Lantheus Holdings, Inc. (LNTH) Earnings Call Transcript & Summary

All right. Good afternoon, everybody. Thank you so much for being here. I hope the conference has gone very smoothly for all of you. My name is [indiscernible], I'm an associate in the health care group at JPMorgan. Today, I have the pleasure of introducing Mary Anne Heino, President and CEO of Lantheus. She is planning on doing about a 20-, 25-minute presentation followed by Q&A. I'll have the microphone here ready for any of you who have questions. Thank you very much.

Thank you. And thank you, everyone, for joining here. I see some familiar faces in the audience. For those of you who are new to Lantheus, I will use our time today to overview Lantheus and offer some highlights into our current business and short-term drivers and then really talk about the strategic plan that's underway for the management team and I to be executing. Before I begin, and I think we can move forward side, this is the necessary and always present safe harbor statement slide. It's also available on our website. It just, of course, advise as I may be making some statements here that you should take into consideration outside of our business and not make investing decisions off of. If we go to the next slide, this is the opening slide. But before I kind of address this slide, I really wanted to address what I think are the 3 attributes that really help define Lantheus as a growth company. I hope you'll see evidence of these attributes really throughout the presentation as I offer it. First and foremost is our revenue performance. And as you see on this slide, we have a 5-year trailing CAGR now of over 25% with our revenue. And we feel that really reflects the management team's intention and the execution of our strategic plan. That revenue comes with very purposeful attention to the markets that we serve and some of them we've served for a very long time and continue to be very successful in. But we believe we have what's in place now that will allow us to continue to drive sustainable revenue growth for the company going forward. Second is the choice of markets in which we compete. And we are unique in some aspects as a company in that we are largely focused in radiopharmaceuticals, which is within healthcare, I'd say, a niche market. But even within that, we choose very carefully what markets we want to compete in because it's our intent once we enter a market to be the category leader of radiopharmaceutical offerings in that market. And I think some of our work to date has also demonstrated that, and it's certainly an integral part of our strategic plan going forward. And finally, and third, I'll mention here is our investment strategy because it is a very purposeful one. We pride ourselves again on staying where our expertise will be most valuable to us and to whoever we partner with if, in fact, it's not an organic project that we're working on. But when we are considering whether we're talking about capital allocation within the company, funding of the organic projects or consideration of inorganic projects, we have a very thoughtful, prudent and purposeful approach to where we invest ensuring that we bring additional value beyond what the assets would have offered without our kind of, I'd say, interplay with them. So with that, I'll begin to go forward. This slide offers some additional highlights into the company. As you can see, from a trailing revenue perspective, our revenue, and I spoke, our CAGR continues to grow. But I think it's also important to note that we were founded as a company in 1956. And I say that because, again, in this space, there are a few companies that exist and even fewer companies that have any legacy or endurance in providing radiopharmaceuticals and other products into the health care stream. And Lantheus is recognized worldwide as one of those companies. If we flip to the next slide, I'll begin to talk about how we structure our company. And currently, we have our company structured around 3 verticals. The first is precision diagnostics. And those are our products and they are essentially at this time, diagnostic portfolio that focus from either, and this includes products that are both radiopharmaceutical in nature and non-radio pharmaceutical in nature but exists outside of what we would call the oncology space, we have a separate category for that. I am going to be offering highlights on 2 of our products today, and one of them falls within this category, and that is our product DEFINITY. The second category is our radiopharmaceutical oncology category, and this is one of truly exciting innovation and growth potential, and I will use our progress to date with our product PYLARIFY to demonstrate what our intent is within this category. And finally, we have a third vertical of our business, which we call strategic partnerships and other. And this is something we think is truly unique to Lantheus and will bring sustainable and significant value in the future. This is our focus on understanding and ongoing clinical development, what are the biomarkers and other molecules needed that can be used in conjunction with clinical trials already underway to demonstrate the clinical promise of those therapeutic products that are being assessed in their trials. It's a vertical that we initiated and built starting about 18 months ago and that we've been very successful in building out. And our intent here is to build out a broad portfolio of radiopharmaceutical-based biomarkers that will become the industry standard and the industry choice for inclusion in clinical trials, and I'll show you just how much that clinical trial work has really expanded over the last several years. If we move to the next slide. This is our kind of demonstration of Lantheus' position within a