Telix Pharmaceuticals Limited (TLX) Earnings Call Transcript & Summary

Thank you very much. Good morning, shareholders and colleagues. Welcome to the Telix Pharmaceuticals half year shareholder update call. And we appreciate your valuable time. As the company transitions from a pre-revenue stage company to a commercial-stage company, we're also starting to evolve the way that we engage with shareholders and relate them to results reporting, and I hope that you will find this update both useful and interesting. Moving past the standard disclaimer to the third slide. I'm not going to go through this in bullet point by bullet point detail. But over the last 6 months, our shareholder registry has changed a fair bit, and we have plenty of new shareholders. So I'll take a few minutes to provide a short introduction to the company and what it does, focusing on a few specific highlights. We are a late-stage pharmaceutical company developing radiopharmaceutical or Molecularly Targeted Radiation products, as we like to call them. Our 3 disease focus areas are prostate cancer, renal or kidney cancer, as it's more generally known, and glioblastoma, which is a type of aggressive brain cancer. We're going after a very significant market opportunity for our products both in imaging and therapy, and I'm going to explain the technology basis of that in a minute. We're a very clinically active country (sic) [ company ], where we're currently running clinical trials in 25 countries around the world. We have just submitted our first marketing authorization for our lead product, which is in prostate imaging, in Europe. And a U.S. FDA submission is very, very near to being final. And we're in the process of preparing for market launch both in the U.S. and in Europe. Also this year, we became a vertically integrated pharmaceutical company in Europe, so we acquired a manufacturing facility in Belgium. And that enables Telix to in-house produce all of our products for the European market, which is a very exciting opportunity. Finally, per the results that we released to market last night, we are in a strong financial position. We have a solid balance sheet and cash runway until late next year, sufficient to deliver on our first 2 commercial products, which is in prostate and kidney cancer imaging. Moving on to the next slide. So the basis of the technology is very exciting. I'm not going to spend lots of time talking about the nitty-gritty details, but essentially, we deliver targeted radiation for oncology. We use a drug as a carrier. It can be a small molecule or an antibody, and we use that drug to deliver a radioactive payload to the patient via a systemic administration. And what that means in lay terms is it's a shot in the arm. We are not placing radiation in a particular location in the body. This is an IV injection that visits the radiation around your body and wherever the target is present and wherever there's a piece of cancer, it targets the cancer. If the payload is a low dose or a diagnostic radionuclide, you get these beautiful images that you can see on the right. And we put the patient in a device called Positron Emission Tomography, or a PET scanner, and that's how we generate those scans. If you increase the dose or if you use a therapeutic radionuclide, you can treat the patient's disease in a very optimized way. And clearly, the imaging guides that therapeutic process. And that's why we call it Molecularly Targeted Radiation, although it is colloquially known as theranostics. Radiation is an important part of cancer care, and this approach makes it even more useful and effective. The next slide, please. So this is what we call a concept see and treat. I often get told by shareholders that our company is a little bit complicated, but I'm actually -- it's pretty simple. You -- effectively, you put in a low dose of the drug and you get an image. You put in a high dose of the same drug or a targeting agent that goes after the same target and you get a therapeutic effect. And this is a highly beneficial strategy because you don't just optimize the therapy, but you also streamline and derisk clinical trials and you ultimately improve the cost of clinical service because you're just treating patients that you know are going to respond to therapy. And in fact, from the imaging, we can even predict to a significant extent what the patient response is going to be from imaging. So this is truly personalized or precision medicine at its finest. Moving on to the next slide. This is for your reference, but this is a high-level snapshot of our pipeline. I guess the main point here is that most of our assets are in late-stage developments and our 2 lead programs in prostate and kidney cancer are the furthest along with the imaging part of the pipeline ready for commercialization, particularly for the prostate cancer program. So a very exciting pipeline of assets in late-stage development and significantly derisked from a clinical perspective. Okay. So moving on to the nub of the presentation this morning and moving on to Slide #8. This graphic sort of summarizes Telix' key focus areas at present. I'm going to talk about each one of them in this presentation, including at the end a short update on what we've been doing on the R&D front, which is really exciting. We don't often talk about new product development because, to be fair, our investment in noncore assets was pretty modest. And we believe that shareholders expect us to be focusing our financial and corporate resources on our core pipeline. But as we get our first couple of products out to market, it's important that we have a game plan to backfill our product portfolio, and we consider this to be a crucial part of maintaining our leadership in this space. And by the way, that's something that's typically done late and poorly by small companies, so we aim to be ready with a very good road map for second-generation products as our first generation of product starts to produce revenue. Moving on to the next slide. This is a synopsis of our key accomplishments in the first half of the year. It's been an incredibly busy first half. We're a December year-end company, with a significant number of key accomplishments. As I mentioned before, we've successfully submitted a European marketing authorization for the prostate imaging agent. And with the U.S. application imminent, we also had an excellent pre-Phase III meeting with the FDA for our prostate therapy program, and that's enabling us to finalize protocol for that clinical trial, which will start before the end of the year. As I mentioned, we acquired manufacturing sites in Belgium. This is one of the deepest private nuclear licenses in Europe and really enables Telix to meet the commercial opportunity for its products over the next 5 years. We are in the process of completing a Phase III trial, the ZIRCON trial, for our renal imaging agent and that included getting full recruitment up and running across all of our sites, although I'm going to talk later in the presentation about the impact of COVID on our clinical activity. We are working on indication expansion for that asset as well as noting that we recently achieved breakthrough designation from the FDA for that asset. So that enables us to have a much more streamlined pathway to commercialization for that asset in the United States. In the first half of the year, we announced several distribution agreements in Europe and the United States. And I guess the signal there to shareholders is that we're working extremely hard to build our production and distribution and sales and marketing capability as we go to product launch. That's a major focus area for the company right now. As I mentioned, at the end, we've been active on R&D, including some nondilutive funding, which is always good to see. And then I think it's fair to say that we've been working to build out the bench strength of the company, particularly in our international operations. Overall, we did institute a hiring freeze during the pandemic or