TLX 6.45% $19.00 telix pharmaceuticals limited

Ann: Telix 2023 Full Year Results and Investor Webcast/Call, page-129

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    Operator

    Thank you. [Operator Instructions] Your first question is a phone question from David Stanton with Jefferies.

    David Stanton Analyst

    I wonder if you could give us an idea of what you're thinking for percentage gross margin for F '24. Should it be similar to down on F '23 given you've taken price?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    I don't think that we're expecting a great change. We see plenty of reasons to have pricing stability remain in 2024. We haven't seen the competitive perturbations around pricing yet that really gives us concern around gross margin. We also continue to invest in manufacturing, infrastructure, and operational improvements that will continue to maintain or perhaps even slightly improve gross margin. And then clearly the follow-on products, I mean, Illuccix has a certain production and distribution profile. The follow-on products have some similarities with Illuccix in terms of their cost base, but I think that sort of 65% to 70% gross margin should be taken as an indicative gross margin for an imaging product in the Telix portfolio.

    David Stanton Analyst

    Understood. And in terms of -- second question, in terms of ProstACT SELECT and the PFS data that we're looking forward to seeing, we should still be thinking around the middle of the year calendar '24 for that?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Well, it's a bit hard to say, David, because it's an event-driven process. Unfortunately, a certain number of patients have to progress before we can make that readout take place. And those events have not yet happened. We closed the trial last May. We disclosed that publicly. So we're still waiting for adequate progression data to enable us to give that readout. But best guess at this point in time is sometime around the middle of the year. Obviously...David StantonAnalyst36:21Interesting. And last one...

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    It's one of those perverse things, right, where longer is better in some respects, even though it's frustrating for the market.David StantonAnalyst36:30Understood. And finally, last one for me. Thanks for the extra clarity on the contingent considerations. The ANMI contingent consideration looks like it's around 10% of Illuccix sales. Is that correct? Just broad brush.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Broad brush, I mean, it's -- there are some costs that are deducted from that, but that's roughly correct. And obviously, I mean, we're only paying this consideration out as a function of commercial success. it's not -- as we've disclosed to the market before, it's not a never-ending contingent consideration. It's only for a period of time, and there is the ability to terminate it after 3 years. So this is something that people are just going to have to get used to seeing. It's a function of our commercial success.Operator37:34Your next phone question is from Laura Sutcliffe with UBS.

    Laura Sutcliffe Analyst

    First one is just on the preparations for the Zircaix launch, please. What sign-offs in terms of manufacturing facilities do you need to get it launched in the U.S.?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Yes. Good morning, Laura. Thank you for your question. So we have fully engaged the manufacturing infrastructure that we will be using because in order for us to engage in a BLA submission process, those manufacturers of record need to be defined. We haven't, for commercial and competitive reasons, yet disclosed to the market who our manufacturers will be. But obviously, as we start to get ready for commercial launch, that information will come into the public domain. But as of this point in time, all of the infrastructure that we need, ranging from raw material, production, antibodies, production systems for zirconium, nuclear pharmacy partnerships for distribution, which we have several, that infrastructure is all in place and validated for commercial launch.

    Laura Sutcliffe Analyst

    All right. And then a second question just on Illuccix and pass-through payments. I'm sure you're extremely bored of this topic, but I think Lantheus said overnight that they think about 20% of prostate cancer patients are impacted by that price reduction as a result of the end of pass-through. I think that's somewhat lower than what we've assumed for Telix, and therefore our forecast could be a little bit too harsh. I realize you can't comment on Lantheus' business, but perhaps you could tell us what you think that portion looks like for Telix.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Well, we don't have a -- I mean, you are right. I'm more than bored of the topic of pass-through, but I can also understand why it's an important topic to kind of get right. Lantheus and Telix don't have a terribly different payer mix, and the impact of pass-through has a very defined payer nexus. So I think it's relatively straightforward to calculate. I don't think Lantheus' commentary is too far off the mark. I think that we have to remember that pass-through only affects a certain segment. So there's a certain analyst model that implies that when pass-through ends for one vendor, it just kind of moves to the next person because there's some expediency in that. And in practice, we all service customers that have multiple payer segments, and so the net result is you're going to see a drop in ASP across the average of those payer segments. We don't think that drop is dramatic. We think that the market will continue to grow, that the top line of the business will continue to grow, even in a post pass-through environment. We think that our customers are sticky and have chosen our product for a reason and remain loyal to the product.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    And I think Lantheus would make a similar claim given that we are competing effectively with each other in the market. And I think we would both agree that the appearance of new entrants hasn't been particularly dramatic or successful. So I think that customer relationship continues to be an important factor in how the market plays out over the next 18 months. That said, we don't take any chances on pass-through. So whilst as an industry it's a topic that has a lot of spotlight from an analyst perspective, clearly a lot of people are thinking about it. We're going to make sure that when our pass-through expires, that we're in the market with a lifecycle management that preserves our position in the market. And so we have a multipronged approach to managing our position in the market, which is about maintaining our ongoing commercial relationships, being part of an industry-led reform of the reimbursement landscape for this class of products, and then also making sure that our lifecycle management strategy specifically addresses the topic of pass-through. Does that answer your question?

