Sorry. Okay, we're ready? All right. Good afternoon, everyone. Thank you for joining us. My name is Tara Bancroft. I'm one of the senior biotech analysts at TD Cowen. And thank you so much for joining us for TD Cowen's 45th Annual Healthcare Conference. So for the next session, we have Lantheus. And here from Lantheus, we have the CEO, Brian Markison, to give a presentation for us. So Brian, whenever you're ready, you can take it away.
Okay, thank you. And good afternoon, everybody. And also with me today is Bob Marshall, our CFO, in the audience, and Mark Kinarney, head of Investor Relations. And thank you, everyone, for joining us. And I'm happy to be here. And hopefully, we'll have some time for questions. Please note the Safe Harbor. And for those of you that don't know us that well, Lantheus is a leading radiopharmaceutical-focused company. And the reason we get up every morning is our slogan, if you will, our motto, raison d'être: find, fight, and follow disease for better patient outcomes. And that's what we're all about. That's why we get out of bed in the morning. As we mentioned in our 2024 recap of the year and our guidance two weeks ago or last week, we talked about setting the stage for double-digit growth.
In 2025 and beyond, what we're looking at is a number of key catalysts. Most notably, we hope to close on Life Molecular Imaging on the right. We also hope to close on Evergreen Theranostics on the right as well. With them will come a number of very interesting assets. I think in the near term, we're looking at a number of launches. First, we're looking to file and then launch MK-6240, NAV-4694, Octave, which would come from Evergreen, and PNT2003 that has come from our POINT/Lilly collaboration. I'll get into the rest of the pipeline as we progress through the presentation. We've had extraordinarily strong financial performance, as depicted on the slide. We also gave guidance last week. What I'd like to highlight sort of in the middle right of the slide as you're looking at it is our ability to produce cash.
Our cash guidance for this coming year is between $550 million-$600 million. And I think that's a very strong testimony to the strength and underlying foundation of this business. And it gives us the tools and the leverage to do a lot more, everything from returning value to shareholders to actually continuing on our business development and M&A adventure. And I'd also like to note, as of Friday last week, we did cross $1 billion in cash. So yeah, I love it. Anyway, moving on. So Lantheus has been around for quite some time with a very steeped history in radiopharmaceuticals. And we can take our history all the way back to 1956 with the formation of New England Nuclear.
I'm not going to drag everyone through this slide, but I'll take you through some of the more recent events that have really helped define who and what Lantheus is. So in 2020, we announced the acquisition of Progenics. And then that led to the approval of Pylarify in 2021 and this company's great march in developing that financial profile that you saw earlier and our ability to spin off as much cash as we do at this stage. In 2022, we entered into the collaboration with POINT, which was not yet Lilly. And then in 2023, we acquired MK-6240 from Cerveau. And then Pylarify was approved in Europe under Pylclari. And we partnered that with Curium, where we get royalties that we disclose every quarter. And then 2024 became a pretty busy year. And we're going to talk a lot about what's going on in 2024.
We developed our partnership with RAD, where we picked up LLRC15 and Trop-2. We acquired NAV from Meilleur, which is also related to Cerveau, same group, different name. They're very good at that. And we saw an expansion of our profile and programs. And then very recently, in 2025, I think everyone saw that we announced Life Molecular Imaging and Evergreen. And now we're waiting for customary regulatory clearances so we can close and begin the integration of these two companies, which offer enormous strengths. So we're going to start with a little bit on the commercial portfolio, and then we're going to head into the pipeline. And Pylarify clearly leads the way. And I think what we're seeing here is 2024, over $1 billion, a true radio diagnostic blockbuster. And it is the first of its kind.
I think a lot of credit here goes to our commercial team, our manufacturing team, for being able to swiftly bring up a very large commercial network. What does Pylarify really do that makes it so special, if you're not that close to this? Excuse me. What Pylarify has enabled is a change in patient management from conventional imaging. If you look at the slide here, conventional imaging versus the new imaging capability with Pylarify, we are detecting lesions where they were not detectable before. We are changing, or at least giving physicians the tools to change management and prolong life. This is extraordinarily important. It would seem obvious on the surface, but this has led to a sea change in the diagnostic landscape and the management of prostate cancer. It is just very exciting.
