Ann: Notification of upcoming quarterly results and investor call, page-70

Operator

39:35

Our next question comes from John Copley with UBS.

John Copley

Analyst

39:43

John Copley on for Laura Sutcliffe. Could you tell us, please, what percentage of U.S. Illuccix sales the same shop versus new customers at this stage?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

39:54

Yes, we don't really disclose that sort of level of detail about customer build. So it's not something that we've sort of tended to do because we don't see a competitive advantage in doing that. What I can tell you is that our growth this quarter was a fairly balanced mix of white space customer acquisition and increasing our share at either sites where there are users of multiple products or where we've been able to acquire business away from competition. So I think it's a fairly evenly mixed profile that makes sense.

John Copley

Analyst

40:36

Okay. And one more for me. Since Novartis don't report Glucomed sales, could you tell us please what market share you think you have by value and volume at this point in time?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

40:49

We have an internal viewpoint on Novartis. I mean we have a very clear understanding of what accounts Novartis has. So I think that's a well-understood number. I think as a total market share, it's a low single-digit percentage.

John Copley

Analyst

41:03

Okay. And how about yourselves? Do you have a view on those as well?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

41:07

Well, I mean, just in terms of -- [indiscernible] hasn't put out their quarterly guidance yet, but I'd say we're pretty robustly trending to about a 30% market share.

Operator

41:28

Our next question comes from Steve Wheen with Jarden.

Steven Wheen

Analyst

41:35

Just a question on the STARSTRUCK program. And the expression of CA9 on other tumor types. Just interested in whether or not the data that you've collected and have received on clear cell renal cancer, how much you can rely on that to actually fast track labels for these other cancer types in a diagnostic setting?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

42:02

Well, I'll give an initial comment, and then Ky, if you've got anything to chime in on, feel free. Essentially the purpose of STARSTRUCK is, it's a -- sorry, STARBURST study, it's more of a setting study. So it's about narrowing down the half dozen to a dozen or so cancers where we know that CA9, it's an important biomarker where it's been well studied and well understood. And so that's really the scope of it. And then what we expect is that it's very unlikely that we would run a pivotal trial for the therapy program just in a single cancer setting. What -- the front of studies that we're developing right now even more towards a kind of a Loxo style basket study, where the label that you'd be ultimately seeking to go after would be something along the lines of CA9 -- treating a CA9 positive tumor by -- verified by imaging, right, where imaging becomes the biomarker tool.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

43:10

And that's obviously why the approval of the 250-CDx imaging agent is actually a critical milestone towards the clinical availability and sort of acceptance of the therapy. From a predictive perspective, the great thing about Zirconium-89 is it gives you predictive dosimetry for a variety of regular requires in fact, not just lutetium, but also alpha-emitters. And so that's why the STARBURST is so informative. It's going to not only tell us about expression level but it's going to tell us predictably where they're getting enough radiation into those tumors to have a likely treatment effect. Does that make sense?

Steven Wheen

Analyst

43:54

Yes, that did. Yes.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

43:58

Colin, do want to add anything?

Colin Hayward

Group Chief Medical Officer

44:00

Well, I think you covered it extremely eloquently. But just to be clear, the STARSTRUCK study is the combination with the DNA damage repair agent, it does include a renal cohort and a non-renal cohort that we will identify by using zirconium rituximab. In terms of the imaging utility, again, we'll see within the STARBURST study where we really examine CA9 expression used [ enlighting zirconium brentuximab ]. And yes, that could potentially lead to imaging, but also perhaps more interesting and more relevant to that patient population that we're starting potential therapeutics in the future as well.

Steven Wheen

Analyst

44:39

Yes, great. Understood. Can I just also ask a lot -- I mean, obviously, the Brussels plant is -- allows you to be a bit more vertically integrated. Just wondering, is the gross margin implications from that and when we might expect to see that come through your numbers?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

45:01

Well, it's not about gross margin implications, it's about enablement. So just to be clear, we won't launch a product in Europe with [ Potodium ] or lutetium without the use of that facility. So it's not about margin improvement. It's about actually having the scale of manufacturing capability to deliver to the European market.

Steven Wheen

Analyst

45:22

Okay. Yes. Understood. And then lastly, just on the European approval. The pathway that you're undertaking at the moment, that seems to be certainly relative to our expectation sooner than expected. Is that your understanding and what -- with the first half '24 expectation of a decision, can you start commercializing that product in Europe straight away after that?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

45:50

Well, once we have an approval, we can start to commercialize. I mean, obviously, reimbursement varies from country to country and can be shorter or longer, depending on the relevant bureaucracy. But yes, certainly, once we have approval for that product and our dossier has now been accepted in all of the countries that we've applied for. So it's 19 European countries plus the U.K. We are -- once we have that approval, that reference company authority approval, we could start. We are obviously making Illuccix available under -- or making it available under appropriate compassionate programs, which varies from country to country and varies depending on whether there's an approved product on the market or not. And we can continue to see a robust utilization of Illuccix in Europe. Clearly, as we have approved products coming into the market, that dynamic will change over the next 12 months, but in the market ourselves. So I think it's going to be a pretty tight concentration of new product availability and approval. And as you would have seen in the U.S., Steve, although we were second to market, our ramp-up is very fast with Illuccix. So we're pretty confident that there's an informed and loyal customer base out there that's committed to using the product for the long term. Can we move on to the next one?

Operator

47:27

Our next question comes from Dennis Hulme with Taylor Collison.