the first wave of the pandemic. Obviously, it's not over yet. But we did still bring on some key recruitments in the commercial and the clinical areas to augment the team in a strategic way. Moving on to the next slide. We released our results last night, but this, I suppose, is a snapshot of how we see the business and how we financially evolved over the last 6 months. Clearly, our expenditure and, therefore, our loss has increased as we move our products into late-stage clinical trials and build out the operational bench strength of the company. We believe that this growth in operating expenditure is commensurate and reasonable for a company of our stage. And we also believe that we are an efficient and frugal deployer of the capital that we have. We do continue to grow our revenues from early sales of the prostate imaging kit. Although this product is not yet approved, we have the ability to offer it commercially on a limited basis in some territories, although it's worth noting that the adoption rate is a very small fraction of what would be expected of an approved product, and the same goes for the price point as well. Our improved cash from sales activity is partially a function of a generally improving commercial landscape, notwithstanding COVID-19, which, again, I'll talk about in a minute. It's also partially reflective of better processes and systems for collecting receivables and managing debtors. And again, that's part of the maturation process of the company. Over the last 6 months, we've dialed back external expenditure, which included program cost by clinical trials and drug product manufacturing, mostly in response to the pandemic. And again, I'll talk about this more later in the presentation. But the point is that we've responded with alacrity to the changes over the last 6 months. We haven't dilly-dallied about waiting to see what happens. We've preserved our cash and judicious in our expenditure, particularly around working capital costs. Moving on to the next slide. On the sales front, this slide illustrates the impact of COVID-19. We started the year off in a fairly strong way with the expectation that we see baseline of 350 to 400 kits a month, growing at 20% to 30% a quarter from there. Because our kits support multi-dose preparation, this equates to around 1,000 patients. And our expectation for 2020 was that we'd roughly hit the 18,000 to 20,000 patients' level, up from 11,500 patients from last year. However, by March, it was already evident that noncritical oncology services were being dialed back. And this is particularly evident as we got into the worst part of the pandemic in European countries around the May time line. The good news is that we're seeing good recovery and resumption of oncology service provision, including imaging. Our general perception at this time is that there's a degree of understanding that there's going to be multiple COVID-19 waves and that service provision can't stop. So it's a changing landscape. The first experience of the pandemic incited a more extreme response, but we believe that in the future waves that service will have a more normal operational profile. Again, I want to stress that these are opportunistic sales from preapproval product, and the pricing and commercial structure is not reflective of what we would achieve in a post-approval world. However, the value of this exercise is to start to build a customer base. And this activity has delivered Telix hundreds of customers around the world, typically large tertiary referral cancer centers that have an intimate understanding of the company and its products, thanks to this activity. So this is a significant advantage when we achieve market launch next year. We have a customer base that knows us, understands our products and is ready to use our products as an approved technology. Moving on to the next slide. This is a snapshot of our clinical activity. Currently, the company is very active on the clinical front. I'm not going to go exhaustively through each trial, but I do want to impress 3 things here. Firstly, although many of our investors view Telix as a diagnostic imaging company, we are, in fact, a therapeutics company predominantly that does diagnostics. And our most significant clinical activity is around our therapeutics programs. It's activity that will get a lot more spotlight over the next 12 months clinically and commercially, particularly our prostate therapy program, which is probably Telix' highest value and most important program. Secondly, unlike many of our peer ASX or even overseas listed small-cap biotech companies, Telix has a significant pipeline of clinical trials that are recruiting very large numbers of patients. These are typically not 10-patient trials designed to crank out a bit of news flow, but are often hundreds or more patients to generate Tier 1 evidence to support product approval. Across our trials, we are amassing an astonishing amount of data and information about how to make this technology work. And so not only are our clinical trials there to generate the necessary evidence to get product approval, but Telix is rapidly becoming the master of our domain in terms of fundamental understanding. And thirdly, our trials are truly global. Although we recruit, for almost all of our patients -- all of our trials in Australia, the majority of our clinical activity takes place overseas. We're currently active in about 25 countries around the world, not just to gain access to a diversity of patients, but to build the clinical and commercial visibility for the company for the future. So again, this is highly differentiating. It means that, when the time comes for our products to become commercial stage, we have the visibility that we need in the key markets that we serve. Moving on to the next slide, please. Under the revised disclosure rules, we're required to provide detail in relation to the impact of COVID-19. I'm not going to do this on a line-by-line basis here, but we've clearly had a lower pace of recruitment for clinical trials between March and July. We've seen essentially normal resumption of clinical activity in Europe. But Australia, mainly because of border closure and access to drug product therefore being restricted and the U.S. because of the really severe state of the pandemic is still not at 100% normal operation. We dialed back our expenditure with a number of initiatives to maximize runway, and we reallocated clinical and operational staff to other more internally directed activity that's to the benefit of the company. The net result is that, notwithstanding the challenges of operating in a pandemic, we probably emerged from this first wave a stronger and more capable organization. I'm certainly very proud of all the women and men at Telix that have not slowed down in their pursuit of the company's goals during this period despite working-from-home challenges and juggling the work-life balance and families and the general stress of living through a pandemic. It's been a lot of work. But finally, unlike very large vertically integrated pharmaceutical companies, Telix is dependent on many external service providers. This in turn means that their challenges and delays become our challenges and delays, so it's meant a much higher degree of management of our service providers generally. So a tough time on the company. But notwithstanding the delays and challenges of our operating environment, we still continue to make a lot of progress. Next slide, please. Perhaps our biggest unnoticed achievement this first half of the year was a European Marketing Authorization application, which was submitted back in April. This process is going very well, and we're now engaging with each of the individual European member countries that we've submitted to the total of 14 countries. The Danish Medicines Agency agreed to be our reference competent authority for the process. And we're now, as I said, in individual competent authority review. We're expecting to get a consensus on our application late 