field that is also rapidly growing. And that field is radiopharmaceuticals. Someone described it this morning as being slightly sleepy until recently. And that is really an accurate description. Radiopharmaceuticals are really coming into their own as mainstream parts of life sciences and of care determination and care treatment. And the evidence of that is shown in the middle of this slide. If you look at the number of radiopharmaceutical therapies in development and you look more importantly, at the change in the pace of that -- of the use of radiopharmaceuticals and development versus -- and this is versus 2019. You can see that the isotopes that are currently used most specifically and most frequently in trials are up anywhere from 12% through 45% as in their representation in clinical trials just versus 2019. This is demonstration that radiopharmaceuticals are here to stay and that they will be mainstream within the caregiving -- the care determination and caregiving of important categories in life sciences. And I'm going to speak to 2 of those categories today. If we move to the next slide, I'm going to talk about near-term growth drivers for our company. And here, I'm really going to hone in on 2 of the products that we currently offer out to the medical community. And the first of those products is on the next slide, PYLARIFY. This is a product that we had approved at the end of May 2021, and this product is classified as a PSMA PET imaging agent. Now that's a lot of letters, and I'll explain what they need. PSMA is the product -- prostate-specific membrane antigen, and it is as a marker as an antigen highly specific to the presence of prostate cancer cells in the body. And when you can tag to it as an antigen on the acellular surface of a cancer cell, it's even more specific for prostate cancer, because PSMA does exist in other organs of the body. But the presence and if you can tag to it on the extracellular surface really becomes a highly specific marker for the presence of prostate cancer. In this case, we have an inert molecule that's conjugated to an isotope. In this, the isotope is F 18, and you inject this combination into the body, the inert molecule tags specifically to the PSMA antigen and the process of F 18 as an isotope and the submission of positrons allows for image capturing under PET imaging. This has been hailed as a true innovation in the recognition and treatment of prostate cancer. And it is analogized to the most recent innovation being the introduction of PSA blood sampling for the presence and monitoring of risk of prostate cancer. As I mentioned, we launched this product in -- approved in late May 2021, launched very soon after. And to date through Q3 because we have not yet announced Q4, we have already seen $410 million in cumulative sales. And more importantly, and as noted here on the slide, over 90,000 men have already been imaged with PYLARIFY. Our launch has been highly successful. We describe it as innovation meeting execution in that the prostate cancer treating community was really waiting for this innovation to be available. And because of the execution, we were able to perform with the launch of this, there has been rapid and broad uptake of the product. But it's not done at all yet in what the promises of this product and products like it out in the marketplace. And I'll show you that in the next 2 slides. The reason a product like this is so important is because, unfortunately, the patient population, it will serve, is very large. Prostate cancer is not only a disease of high incidents, it's a disease of high prevalence. And the most recent data, and this is data that we've just looked at again recently in the SEER database shows that approximately 280,000 men on an annual basis will receive a diagnosis of prostate cancer. And unfortunately, it still accounts for over 34,000 deaths each year. The patient population in their demographics are actually very specific. It's up -- it's 1 in 8 men who will receive a diagnosis, but the high majority of those men, over 60% are 65 years or older. And that's one of the -- if there is any kind of good news to talk about with prostate cancer, after diagnosis, a gentleman lives up to 15 to 20 years with this disease. And that's because now especially along with PYLARIFY, there are excellent tools to monitor the status of this patient across the journey of their disease. If we look at the next slide, I'll show you some of what we see as the data supporting the total addressable market for prostate cancer. We have just completed, again, this updated work. And for those of you who have followed us, you'll know that this is updated versus information that we've been sharing earlier this year. But we now value the total addressable market for PSMA PET imaging at $1.6 billion. And that's simply the math of taking what the approximate number of scans that will be performed annually every year and multiplying by price that I will not share with you regardless of whether you ask me directly or not. And we now estimate that PYLARIFY is eligible for scanning in up to 350,000 -- and I'm saying scans a year because there are certain patient populations who will receive more than 1 scan a year. So for that, I'll just have everyone follow me in my talk track noting that these are scans and not patients when I speak to this total addressable market. PYLARIFY is currently indicated with 2 indications. Those indications really do span the entire breadth of prostate cancer. But from a guidelines perspective, there are very specific guidelines that are offered for the diagnosis and treatment of prostate cancer. And within those guidelines, there are 2 key areas where our indications match where the guideline suggests that PSMA PET imaging should be done. The first is what's called