Thank you for standing by, and welcome to the Telix Pharmaceuticals Limited First Half 2022 Financial Results Presentation. All participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. Following the presentation, if you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. If you wish to ask a question via the webcast, please enter it into the ask a question box and click Submit. I would now like to hand the conference over to Kyahn Williamson, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.
Good morning. Thank you, Harmony. Thank you everybody for joining us today. It's my pleasure. As mentioned, my name is Kyahn Williamson. I'm Senior Vice President of Investor Relations and Corporate Communications at Telix, and it's my pleasure to introduce my colleagues who are also presenting on today's call. In order, Dr. Christian Behrenbruch, our Group CEO and Managing Director, Darren Smith, our Group Chief Financial Officer, and Dr. Colin Hayward, our Group's Chief Medical Officer. Just move to the next slide, please. Our financial results were lodged this morning on the ASX. You'll have seen those documents there. For those joining by phone, if you refer to the copy of the presentation on the ASX, we'll give you a verbal cue of next slide so you know when to move along.
If we can move to the next slide, please. Just by way of introduction, it's been a really tremendous start to 2022 for Telix, and the commercial launch of Illuccix has been a major area of focus for the company and for our investors, but we've also made progress right across the business. We've previously outlined our strategic roadmap for the company, and this consists of four key pillars to successfully launch Illuccix, to build on this foundation and follow on with a portfolio of high-value diagnostic tools, including follow-on products for the urology, urologic oncology field, to unlock the value in our therapeutic programs as we advance multiple clinical studies, and to selectively expand the pipeline with new assets, targets, and technologies that will add value to the company over time.
The milestones delivered in the first half demonstrate that we are delivering to these priorities. The launch of Illuccix in the U.S. is off to a flying start, and Chris will talk to you in more detail about this shortly. The completion of the ZIRCON study, our kidney cancer imaging agent Phase III program, was a really important milestone in the company's history, and it's proven our ability to complete a global Phase III study. We've also made meaningful progress across all of our core therapy programs, and Colin will be talking about the highlights and future plans for these programs. We're also investing selectively in the pipeline expansion, and Chris will take you through some of the key developments here and how these will further differentiate Telix. We've also made some really important new leadership appointments during the half.
Darren Smith, on the call today, joined the company in February and has now stepped into the role of Group CFO. Kevin Richardson has now been in the role of CEO of Telix Americas for a little over a month. Tiffany Olson, who was previously head of nuclear medicine at Cardinal Health and is a highly regarded leader in the U.S. industry, has been a notable addition to the board. These individuals have a really excellent track record themselves in leading and scaling up fast growth companies and experience in translating radiopharmaceutical development into commercial outcomes, and really reflect, you know, the type of caliber of talent we can attract at this really important transition stage in our company. Just to move to the next slide, please. I'll just touch very briefly on the headline financial metrics.
Darren's gonna take you through the key elements of the financial results later in the presentation. The uplisting revenue result reflects our maiden commercial revenues from the U.S. sales of Illuccix delivered in Q2. We raised $175 million in January this year, and when we now have a balance sheet, that puts us in a position of strength and provides us with sufficient funding to execute on our three-year plan. The increased investment in the business reflects the fact that we've operationalized a major product launch, and we've completed a Phase III study.
The ongoing investment in R&D is now focused largely on our therapy programs, and we are taking a very well-planned and rational approach to investment in line with the stated use of funds in our capital raise and in support of our goal to advance the development of our core therapy programs into pivotal trials. With that brief introduction, I'd like to hand over to Chris to talk in more detail about our commercial activities.
Thank you very much, Kyahn. Yeah, next slide, please. Thank you very much, Kyahn, and good morning to everybody. Obviously, given the commercial transition in the company, the focus of my presentation today is really gonna be on Illuccix and to really convey to you that the progress that we made. We had our first commercial dose sold around the middle of April, and we had really a spectacular launch in the U.S. market. This pictogram on the left actually kinda illustrates the fact that we're able through the penetration model that we have for Illuccix to really get broad customer coverage. We are currently delivering Illuccix to 43 states and growing fast in the United States.
You can sort of see there, we've broken out on a month-by-month basis, really how this revenue ramp-up has transpired. We also wanted to give a little bit of color to the reimbursement landscape in the sense that as of the first of July, Illuccix is a fully reimbursed product in the United States. We had a very strong July, which, you know, clearly on an annualized basis, puts us well north of $100 million in annual revenue. As you can see, you know, growing fast as we roll out our product. This has been a very strong and a successful launch.