2020 or early 2021. But generally speaking, the feedback and the questions that we're getting appear reasonable, and I think that's a well-managed process led by our Belgian team. We're also in discussions with several European health care authorities for temporary marketing authorization. So essentially a stop-gap approval whilst the product gets its final approval. So hopefully, we'll be able to provide you with updates on that process between now and the end of the year as it will have a material impact on revenues. Moving to the next slide. On to the U.S. front, we're painfully aware of the frustration and waiting that shareholders have had to endure with this process. Unlike the European submission, which was essentially able to get filed on the basis of a mostly complete package pre-pandemic, the U.S. application has taken a considerably longer period of time. This was due in part to COVID-19, I'd say maybe a 3-month impact because of COVID. But also, the Telix management team decided that, on the basis of some new data that we'd revisit the extent of the label for our submission to the FDA, and this has also added time to the process. We're now on track to finish this package by the end of the month. That's the end of August. And then the e-publishing will take a couple of weeks thereafter. It's a pretty large package. It's not just uploading it to a website and hitting return. I assure you that it will be done this quarter. And in the meanwhile, we are working very closely with our market launch partners in the U.S. and getting sites ready to use our product. I should note that over the last 2 quarters we've worked with almost 30 new clinical sites in the U.S. to get up and running with investigational access to our product, and we expect to add plenty of new customers between now and market launch in the first half of next year. Assuming that the FDA is satisfied with our submission, it's going to be a really interesting time for the company in 2021. So it's an extremely busy period for the company, and we are ramping up the U.S. team in readiness for that. And I have to say that our go-to-market partners in the U.S., both on the manufacturing and the distribution front, are doing a fantastic job, too. There's a real commitment there to success for the whole initiative. Moving on to the next slide. I often get asked by shareholders about other jurisdictions, especially Australia, given that it's our home turf. I can confirm that we are in the process of preparing a TGA submission, which we expect to submit before the end of the year. And actually, there's an MSAC approval that's likely to happen in the middle of next year, so all the patients will definitely get serviced by our products, again, subject, of course, to regulatory approvals. Similarly, we get regular HealthCanada compassionate use requests. We service Canadian patients every week. So we are currently preparing a submission package for HealthCanada that will likely ride on the back of our FDA submission. We have a Swissmedic application in progress. I suppose if you look at the map of Europe, there's a big hole in the middle if you don't have Switzerland, but it's not just about the geographic aesthetics. Switzerland is strategic jurisdiction for some countries that follow European or Swiss regulatory approval. So we are in the process of dovetailing our European submission with the Swissmedic application. And finally, we don't often talk much about our commercial activity in Japan, mainly because it just takes a long time and it's an extremely heavily regulated environment, but we've had good interactions with the PMDA, which is the Japanese FDA, and the Ministry of Health, Labor and Welfare, which regulates a lot of the radiation safety aspects for establishing bridging clinical activity in Japan. So we have Japan very much on our radar, and we expect early next year to be able to start getting this product into patients in Japan under clinical studies with a goal then of bridging to the international approvals that we have in fairly short order. So yes, really exciting and just to give you a sort of sense of the breadth of what the company is currently involved in. Moving on to the next slide. I mentioned before, in my view, in the company's view, that the Phase III prostate center therapy is our biggest program now moving forward. ZIRCON is under control. The submission for the prostate imaging product is under control from a clinical and regulatory perspective. We're currently refining the clinical protocol based on the FDA feedback we received, which was particularly useful in understanding how we're going to use imaging to enrich the trial. So one of Telix' differentiators is that, for all of our programs, we have an imaging agent and therapeutic. And if we can combine the 2, we can generally develop trials which are much more streamlined and much lower risk to execute. So we are expecting to send a further package to the FDA in the next few weeks for an additional pre-IND meeting, and then that will enable us to finalize the protocol in Q4. And we expect to start recruiting, subject to regulatory approvals, start recruiting that trial before the end of the year or opening that trial before the end of the year and then with U.S. patients early next year. So we're making great progress at a significant focus area for the company right now, and the team is doing a great job in moving this along. Next slide. So just to wrap up and summarize this, I hope it's evident that it's been an extremely busy couple of quarters for Telix. Notwithstanding that we're in the middle of the global pandemic, the team has accomplished a huge amount. And although not everything has been perfectly timed, the last 6 months have yielded pretty astonishing progress. The second half of the year, so just to remind, we are a December year-end company, it's even busier as we ramp up to becoming a fully commercial-stage company in 2020. It's an immensely exciting time to be a part of Telix. And I do want to reiterate that, notwithstanding the challenges of COVID-19, we've carefully preserved our capital, we've adjusted our operating plans and we have plenty of runway out until the end of next year, if necessary, with our current financial resources. So the priority is to get some of these therapeutic trials up and running. But clearly, the financial resources are going to be driven by our commercial launch for the prostate imaging product in the first half of next year. Okay. I'm going to skip ahead now to Slide #20 for those of you who are reading at home from the deck that we loaded to the ASX this morning. This slide gives you a high-level perspective on how Telix tackles R&D. So essentially, we don't do basic R&D in-house. We prefer to build on top of the platform that we already have. So on occasion, we do in-license technology from third parties if we think it will augment our capabilities. And we certainly don't have a not-invented-here mentality. But because our first products are going to market, we're already thinking about the life cycle management aspects of our portfolio and maintaining what we like to think of internally as category leadership. We also have many opportunities to push our existing pipeline into new indications. So for example, TLX250 for renal cancer has potentially as much utility in ovarian or colorectal cancers as it does in kidney cancer. But of course, we have to do the studies to show that. But the incremental cost of doing so is much less than, say, in-licensing a new asset and developing a new molecule for a disease indication. So we aspire to do both, but the point is that a big part of our R&D is about leveraging what we have. Moving to the next slide. This is a rather dense slide, and I apologize for the sort of visually uninspiring nature of it, but it illustrates the point I just made, how we've taken our core product and technology platform and expanded into new application areas. To do this, we work closely with really good academic centers and other