initial staging. And this is men who first present with risk with diagnosis of prostate cancer and unfortunately, risk of metastasis of prostate cancer. And it truly is essential at that point in the patient's journey that the right diagnosis is made because these options of what to offer that patient are very different depending on whether you determine at the time whether the disease is localized to the prostate gland in its bed or where the disease has already had metastatic transfer, I'll say, or evidence of metastases in other parts of the body. PYLARIFY, at the cellular level, can identify that because you do a whole body scan. And what lights up on the body are only those cells that are specifically prostate cancer cells. So it's a key new diagnostic agent that can be used at that critical time in a gentleman's diagnosis. The second is the -- when unfortunately, as a gentleman progresses, his disease recurs. And this happens with high frequency in prostate cancer patients. At that time in its term biochemical recurrence, there is evidence usually through PSA, changes in the PSA levels that disease is once again present and is expanding or rising in the patient. And that's, again, a critical time point to determine where is this disease because where the disease lives and how broadly it kind of evidences itself will again be very determinative as to what treatment option is offered to the gentleman. And that really, when we talk about these 350,000 scans, we're really taking those 2 different parts of the patient process and numerising them. And we allow that for initial staging. It's probably appropriate to think that on an annual basis, each of those patients receives one scan. Further down the treatment process for the patient, it's typical and our research has demonstrated that it's more likely that up to 1.5 to 1.8 scans could be done on a patient every year to, again, follow that diagnosis and ensure -- follow the treatment plan to ensure that the patient is responding. And that is what both account for the TAM, the total addressable market, that we are now estimating at $1.6 billion annually for PSMA PET imaging, of which PYLARIFY is the leading agent of choice in that market. If we move forward, I'll speak to the other growth driver that we currently have at Lantheus, and this is a long-standing source of success for us, and that is our product DEFINITY. DEFINITY is an ultrasound contrast agent that is used in conjunction with echocardiography to make cardiology or cardiac diagnosis for patients. And specifically, we're talking about the left ventricle here, the main pumping chamber of the heart. DEFINITY is an agent that once -- while it's injected systemically, you're really looking with ultrasound -- with specific ultrasound at the left ventricle where hard to see whether that particular chamber is pumping efficiently and with even motion across the chamber wall. The outcome or the impact of injecting DEFINITY into a patient is essentially like putting a flashlight behind the heart. It takes what is somewhat of a dark kind of unspecified image and makes it very clear. And we call that diagnostic certainty, and that is the main clinical value that the use of DEFINITY adds to an echocardiography scan. Again, this is a product that we have had in our portfolio for over 20 years. It has essentially been the market leader with over 80% market share for the entire time that it's been in the market. And I like to say since it was its 22nd year of availability that we have -- this product DEFINITY has graduated cumma sum laude with diagnostic certainty in the echocardiography market. Our sales to date through 3Q '22 are $181 million, and this is another product that we offer in our portfolio that offers us back sustainable growth. We have seen sustainable growth with this product over the 20 years we've had in the market. And our investment and our intent is to have it to continue to support and to contribute to Lantheus as a whole. If we look at the next slide, I'll show you some of the incidents and prevalence data here. This is cardiac disease. So as we all know, I think this is a highly incidental and also highly prevalent disease in the United States medical market. Every 40 seconds on average, someone will have a myocardial infarction. Ultrasound of the heart or echocardiography is used second only to EKG studies in frequency as what is done to diagnose and understand cardiac disease in patients. It is essentially -- and EKG, I think, we all say is a wonderful screening tool. Echocardiography is a wonderful tool for the amount of data it can offer about a patient, again, hopefully ruling out disease, but when disease is present, showing you what are the decision point that you should be making for a patient in their treatment. If we move forward, I'll talk about this market and the TAM that we have here. We estimate that the current ultrasound-enhancing agent market within echocardiography is valued at over $600 million annually. Now you saw me note before that through 3Q of 2022, we have booked approximately $181 million in DEFINITY revenue. This TAM suggests that there continues to be strong upside for growth for use of ultrasound enhancing agents. And we would say specifically for DEFINITY as we remain the category leader in that market. And the way that we look at this TAM is we take the total value or the total number of echocardiography studies that are done annually, and that can be anywhere between 25 million and 32 million studies. And we look at what subset of them is likely to require the addition of an ultrasound-enhancing agent because the study unenhanced is not diagnostically certain and maybe what may require, if you do not add an ultrasound-enhancing agent, for the patient to undergo additional or retesting