Good morning and good evening, everybody, and thank you so much for joining us today to discuss the announcement we made a short time ago regarding the merger of Telix and ITM. If we could just move to the next slide, please. Before we get into the official proceedings, I just have a few short disclaimers to read to you. This presentation contains forward-looking statements regarding our proposed transaction with the shareholders of ITM and expectations for ITM-11. These statements are subject to substantial risks, including, but not limited to, the outcome of the FDA's review following NDA resubmission, clinical trial results, regulatory approvals required in multiple jurisdictions, and our ability to realize projected synergies. Actual results may differ materially. You, therefore, should not rely on these forward-looking statements, which are made only as today's date.
Please refer to the risk factors across our ASX and SEC filings and the legal section noted in this announcement, and the ASX, and the full disclosure materials. With that, let us move into the official proceedings. I am very pleased to be welcomed today by Dr. Christian Behrenbruch, the Managing Director and CEO of Telix Pharmaceuticals, along with Dr. Andrew Cavey, CEO of ITM, and Darren Smith, Group Chief Financial Officer of Telix. We will run through some formal remarks and then a noted move to questions, as time allows. With that, I would like to hand over to Chris.
Good morning, everyone, and thanks for joining us today. Thanks, Kyahn, for the introductory comments. Today's news is a transformative step for Telix and for ITM. This transaction brings together two best-in-class companies that have really shaped the radiopharmaceutical industry over the past two decades, each with deep expertise, differentiated capabilities, and a shared commitment to innovation for the benefit of patients. Telix and ITM have a long history of partnership and collaboration spanning almost a decade. Through that relationship, we developed a deep appreciation for ITM's capabilities, its technology platform, and its excellent people. We enter this agreement with confidence of the strategic and cultural alignment between our firms. As many of you know, this industry is undergoing a rapid evolution and a period of consolidation.
It has always been our view that long-term leadership in radiopharmaceuticals will require control across the whole value chain, from radioisotope supply and product development through manufacturing and logistics to ensure that we can meet the needs of patients worldwide. This is why this combination is strategically important. This merger brings together complementary strengths across supply chain, manufacturing, development, commercial reach, and adds therapeutic pipeline depth. We will go into that in a little bit more detail in a minute. Just as importantly, it combines two highly experienced teams with specialist capabilities that are very difficult to replicate. In summary, and with reference to this graphic, ITM brings a commercially scaled and validated isotope business, particularly Lutetium-177, and important capabilities in next-generation radioisotopes that are important to the pipeline, particularly with actinium and terbium. It also immediately adds revenue and cash generation to the group.
This is a very commercially successful business and will be additive to Telix's financial position. Secondly, it will have the industry's most advanced therapeutic pipelines, including four therapeutic assets in phase III trials. The addition of ITM-11 accelerates Telix's entry into the commercial therapeutic space and into a well-validated therapy market in neuroendocrine tumors, and we are really excited about that. Finally, this also builds on Telix's market-leading precision medicine platform and specialist commercial organization, which we believe are strategic assets in their own right. As you will see in a minute, ITM expands our global footprint and creates additional opportunities for life cycle management across our portfolio. As we have demonstrated with our multi-product PSMA imaging portfolio, this has been quite a successful hallmark of our sustained commercial growth.
In short, I believe that this transaction is accretive to shareholders with the strategic and financial benefits creating pathways for significant value creation. Moving on to the next slide, please. Overlaying the strategic rationale with the transaction terms, we believe this is a compelling and financially disciplined opportunity for Telix shareholders. At a high level, ITM adds a profitable and growing isotope manufacturing business, strengthening the group EBITDA and giving Telix greater control over a critical part of the therapeutic supply chain. ITM-11 brings potentially an accelerated entry point into commercial therapeutics with a differentiated and novel late-stage candidate in neuroendocrine tumors that we believe is highly differentiated and well-positioned to compete. ITM is expected to deliver a positive EBITDA contribution in 2027, supported by revenue growth and cost synergies between the businesses.
In terms of the structure, Telix will acquire 100% of the shares of ITM for $1.65 billion upfront on a debt-free, cash-free basis. That means a total of $1.25 billion upfront. That is less approximately the $400 million in debt and transaction costs will be the amount paid to the sellers. $302 million of net debt will be assumed by Telix at closing. A meaningful portion of the total consideration is also performance-linked, with $700 million of deferred milestones tied to ITM-11 regulatory approvals and a 2030 net sales target. The upfront consideration will be settled in Telix shares and released as ADRs after the escrow periods.
