to use, for example, a taxane in that patient population as a combo. That's why the ProstACT global trial has three arms. It has two of the most common RPs, and that supports that RP switch in that patient population. Then, the docetaxel arm is probably more of an ex-US, you know, Europe, Canada type of environment.
You know, we wanted to have one pivotal trial that had flexible standard of care, and that standard of care is obviously evolving over time. We have had, and the market's waiting for the Part One data. The only reason why we've had a bit of delay, it was supposed to be wrapped up at the end of last year, is we just had some data gathering and CRO closeout delays. The Part One study is quite demanding on patients. It's a lot of repeat time point imaging and dosimetry, and a lot of analytics that comes out of it, so it's just taken a bit longer to close out that study. The data will be out very shortly, like, you know, like I'm counting down the days kind of thing until it's out.
I know the market is as well. One of the things that I've been trying to impress upon folks is that the timeline on releasing that data is about the formalization of a database lock, and a closeout, and data cleansing, and having a CSR that we can present to the FDA, and of course, disclose to the market at the same time. I'm not part of the clinical charter for the program, but in fact, an independent data safety review board already reviewed the data late last year in order to permit progression to randomization ex-U.S. Have I lost you?
No, I can hear you fine. We may have lost your video.
Oh.
I can, I can hear you just fine.
That's weird. Yeah. All of a sudden, my video disappeared. Let's keep going.
Yeah
It reappears. The point of it is that we actually did proceed to randomization ex-US on the basis of the pre-specified safety endpoints for that study. I guess what I'm signaling, without, you know, fully knowing what we're gonna present in a few days' time, is that, you know, there's a high comfort level in the study, that there's nothing kind of untoward. What I think will be exciting for the market is the difference in dosimetry, and if there's any patient characteristics between the two different ARPs. That's gonna be the topic that we'll obviously be really, you know, exploring with the agency.
Okay.
Yeah.
As you noted, you are enrolling ex-US.
Correct, yeah.
The study is continuing to enroll. We're just waiting on this sort of early analysis. Is it 30 patients for the run-in?
That's right, yeah. As you said, it's really. So what you'll expect to see in that data is comparative safety dosimetry between the three different combo cohorts. Again, I think from what the feedback we've been getting, you know, particularly from U.S. analysts, I think the real interest is gonna be in: Is there a difference between Enza plus and Abi plus? Because that's the cornerstone of the use case for that drug in the U.S., you know, treatment context. I don't know the answer to that one, but I'll be as excited to see the results as anybody else will. I'm doubtful that we're gonna see a lot of difference between the two.
As I said, on the basis that we have proceeded to randomization ex-U.S., on the back of a, you know, not database locked, but an independent safety review, I think we're fairly comfortable that, you know, we're heading in the right direction with that study. Part Two, you know, Part One was just a glacial recruitment. We limited it to a limited number of sites because of all the SPECT dosimetry work. It's quite specialist. It's not a mainstream kind of treatment protocol. Now that we're in the Part Two, the study's going much faster because it's a more of a set and forget type of clinical protocol, and it's much more consistent with what people are expecting to see when they give lutetium therapies.
Frankly, it speaks to one of the differentiators of the dosing regimen, which is that it's a short course of therapy. It's two shots, 14 days apart. It's a much lower dose therapy. You know, really from an ease of participation in the study, you know, the Part two is night and day different than Part one.
Just as we think about, you know, Pluvicto being the market leader as far as the targeted radiotherapy for prostate cancer, where are you looking for? Sort of what is success here for five nine one? Is it, you know, you and I have talked about this a bit in the past. Is it the, "Do we get comfortable on PSA 50, PSA 90?" Is it an OS, PFS benefit that you're looking for more to distinguish? What's gonna help you be successful in the market here versus a Pluvicto?
Well, the regulators have made it clear that success in this area is survival. Our PFS profile and our PSMA 50 profile... I mean, so far we've demonstrated that we have a ballpark similar sort of PFS to Pluvicto. You know, we previously presented some results around the late eight months PFS, RPFS. You know, that's certainly indicatively positive. I'll caveat, you know, that was in a fairly heterogeneous patient population, including some patients that were more advanced than what we're looking at in this patient population. I think, you know, we're not aiming to be inferior, obviously, to Pluvicto, but OS is really the name of the game.
We've previously reported that we don't have 'cause of our very low dose and the long internalization time of our product, we don't get these acute PSA drops the way that the small molecule agents do. You know, if you look at our dosimetry, you know, if you compare our dosimetry to, say, the current standard in the market, you know, at about three to four days post-administration, a SPECT scan is essentially a cold scan. If you look at our product two weeks post-administration, you get a day decay-corrected scan of day two, basically. The whole mechanism of action of an antibody internalized lutetium is very different. As a consequence, we take a lot longer to get down to those PSA nadirs than a small molecule type of asset does.