to get to a firm diagnosis on that patient. So we see here, again, a market that has served us well for a long time and one that we will continue to serve and we believe will continue to contribute to our -- not only our revenue but to our revenue growth in the years to come. If we go to the next slide, I'm going to speak to, again, some of the attributes about our current, I'll say, capital structure and about our executive management that we believe will continue to contribute to sustaining double-digit growth for our company. One of those certainly is our pipeline. And this is a pipeline slide. And I'll say for -- again, for those of you who do not know us, this pipeline slide looks very different than it did even a year ago. And I'm going to highlight some of the changes that we've driven to it that we think are very important. But notably on this slide, I'll call your attention to 3 items. The first, again, is PYLARIFY. PYLARIFY is important because it's not only already a commercialized product, but in its role as a biomarker, it is also continues to be used and introduced into clinical trials that are underway for prostate cancer. So it remains in our pipeline for that reason and also because of the life cycle management opportunities there are that can be considered for what other diseases demonstrate presence of PSMA and how you might use a PSMA imaging agent in the diagnosis path for those diseases. The other 2 notes that I'll make here are Flurpiridaz, which you see on the very last line of this slide. And that is our cardiology asset, which we out-licensed to GE Healthcare after we had completed our first Phase III trial. As part of the development that -- with that and our agreement with GE Healthcare, we retain not only the right to assist in the commercialization under certain conditions once the product is approved, but we will enjoy double-digit royalties from the sales of that product in the medical -- in the U.S. medical market and others. And the medical market for Flurpiridaz is the MPI or myocardial perfusion imaging market, another type of cardiac study that is frequently done. And in this case, about 6 million studies a year are done that are termed MPI studies which are again used in very early in the path of a cardiac patient who is trying to determine what their disease actually is, where it is and what can be done about it. So this is a very large market we know very well because we already serve it, and we have served it for over 30 years with our product Cardiolite, which remains the most successful radiopharmaceutical imaging agent ever launched in the U.S. medical market. The other note that I'll call your attention to here are the 2 assets that are noted under tumor micro environment. And this is really a demonstration of the progress that we've made in our Pharma Services vertical of our business. These are both assets that we have in-licensed with the rights to develop for use biomarkers and trials. And these collectively, these 2 assets address a pan approach to oncology and to the multitudinous number of diseases that exist in that category. As part of our work with these assets, we not only work to provide them for use in clinical trials that are underway. But for having done that, we get access to the data about these assets as they are used in the trial, which allows us then the privilege of deciding what the commercial path might be for these products and how we might support that path with data already being gathered from the trial that's being used in and what additional data might be needed to complete an NDA package for commercial approval for these products. But I'm going to now specifically move on to talk about 2 of the items on this chart. And those are the 2 items that we just recently announced collaboration with for in-licensing from POINT Biopharma. The first of those 2 candidates is referred to as PNT2002. And this is a radiopharmaceutical product that will compete as a radioligand therapeutic for the treatment of prostate cancer. And for those who are at all familiar with this category, this is a category that Novartis has recently launched a product called Pluvicto into. As is typical with oncology development, this product is being studied later stage for patients. So when you talk about lines of therapy, this would be later lines of therapy for patients who have, again, unfortunately, undergone biochemical recurrence, which indicates that they have disease present again in their body. The advent of radiopharmaceuticals and the renaissance I spoke to earlier, is no better demonstrated than in prostate cancer. With the inclusion of Pluvicto in treatment guidelines and available for use with physicians, you really have radiopharmaceuticals moving into the mainstream of large, almost primary care type areas of incidents and treatment. PNT2002 is being studied in a slightly different patient population than the product Pluvicto is already approved for in that this patient population is pre-chemo exposure they have already demonstrated evidence unfortunately, of disease recurrence, but they have not yet been exposed to chemotherapeutic agents. And as you can see on the bottom of this slide, we estimate that there are approximately 70,000 patients annually who will be eligible for this type of therapy once the product is approved and in the marketplace. As part of our collaboration agreement, POINT Biopharma will continue the development, the clinical development, they will complete out the registrational Phase III trial that is underway. And then we will -- of course, in conjunction with them through that process, we will then take forward all commercialization efforts for this product. For us, it really sends a statement we want about our commitment to and our intent to be invested in