The use of ADRs is expected to support greater liquidity and visibility on Nasdaq over time. The deferred consideration will be paid in either cash or shares at our election, and closing remains subject to shareholder approval and is expected to conclude before the end of 2026. I am pleased to say that Andrew and the ITM leadership team will play an important role in the combined business, subject to Telix shareholder approval. Dr. Andrew Cavey and Dr. Barbara Weber, who are both members of the ITM supervisory board, will be appointed to the Telix board. I could not be happier about these additions to the Telix board. These additions reflect the strength of partnership and trust between the two parties.
Both bring a great degree of scientific and commercial acumen with years of industry experience in our field. I am very much looking forward to working more closely with both of them. With that in context, I am now going to hand over to Andrew to speak a little more about ITM's business, its manufacturing platform, and the growth opportunity ahead. Over to you, Andrew.
Thank you, Chris. I am delighted to be with all of you here today to share more about this exciting announcement. Just to introduce myself, I am Andrew Cavey. I am the CEO of ITM. I joined just over two years ago, having spent much of my career in radiopharma, including some time at BMS, where I helped the company establish its entry into radiopharma, and then at Novartis, where I co-led the company's RLT platform. Let me turn to ITM. ITM was founded over two decades ago, and like Telix, it has been one of the foundational catalysts of the field. We have two pillars of value at ITM. You can see these on both halves of the page. A leading radioisotope production and manufacturing business that is on the left, and a radiopharmaceutical drug development capability on the right of the page, both under one roof.
Having this dual competency is rare. Most of our peers specialize in one or the other, and being able to bring this to Telix will offer us significant strength. Let me talk about the radioisotopes first on the left side. Our company has been built on the innovation and scale that we have brought to non-carrier-added Lutetium-177, which is now really the established therapeutic radioisotope in oncology, and it underpins more than 100 clinical trials today. It is really the workhorse radioisotope of the industry. We have a broad manufacturing business here with multiple customer relationships across pharma companies, including Telix, hospitals, and scientific research institutes. Through doing this, we have really seen firsthand how demand for therapeutic radioisotopes has continued to grow, both for approved products and also clinical development programs. We are not stopping there. We are also moving into actinium.
Already today, we supply one of two approved products in this class, Pluvicto, and we think that commercial validation has come because of our consistent approach to quality and reliability as a partner. To introduce the right side of the page, our second pillar of value, the radiopharmaceutical pipeline. Much like Telix, our central position in the industry for so long has allowed us to identify promising assets early. As we grew our isotope leadership and the deep relationships we had with customers who were researchers and research institutes, gave us firsthand access to new innovation, and it allowed us to expand our own pipeline of radiopharma medicines. Today, that pipeline spans multiple cancer indications, late and early-stage assets. Our lead late-stage asset is ITM-11, which I will speak to more about in a moment. We also have early-stage assets, including, for example, ITM-31 in glioblastoma.
This pipeline also spans a range of radioisotopes across lutetium, actinium, and Terbium-161. Next page, please. Importantly, this is an existing growth platform. ITM delivered approximately 40% of revenue CAGR between 2021 and 2025. If you look at where this goes next, to understand where the outlook, it helps to look at the current status of clinical trials as these are lead indicators of future potentially approved products. We really see the field here reaching an inflection point. In that middle bar chart on the page, you can see lutetium. That is lutetium. Lutetium already supports two commercial therapies, and there are further 41 assets in development behind these, speaking very much to the depth of the field and its future potential. If you look on the right-hand bar chart, that is on actinium. The next wave of radioisotope growth is also taking shape.
Actinium is now the second most used radioisotope in clinical trials. There are 34 assets in development, and we see this as strong evidence that the industry is moving well beyond a single isotope. Overall for us, the commercial opportunity is substantial. We see radioisotope markets forecasted to grow by roughly 30% annually through 2035, with risk-adjusted markets of over $2 billion for lutetium and around $1.5 billion for Actinium-225 in that time period. Back over to you, Chris.
Thanks, Andrew. Just on the next slide here, just to wrap up all of the pieces together. Most of you will be familiar with Telix's growth strategy. We have talked about a lot over the last couple of years, which is really to build a global radiopharmaceutical platform with the capabilities that are necessary to develop, manufacture, and commercialize products at scale. The combination with ITM fits that strategy very deliberately. It strengthened the areas where we believe that will matter most over time, which is securing radioisotope supply, differentiated manufacturing capacity, and additive depth to the therapeutic pipeline. ITM also adds proven commercial-scale isotope production and expands our near-term therapeutic opportunity through ITM-11 and the broader pipeline, and really brings a team with deep operating experience in a highly specialized part of the industry.
Taken together, this reinforces a competitive moat around our combined platform and gives us a greater strategic control over all aspects of that radiopharmaceutical verticality as the field continues to grow. I think now I would like to ask Andrew to go back in and give us a little bit of a deeper dive into the ITM manufacturing platform and why that capability is so important.