We now have a geographic coverage via almost 150 pharmacies, and we expect to continue to add pharmacies where we have a market competitive need or where we're targeting a specific market opportunity. You know, I also wanna impress upon you, and again, sort of aided by this illustration, you know, we are certainly active across the entire geography of the United States. You know, we've been very strong in major metropolitan areas. You know, our largest markets include New York and the Tri-State area. We're very dominant in Florida, where we've had a very successful launch.
I just wanna impart to you that the gallium model that we have for PSMA sets us up for success, both in major markets as well as competitively in regions where really only Illuccix can be successful. Moving on to the next slide, please. The landscape for PSMA imaging is clearly growing fast, and there's no doubt that the two initial indications that we have for biochemical recurrence and high-risk men, this is the current label that we have on Illuccix, is driving the excitement and it can clearly drive the sales volume. But we continue to see this market opportunity grow and evolve. I'll ask you, Colin, to chime in for a second and give your viewpoint on how we see the PSMA landscape continuing to evolve.
Sure. Thanks, Chris. Well, look, I mean, as you said, we recognize that utility with the great demand that we've seen at launch in those approved indications. You know, what we're hearing from sites, from patients alike and from, you know, potentially pharma partners as well, is that we want to be making management decisions based on PSMA imaging throughout a patient's journey of prostate cancer and throughout that continuum. You know, there could be up to five-plus scans for a patient over their lifetime. We're certainly looking to expand those indications from helping in terms of making management decisions and having metastases-directed therapy later on.
Yeah. Thanks, Colin. You'll be aware from our half year report and/or from our fourth Q as well, that we've now filed a supplementary NDA with the FDA for the use of Illuccix for patient selection for PSMA therapy, and we continue to explore a number of exciting label indications for Illucccix and really engaging effectively with key opinion leaders to expand the utility of PSMA in prostate cancer and in other malignancies as well. Moving on to the next slide, please. I thought I'd give a little bit more color around distribution. You know, our success has been both through the well-understood clinical utility of PSMA. We've been part of a very effective market education process. As you may recall, we were very active in making Illuccix available under expanded access and compassionate use programs prior to approval.
I think that was important to educating the physician base around how, particularly referral urology, around how PSMA imaging can play an important role. We've also been subjected to a fair bit of competitive misinformation about our rollout strategy. I think the purpose of this slide is really to convey to you that while we've chosen to very much localize our production into the backyard of our customers, and this map actually shows how our nuclear pharmacy coverage and transport times in nuclear pharmacy just literally peppers the entire map. You know, there isn't a market that we can't reach through this model. It's a highly penetrative model. We are very much in our customer's backyard and leveraging the tight relationship between the nuclear pharmacy and the customer.
We're also following the well-trodden pathway and actually, you know, F18-based PSMA products and the use of cyclotron networks is actually a minority strategy for delivering nuclear medicine. Of the over 65 million procedures delivered every year globally, more than 80% of those procedures are delivered through a nuclear pharmacy distribution model. The fact that PET products are relatively novel to this approach is somewhat incidental. I think it's really important for shareholders to understand that while this model is novel from a PET perspective, it is absolutely the well-established pathway for nuclear medicine, and we're following a really well-understood commercial paradigm for nuclear medicine products. We, we have the coverage, we have the capacity. There isn't a customer demand issue that we can't deliver through this model.
As we continue to expand our network, we're also expanding the capability of access to gallium, both from higher capacity generators and cyclotron-based production. Uniquely, our product is able to be used both in a cyclotron and gallium generator nuclear pharmacy environment. You know, you'll expect to see that scalability. Moving on to the next slide, please. One of the things that I also wanna kind of impart to you, which I think is a really unique part of the Telix opportunity, is we are delivering PSMA globally. When we started the company and we decided to pursue the opportunity of Illuccix, we had a clear ambition to deliver this really important clinical capability globally. We are doing that, prosecuting that very effectively.
At the moment, competing products are not available outside the United States, that's on an ad hoc or a compassionate use basis. While we see clinical trials delivering data that may lead to future regulatory approvals for competing products.
As of today, the global standard is gallium PSMA, and we are a key deliverer of that global standard. What this means, and Colin alluded to it before, is when we look at the clinical trials that are important, the clinical trials that are delivering globally meaningful data, there's really only one solution that's gonna deliver that, and that's gallium PSMA. That'll change in the future, but today that's the standard, and we are very much delivering that standard to pharma partners globally. Of course, we're expanding our product portfolio to consider other markets where PET imaging may not be so prevalent. Our success with the NOBLE registry for SPECT imaging with PSMA is also something that's garnered a lot of attention and appreciation from the field.
I think what you're seeing here, just to summarize, is a global commitment to this very important development in medicine, and Illuccix is very much front and center of that momentum. I think on that note, Kyahn Williamson, hand it back over to you.
Thank you. We'll now spend a few minutes on the financial results themselves. I'm gonna invite Darren Smith to take you through this.