companies as well to leverage their expertise in technology. I'm going to go very quickly through these 5 examples. There are by no means an exhaustive summary, but shows some of the key focal points of our R&D platform at the moment and some of the more exciting things that we are working on. So the next slide, this is what we call TLX102. This product candidate builds on top of our experience with TLX101, which is currently in clinical trial for glioblastoma. It's essentially a new chemistry that swaps out iodine-131 with astatine, which is an alpha emitter. Alpha emitters are interesting because they have highly localized radiation profile. And so you can essentially target a very, very localized area. It turns out that in multiple myeloma, which is a cancer that's evolved a lot in terms of treatment options, but still ultimately requires more durable therapies, it turns out that the target that we develop 101 for is also present in myeloma. The problem is, is that it's in the bone marrow. And what we want to do is we want to avoid irradiating the healthy bone marrow whilst we're treating the cancer cells, so that's why alpha emitters are exciting. So we've completed a lot of chemistry and preclinical development, including some extremely nice animal data in what are considered to be industry standard models of multiple myeloma progression. We don't -- as a general rule, as a company, we don't put out a lot of flashy ASX disclosures around preclinical studies. We prefer to wait until we have peer-reviewed publication. But I want to let you know that we are developing some really exciting science here, and we expect that in the second half of next year that we'll be able to start, obviously, financial resources permitting, we'll be able to start some first clinical activity for this asset. So really exciting extension of the company's existing core technology. The next slide, this is a pretty visually stunning technology and sort of rightly so because the target is the surgeon, so moving on from multiple myeloma to surgery. I'm really excited about this research area. This program is part of Telix' life cycle management strategy for the lead product for the prostate imaging program. So the commercial objective here is to deliver a second-generation product that not only gives you a PET scan, but also gives you intraoperative guidance with the floor for. So you inject the patient, you get your scan. And then for 72 hours after injection, you get fluorescence imaging in the operating theater. And it turns out that robotic surgery or laparoscopic surgery is the big thing in prostate surgery. And if we can show the surgeon where to go by lighting up in their field of view where the cancer is, this is something that's highly desirable. So we've been licensed some technology as well as developed some in-house capabilities in this area. And we're a few weeks away from seeing first patients getting injected with this dual-modality tracer of optical and PET imaging. And then if that preliminary academic experience looks as promising in people as it does look in 4-legged patients, then we'll consider what our clinical development plan is for next year. But really exciting example, again, leveraging our core technology platform for a future application area. Moving on to the next slide. This R&D program has the internal moniker, which is no bro left behind, reflecting probably the use and energy of our workforce, but I suppose the term bro doesn't project all that well in the public domain these days. Nonetheless, the goal of this technology is to make prostate cancer imaging available outside of the major markets that don't have PET. So PET imaging, it's fairly expensive. It's not an institutionalized part of cancer care in many countries, and so we've got to have an alternative solution. And it turns out that pretty much everywhere in the world has nuclear medicine and they use a thing called a SPECT, single photon or a gamma camera, for imaging nuclear medicine. And so we have a variance of this product -- essentially a variant of our lead product that allows us to use an isotope called technetium-99 instead of gallium-68. And what that does is it opens up the whole rest of the world for our products. So it turns out that there's about 12 million men living with prostate cancer outside of the major markets that we can serve with our lead prostate imaging product. We'd like to take a portion of that. But more importantly, we'd like to make sure that imaging is available everywhere because imaging will drive therapy. And so this is an important lead-in product for delivering our prostate cancer therapeutic globally. We actually have a Phase II trial. It's a registry study that's about to start called the NOBLE study. Nobody Left Behind is the acronym, so it's NOBLE. And this will start in a bunch of companies -- a bunch of countries in the next month or 2 and is expected to complete before the end of the year. It's within our planned 2020 R&D expenditure, so this is not an incremental cost for the company right now. And we are planning a Phase III trial for this asset early next year. So again, part of life cycle management and category leadership in prostate imaging. Moving to the next slide. I'm not going to spend a lot of time on this one, but I just wanted to illustrate this is a snapshot of the NOBLE study, really illustrating how Telix is committed to making sure that we don't just deliver nuclear medicine to a few privileged countries, but make it a global business. You'll note the focus is on emerging markets, but we've also managed to include Australia, more specifically Western Australia, which also has a need for this kind of technology in rural communities. So I suppose I can make a joke about WA being a third world country, but we have too many Sandgropers as shareholders, so I'll refrain from doing that this morning. Moving on to the next slide. As TLX591, our prostate cancer therapeutic dose in the Phase III trials, coming up behind is TLX592, the goal of this asset is to treat patients that are progressing off lutetium therapy. So they'll have had either the Telix therapeutic or perhaps the Novartis drug, and they'll progress. It turns out that a significant subset of patients still progress and demonstrate reduced response to lutetium. Some men will live out their remaining days with controlled metastatic disease and pass away from some other cause, but 40% or 50% will need further disease management. So the purpose of this asset is to address that progressing population. And I'm pleased to say that it starts clinical trials in a few weeks' time, which is really exciting. We'll be looking to get our first in-human experience with this asset and understand the pharmacology behind the asset and suitability for this application. Again, this is a Targeted Alpha Therapy product, so this is about providing highly localized radiation. And we think that this asset has a lot of potential in treating those metastatic patients that are progressing off lutetium. Moving on to the final R&D slide. This one is really about indication expansion. These really beautiful images, which are courtesy of our colleagues at GenesisCare, illustrate the potential of the TLX250 portfolio both diagnostically and therapeutically in other cancers. So these are obviously not renal cancer patients. Interestingly, this research very much came alive during COVID-19. When we paused our clinical trials, we still had to operate and maintain our manufacturing capabilities around the globe. And so rather than throw an unused quality-controlled dose down the drain, we made these doses available to our clinical researchers or the patients that needed compassionate use access because they couldn't participate in our trials. And when we paused our clinical trials, we were very careful to make sure that we didn't leave anybody hanging. And the result is that we start -- we are able to develop a picture of the utility of our assets in other indications beyond renal cancer. So it's