Thanks, Chris. I know many of you will already be familiar with the field of radiopharma, but if you will indulge me, I will maybe just say a word about what radioisotopes are. These are the individual atoms that form the cancer-killing payload of the radiopharmaceutical medicine. What makes them tricky is that they decay rather quickly. In the case of Lutetium-177, for example, within 10 days, you have to irradiate the raw material, manufacture this under GMP, deliver it across the world, and inject it into a patient in that very short period of time. It is the proverbial delivering the melting ice cube around the world. At ITM, we have been doing this for a long time now, and we have built unique capabilities at each step of the value chain. Let me take you through that.
This little wheel here, if you start at 12 o'clock at the top of the page, that is the value chain for non-carrier-added Lutetium-177. What does it take to make it? First, at the top right, you need to start with a raw material. In this case, enriched Ytterbium-176, and we have substantial stockpiles of enriched Ytterbium-176 underpinned by exclusive supply agreements. Next on the wheel at sort of three o'clock, you need to take that ytterbium and you need a source of neutrons to irradiate it. We have, like other companies, an extensive research reactor network, but uniquely, we also have an exclusivity with the largest power plant in the world, giving us a much more reliable and regular access to neutrons.
As you move to the bottom of this wheel, next in the chain, you need to purify the hot material you have got. We have the two largest GMP manufacturing plants in the world, both outside of Munich in Germany. From there on the left side of the wheel, you need to sell and distribute this around the world. We do this daily to 400 + customer sites around the world. Next page, please. This page just shows an overview of the radioisotopes we play in today. I have talked a lot already about lutetium at the top of the page. As I said, it is the workhorse therapeutic radioisotope of the radiopharma industry. Maybe I will just make one additional point on lutetium before I move on. ITM supplies lutetium for Pluvicto.
Pluvicto is one of only two approved products in the class, an important medicine, and we see this as direct validation of our manufacturing position from the market itself. I also mentioned that Telix is already a customer, and we really view the merger as it gives us a strong ability to help ensure supply security for the supply of our merged pipeline as well. Just maybe touching on the other two isotopes. You see actinium here in the middle of the page and terbium below that on the ITM side. We are very much focusing on Actinium-225, kind of the next wave of growth from our radioisotopes. To do this, we have formed a joint venture called Actineer with the Canadian Nuclear Laboratories, where we bring the best strengths we think of both organizations.
The path we've taken to produce Actinium-225 involves starting with Radium-226 as a raw material. It's a very difficult radioisotope to use with a 1,600-year half-life, and that's why we combined with CNL because they bring deep expertise and significant stocks of this precursor material, and they also have long-standing experience of managing the waste. In turn, in this joint venture, we bring our expertise in GMP manufacturing, and supply and distribution. We're also now exploring Terbium-161. You can see that third bucket on this page. This is a promising isotope. It's a beta emitter, just like lutetium, but it also emits what are called Auger and conversion electrons, which in many ways behave with short pathway lengths and high energy akin to how alpha emitters behave. These have shown strong data in pre-clinical data and early clinical data, which give us excitement to invest.
Additionally, the supply chain for Terbium-161 is highly synergistic with the supply chain of Lutetium-177. It's essentially the same, although you start from a different raw material. We view this strength of radioisotopes that we bring across these three isotopes as also very synergistic with what Telix has also been building over recent years. Maybe, Chris, you want to talk about that?
I think this slide shows the complementarity. I'd say, in a nutshell, ITM is the master of, for the most part, reactor-based radionuclide production. We have a very strong cyclotron-based capability through the ARTMS acquisition. As you can see, we've got a very complementary set of capabilities. I think for Telix, this materially de-risks, as Andrew said, the lutetium supply chain for our own therapeutic pipeline and strengthens our ability to plan, develop, and ultimately commercialize these products, which are in late-stage development. Then we look forward to bringing the ITM team in with real experience in scaling radioisotope production for therapeutic use. I like to reiterate what Andrew's just said, that operating experience is difficult to build. It's highly competitively differentiated, and it gives the combined company a stronger foundation to move products all the way from early development to commercial supply.
I'd say together, the combined entity will have the broadest and most capable portfolio of both diagnostic and therapeutic radioisotopes, and can cover both the workhorses that are being used today and the things that are in the combined pipeline, as well as the next generation of isotopes that may ultimately shape the future of the field. I think this is a very exciting picture. Maybe just to continue this, if we can move on to the next slide. I think Andrew very eloquently noted their enormous customer reach and the fact that they deliver mission-critical isotopes to hundreds of customers around the world every day. In fact, I consider ITM's logistics team to be really unparalleled in the industry.