    Laura Sutcliffe Analyst

    Yes, very much so. And it leads to my last question, which was, is there anything you can say to us at the moment about the opportunities for lifecycle management of Illuccix?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    We've been working really hard on this for many months and we expect to have a follow-on product filing in the first half of this year and we will give more detail to the market at the time at which that filing takes place, including the indications associated with it.Operator42:22[Operator Instructions] I'll now hand back to Ms. Kyahn Williamson to address any webcast questions.

    Kyahn Williamson Senior Vice President of Corporate Communications & Investor Relations

    Thank you. Our first question from the webcast is, is the bulk of R&D spend in FY -- going to occur in FY '24? Or do you anticipate similar levels of R&D over the next few years?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    I don't really understand that question. We haven't given guidance beyond FY '24. But again, I think it's worth reiterating what the commercial strategy of the company is. We believe that the best use of our earnings is to reinvest into the company's pipeline. That doesn't mean that over the course of time we mightn't take a more diversified view of where our earnings go. I mean, I think I'd speak on behalf of Darren. We'd like to see maybe a little bit more allocation to risk management, a little more allocation towards building a balance sheet that gives the company optionality for strategic transactions. So I think there's plenty of things that can be done to grow the business with that cash and of course, to risk manage the business. But for the foreseeable future, shareholders should understand that we are going to invest proportionately into our R&D programs.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    We have a terrific pipeline. We've shown already that we can build USD 2 billion of enterprise value in the company just with one product. We have a follow-on pipeline that has near-term commercial prospects where we can significantly increase that enterprise value. And our strategy is to continue to do that. And clearly, the big prize in all of this is our therapy programs. And over the last couple of years, we've been able to invest and develop those therapy programs to the point where they're on the cusp of adding value to the business as well. So I think in a nutshell, that's the game plan for the company and isn't going to change in the near future.

    Kyahn Williamson Senior Vice President of Corporate Communications & Investor Relations

    Thank you. Our next question is, I understand the growth in R&D and sales and marketing investment. What is driving the growth in admin expenses? Is the go-forward for this to grow much slower than revenues?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Yes. I mean, you've seen it over the course of the last 3 years, our admin cost as a proportion of revenue has decelerated significantly and we expect that trend to continue. SG&A is not going to grow at the same rate as our revenue because the incremental cost of prosecuting the current commercial opportunities is much lower than the revenue streams that they enable. So, I mean, just as kind of a rough kind of signal, we would expect SG&A, which is predominantly U.S. SG&A, of course, Europe will also increase a little bit around the middle of the year as we expect to get our regulator guidance around Illuccix for the European market. But -- so second half of the year, Europe will increase a little bit as well. But for U.S. SG&A, we expect to see a 15% increase this year, and that's clearly a much, much smaller increase than the expected revenue forecast. So I think that modest SG&A increases what should be reasonably expected from a commercial evolution of the business perspective. I hope that answers the question.Kyahn WilliamsonSenior Vice President of Corporate Communications & Investor Relations45:57Thank you. Our next question is, when do you expect to complete the rolling submission for Zircaix?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Great question. We actually have answered this question in the public domain before. Our agreed timeline with the agency is to have it completed by May.