Dennis Hulme

Analyst

47:37

With the first patient to be treated in the ProstACT GLOBAL trial this quarter, can you give us some color about what we should expect to see if the site rollout, both in APAC and in other territories? And also, when you're targeting opening up ProstACT GLOBAL in U.S. sites?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

47:58

Yes. So the regulatory work should be done by the end of the year, and we're on track to achieve that for the U.S. and Europe will be the focus early next year, but we do want to include European studies. I'm also -- I'm currently in China at the moment where we're meeting with our partner, Grand Pharma, to talk about how we include some wider APAC region patients into the study as well. So overall, the progress on ProstACT GLOBAL has a lot of momentum in all the territories that we plan to operate in beyond just the current A&Z footprint. We haven't given guidance on site ramp-up. It's very unusual for companies to do that kind of thing, to be honest. But clearly, once the study is in a more steady-state recruitment mode, I would expect that we'd be able to give visibility on time horizons for recruitment milestones. I don't think that's likely to happen until the beginning of next year at the earliest. And I do think that, clearly, there's a ton of patients available. So we don't see recruitment as being a challenge. But once the study is fully operationalized, I think that will be the time for us to give a clearer picture on that.

Dennis Hulme

Analyst

49:18

Okay. And secondly, we see that Blue Earth announced the commercial launch of their 18 F imaging agent POSLUMA late last month. Are you seeing any evidence of the presence of Blue Earth in the market with POSLUMA in the U.S.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

49:37

Well, there's evidence, I mean, their advertising and their marketing and got sales force out there. I have to admit, I don't think we bump into them an awful lot. But I think as I've alluded to before, not all F-18-based agents are created equally. And I think that they've got a significant headwind to overcome in terms of both the market being satisfied with the availability of an 18 F-based product and also a product that's currently available, widely available that has, we think, clinically better performance. And so I think what it's going to come down to is kind of an Olympic podium style bake-off between the well-established use of Gallium PSMA and clarify and a new entrant, which really hasn't demonstrated any clinical differentiation or clinical advantage, in fact, may have significant disadvantage compared to the incumbent solutions. So we obviously believe that there will be a market share effect and they'll pick up some customer base for sure. But so far, we don't really see it as a strong commercial contender. It's a market that's pretty well educated. Customers have either decided that they're happy with cyclotron-based products, or they're happy with the nuclear pharmacy delivered product. And so they're going to probably have a larger impact on our competition than off. That's what we currently believe at this point in time.

Operator

51:31

Our next question comes from David Stanton with Jefferies.

David Stanton

Analyst

51:40

Happy to jump back on. One for Darren, please. You've mentioned in the fact that overall investment is currently tracking to plan for 2023. You've previously talked to about $100 million in F '23 R&D expense. Should we still be thinking that number?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

51:57

We haven't given any modified -- we haven't given any modified guidance to our R&D expenditure.

David Stanton

Analyst

52:04

Okay. All right. Understood. And Chris, my final one. Do you think there's any -- are you starting to see any seasonality in holistic sales in the U.S. at all?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

52:16

Sorry, you just broke up a bit then. Can you say that again?

David Stanton

Analyst

52:18

Sorry, sorry. Is there any reason to think that there might be seasonality in Illuccix sales in the U.S. over the medium to longer term?

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

52:28

I think there's always seasonality, but the pluses and minuses and the swings and roundabouts of each month end, 4th of July holidays and Christmas season and summertime and whatever, they all sort of -- there's also the pluses and minuses, and they all kind of average each other out. I think every quarter has got something. So I don't really think that seasonality is going to be something that we're going to kind of obviously be too super worried about. The only thing I'll notice that this whole field is growing at an extremely fast rate. And that, I think, you serves, [ any severe ] kind of localized effect. Yes. But I'm sure you'll hammer me next quarter when I put out our results and then I'll say, well, it was a seasonal effect. So you'll then have the license of this answer to draw a reference upon.

David Stanton

Analyst

53:29

Looking forward to.

Kyahn Williamson

Senior Vice President of Corporate Communications & Investor Relations

53:33

All right. So we just have...

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

53:34

I think -- you go on.

Kyahn Williamson

Senior Vice President of Corporate Communications & Investor Relations

53:37

Just on time, we've just got a couple of questions on the webcast. We've got time for those just before we wrap up. So I think the first question is just -- just a couple of questions about update on the submission process in Europe for Illuccix.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

53:53

Yes, I think I've covered that one off.

Kyahn Williamson

Senior Vice President of Corporate Communications & Investor Relations

53:55

Yes. And finally, just a question around the life cycle management for Illuccix, whether there is the opportunity to extend patent or make product improvements with a next-generation product.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

54:13

Absolutely, yes. I mean we've been quite public about it. We have a clear vision for what Illuccix 2.0 and other looks like. We are committed to being a category leader in prostate imaging for a long time. Our product has some attributes that make it quite amenable to product life cycle management. So yes, watch this space. But that will become a lot clearer over the next few months. Clearly, there's a number of ways to risk manage pass-through. And one of them, of course, is to continue to provide new products. So yes, we'll be talking a lot more about that in the coming months, but life cycle management is absolutely a key focus. I've said in the past that it surprises people, but probably 25% to 30% of our R&D budget is actually focused on building and growing Illuccix. And that doesn't just mean label expansion and new clinical utility, but it also means thinking about the product itself. So watch this space. That's my only teaser statement for the morning.

Kyahn Williamson

Senior Vice President of Corporate Communications & Investor Relations

55:20

Well, thank you. That's all the time we have for questions now. Thank you, everyone, for your attention. As we all know, it's been a quarter of significant progress and a lot of exciting things happening right across the pipeline. So thank you for your attention, and we will -- always get in touch with me via e-mail if you have any further follow-ups.

Christian Behrenbruch

Co-Founder, MD, Group CEO & Executive Director

55:45

Thanks, everyone, for your time. Much appreciated.

Operator

55:53

This concludes today's conference call. Thank you for participating. You may now disconnect.