the prostate cancer therapeutic area. Our product PYLARIFY brought us into that market. PNT2002 as well as our own pipeline candidates, 1095, which is earlier in development, really cement our presence in that therapeutic category, which we believe is very responsive to the concept of using radioligand based therapies. On the next slide, I'll talk about the other asset that was part of the collaboration agreements that we finalized with POINT and announced recently. And this is PNT2003, and this is a radio ligand-based therapy that will be used to treat neuroendocrine tumors, certain types of neuroendocrine tumors. This is an area of high unmet need in the United States medical markets as unfortunately, these patients have fewer options available to them for first and second line treatment, and they also have, unfortunately, a history and a demonstration of recurrence. And this product is, again, a radioligand. In this case, it's Lutetium-177, that's been conjugated to a therapeutic molecule. So it allows, again, for the premise that I think is so important and so value offering about ready pharmaceuticals, and that is precision medicine. You are delivering medicine exactly to the sites where it's needed and localizing the impact and the effect of those medicines on the direct areas of needed treatment. And this is as true about PNT2003 as it is about PNT2002. We estimate that the number of patients in the U.S. medical market will be eligible for this type of treatment annually is approximately 18,000 as you see on the bottom of the slide. Our regulatory strategy, and we will lead the regulatory strategy for this asset, is to submit an ANDA approach based on a product that's already in the market. And one of the, I guess, items I'd like to add about that is to say in the radiopharmaceutical market, the market always bears more than 1 product because the manufacturing and the supply chain of these types of products is so unique that there is always need to have additional options available to ensure that there is product supply and consistency in the market. Now I'm going to kind of finish some of my remarks talking about our financial profile because our financial profile really drives our investment strategy. And we feel that over the last several years, we've made very good decisions about how to invest our assets, where to invest them and that has already returned solidly for the company. So I'd like to speak a little bit about that. We really think about ourselves as having a very disciplined approach to growth. And I'm not sure anyone else would stand up here and tell you anything different. But I think in the case of Lantheus, we've been able to demonstrate that with some of the actions we've taken in not only internally, but with external M&A that we've done over the last several years. We are intent on sustaining double-digit growth for the company. We are intent on diversifying our portfolio. And those 2 -- I would say those 2 are actions that we've already met quite handily over the last 2 years, but we're not done. And we -- as I mentioned earlier, we are intent on where we decide to compete that we be the category leader in the radiopharmaceutical parts of that market. For having conducted ourselves as a management team, the way that we have over the last several years, we have really created a very attractive financial profile, both through capital structure and just balance sheet perspective. Our revenue growth, and I'm going to show you in a minute, our revenue projections, our projections for certain financial variables out over the next 5 years, but our revenue growth, our margin expansion, our ability to generate free cash flow and what that then has afforded us from not only a flexible balance sheet, but for it to be attractive if we need to go into the capital markets, has really been built out over the last several years, and we think we have the possibility to improve that further. We do have the intent to continue to execute M&A where those opportunities meet our criteria. And our criteria very simply, our most simple criteria is we have to believe that we will do better with the assets than where the assets currently are. That was our investment strategy and thesis with our Progenics acquisition and that was our investment strategy and thesis with the collaboration that we formed with POINT, which I would say most simply, has us using our core strengths and then continuing to use their core strengths. Ours are late-stage portfolio and commercial execution, and theirs are unique skills for manufacturing and development of radio ligand-based products. So let's go forward and I'll show you what those projections are. These are the 5-year financial targets that we updated and released as of this morning. And again, for those of you who follow us, you'll note that they are different and updated since the last time that we offered these variables, which was at our Investor Day in May of this year. So we now project over the 5-year period going forward through 2027 that we will be able to achieve a 70% plus gross margin and that is up from a number that was cited at 65% at our earlier Investor Day in May. Our EBITDA margin remains same at 45% versus what we had offered previously. But the difference here is that our investment now, our investment needs will be larger because with the addition of the POINT assets into our product portfolio and the markets they will serve, we recognize that we will need to be able to invest in those markets to ensure that the products are optimized. And even with that need for investment, we are confident we can maintain an EBITDA margin percent of 45% plus. And finally, from a free cash flow generation perspective, when we first offered this outlook, it was at that time for the period '22 through '25, we had noted that we expected to generate about $900 million in free cash flow. Here we are now a few short months later, with the different outlook as our new outlook now is inclusive of '23 through '27 and we are estimating that we can generate in excess of $1.5 billion in free cash flow generation. That gives us lots of options to think about our business, invest in our business and continue to grow our business. If we move forward, I'm going to come back to a summary, and I'll challenge now here did -- where my -- was I consistent with offering the messages that I promised I would offer to you as I started this presentation. And that is that we are truly founded on 3 driving attributes that really drive the management team into what we do and really underpin our strategic plan. And that is revenue performance is key and that our shareholders expect to see continued double-digit growth in our revenue. And can we deliver that and earn back from them the value in our share price that we feel we deserve and the answer there is yes. The second is about our choice of markets to serve. We will remain very close and very purposeful about what markets we enter and how we enter them with what products and then how we compete there. It is absolutely our standard of care that once we're in a market, we built relationships with the caregivers and the influencers in that market. And I think we've achieved that both already with DEFINITY, and certainly, we're well on the way to that with PYLARIFY. And then finally is our investment strategy. I just showed you the free cash flow that we expect to generate over the next 5 years. We will put that cash to good work for our shareholders and for the employees and the patients ultimately that we serve. It's a fairly simple strategy, but we think it's one that's effective and that has worked for us and one that we can look forward to continuing to offer out into the market. If you go forward, those conclude my kind of formal remarks. What we'd like to do now is I'd like to bring up Paul Blanchfield, who is our Chief Operating Officer as well as Mark Kinarney, who heads up our investment strategy group and have them take any questions you may have from remarks today or that you came prepared with to ask us. And we have someone here to work around with a microphone and offer you a microphone if you can't be heard. So please.

Well, Mary Anne, there's couple of questions actually coming in online about TAM. I understand from your presentation that you updated your TAM figures versus their previous numbers. So first of all, maybe you could walk us through the difference what you changed? And then secondly, individual here would like to know, it looks like this TAM calculation calculates about 1.5 scans per patient. The question there is what do you have to say maybe to folks who think that number might be conservative and that the real number should be 2 or 3 scans per patient?

Fair question. And I will tell you the TAM question is the most common question that we've been receiving from our current and potential investors. I'm going to actually turn to Paul. Paul completed the work with his team that drove our update to the TAM, which I would like to say is data driven and fact verified. Not only did we use what were updated statistics from the SEER database to look at incidents and prevalence, but we then performed market research -- primary market research that was powered to be statistically to correlate those data too, but Paul can give the details on that.

Thanks, Mary Anne. Yes, so as was referenced previously to this meeting, our last update of the total addressable market for PYLARIFY was about $1.1 billion or $250,000, as you can see on the slide and as Mary Anne presented. We now estimate that potential for 2023 to be about 350,000 or $1.6 billion. The 2 key drivers, and I'll dig into them, is one, an increasing overall incidence and prevalence that we've seen since we first based our estimates upon launch of PYLARIFY in early 2021. And that's driven by an overall increase in the survival rate as well as in the diagnosis rate. The second big driver, as was alluded to, is the frequency of scans. And so I'll dive into both of those. For the initial staging piece, we now estimate 125,000 scans per year, consisting of 125,000 patients or 1 scan per patient. That's up from 90,000 articulated in 2022. The second piece would be in the suspected recurrence. And this is an update both on the number of patients that are included to 110,000 as well as the frequency of scanning. Per the question that was alluded, we conducted significant market research, and while we are early on in the adoption of PYLARIFY only 18 months since launch, we do see differences across patient type as well as physicians for the frequency they like to scan. In some cases, physicians will plan to scan on time per patient, others 2, others 3, and in some cases, even 4 or more. And so it's certainly possible that there will be physician types and patient types that we'll want to do significantly more. But when we look at a statistically significant mean where we are in the adoption curve of PSMA PET, we think that's about 1.8, which leads us to the 195,000. The third piece in which remains unchanged is the PSMA-targeted radioligand therapy. This is for patient selection as well as monitoring. This also remains unchanged and is strictly in the post-chemo or third-line setting, reflecting currently indications and guidelines. So overall, significant growth already from medical practice as well as incidence and prevalence, we would expect 2% to 3% annual growth from those drivers as well and the opportunity for considerable growth as medical practice evolve both in the number of scans as well as new indications and guideline changes.