Thank you, Kyahn. Turning to slide 13, these interim results represent a transition of Telix from a product development company to a commercial phase enterprise. The results represent 10 weeks of post-commercial sales of Illuccix. We are off to a great start. It's worth noting that the $19.3 million of revenue represents doses received by patients and not inventory billed at distributors. Additionally, our European pre-commercial sales continue to increase, reflecting growing awareness of the Illuccix in preparation for the European approval. Turning to slide 14, it's worth noting that this is the last time that Telix will be reporting the receipt of an Australian R&D Tax Incentive, as we now have revenues of over $20 million. Going forward, Telix will fund its business through its commercial activities.
Beyond supporting the commercial build-out of the business, these funds will be reinvested with a primary focus on developing our therapeutic assets. During the half, Telix secured an in-license deal with Eli Lilly, complementing the therapeutic program. Colin will talk to our plans to develop this product later in the presentation. Telix also invested $4.5 million in the build-out of our state-of-the-art radiopharmaceutical production facility in Seneffe. As announced on the 22nd of March, Telix secured a EUR 12.1 million debt financing package to fund the development of this asset. Turning to slide 15, and I'll make some comments on the specific expenditure. The uplifts in COGS in the first half is obviously driven by the commercial launch. We project the second half of the year to see the gross margin improve and normalize.
The first half was impacted by the typical start-up costs and inefficiencies due to low volumes. As previously stated, our R&D expenditure is directed towards progressing our therapeutic development program. Sales and marketing expense is chiefly driven by the costs associated with the preparation for and the launch of Illuccix, including launch costs. Finally, Telix continues to recruit and secure talented employees to grow the capability to deliver on the optimization of the commercial value of Illuccix and to progress our therapeutic programs so that we will realize Telix's future. I'll now hand back to you, Kyahn.
Thanks, Darren. You've highlighted that the investment in the therapy program is really and it will start to define the company even more. I'd like to now hand over to Colin to really give a highlight on the clinical program achievements in the last half and some future plans for a couple of the key focus programs.
Thanks, Kyahn, and if we could move on to the next slide, this is the core pipeline graphic that I'm sure many of you are familiar with right now. As Darren was mentioning, well, clearly, it's very important that we become a true Theranostic company evolving from diagnostics but really growing those therapeutics as we go forward. What I want to show you with this slide is really continue to emphasize our unprecedented depth in urology here, focusing really on those big indications of prostate cancer and renal cancer and making Illuccix central to that long-term engagement and that long-term vision to be with patients in urologic oncology. Look, ultimately, we're a small company right now.
We can't just have big major indications, and that's why I want very much to have rare diseases, small orphan indications as part of our development portfolio. You can see that with GBM and TLX-101 and TLX-66, and not even mentioning the Lilly asset that Chris is gonna speak about later. If we can go on to the next slide, please. This gives us the key highlights here, in my opinion, for this year. Of course, as was mentioned earlier, ZIRCON has completed recruitment, and I'm gonna be extremely excited to give you the results of that very shortly. With prostate cancer therapy, we're making progress and building momentum in terms of delivering TLX591 to patients. As I mentioned, glioblastoma. That's a rare disease itself and with imaging and therapy.
Firstly, I'll be presenting IPAX's data very soon, with the results of that, with some potential activity seen there, and as we plan that basis for our future development in glioblastoma. Of course, the rare disease portfolio as well with TLX66. If we can go to our next slide, I want to start by focusing on this is very selfish of me because this is an area that I was extremely interested in when I first joined Telix, the CA-9 as a target. From my own perspective, I think it's a really interesting target, and girentuximab is a great antibody to this target. Yes, in clear cell renal cancer, it's almost ubiquitous. Our research really reflects this as a potential pan-cancer opportunity beyond clear cell renal cancer alone.
We'll be having some interesting data to go on our collaboration for you to look out for at the EANM conference in Barcelona in October around triple-negative breast cancer. If we can go to the next slide, please. Yeah, well, we mentioned Zircon, and I'm gonna be mentioning it again now because, you know, TLX250-CDx is really our follow-on from Illuccix. I'm a pretty simple oncology drug development physician, but you don't have to be an expert radiologist to look at those images on your right. Look at that top one. I think most of you there can identify the clear cell renal cancer on that image compared to the conventional structural imaging alone below. This is our follow-on to Illuccix, and we've established those relationships with the GU community.
Physicians are already coming to me describing this as a potential PSMA for renal cancer. What's the medical need? Well, the patient volume is not gonna be dissimilar to Illuccix. We think the total addressable market is 100,000 plus in the U.S., confirming histology of clear cell renal cancer and being able to effectively manage and stage those patients. We go to the next slide. I want to just touch on TLX250 therapy. As I mentioned, I believe CA-9 is a really interesting therapeutic target, clear cell renal cancer and beyond. For me, it's important in all of our activity that we're integrating our products within mainstream oncology treatment and diagnostic paradigms.