    Kyahn Williamson Senior Vice President of Corporate Communications & Investor Relations

    Thank you. And what will be the trigger for the ProstACT GLOBAL interim readout, and what type of data do you expect to report?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Yes. So we'll be talking a lot more about the ProstACT GLOBAL study over the coming months. A lot of it is dependent right now on getting our IND finalized with the FDA, which we're making great progress on. That's an imminent event. That trial design will then obviously be much more the focus of investor attention, and we'll be spending a lot more time talking about it. We do expect, on the basis of our current clinical recruitment plan, to have an interim readout that would be able to provide a preliminary PFS signal from the GLOBAL trial. We would expect to have that readout recruited by around the end of Q3 of this year, and that would lead to a first half of next year likely interim readout from the study. And we've designed that interim readout in such a way that it will enable us to compare to the PFS signal from ProstACT SELECT.

    I'd like to remind you that the ProstACT SELECT trial, while it's a similar patient population in some respects to the ProstACT GLOBAL trial, it's a little bit more advanced stage patient. So I describe the patient population as somewhere between ProstACT GLOBAL/PSMA-4 trial and the VISION trial. So it's sort of in the middle. It's a mixture of those patients. So the PFS result that we're going to get this year is going to be a really interesting kind of flag in the sand for PFS. And then we want to be able to compare that PFS to what we see in the ProstACT GLOBAL trial, which is in a true second-line patient setting. And again, to reiterate, we expect to be able to do that in the first half of next year. So, yes, these commercial milestones are not far off for the ProstACT GLOBAL trial.

    Operator

    Your next question is a phone question from Laura Sutcliffe with UBS.

    Laura Sutcliffe Analyst

    Just one this time around. I think you mentioned just now, I'm sorry if I misheard, that there would be opportunities to talk about the alpha emitter at some point this year. Could you just give us a little bit more color on what you hope to do there?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    We actually have several alpha programs, but I assume you're meaning TLX592. So we have actually completed the CUPID trial. We're expecting -- we're just going through the machinations right now of closing out that study and reporting data, and we should have a readout to talk about to the market in the next couple of months.

    Operator

    Your next question comes from John Hester with Bell Potter.John HesterAnalyst49:10Chris, just on the interim readout from the ProstACT SELECT study, we've got a few data points there from competitors in the market. PNT2002 did an rPFS of 9.5 months, and the Novartis product did 12 months. What's the sort of number ballparking that you would hope to achieve with ProstACT SELECT? And what would be the number that you would kind of have to consider that this trial is not worth progressing if you didn't achieve a certain level of rPFS?

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Well, we wouldn't give speculative guidance on what rPFS might or might not be. I think that if you look at the range of trial PFS is, they range from mid-6s up to -- not quite sure your summary PFS is quite right there on VISION. But nonetheless, the range of PFS tends to be in the [ 6 to 7 ] and above. And I think that we always have to remember, and clearly, we have published PFS data for this asset before, so you can go and historically look that up. But I think that fundamentally, PFS isn't a strong indicator of overall survival. So it's really more of an indicator of whether our dosing regimen is effective or not. And yes, we'll look forward to providing that update when it's available. Just to remind you of my earlier comments, we finished recruiting the ProstACT SELECT study in May of last year, so we're still waiting for sufficient events to be able to report this study out. And so giving guidance beyond that at this time isn't feasible.

    John Hester Analyst

    Fair enough. I wasn't actually referring to the VISION study in my early comment. It was the subsequent Novartis trial, but we won't get hung up on that. But you said that rPFS is not an indicator of overall survival. Is that -- did I understand that correctly? Is the...

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    That's correct, yes. So across every study that's been performed with these assets, with the PSMA class of assets, and indeed many of the androgen receptor inhibitors as well, PFS is not a strong predictor of overall survival. So it's a useful measure of whether or not something is worthwhile taking a deeper look at, but it's not really a prognostic measure.

    John Hester Analyst

    Okay. Well, perhaps we'll explore that offline, but thank you very much. That's all.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Yes. Is there another question?

    Operator

    There are no further questions at this time. I'll now hand back to Ms. Kyahn Williamson for closing remarks.

    Kyahn Williamson Senior Vice President of Corporate Communications & Investor Relations

    Yes. Look, thank you very much for your attention today and for the questions that have come through. We really appreciate the time taken to tune in, and we'll be looking forward to keeping you abreast of our progress over the coming year.

    Christian Behrenbruch Co-Founder, MD, Group CEO & Executive Director

    Thank you very much, everybody.

    Operator

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