What you can see from this map is that together, Telix and ITM bring a highly complementary global footprint, lots of opportunities to align our commercial teams. That just covers everything from isotope production, radiopharmacy distribution and delivery, and of course, spanning both diagnostic and therapeutic products. In the United States, our last mile delivery network already covers approximately 85% of the market. Internationally, the combined network spans more than 65 countries, including in key growth markets across Europe and Asia, and including China and Japan, which are important focus areas for Telix at this point in time as well. We think this reach really matters. In radiopharmaceuticals, supply opens markets. Where reliable isotope supply exists, then the commercial market follows because customers, that is hospitals and physicians, will have the confidence that product can be manufactured and delivered consistently.
I think that is the precursor for commercial success. For us, we see this as not just infrastructure and supply chain for the products we have today, but it is also infrastructure that can support new market entry, broader adoption, and long-term category growth for the combined business. I just want to note, we remain very committed to working with our partners, customers, hospitals, and physicians. Both companies have a lot of third-party relationships that are extremely important, and we have really built both companies on partnership and collaboration. The combined organization will be there to support third-party development, to continue to supply isotopes to all corners of the industry. But it is also about shoring up the pipelines that we have together.
I am sure that we will continue to be an organization that helps to foster innovation across the industry for the benefit of patients in a collaborative way. Okay. I would like to just change gears a little bit and shift into the therapeutic opportunity of the ITM transaction. Just stepping back from ITM-11 specifically on the next slide, please. This slide shows selected elements of the broader portfolio optionality that comes with ITM. We can see why this is more than a single product transaction. Clearly, ITM is the lead value driver, given that it is a very late-stage program. It has completed phase III development in its initial indication and already has potential expansion opportunities in areas such as more aggressive neuroendocrine tumors, lung NETs, and pediatric indications. This gives us a lot of growth trajectory around this lead asset.
Andrew is going to talk a little bit more about the lead asset in a minute. ITM also brings some early-stage programs that are highly complementary to Telix's existing portfolio and areas of focus, particularly in neuro and uro-oncology, which as you know, are key focus areas for Telix from a disease area perspective. When we go about optimizing the pipeline, we will be thinking about how we prioritize the programs with the strongest strategic and commercial fit. That is those that provide lifecycle management opportunities, and also how we use the combined capabilities of Telix and ITM to build durable positions in these disease areas that we think are the winning areas to focus on. This is important strategically, but it is also important financially. It allows us to remain disciplined about R&D investment and capital allocation while pursuing the most compelling growth opportunities.
And so maybe at this point, I'll hand back over to Andrew to go into a little bit more detail about ITM, which I think is a really exciting asset and a big part of this transaction. Andrew, over to you.
Yeah. ITM-11. ITM-11 is indicated in GEP-NETs, gastroenteropancreatic neuroendocrine tumors. And these are tumors where there remains a substantial unmet medical need. GEP-NETs are frequently diagnosed late. And the true population is in all likelihood underestimated. We are also seeing incidents of this disease increasing over recent years. And the market is attractive in what is already a commercially validated category, and a market we estimate to be around $1.7 billion in the United States alone. So what is ITM-11? ITM-11 is a differentiated next generation therapy combining an SSTR targeting molecule with our high purity non-carrier-added Lutetium-177. We have already started to build a compelling clinical data package here. I'll start talking about COMPETE, which is our first phase III study. COMPETE produced positive phase III results early last year, demonstrating progression free survival. And I'll show you those charts in a moment.
But importantly, also in a harder to treat pancreatic neuroendocrine population. And we designed the study at the time. When we designed it, we knew we needed a competitive edge. And so the study design was rather unique. It was a monotherapy of ITM-11 versus an active targeted therapy comparator in everolimus with a favorable dosing schedule every 12 weeks. And also it is a medicine that benefits from a longer shelf life. I'll come back to that in a moment, but that's very important in a field where you only have a limited time to get your medicine to your customer and to your patient. There's also meaningful room for expansion. We have other phase III studies that are ongoing, and I'll also come to those in a moment. Next page, please. This was the first head-to-head study against an active comparator with ITM-11 as a monotherapy.
Here on the chart, you can see the Kaplan-Meier curve showing the primary endpoint of progression-free survival. The dark blue line is ITM-11 with the red line the comparator of everolimus. And the primary endpoint was met convincingly. There was an impressive median progression free survival reached at about 24 months with ITM-11 compared to about 14 months for everolimus, so a 10-month delta of PFS. And that represented about 33% reduction of risk of progression or death. And this is very much a clinically meaningful outcome for patients and physicians alike. But importantly, this efficacy was also accompanied by a favorable safety profile. Grade 3 or 4 treatment related adverse events occurred in 18% of patients receiving ITM-11 compared with 40% for everolimus. I also touched on a moment ago the longer shelf life, and this gives significant advantages when it comes to customers and nuclear pharmacies.