You know, that is reflected within our therapeutic program with TLX250 and using that to combine with checkpoint inhibitors and with other oncology agents, such as DNA damage repair agents with the Merck collaboration. We go to our next slide. I'll touch on the PSMA program. Look, clearly, PSMA is becoming established as a class of asset, both in, obviously, in diagnostics, but now in therapeutics as well, with the first radioligand therapy approved. With TLX591, what we're doing that's different, well, we're delivering radiation differently with antibodies. We're delivering precision delivery of radiation with high tumor retention for beta emitters, but then, of course, we also have our own planned alpha emitter program with TLX592.
If we go to the next slide, I just wanna go into some of those differences again a little bit more. The landscape is there's a number of small molecules under development. You know, we are coming on the back of a pandemic, and that's really emphasized to the world that we don't want to have unnecessary visits to hospital. We don't want to be traveling, you know, more than 50% of patients live more than two hours from a hospital in the US. You don't wanna be traveling all that time for a lot of visits. I think fewer visits are better. I think with an antibody, you have that potential and also delivering a different side effect profile with none of that quality of life-affecting dry mouth.
I'll show you a nice image from one of our prostate studies in a few moments. If we go to our next slide, this gives you an overview of our ProstACT program from ProstACT Select, ProstACT Target examining the potential, and as I said earlier, we want to integrate within existing oncology modalities. This combines with external radiation. In those patients with new biochemical recurrence, and of course, ProstACT Global, which is the large Phase III program where we're getting our plans in place and our logistics in place for delivery at 80 sites around the world, delivering into 2023 there. We're collecting data in a number of settings, and as I mentioned, ProstACT Select, very similar, looking at the tumor targeting for the agent.
That's, I'll go and show you some exciting data from that in a minute. Let me just go to my penultimate slide, which is the next slide. It really is showing this PSA journey. The PSA rise over time is really a reflection of that patient's journey, from their newly diagnosed prostate cancer to potentially end-stage disease. Now, we want to be with that patient and with his healthcare professionals throughout that journey, and we want to be there in diagnostics, therapeutics, and of course, potentially surgery as well. We want to, as Chris said, be not only with the patient journey throughout their prostate cancer but also with patients all around the world as well. As I try to tease you with my last slide, I wanted to give you this recent example from the ProstACT SELECT study.
You can see the Illuccix image on the far left. This is the gallium PSMA agent showing clearly prostate cancer metastases in the bone there. This is an image using lutetium 591. If we go to that first, that furthest image on the right, you can see the retention of the antitumor activity over time that has the potential to produce sustained benefit. This is that rationale behind just small molecule. Two visits is important. I can tell you as a medic that my clinical colleagues don't really like sending their patients away to other specialties if they can help it. That's all from me, but I'll be looking forward to hearing from your questions a little bit later on. Thank you.
I'll just hand back over to Chris, just to share a few highlights from the pipeline. Innovation and research is certainly something which is at the heart of our core. You know, we're fortunate to have a lot of interesting technologies come our way. But we'd really like to share just three of the key highlights for the last half in terms of pipeline expansion. Over to you, Chris.
Thanks very much, Kyahn. Yeah, thanks. We can move on to the next slide 28. So this is my opportunity to be a little bit nerdy for a few slides. Just something I don't often get to do these days with the launch of Illuccix. The first one that, you know, is a really major development for the company is our in-licensing deal with Eli Lilly. The opportunity to develop a product in sarcoma is something that I've personally always wanted to do, and we think that this is an asset that's gonna deliver a lot of potential in that space. It was originally developed and approved as, in fact, as a drug to treat sarcoma.
However, it had a speed bump in late-stage commercialization for a variety of reasons that I think we understand pretty well. There's an opportunity here to leverage a well-identified target that has shown some utility in sarcoma and to pivot that asset into a radiopharmaceutical. There's a lot of nuanced aspects to our deal with Lilly that includes the opportunity to make the imaging agent that we're developing available to Lilly as well as part of their ongoing development. We see this as a really high potential opportunity in a patient population where there's just a major unmet medical need.
Because this program builds on top of a prior commercial product, we believe that this is an asset that we can develop, demonstrate utility in patients, and develop very, very quickly. This is the sort of deal that I'd really like to show you as a benchmark deal for Telix and very much indicative of the way that we intend to continue to develop our pipeline. Moving on to the next slide, please. The opportunity for us to recognize that when we do theranostics and we have a diagnostic imaging agent there's a real depth of information that is incredibly valuable to the entire care team.