immensely exciting and high-value clinical research, and it's very much an ongoing activity in the company. But we now know that Telix portfolio has applications in other areas, and this is very exciting and high value and incrementally very cost-effective research. Okay. So just to wrap up on the next slide. So this is by no means an exhaustive activity list, but the purpose of this graphic is to illustrate to shareholders how strategic Telix is and how exciting our future is. As I said before, I often get told by shareholders, well, Telix is a very complicated business and there's a lot to understand, and that's true to some extent. But it's also a really powerful business because it will almost uniquely integrate the practice of oncology in a bunch of very powerful ways. And so we have on our radar 4 key parts of the oncology care continuum that we are able to deliver extremely important new capabilities to. By combining radiation with medical oncology, we're going to improve our therapeutic performance in sort of mid-stage cancer care, and that's reflected in the ProstACT and the STARLITE trials. We are combining internally directed radiation with MTR with externally directed radiation from traditional radiation oncology, and we announced a collaboration with RefleXion just recently, which is a San Francisco Bay Area-based company that's doing some highly innovative work in this space. And our clinical trials are also reflective of this. So for example, the IPAX-1 trial is a combination of internal and external beam radiation. I don't probably need to explain the diagnostic imaging part. But clearly, that's our first commercial focus area for the company and is going to happen very quickly. And then just with the R&D update, you can see that we are now taking the concepts of molecular imaging and patient staging directly into the operating theater, so going beyond just the pre-intervention image into image-guided surgery. And so this is a really unique position. And for every single one of these oncology areas, we not only have to deal with those clinical stakeholders, but we also have to interact with the companies that are in the leadership position in those different fields. And so it creates lots of great opportunities for Telix to form partnerships and strategic alliances. And this will certainly be evident as the year progresses. So there's a lot of exciting stuff to talk about in the rest of the year and the years ahead. Next slide, please. We put this slide together really as a nod to our domestic Australian shareholders and taxpayers, frankly. We are fortunate to be the beneficiary of an $11.4 million R&D tax credit this year, which is an astonishing amount of money. Frankly, it's the balance sheet of a lot of our peer companies on the ASX. Although we don't plan our runway on the basis of government funding, it's immensely useful money for building out our R&D and clinical capacity, including in Australia. So we put this slide together to demonstrate our commitment to research activity in Australia, alongside our global research activities, and that includes clinical and manufacturing partnerships. We're active in almost every major Australian city. We have a dozen collaborations with different universities and research institutions. And I'm pleased to say that we even manufacture drug product intended for global exports from Australia. So a key message behind this graphic is that we are immensely fortunate that we have a very strong nuclear medicine and pharmaceutical development resource landscape in our own backyard, and we work with it extensively. So we're very proud of this work, and it's great to have so much homegrown talent to tap into. So just to wrap up on the last slide in the R&D overview, I hope this has been interesting and useful, although very fast update and by no means exhaustive. And I hope that I've gotten across the point that our R&D is about building on the core pipeline and technology strength that are already under development in the company. So part of it is about new product and indication development, and it's partially about life cycle management. Some of our research projects are about building incremental value in our core pipeline, but a few R&D programs are also pretty cutting-edge, including some of the Targeted Alpha Therapy that I've talked about before. This is a very, very big focus area for the pharmaceutical industry right now as they start to understand the impact of MTR technology in the mainstream pharmaceutical landscape. Okay. So just to wrap up, we have a lot of commercial and clinical workflow and activity over the next 6 months, but there are really 5 major events that will define the company between now and the end of the year. Clearly, the long awaited for NDA submission, which is in the final stages of being done. I suppose the analogy is we've just turned off the highway and we're driving up the driveway. And you can see the lights in the house in the distance and the front gate is open. That's where we're at. So just bear with us for a couple more weeks while we get that done. But we believe that we have a very excellent package to submit and a strong clinical rationale for approval of that product. And so that's going to be a really key milestone for the company that we're excited about accomplishing both for ourselves and for the team and for shareholders. We are really focused on the market launch. This is consuming a lot of resources of the company right now as we build the sales and marketing and customer service capabilities for Europe and the U.S., obviously, in conjunction with our go-to-market partners. So it's a commensurate investment, but really designed to maximize the opportunity for our product launch. And we're also really focused on getting the Phase III trial for the therapeutic program. This is really designed to be a fast follower to the imaging and to be able to offer a comprehensive theranostics solution in prostate cancer, which is -- which was the original vision of the company to begin with when we started the company. So tremendous amount of progress in the prostate area. We do expect to complete the ZIRCON Phase III trial, complete enrollment for that trial around the end of Q1 of next year. Again, we've had delays because of COVID, but we're also scrambling to really pick that up. If we complete enrollment around the end of Q1, that means that we'll probably have a readout around the middle of next year. Very pleasingly, we did get breakthrough designation for this product, which potentially shaves 6 months off the development time line. So although we've lost time, we've also regained time. And we've previously disclosed to the market some of the benefits of that designation. But very exciting. The data that we're getting in the ZIRCON trial is extremely exciting, and the level of clinical engagement is really outstanding. And then last of all, we don't talk about it a lot, but our brain cancer program is certainly very active. It is recruiting again. In fact, all of our European sites are recruiting into that trial, and we are -- we even picked up patients this week. So that trial is alive and well. And I would imagine that before Christmas, we'll be able to provide a first formal update to the market on that program as well. So personally, I find that it's one of our most exciting programs. It's just because it's early stage, it obviously has less investor focus. So for the final slide, Slide 33, I'll leave this here as we transition to questions. We presented a variant of this slide at the start of the year, and I'm pleased to say that notwithstanding a few delays here and there, we're actually on track to achieve a very comprehensive set of accomplishments for our shareholders and, of course, our clinical partners and patients that are so important to the momentum that the company currently has. So I think I've covered all of these topics in various forms. And I'll now open it up to questions from the webcast or admitted online from shareholders.