In fact, this is an area where we view the merger with Telix. We think this will contribute, thanks to Telix's deep operational understanding of how radiopharmacies dispense products in the United States. And so we see the totality of this data as positioning us to have the best-in-class product in the neuroendocrine tumor space. Next page, please. Data that you just saw was published in The Lancet a few months ago, and that provided us with important external validation. We had also submitted the study to the FDA about a year ago. On August 7th, we received a complete response letter for ITM-11 from the FDA. I want to be clear about what that letter does and doesn't reflect. Importantly, the FDA did not identify any concerns regarding the clinical or non-clinical data package, nor on the safety profile of ITM-11.
The entirety of the CRL was contained around CMC and inspection items related to a third party facility in the United States which received a Form 483. We are already working with that third party to address the items that were cited with a clear goal to resolve them as quickly as possible, and we've also already announced our intention to resubmit. We will request an FDA Type A meeting before the end of the year to make sure that we fully address the FDA's feedback and we align on the remediation pathway. Overall, we think we have a full understanding of the CRL and our remediation is on track, and we're in process of working with the agency to align on our pathway.
Yeah, and Andrew, if I could just—
Chris, yeah.
If I could just chime in from Telix's perspective. We have obviously had direct experience in managing CRLs, so we understand the process and the practical steps required to work through it. Importantly, as Andrew said, the issues identified are CMC and inspection related. They are not clinical or safety issues, so we have full faith in the clinical data, and the FDA has not requested additional clinical data. I think it is also just worth noting that we know this third party facility very well, and the broader regulatory context. Radiopharmaceutical products are technically complex and in many ways the regulatory framework is still evolving alongside the science, particularly when it comes to manufacturing and handling and delivery. Through our own experience, including PIXCLARA, we have demonstrated that a CRL is not the end of the road where the underlying product profile is very strong, and this is certainly the case here.
From a transaction perspective, we have also reflected this appropriately in the deal structure. A meaningful portion of the consideration, up to $ 700 million, is deferred and linked to regulatory approval milestones with specified achievement dates and net sales targets. I think that the parties have really apportioned risk appropriately in this transaction. Of course, I will note that it is a closing condition of the transaction that the ITM-11 NDA is resubmitted. This is not expected to be a protracted and drawn-out process. I think that is sort of all I have really got to add on this topic. Maybe Andrew, do you want to go on and talk about some of the upside of this program?
Yeah. Let me talk a bit about our ongoing clinical development plan. Next page, please. We have several expansion programs for ITM-11, which represent significant opportunities. Importantly here, the investments for these opportunities are already behind us. The first on the left of the page is the COMPOSE phase III study. This addresses a more aggressive form of the disease, evaluating ITM-11 in Grade 2 and Grade 3 SSTR+ GEP-NET where effective treatment options are frankly rather limited. The recruitment for this study is complete. We have enrolled our target population of, I think, 250 patients, and we are evaluating this in first and second line, again, importantly, against an active comparator with PFS as our primary endpoint. On the right of the page, you see a third phase III trial called the LEVEL study, evaluating ITM-11 in lung and thymic neuroendocrine tumors.
To give you a sense, lung NETs represent about 20%-30% of all neuroendocrine tumors, but with really limited treatment options today. For this study, the LEVEL study, we have recruited already approximately 90% of our target 170 patients, meaning the study is approaching full enrollment right now. With that, I will hand back over to Chris and Darren for the next section.
Yeah. Thanks, Andrew. It is really exciting indication expansion and looking forward to seeing that extra data come out. Look, at this point in time, I think I will hand over to Darren to go through the numbers in a little bit more detail. Darren, you want to pick up?
Yeah. Thanks, Chris, and hello, everyone. I want to spend a bit of time on the financials. As Andrew has outlined, ITM's radioisotope manufacturing business has delivered impressive revenue growth, primarily through the supply of lutetium. Importantly, this is a business operating in a high-growth market underpinned by long-term contracts with multiple customers. As discussed today, ITM is well-placed to maintain its leading position as demand for therapeutic radioisotopes continues to grow, driven by commercial adoption and increasing clinical trial activity. For Telix, this adds a resilient and growing revenue stream and diversification. On a pro forma basis, taking into account our current guidance, reported income, and ITM's current run rate for the first half of 2026, the combined business would be on track to deliver revenue and income in excess of $1.3 billion this year.
On the right-hand side of this slide, you can see that the combined business today would have three primary sources of revenue. Firstly, from our position medicine product sales, including ILLUCCIX, GOZELLIX, and shortly, PIXCLARA. Secondly, external revenue from Telix Manufacturing Solutions, predominantly third-party sales through RLS, our radiopharmacy network. And thirdly, revenue from ITM's isotope manufacturing business. Together, TMS and ITM would represent just under 40% of the revenue on a pro forma basis for the first half of 2026. ITM is expected to contribute positively to the group EBITDA from 2027 onwards, which I will cover in the next slides. Next slide, please. To build on that, I wanted to spend a moment on the financial profile of ITM and why we believe it is an attractive fit for Telix. Firstly, ITM adds to our revenue.