In our view of how software and artificial intelligence and machine learning can play a role, it's really about linking the diagnostics and the therapy together. You know, we're sort of less interested, frankly, from a competitive perspective in just highlighting regions of interest. We think that if we can explain to the physician how the imaging is gonna change care and how it links to a therapeutic strategy, that's gonna be something very powerful. We've developed an AI platform, which we demonstrated at the Society of Nuclear Medicine meeting in Vancouver with a tremendous amount of key opinion leader interest. This is a platform technology, so it will be applicable to our prostate cancer, renal cancer, and brain imaging, near term and of course, longer term, other products.
We are planning for an FDA approval for this product next year as a platform for the company's theranostic program. Last of all, you know, Darren mentioned earlier, our South Brussels or what we formerly referred to as the Seneffe site. The build-out of the site is going extremely well. You know, this is an absolute jewel in the crown of Telix's capability. It's not only necessary for our product launches in Europe that are planned for TLX250-CDx for renal cancer imaging and beyond, but it provides us with an amazing development capability for new products, including a state-of-the-art alpha emitter development lab. We're really excited about this.
It's a huge production capability for the company, and really serves, frankly, as a sandpit for collaboration with a lot of key partners in the radiopharmaceutical field. I do know we're very grateful to the regional and the Walloon development agencies for their support and partnership in making the financing package available to the company just to support the development of this asset. It's been a very successful initiative. Those are the three major initiatives for me, and I'll now hand it back over to you, Kyahn, to wrap up.
Thank you. Just to the next slide, please. So look, suffice to say it's been a huge half year. We're really proud of what we have achieved. We're energized, but we're also really focused on the next goals. You know, there's a lot of points here on this slide. I'm not gonna read them out to you, but I think the message there is the second half is shaping up to be just as, if not busier than our first half. We'll be focused on continuing the momentum of Illuccix globally with further regulatory approval decisions coming this. We already filed a supplementary NDA for label expansion and expect a decision on that in March next year. Like to point ahead in the readout of our first Phase III study.
The key characteristic of the coming 12 months will be the focus on the therapy programs, and that's gonna create multiple and significant opportunities for news flow as we initiate and progress our studies and also deliver some clinical readouts. As always, we're really appreciative of the support of our investors, and thank you for taking the time to listen in. I'd now like to open the call up to your questions. I'll hand back over to Harmony.
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. If you do wish to ask a question via the webcast, please enter it into the ask a question box. Your first question comes from David Stanton from Jefferies. Please go ahead.
Good morning, team, and thanks very much for taking my questions. Hope everyone's well. Two from me. I wonder if you could give us an update on formal approval timelines for Illuccix in the EU, please. I see the second half. Any further color on that would be great.
Yeah. Thanks, David. Per our prior disclosures, we have submitted the final package, and we are expecting a response from the DKMA at the latest by the end of September. That will be a definitive response. We were able to satisfy all of the information requests from the various competent authorities. As you recall, we've made a hybrid submission, so it's a multi-jurisdiction submission, and we feel like the package is in really good shape and look forward to reporting on that outcome shortly.
Thank you. Second and final question from me. What's the likely timeline for top-line results from ProstACT Global, which I presume will be sort of the major announcement in that space with those three clinical trials, please?
Yeah, David, we're expecting to have that trial fully operationalized by the end of this year or early next year in terms of all of the international jurisdictions that we're aiming to include, with the possible exception of China. That's going to take a little bit longer, and we've talked a little bit about that in the past. But that's also not on the critical path right now for recruiting that study. We expect that given the interest in PSMA imaging and the PSMA therapy and the momentum that that has, that we're looking at a sort of 18-24 month recruitment period. But I will note we are planning an interim readout for the study.
We haven't finalized what the patient count's gonna be for that yet because different regulatory jurisdictions have a varying viewpoint on how the statistical plan for that should be managed. We're very shortly going to be giving a more fulsome update on the ProstACT Global timelines and that will include an indication of when we'd expect to share an interim readout, which I think from a shareholder but also a key opinion leader perspective, you know, it's gonna be really important for us, given the competitive landscape for PSMA, to be able to show an early dataset from that study that demonstrates clearly that we're on track from the efficacy perspective and that there's engagement from practitioners around our dosing strategy.
Understood. Thank you.
Thank you. Your next question comes from Shane Storey from Wilsons. Please go ahead.
Good morning, everyone. Yeah, look, two questions from me as well. The first, Chris, just trying to understand a little bit more about the PSMA volume that you've seen sort of emerge over the last nine to 12 months. Just trying to disaggregate that between sort of how much pent-up demand there may have been ahead of the availability of PSMA and then, and then how you think the industry is going, as far as I guess the organic piece of how a new modality rolls into life.