[Operator Instructions] Your first question comes from Hashan De Silva with CLSA.

Chris, my first question is just on illumet. So when we're thinking about the commercialization process of illumet, can you talk specifically of how you will get the dose to the patient given the half-life of gallium-68 as well as what the marketing expense -- sales and marketing expense will likely increase as you launch the program?

Sure. So in Europe, when we commercialized that product, we're really commercializing a kit, which means we're putting the kit directly into the hands of the hospital. And most of the production is done on site. The presence of nuclear pharmacy networks like what we have in the U.S. is not the same. It's a very different model. So we're shipping that consumable directly into the clinical environment in Europe, so that's extremely straightforward. In the U.S., we are relying very heavily on nuclear pharmacy networks. About 90% of the delivery of Telix' products will be in the form of a final finished dose product. So we work with Cardinal and Pharmalogic and perhaps in the future other networks to fill specific geographic niches on a completely turnkey basis, where the dose is driven out from a nuclear pharmacy that's serving about a 90-minute driving radius. So the dose is ordered and made on the fly and then delivered as an injection-ready dose timed to deliver into a particular patient treatment window. We are expecting that by the time we're ready for market launch, we'll have over 100 nuclear pharmacies ready to do that across the United States, covering probably 95% of the U.S. patient population. And this is a real advantage of the gallium approach because we are compounding and delivering these doses under practice of pharmacy. That means it's a state-regulated process. It means that nuclear pharmacies can be ramped up and ramped down or reallocated in terms of their maximum cost effectiveness. This is competitive to -- compared to our competition, which has to use a cyclotron facility, which is clearly not a movable or a particularly flexible manufacturing approach. It means that we can really optimize our network for cost and transport to the end patient. We do expect that about 10% of doses delivered in the United States will be done via the sort of kit model like Europe, where we'll sell directly into tertiary referral cancer centers that have their own nuclear pharmacy capabilities, but the vast majority of our doses will be delivered by our manufacturing and distribution partners. That's the first part of your question. It's a bit of a complicated answer, but it's a really a big question, so I hope that answers it thoroughly. And then in terms of sales and marketing spend, we expect in ASP in the USD 4,000 to USD 5,000 range for a dose, at least during the initial period of our sales. And we expect that the SG&A component will be around the USD 500 to USD 550 per dose. So that will give you a sense of what the investment on sales and marketing activity is going to be for the company.

Perfect. And just to build on that, I mean, I know investors on ASX small cap biotech side have seen products launch into the U.S. and demand eventually not being there and not being able to breakeven on that product. How is illumet different? I mean how do you get confident around the demand side given the expense that you've had to incur to get this product to where it is?

That's such a tricky question, Hashan. But basically, there is a standard of care that's already approved called Axumin. It has a well-understood sales profile. We have the clinical data that shows clear superiority. We've engaged extensively with payers on what they think the clinical evidence is behind the illumet asset. And so we're very confident that the adoption rate is going to be high. In other countries, in non-U.S. countries where we operate, we almost ubiquitously displaced Axumin in terms of its clinical utility. And Axumin has a relatively low insurer -- relatively low level of insurer support in the United States where we don't expect that to be the case for PSMA. I think that the clinical evidence that supports the use of the technology is extremely high. There are going to be a relatively limited number of actors that are going to enjoy commercial success. And so I think that the commercial opportunity is very clear. And the partners that we have for doing ramp-up are our excellent partners that have a dominant market share and the ability to get our product ubiquitously out to the U.S. market. So to answer your question, part of it is the conviction we have around the product and the clinical data and the fact that we don't have an approval yet and we're already on a week-by-week basis dealing with customer requests. And we have to, of course, field that very differently, and we have to deal cautiously with it because it's not an approved product. We don't market a product yet because it's not an approved product in the United States, but we work extremely closely with leading cancer centers to get investigational product use up and running or compassionate or magisterial use depending on the country. And we ship routinely to more than 400 hospitals around the globe already. So if we were to just activate our existing customer base with an approved product, it would be a very significant revenue stream to the company that would provide a very attractive return on investment.

Then, just moving on now to 250-CDx, you'd mentioned that the ZIRCON trial top line results are middle of next year. When would you expect launch of that into the U.S. and Europe? And also on the breakthrough destination, how does that affect the commercial prospects of the drug, focused specifically on pricing?

It's a diagnostic imaging product. So the pricing is probably going to be fairly similar to the prostate imaging agent, which is already a premium product, at least during the pass-through period, which would be at least, theoretically, I mean, we're in the process of finalizing that, but it would probably be for the first 3 years. The breakthrough designation does make our engagement with the agency a little bit more streamlined, and it does enable us to do a rolling BLA submission. And we're working on the premise that will have a post Phase III meeting with the FDA shortly after we complete the rollout, which will be in -- complete the clinical trial, which will be in the first half of next year. And that may mean that, if we do everything right and we're all on track from a manufacturing perspective, that we ought to be able to get a BLA submission in by the end of next year. And that would -- and then the potential is there for us -- because of the breakthrough designation, the potential is there for us to get an accelerated review. And we have to obviously go through that process with the FDA. But what it practically does is it gives us a much more streamlined pathway from completing the Phase III trial to getting a product marketing authorization in the U.S. In Europe, we don't have that sort of a designation. So it's going to have to follow its own course of action. But certainly, for the U.S., we have an accelerated pathway potentially if we can demonstrate the utility of the product.

Great. Just my final question on TLX592. There was a post that ASCO that -- for a product that looked specifically similar to 592. If it is the same, then side-effect profile looks significantly better than 591. Would you potentially not progress 591 into Phase III and look to go straight with the 592?

No, we -- the clinical data that we have for 591 is really excellent and fully supportive of the Phase III trial. And we have a lot of differentiation in that product in terms of what we expect the clinical performance of the product to be, use of the supply chain and a lot of other aspects. So we think that's a -- we think 591 is really an excellent product that has a clear clinical pathway. The 592 product, your observations are correct. Dr. Bender at Cornell and Dr. Tagawa took human J591, which is the antibody behind the TLX591 program and radiolabeled it with astatine -- sorry, with actinium. Our view is that this is a very promising proof of concept. It really demonstrates the utility of our platform. But with 592, we've made some important modifications to the antibody that we think will even further improve its utility. But you're absolutely right. It's an excellent clinical proof of concept. It's really promising. It showed that patients that are no longer responding to lutetium therapy, which we think will be a good half of 40% to 50% of patients, can achieve further therapeutic benefits. So not only is 592 going to be life cycle management for 591, but it will also become life cycle management for the Novartis product as well. And so that's clearly an interesting commercial opportunity for the company.