In the first half of 2026, ITM generated revenues of $156 million and an attractive gross margin of approximately 40%. It is a very different margin profile to the external revenues currently generated by Telix Manufacturing Solutions. It adds a high-quality revenue stream to the group. You see two key growth drivers. Firstly, the continued expansion of the isotope manufacturing business, which today is anchored in lutetium. However, there is the additional near-term growth potential from actinium, an isotope that is increasingly relevant across the industry in clinical development. Secondly, the potential approval for ITM-11, which would create an additional source of high-margin therapeutic revenue. This is directly aligned with Telix's stated growth strategy.
Moving to the second column, note that ITM enhances our EBITDA, and we expect this transaction to be EBITDA positive from 2027. ITM's manufacturing division is expected to generate EBITDA of $106 million in 2026 on an annualized basis. We see three factors supporting a pathway to positive EBITDA contribution from ITM. The first one, continued revenue growth from the manufacturing business. Secondly, cost synergies and operating efficiency, including disciplined management of the group's operating expenses. ITM has initiated a cost-saving program following the receipt of the CRL, which is expected to bring the operating cost down to the FY 2025 levels. We see further synergies as a combined organization, which I will come to on the next slide. Historically, we have maintained operating expenses as a consistent percentage of revenue, and we do not see this changing with the addition of ITM.
Thirdly, pipeline optimization across the combined R&D portfolio, in keeping with our disciplined approach to capital allocation. The combined Telix and ITM pipeline is extensive, and that is an asset. In terms of prioritization, our immediate focus will be on the ITM-11 program. Clinical development is largely finished, with two phase III studies completed, and the third indication expansion trial nearing its target enrollment. We will selectively advance ITM's early-stage programs with a focus on those that complement our existing clinical areas of neuro and neuro-oncology, and where we see attractive life cycle management opportunities. This is very consistent with Telix's disciplined approach to building sustainable commercial franchises in our focus markets. Looking at the third column, note that the combined group will have a strong cash balance with sufficient flexibility and balance sheet capacity to manage the capital needs of the enlarged business.
This transaction does not change our approach to financial management. We will continue to invest in the pipeline, and we will do so in the same discipline around capital allocation and cost control, prioritizing the assets we believe can deliver the most attractive near and medium-term returns. ITM's existing debt of $302 million will be rolled over and deducted from the upfront consideration. So it is built into the valuation and deal structure. Turning to the next slide, please. In addition to the cost savings noted previously, we also believe we can generate cost synergies of $50 million over the first two years from efficiencies within the combined organization. This is in addition to the cost savings program already underway at ITM to achieve a positive EBITDA in 2027. From a synergies perspective, we see value across several areas.
This includes operating efficiencies from bringing together complementary infrastructure, manufacturing expertise, and corporate functions. Second, there is a portfolio efficiency as we prioritize investments across the combined R&D pipeline and focus capital on assets with the clearest clinical, commercial, and financial return profile. I do want to reinforce that the value of this transaction is not driven by cost savings alone. Radiopharmaceuticals is a high-growth and emerging industry. Therefore, the transactions we undertake has to be judged by its ability to accelerate our strategy, deepen our capabilities, and create attractive growth opportunities over time. We have spoken today about the growth potential of ITM's manufacturing business. It is clearly important financially, but it is also strategically valuable. ITM strengthens our access to lutetium, which will be used for ITM-11, our two prostate cancer therapy programs, and our kidney cancer therapy program.
All of these are late-stage assets, and it is vital that we build this capability now to support the therapeutic programs as they move towards commercialization. The transaction also deepens our pool of specialist talent in manufacturing, radiochemistry, and scientific and clinical development, which are also key to our long-term success. Taken together, these factors support the financial and strategic rationale for the transaction. We expect ITM to broaden Telix's revenue base and to contribute positively to EBITDA in 2027. Over time, the opportunity is to translate that additional return on invested capital through a successful commercial launch of ITM-11, and is supported by disciplined integration, rigorous R&D prioritization, and continued cost control. Back to you, Chris.
Thanks very much, Darren. Just to close out, and this is our last slide before we go into Q&A. I want to bring this all back to why we believe this proposed transaction is important for Telix shareholders. Today, we've outlined why Telix and ITM fit together strategically. Telix brings a global precision medicine platform, development and commercial capabilities, and a late-stage therapeutic pipeline. ITM brings scaled isotope manufacturing, specialist supply chain expertise, deep radiochemistry capability, and a complementary therapeutic portfolio. Subject to completion, those capabilities will create a stronger, more integrated radiopharmaceutical platform with the potential to support products from development through to patient delivery. So the full end-to-end solution.