Look, it's definitely a complex landscape, Shane. I mean, on an incidence basis, depending on how sort of how catholic you wanna be about the guidelines, you know, there's somewhere between 200 and maybe 250,000 patients on an incidence basis. You know, we've got a couple of factors which play into the patient volume. The first one is, you know, with COVID, we've got a backlog of prostatectomies. So there's a sort of larger prevalence pool of men that will benefit from PSMA imaging prior to surgery.
Of course, you have to remember that because of the nature of prostate cancer and the survival durations, you know, there's 3.5 million men living with prostate cancer in the U.S., and about 450,000-500,000 of those men have radiographically occult disease and may even have a benefit, frankly, in terms of treatment options by having a PSMA scan. You know, we are seeing very broad uptake of PSMA, and I think that those two pools of patients, you know, really expand the market opportunity probably for the next two years. We also have to remember as well that there are plenty of other utilities for PSMA imaging beyond just the two main labeled indications right now.
I think that as the field gets experience with this modality, you're gonna see plenty of other opportunities to use it. It's an evolving field. You know, perhaps last of all, just to note Colin's comment. You know, global pharma now understands that, you know, if you're developing or you're delivering an anti-androgen therapy or a second generation androgen therapy or a PARP inhibitor, that you've got the opportunity to optimize that patient management by how you track disease progression. You know, we see a clear role for PSMA imaging to get into that multi-dose per patient opportunity, and that's gonna considerably expand the opportunity for PSMA imaging and obviously for Illuccix by extension.
Great. Thanks, Chris. Look, my final question maybe, just a couple on the financials, please. Just, around working capital, just sort of as you sort of move into the, I guess, the more fulsome stage of the Illuccix launch, maybe some help as to how to think about the working capital investment that that's going to require. Just on the SG&A, I know that that was sort of ahead of our model, so just how to think of that maybe over the next few periods as a function of revenue. Thanks.
I'll maybe make a preliminary comment, and then I'll invite Darren to add anything. We had a launch cost because we needed to build inventory for launch and to make sure that we've got the necessary inventory to deliver on this opportunity, so that's the front-ended investment. That's clearly an investment that is effectively amortized over a you know fairly extended period. We also, SG&A is one of those things that's a fairly fixed cost for us. We do intend to expand the sales team as a function of need, but it's a pretty modest cost right now. So there has been a bump up in cost, but that's something that you know we view over a...
as an expenditure over the total annual period of that revenue stream. I think, you know, our gross margin for this product are very compelling. We'll be at some future point in time reporting a bit more clearly on what they are. you know, this is a highly cash generative product for us, and that inventory investment and our SG&A today doesn't detract from that cash generation. Darren, you wanna add anything?
Yeah. I think from a working capital perspective, what we're seeing at the moment is given the demand for the product, we're not seeing any real increase in our stock levels. Basically our production is catching up with the bandwidth of increases and then not building stock. From a receivables perspective, however, obviously we do have debtor days that are building quite quickly, so that will be a little bit of a focus for us going forward. In the end, that's really just a timing difference of the 45 days average or maybe up to 60 days that we're seeing that is quite typical in a commercial environment. That's just probably really the receivables management that's gonna be the key thing for us from a cash perspective.
Right. Chris, Darren, thank you. That was really helpful. Thank you.
Thank you. Your next question comes from Andrew Paine from CLSA. Please go ahead.
Yeah. Morning, everyone. Congratulations on the launch. Just looking at the sales ramp up for Illuccix over the next 12 months and beyond, and really thinking about this in unison with the increasing TAM estimates and your ability to ramp up market share, you know, towards that 40%. Do you think that market share is still achievable given the expanding TAM, and what timeframe do you expect for this, given that there seems to be significant demand for these types of products in the market?
Yeah. Thanks, Andrew. We haven't given a forecast either on revenue or market share.
Okay. Look, kind of leading into the back end of this year, you're considering, you know, similar growth profile to what you're seeing in July, or you can't talk about that?
Well, it's not that we can't talk about it, but we've had, you know, now four months or three and a half months of sales. I think it's, I think it's beholden upon us to, you know, we're one month now or six weeks post reimbursement, and obviously we've seen a significant bump up in sales. I mean, a reimbursement doesn't result in an overnight change, so it's something that will continue to grow and we see that order appetite. I think, you know, by the end of the year, you know, analysts will be in a good position to understand what our ramp up looks like and what our market share is.
Sure. That's great. Just thinking about the sales splits between different groups of customers, so hospitals, community clinics, imaging centers and things like that. Are you able to give any details on what that looks like? I know it might be early, but any insights there?