Your next question comes from Shane Storey with Wilsons.

Chris, maybe if I can go back to the 591-CDx in Europe where you mentioned that the cold kit presentation would be the dominant format. But will you lean on the Seneffe facility there to supply prepared patient doses within a sensible radius given the half life? And as a follow-up, I mean, would you constipate partnering with others to leverage sort of other gallium availability for the field across Europe in terms of covering the continent?

Yes, definitely. Shane, if you get bored of being an analyst, we've got an operations role open in Europe. But you nailed it on the head. So the Seneffe site, the 2 cyclotrons that will be upgraded at the Seneffe site are capable of producing gallium-68, and we would imagine -- and not just small amounts of gallium-68, but really bucket loads of gallium-68. And we announced a collaboration a few weeks back with ARTMS, which is a Canadian company that's developed ultra-high activity cyclotron production at gallium-68. So we're investing in that technology partnership because we can probably service a good chunk of 5 decent European countries from the Seneffe site and plan to do so, obviously, subject to a marketing authorization. There are a few other markets where we do exactly what you said. In the U.K., we work with Curium and GenesisCare to do exactly that sort of service provision. We're in similar discussions with sites in Spain and some of the Central European countries. So I think you're right, there will be some partnerships where we work on delivering doses. But the practice of gallium-based radiopharmaceuticals in Europe is very evolved and it's highly hospital-centric. And there's a good reason for that. You just don't have the homogeneity of regulatory environment in Europe that you do in the U.S. So the networks that have evolved in the U.S. have done so against that regulatory backdrop, whereas in Europe, it's very fragmented and the radiation-handling aspects are unique country by country, and that's why it has a different profile. But certainly, the opportunity that you've described is there, and it's a nice way for us to make the Seneffe site fairly profitable from an operating vantage point early on.

I might just switch to the U.S. part of that story on 591-CDx. You said third quarter there is the NDA submission target. I mean should we be treating that NDA as having sort of routine kind of 10 months to do sort of assessment phase? Or am I missing something there that might expedite it because the investor deck sort of implies an early 2021 sort of launch? Am I missing something there? Or...

We never try to guess what the FDA will do. It wouldn't be appropriate. But what we can say is that we have some statistics on what prior approvals have been like for similar products. The FDA has a high degree of understanding of this technology. Every time we have a clinical site set up, an investigational protocol or an expanded access IND, it goes back to the FDA, and they're intimately familiar with our manufacturing package. The advantage that Telix has from a regulatory approval pathway is that we're asking the agency to regulate a product box. We're not asking the agency to regulate a manufacturing process. So although that means that the FDA will have to audit our manufacturing partners for the product, we don't have to have a reference site inspection, for example, for a cyclotron facility or for a production facility. And because we dispense our product under practice of pharmacy, which is a state-based regulation, we don't have the same burden that our counterparts do on the F-18 side, which is where every single manufacturing site is regulated as a Part II 12 GMP manufacturing facility. So we have a much more streamlined rollout process, and that does have potentially an impact on the review period. So look, they can take all the time they want. And of course, the clock can stop and start again depending on how they feel about our package. But we think that the product is relatively straightforward to review. The FDA has a high degree of familiarity with it. And it has the potential to be fairly quickly reviewed.

Finally, if I may, just on the numbers. Like if you maybe talk through the expense outlook for the remainder of 2020. I mean I've seen what you said there in the 4C. But should we model similar sort of overall the first half? Or will it be a bit of a step-up in the last quarter, I guess, as the prostate campaign rolls into action? That's it from me.

Thanks, Shane. We're going to end the year with somewhere around $21 million to $22 million left on the balance sheet. That will be our ending balance sheet for the year. And I think that's fairly well sort of extrapolatable from our 4C. That gives us ample financial resources to do the market launch for 591-CDx in the first half of next year. We clearly have -- we have clearly stated in the past that we do not have the financial resources right now to run a Phase III prostate cancer therapy program. So the goal right now is to focus on the regulatory and the clinical trial readiness aspects, which will take us through until the end of the year. We have a little bit of cash set aside for starting to recruit early patients into that trial, which has a very different price point for the company. But adding U.S. patients in, let's say, by the end of Q1 or early Q2 of next year, that's going to require further capital. And we've said consistently, I think, over the last 12 months, that, that capital, it may come from a capital raise next year. It's a possibility. But more likely, it's going to come from partnering and commercial activity around that asset. And to Hashan's question, why are we still committed to developing that asset? The answer is absolutely because we have a lot of commercial interest in it. And it would be great. Obviously, if we can leverage partner funding or partially leverage partner funding, that will have a positive impact on the company's financial resources next year.

Your next question comes from Dennis Hulme with Taylor Collison.

My first question is also on TLX591. Can you talk us through the steps that you need to complete before you can commence recruiting patients in that study? And can you give us an indication of the likely cost of running that Phase III study?

So we'll be ready to recruit patients in Australia by the end of the year. And because of the additional manufacturing package requirements for the U.S., I mean, we're trying to be conservative and say that it's likely going to be end of Q1 next year that we get the nod from the FDA to start. And that will depend on a lot of things, and a Phase III trial is obviously a much more complicated -- it's a much higher bar. It's a bar, by the way, that we have jumped over before, but it's still a high bar, and that should be acknowledged. So I don't see any barrier to us being up and running in the U.S. in the first half of next year in that trial. And as I said, we can potentially start in Australia sooner. In terms of giving an absolute budget for that study, that's been hugely dependent on our discussions with the FDA, which are not final yet. In our original planning, we said that the likely trial size would be around 600 patients. Internally, we budget, of course, for dropouts and for needing to recruit more patients for various operational reasons. We think that on the basis of the current trial design, which we are socializing with the agency, that we can improve that patient size, but it remains to be finalized. And I expect that we'll have that final trial, that statistical plan and trial sizing by the end of October or early November. And then I think we'll be in a good position to transparently disclose what we think that trial cost is going to be. I don't think we're going to get much change left from about USD 50 million for the trial. And obviously, if we end up having to do either a larger statistical sizing or if we have to move to a more onerous endpoint, then that cost could go up considerably.