As Darren has just outlined, we believe the proposed transaction is financially disciplined with a structure that reflects the key value drivers and appropriately links a meaningful portion of consideration, up to $700 million, to future performance and regulatory milestones within specified achievement time frames. Of course, completion remains subject to Telix shareholder approval and other customary closing conditions. Subject to completion, our combined focus will be clear. Supporting ITM's manufacturing momentum, progressing the regulatory submission and launch pathway for ITM-11, and I can tell you that our commercial team is primed and ready to take on this challenge. Of course, prioritizing the combined pipeline around the areas of strongest strategic and commercial fit, and bringing the two organizations together carefully and deliberately and with cost optimization in mind.
In short, we believe that this has potential to add significant value to shareholders, patients, our partners, and employees, and we're really excited about this opportunity ahead. Now, with that said, I'm happy to open up the floor to questions.
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. Your first question comes from Andy Hsieh with William Blair.
Oh, great. Thanks for taking our question. It's so gratifying to see the two companies combined, Chris and Andrew, and look forward to working with you. I have a question in terms of the value proposition of ITM-11. Just given the dynamic of having an incumbent and also potential generic coming online, I'm just curious about that product in the NET space. Also from a manufacturing perspective, Andrew, I'm curious if you can comment on the actinium production route from Actineer. Just kind of lay it out for us why the P2N pathway is, in your view, the best approach, just given several methods out there. That's all I have. Thank you so much.
Andrew, shall we divide and conquer on this one? Maybe I'll just give a little bit of a view on ITM-11 from Telix's side, and then maybe Andrew, you can fill in the gaps if I've missed them, and then take on the actinium question. Look, fundamentally, we obviously see the increased competition in the NET space. We fully understand the commercial strategy of the incumbent, but this is also a highly differentiated product. It is not a me-too product. It has a differentiated clinical profile. We believe that that's supported in the data. We also see a clinical and label profile for this asset that's highly differentiated that we think lends itself to some unique commercial strategies. Then perhaps, Andrew, you can elaborate a little more on some of the logistic and supply chain advantages that this asset has.
Thank you. Yes, I certainly agree that I look at the strength of ITM-11 both on the basis of its clinical differentiation and its non-clinical differentiation. Chris talked about the former. I think on the non-clinical side, the fact that we have a longer shelf life than the incumbents opens up a lot of possibilities for us, because it gives us more time to leverage the radiopharmacy network and to prepare more customer-friendly and patient-friendly doses that we can deliver directly to the nuclear medicine departments. We've also built an end-to-end customer experience pathway that allows us, or that will allow us, subject to FDA approval, to touch on all the friction points that we're seeing in the market commercially today. By the way, it's nice to reconnect, Andy. Nice to hear your voice.
Andrew, do you want to maybe pick up on the second question on actinium?
[Yeah, pick up on the actinium.]
Yeah, go for it.
Yeah. We spent a lot of time choosing this radium proton route with our Actineer joint venture. I do not know if our audiences know, there are many ways to manufacture Actinium-225. You can start with different starting materials. There has been a legacy route using Thorium-229 generators. That is available today from historic supplies, but it is expensive and there is limited global Thorium-229, which restricts supply. That legacy route is available today, but dying and it is not fit for commercial scale. You have then other routes, two routes, including radium. Radium proton route, the P2N route that we have adopted with Actineer and a radium gamma route. We see significant advantages with the P2N route for a few reasons. First, the availability of starting materials. With our partnership with CNL, we have a strong supply of Radium-226.
The P2N route is also, we believe, the most scalable route, thanks in part also to the size of the targets that are used. It gives high-quality product with negligible traces. Often with Actinium-225 production, you look at a byproduct of Actinium-227, and we see very negligible traces of that using the P2N route. Importantly, it is a proven technology. Unlike the radium gamma route, which is theoretically able to supply but not proven at scale, we believe that the P2N route will allow a significant scale-up within one to two years. It is the combination of all of those reasons that we think the P2N route will be the winning route, and one also that will allow a significant cost advantage compared to the others.
There is your science lesson for the evening, Andy. Hope that was sufficient. Next—
That is very helpful. Thank you so much.
Next question, please.
Your next question comes from Chris Cooper with JPMorgan.
Hi. Thanks for taking the question. Can I just firstly just get an idea of the current customer concentration? The $ 273 million of revenue last year, how much of that was from Novartis or Pluvicto? The reverse question, I guess, do you have a sense of what percentage of Pluvicto supply of lutetium comes from ITM?
Yeah. We do not really disclose that information at this point in time, and we will not be doing customer breakdown. Obviously, Novartis is a significant customer with a long-term and very robust supply contract. But the growth in the lutetium business for ITM has been fueled by a combination of Novartis, other large and medium-sized pharma companies, and also direct to hospital supply of lutetium globally.