Yeah. We haven't given guidance on how the customer list breaks down. Obviously, prior to reimbursement, most of that would've been, you know, out of pocket with perhaps a little bit of VA. Again, given that we're six weeks into reimbursement, you know, we'll be looking to a future point in time to provide that breakdown.
Sure. Any kind of specific-
Yeah, go on. Sorry.
Sorry, I was just thinking any specific areas that you're targeting in those groups or, you know, it's a pretty broad stroke that you're looking for.
No, we're definitely positioned to cover all of it.
Sure. Thanks.
Thank you. Your next question comes from Dennis Hulme from Taylor Collison. Please go ahead.
Good morning, everyone, and congratulations on the results. My first question's on the financials. You've given some good info there on SG&A, but if we're looking to R&D spend, what should we be expecting, I guess, in the second half of the year and also for FY 2023 for R&D spend?
Yeah, Dennis, we haven't given guidance on R&D because it's. You know, we've got an internal target on what we wanna retain as a safe balance sheet.
Mm-hmm.
To make sure that we have the necessary firepower to give effect to our commercialization activity. Our R&D spend is gonna vary a little bit according to that success. Although I am bound to say that, you know, we're tracking well ahead of plan internally. You know, our R&D budget for the year, you know, if you extrapolate from previous years, our R&D budget will be in the vicinity of AUD 100 million for the year. You know, that includes obviously external R&D and internal headcount costs. Again, the exact sort of timing and dollar number, that depends a little bit on how well Illuccix plays out. Again, you know, we're well ahead of plan there.
You know, if you recall back, Dennis, to our capital raise, you know, deck, you know, we talked about what the market opportunity was. We raised a certain quantity of capital that will enable us to meet a three-year development plan for our key assets. That financing plan is largely based on cash generation from Illuccix. I think we're in good shape to deliver on that.
Yeah. Okay. Well, that all makes sense. Secondly, just on the ZIRCON trial, can you give guidance about whether you expect the readout of top-line results to come in the current quarter, or is it likely to be in the final quarter of the year?
It's a little bit in a gray area right now.
Okay.
Colin, correct me if I'm wrong. We have a last patient who's just awaiting their surgery, and that will enable us to close out the study. Of course, we've had the joy of that then landing right in the middle of the European vacation period. I would imagine that the database will walk out in the next couple of weeks. Then, typically, you'd expect to see some results sort of within sort of 60 days of that event. It'll be right on the cusp one way or another of this quarter or next quarter. Good news, Dennis, it's not long to wait.
Okay, great. Yeah. No, we'll keenly awaiting that news. Just finally-
Yes.
Just change tack to.
We are too.
to brain imaging with the 18F-FET opportunity. Have you got any update of your thinking there about, you know, how or whether you're likely to push forward with that as a commercial opportunity?
Yeah. We're making great progress with that program. You know, it's been a really key focus area for the last few months. We do, as we've discussed in the past, intend to file a new drug application for that asset, you know, early next year. I think we're making great progress towards that objective. Again, it's definitely with the launch of Illuccix now behind us, it's definitely prudent for us to focus on explaining to the market where the other programs are gonna start to land commercially.
That'll happen in the first instance with ZIRCON on the back or with TLX250-CDx on the back of the ZIRCON trial, but also, you know, per Telix's timelines, expect to get a more fulsome update on timelines for NDA submission before the end of the year. We've got some key regulatory consultations coming up in the latter part of this year that will really nail down the timelines for that product, but it's looking good. You know, we are expecting to have the FET PET program contribute to Telix's revenue stream within that three-year planning horizon of our capital raise.
Okay, thank you very much. That's all for me.
Thanks, Dennis.
Thank you. Your next question comes from Steve Wheen from Jarden. Please go ahead.
Thank you. Good morning, Chris. I just wanted to touch on, and apologies if I missed this, but you were talking about expanding the indications for Illuccix. Does that include PSMA-targeted radioligand therapy, which is one of the ones that has been talked about before? I just wanted to get an understanding of where you're up to, if at all, on pursuing that label. Thanks.
We've, per our half-year report, we have filed a supplementary NDA. That indication expansion has already been submitted to the FDA.
Okay. Great. And then just a few more on the operational side of things or the financials. The COGS was referring to some one-off launch related costs. I wonder if you could help quantify those just so we can get a bit of an underlying indication as to what your gross margin is starting to look like.
Yeah, we haven't given any guidance on gross margin, and we won't because the eventual gross margin depends on the production scale that we land at over the next sort of quarter or so. You know, you'll have to stand by on that one. Mainly it relates to building and releasing manufactured inventory to support the launch.
Okay. You can't quote the amount that is one-off in the half. I'm not after guidance, just what's actually happened thus far.