Right. Okay. And secondly, with the TLX250 therapy, can you give us an idea of trial timing of those STARLITE trials?

Yes. Yes, so these -- it's a bit frustrating that these trials have been delayed mostly because of the impact of the pandemic. It's just been very slow to get academic centers up and running. And in the case of the STARLITE trials, we're actually doing the product manufacturing in the academic environment. We're using nuclear medicine facilities in our trial sites, which is appropriate for sort of early to mid-stage studies like this. And that just hasn't -- it hasn't been possible to do that manufacturing validation during this first wave of the pandemic. So the good news is that we've finalized those protocols, those clinical protocols. The manufacturing now that we've seen things starting to reopen a bit in the United States, we've almost finished the manufacturing validation of the 250 lutetium product. The INDs are being prepared, and I would imagine in the next 4 to 6 weeks, we'll put the final touches on those INDs and get them filed. In some cases, the protocols are already going through institutional review. So I don't expect there'll be a lot of lag time. So we're still firmly on track, I think, to get these trials open before the end of the year. And that's something we're very keen to see happen. Carbonic anhydrase 9 is becoming a super interesting target. A lot of pharma attention on that target, and we're -- those 2 STARLITE trials are in combination with immunotherapy studies, and we really want to start to collect that data and get that patient experience as soon as we can.

Okay. Well, it's great to hear that they're likely to be underway before the end of the year. And finally, if I can totally change track, just to your competitor Progenics, which has indicated that it expects to file in the middle of the fourth quarter. I'm just wondering what's your expectations of the indications that Progenics is likely to file for? Do you think it'd just be biochemical recurrence or any likelihood that they might go for indications beyond that in your view?

Well, we try not to second guess our competitors too much. And I think that their clinical trial strategy has been very robust, and they have an excellent product site. I fully expect that they'll have equally compelling data to put in front of the agency. So I think we have -- we formed an internal view about what is our maximally competitive strategy. And I think once the FDA has accepted our NDA submission, we'll be in a position to much more forthrightly talk about our label plans or our labeling strategy, which will then, I think, in turn answer that competitive question more clearly.

Okay. That's great. And just finally, in relation to the European approval steps that you said that in a few months you'll have reached consensus with the other authorities. So what are the next steps after consensus is reached? What's the steps from there to getting final approval?

Yes. It all depends a little bit on what that consensus yields. I mean we're operating under the assumption that it's a fairly straightforward approval, again, perhaps even more so than the FDA -- the various European competent authorities know this technology very well. We've had a product dossier in, I don't know, 10 or 12 European countries now for, in some cases, a couple of years. So again, there's high familiarity and understanding with the product. Once we get to that 150-day clock, which is the consensus date, which was sort of be around the end of the year, we've given a rough time line because it can stop and start. So it depends on what queries we get. So let's say, by the end of the year, we get agreement from the 14 countries that we've submitted to that the product is approvable, then it will go to individual national review, and that will be up to the whim of each individual competent authority on how rapidly they review the package. That's why some competent authorities enable the possibility of an interim temporary marketing authorization, which we are in discussions with several competent authorities about. It -- unlike Europe -- unlike the U.S. story, where as we approach NDA, the impetus to fill in a lot of FDA documentation starts to diminish and customers will say, "Look, it's better for us to just wait to get product approval because it's probably going to be the same sort of time line." In Europe, there is much less impediment to just using the product. We obviously don't get reimbursement for it, so that limits adoption. But in terms of clinical access to the product in Europe, in most countries, not all countries, but in most countries, there isn't much barrier to continued use of the product. And so we don't feel the same -- we'd like to get reimbursement and maximum commercial value for our product in Europe, although we don't get a shabby price point for the kit in Europe today. I mean we have a decent average price point, but there isn't the same level of reluctance to use the product because of proximity to approval. Does that make sense?

Yes. Okay. Yes, it's complicated and a little unpredictable. So that's good that we can understand that. Okay. That's all the questions for me, Chris.

Thanks for your time, Dennis. I realize we're going way over time and people have got, I know, other calls to take. Maybe we'll take one more question if there is one.

Your last question comes from David Blake with Bioshares.

Chris, just one minor question. You made a comment about revisiting the label. I think this is in discussions with the FDA. Can you just clarify what you meant by that?

Sure. Yes. When we originally disclosed our commercialization plan for the prostate imaging agent, we did -- we elucidated that our intended to treat patient population is biochemical reoccurrence. So that's patients that have had an intervention with curative intent. So that's prostatectomy or radiation or a combination and then have had a rising PSA post prostatectomy. And this is the indication that has probably the largest data -- largest supportive data set around it, at least for our product, but probably for all PSMA products. But PSMA expression, which is the target that we image. PSMA expression is there for the continuum of prostate cancer from very early prostate cancer, pre prostatectomy, all the way out to late-stage metastatic disease. And so based on conversations with the FDA, but also new emerging data, it's clear that we have the clinical data to support the utility in a much wider continuum of care for prostate imaging. And so part of the delay -- I'd say about half of the delay we've had in the NDA submission is just the machinations of working in the pandemic, but the other half of the delay has been a concerted decision to consider broadening that label. And for competitive and commercial reasons, and obviously, sensitivity towards the agency, we haven't really discussed what our final label will be. But once the agency has had a chance to review our submission, then we'll start to talk more openly about what that scope of label is that we've submitted for. Well, thanks very much. I think we'll wrap it up there, and I appreciate your time and attention. I hope it was a useful update. And we certainly appreciate the enthusiasm and support of our shareholders. And a lot of exciting stuff to look forward to over the next 6 months and beyond. So thanks for your attention.