The name of the game really, at the end of the day, is OS, particularly in that patient population. That's what the payer criteria is gonna be. We will have, certainly for the PFS side of things, we will have a futility analysis towards the back end of this year. That's based on somewhere between 80 and 90 events. I can't remember the exact numbers, 83 events or something like that. We expect that that'll happen sometime around Q4 of this year. That'll certainly tell us at a face value, whether we're stacking up where it needs to be.
You know, the market research that we've done suggests that, if we're, you know, if we're comparable, you know, not inferior on the survival benefit and the PFS, that the advantage we have is that very short course of therapy. We have no exocrine gland uptake. We have no renal toxicity. These are certainly not showstoppers. I mean, patients are getting access to a great lutetium drug today. You know, I think everyone's cheering at the sidelines for Novartis to be successful for this field, and they are. I think that there's an opportunity there for differentiation. We haven't seen it in the, in the point, you know, Lantheus Lilly deal. That's an example that shows you that a me-too small molecule isn't gonna cut it.
We don't think that Curium's data is all that compelling. We think that, you know, that higher imparted dose to the kidneys is something that Novartis will market around easily. I think at the end of the day, the only way that somebody takes a market share in PSMA radioligand therapy is with an asset that has a very different mechanistic profile. You know, this study is designed to elucidate that.
Yeah, the antibody has the opportunity to deliver that, as you noted, the lack of salivary binding, clearing through the liver instead of the kidney. Maybe in sort of, well, I wanted to talk about TLX592 and the actinium and differences there, that's earlier on. Let's turn to TLX250, again, CA9 targeting, matching with, as you talked about, your imaging first strategy in Zircaix. Again, this would be a first-in-class targeted radio program in hitting a really interesting target in the kidney, your programs in phase III. Let's talk a little about the that phase III study that's going on for CA9.
Yeah.
Well, sorry, it's getting ready to kick off.
It's in the process of launching. Yeah. I mean, a little bit differently for the carbonic anhydrase IX program. We recognize that prostate cancer is a high throughput imaging, you know, it's gotta be, you know, you've got to get patients in and out. In the case of renal, we have an additional clinical requirement on the imaging side, which is you can't have any urinary excretion. Can't have urinary excretion, can't have a lot of gastric uptake, otherwise, you're going to struggle to stage a patient with metastatic clear cell. Zircaix was born, and we decided to go down the antibody pathway for both the imaging and the therapies. It's actually the same targeting agent for both, a true theranostic application, because the use of a hepatically excreted IgG gives you this incredibly clear images.
I don't know if you've, if you've seen a Zircaix image in the literature, but we've got a very active EAP. There's lots of images coming out every day. You know, a typical Zircaix patient is a scan with a spot. It's incredibly localized. Now, what Zircaix gives us and all the work that we've done there is a really great understanding of the patient dosimetry. When we switch across to lutetium, and we also have an actinium-based program around carbonic anhydrase nine, at about the same stage as five nine two is, we have a lot of confidence that we have a targeting agent that can deliver great activity into the tumor. What we have decided to do, you know...
The challenge we've had as a company in locking down radioligand therapy in renal cell is that the standard of care has moved so fast. It's very IO-centric. We've got belzutifan now in the end stage setting. We've just seen this constant shift. It's a very dynamic change in standard of care, almost more dynamic than prostate cancer. So we decided that we're gonna start with getting a monotherapy, a VISION trial-like signal, if you will, in renal cancer. In fact, if you look at the design of the LUTEON study, it's almost embarrassingly copy-paste of VISION, except in clear cell renal cell carcinoma. It has very similar objectives. It is somewhat of a salvaged patient population study. It's a, it's an end-stage study.
What it does is it reinforces some of the historical data we have as a monotherapy, and in parallel, we have other studies that are looking at combos with cabozantinib, with nivo. We decided we wanted to get a commercial foot in the door, particularly given the product profile of belzutifan. We think that there's an opportunity there to provide something different in that last line setting, and then in parallel, get the other combination data that's gonna enable that asset to move into earlier lines of therapy.
By the way, where there is a real, research-driven rationale for use of IO drugs in combination with radiation, I mean, when I started the company, you know, a decade ago, the whole construction of our portfolio at that time was based around where do we think we can move the needle on combo therapies with IO? Renal cancer is front and center of that opportunity.
The story's getting better and better around checkpoint inhibitors in combination with targeted radio, to your point, finding the right indication. Unfortunately, we're up on time, but really excited about the diagnostic portfolio, the opportunity to grow and build that business, launches this year, and new data coming out across your therapeutic portfolio as well. A lot to be really excited about as we look ahead into 2026 for you guys. Again, thank you very much for taking the time to sit down with us, Chris.
Yeah, thanks, Jeff. Appreciate it.
Take care.