Well, you're gonna have to look at the total cost of that over an annualized basis. I think by the end of the year, you'll have the ability to make that calculation yourself.
Yeah. Okay. All right. Just the comments around the Veterans Affairs. Yeah, clearly I note your comments about the incidence rate being much more pronounced in that category. Can you talk to when you were able to get access to that patient group, you know, maybe when you were put on their formulary, and who else may well be on that formulary, competing with the patients within that category?
Well, there's only two approved products in the United States right now that are sort of actively pushing a product out there. We've disclosed back in March that we received a temporary VA contract, which has now been converted to a five-year permanent contract. Yes, we've been able to deliver doses since March, although obviously our first commercial sale was in mid-April just because of the way in which our pharmacy network launch plans were executed. From the beginning of our commercial period, we've had access to the VA network.
I will note that VA contracting is a fairly long process, and then of course, once you've matched your agreement, then there's the process of the purchasing cycle of each individual VA group or VA hospital. But we're making really great progress there. We've got some of the leading VA groups in the U.S. using the product already on a routine basis. I expect that over the course of the year, that it will make up a meaningful component of our sales.
Excellent. Is the pricing of the VA sales, is that something that you can talk to?
It's a predefined discount to the Red Book to the CMS price. Well, it's not about talking. It's a 24% discount to the CMS price.
Yeah. That's pretty standard across anyone supplying product into the VA.
It's legislated. It's non-negotiable.
Yeah. Yeah. Okay. Cool. The other thing I just wanted to ask.
Thanks very much, Steve. Thanks very much. Can we take another question?
Thank you. There are no further phone questions at this time. I'll now hand back to Kyahn Williamson to address your webcast questions.
Thank you. I'll just read out a few of the webcast questions. We've only got a minute or two left, so if we don't get to your question, we'll respond to you individually on the line. I'll just start with a question. With the prospective sell down of China Grand Pharma, are you confident Telix IP is protected? One to you, Chris.
We absolutely are. I mean, there's been a lot of speculation about what happened with Grand Pharma, and there's absolutely no basis for a nefarious interpretation. Grand Pharma made a lot of money out of their investment. You'll note that Grand Pharma has a similar market cap to Telix. Part of the cash demands that they have is actually to finance our clinical activity in China. I can confirm the relationship with Grand Pharma is excellent. We continue to make really superb progress on all of our clinical trials. You know, even strategic investors take profit.
Thank you. Our next question is, can you talk to the status of current penetration of Illuccix in the Western states, particularly California?
Yeah. We're making good progress in all states. You know, the payer sort of dynamics of each state is a little bit different. You know, PSMA imaging has been very well established in California. Post pass-through, we're seeing really great uptake in the Western states and expect that trend to continue over the course of the next couple quarters.
Great. Thank you. Just our final question, another one for you, Chris. What agent are you intending to use to label olaratumab? Second follow-on question to that is, soft tissue sarcomas are a diverse group of tumors. To clarify the histologic subtype you're aiming to image. Which is? Is that more or less a subtype?
Yeah. We're getting ready to do a fairly open assessment with imaging first to have a look at what the expression level of the target are like in different subtypes. That's gonna be our first step. We likely expect that program will be an alpha based program, but we're doing the non-clinical work right now to look at a variety of isotope approaches. Certainly for sarcoma and alpha is a really exciting proposition and that's the likely pathway forward for that asset.
Great.
Kyahn, I know there's one other question which I think you may have missed that came in from John Hester. Darren, it's a question for you. The AUD 18 million in R&D cash received, where is this reflected in the income statement?
Yeah, well, the R&D credit was actually recognized as income on last year's account. The only place you'll see it showing up is there's a receipt in the cash flow statement, you know, the receipt of the receivable. That's where it is.
Thanks, Darren. Kyahn, did we miss anybody? I think we got everybody.
I just had one more question on the slide about the cost of Illuccix. Could you just tell us specifically what the unit cost is? The cost per unit is, and if it's profitable per unit basis. I'll let you take that one, Chris. I think we sort of roundabout addressed that previously.
Yeah, I mean, we haven't disclosed what our actual unit cost is for a kit. But certainly, I mean, it is a highly cash generative product for us. As we hit a more sort of steady state commercial model, I think it'll become clear what our growth margins are. But yes, I can confirm that it's a profitable cash generative business for us. Otherwise, we obviously wouldn't be in it.
Okay. With that, we've answered all of the questions. I'd like to thank everybody for listening in today, and with that I'll draw the call to a close. I'm sure there's some of you we'll be catching up with over the next few days and the coming weeks. Thank you again.
Thanks very much everyone.
Thank you.
Thanks all. Bye now.
That does conclude our conference for today. Thank you for participating. You may now disconnect.