Chris, maybe I can add a point here, which is that Novartis today, with two approved products, is the dominant source of demand. It is a good thing that we are supplying them with robust contracts, as Chris put it. Importantly, you need to look beyond that at where will future demand come from. No doubt also from Novartis, but we also have contracts across the radiopharmaceutical industry with most of the biotech and pharmaceutical players. We have these clinical supply contracts that also lead into commercial supply. We see this as a very strong base for future revenue growth as the science advances and clinical trial footprint advances.
There's no change of control provisions at all in any of the existing long-term supply contracts you have?
Any contracts for which there is some sort of commercial variation are considered in the transaction parameters. I think it's a well-managed aspect of the business that obviously we would have looked at very carefully the transaction structure.
Cool. Thank you. One just quickly, if you don't mind, on ITM-11. I see in the slides, and you commented on this, Chris, that the closing condition of the deal is an agreed path forward between Telix and ITM on the resubmission. How much flexibility is there? Does this need to be resubmitted, or could there be some other sort of version that allows you to get comfortable that the deal can close? I'm just trying to assess the risk of delays to the closure, just given that we've seen some of these—
Yeah.
—CMC CRLs can be a little bit tricky.
Look, I think the ITM process is really, the CRL remediation's really well in hand. They moved fast on it, and I'm very happy with the alacrity with which the issue's been managed. As I mentioned during the presentation, we have a high degree of familiarity with the manufacturing partner that received the Form 483, so we're also comfortable in our diligence that this is a rapidly resolvable situation. We obviously aren't going to delay closing unnecessarily. We want to complete the merger. We want to progress the businesses. We want to achieve those synergies. Providing that we can see a Type A meeting having a good, clear pathway with no additional wrinkles added into the process, I think we'd be comfortable closing on that basis.
Understood. Thanks very much.
Yeah. Thanks, Chris. Good questions. Next one?
Your next question comes from David Bailey with Morgan Stanley.
Yeah. Thanks. Morning both of you. Chris, just maybe just in terms of the economics of the therapeutics pipeline for Telix post this transaction, can you just maybe talk a little bit about how you're thinking about the candidates coming through on the Telix side and how the economics may change post this transaction? My second question would be is on slide seven, some very strong growth coming through for lutetium actinium as well for both those radioisotopes. But in terms of the ITM capacity at the moment, what's the ability to grow from here? Is there further CapEx required to meet some of the demand? Can you talk a little bit about the growth CapEx profile for ITM as you look forward to that growth?
Sure. I'll get Andrew to comment on the growth capacity. That's a pretty straightforward one. But you can see what we've been building over the last few years. On the distribution side, we want to streamline distribution costs and essentially give ourselves and select partners a market advantage in terms of the cost structure of our products. Clearly, that applies as well to the lutetium supply chain. When you look at the cost structure of a radioligand therapy, lutetium is a very significant part of that cost structure. So being able to internalize the supply chain, the margin impact is really beneficial. So we see this as being financially accretive in the next few years as the demand for lutetium skyrockets. We see that the margin contribution is beneficial as we go into our own product commercialization activity, including ITM-11.
As far as meeting the demand going forward, part of the driver for this transaction is ITM has a second very substantial scale-up facility that is just in the process of being commissioned. It's a very significant investment, and I can only describe this facility as state-of-the-art. That is going to not only provide redundancy to the primary manufacturing facility, but also is a very significant scale-up capacity step change. I don't know, Andrew, do you want to chime in and add anything about the NOVA facility?
Yeah, maybe I'll just give an overall answer that we've made very significant CapEx investments over recent years that have allowed us now to have very significant capacity for our lutetium production. Most of the lutetium that we produce today comes out of the first plant. As we open now the second manufacturing plant, it's already open and it's doing a lot of activity around warehousing and QC and lab space and reagent preparation and so on. But as it starts to activate lutetium production, we will have significant capacity to accommodate future growth in the industry for lutetium. On the actinium side, one of the advantages for us of the P2N route and of the stepwise scale-up that we're doing is we've already put in CapEx, but future CapEx will be scalable together with rise in demand.
We don't need to put in massive CapEx before the demand comes. We can build these things together, which we also think helps give us a strong financial profile in future years.
Thanks, Andrew.
Thank you.
We'll take the next question, please.
That is all the time we have questions for. I will now hand back for any closing remarks.
All right. Well, thank you very much, everybody. Realize we sprung this one on you, but needless to say, we are extremely excited about the transaction, and really the future impact of this merger is extremely exciting, both for Telix and ITM, and for the industry overall. We look forward to engaging individually with shareholders and investors over the coming weeks. Andrew and I will be working shoulder to shoulder during this period of completion and of course, the post-merger process when we get there. Looking forward to keeping you informed as this evolves. Thanks for your time.