Now, Pylarify is actually an F-18 agent produced on a cyclotron. And for those of you that aren't familiar with it, the F-18 is sent into a tracer's box where it's formulated with Pylarify, which comes in a kit. And it's a very complicated kit. It's quite fascinating, actually. And then patient-ready doses are withdrawn and put into what you can see on the third box here, a little lead-lined, what they call a pig. And that's delivered in patient-ready doses to wherever it is that they're going to use the product for scanning. Our network that we have built with our PMF partners is the most extensive in the industry. We right now are sitting at 62 PMF locations. And we are where most of the prostate cancer is, if you will. If you notice, we just don't happen to have one in Montana. It may not arrive soon.
But we're certainly happy to fly doses there if we need to. So tremendous network, strong partnerships with PharmaLogic, SOFIE in particular, PETNET, and others. But really, SOFIE, PharmaLogic, and PETNET are the foundation here, with SOFIE being one of our leaders. And we're very happy to have them as partners. And it's a very strong relationship. So as we look to the future with PYLARIFY, obviously, there's a lot of conversation around the TAM and how big can it be. And what we're looking at in 2025 is an estimate of roughly 525,000 scans growing to 750,000 plus. I think it may be understated, if anything. I think the strongest growth trajectory is coming from radioligand therapy, as we anticipate radioligand therapy moving earlier into the treatment dynamic post one hormonal therapy, pre-chemotherapy.
I think there's very strong evidence to suggest that that's going to be the ultimate role here, along with other situations. I think at the very top of the bar, you have newly initial staging and newly diagnosed. I think here we're going to see a lot more uptake and use of Pylarify. One of the reasons I have a lot of confidence that I say that is for one fact, we have the MIRA study up and running, where we're looking at the ability to detect lesions in favorable intermediate risk prostate cancer. This is essentially it's presumed that prostate cancer is confined to the prostate bed. Then we're using Pylarify to basically ensure that it is or is not. We know we're going to find lesions outside of the prostate bed.
PSA is a great tool for detecting and helping to monitor and follow prostate cancer, but it may not be the most sensitive tool out there, and in a recent poster that was presented to ASCO GU, we described data where patients with no PSA change or zero or 0 to 0.2 nanograms per mL had an abundance, unfortunately, of lesions that showed up on a Pylarify scan, so I think what we're doing here, if you go back to that TAM, is we are going to rewrite how prostate cancer is initially diagnosed, and I believe Pylarify will ultimately be used much earlier and more repetitively as patients follow up and they go through the journey and they hopefully live longer. Now, a couple of seconds on DEFINITY has been a rock steady agent for us, quite nice growth last year.
But I think that growth is governed by the fact that one of our competitors was out of the market for a little while. So, in our guidance, we've anticipated them being back in the market. They have returned. And we would assume that they'll take the share that they had prior to going out of the market. With our very, very high share, it doesn't really make sense for us to go from 80%-85% at the cost of disturbing the market. So I think it's very rational. And what does DEFINITY actually do? It's a microbubble technology that enhances suboptimal echocardiograms. And on the left of the screen, you're seeing a suboptimal non-enhanced echo. And on the right side, you see the image with DEFINITY. And it's very clear that you can see the definition of the heart valve.
When it's a dynamic image and it's moving, it's actually quite exciting to see. There's an interesting TAM. This TAM is really defined by the current available contrast agents. It is not the total echo market, which is huge. Each year, there's more and more contrast-enhanced scans happening in the ultrasound contrast market. That is increasing at a fairly slow rate. This is a reasonably stable marketplace with more room to grow. We grow each year, roughly, historically, mid-single digits. I'm going to switch a little bit here to the pipeline and share what we view as a very exciting tapestry under development. We have here listed the Lantheus pipeline in green, the potential Evergreen pipeline in blue, and the potential Life Molecular Imaging pipeline in orange. I say potential because we haven't closed yet.
So I can't really spend too much time talking about it. But eventually, you'd like to see this entire slide turn green. And that's because it's my favorite color. So I'm going to highlight some of the assets that are here as a test to see if everybody's awake. But most of you are. So that's good news. Thank you. So we're going to delve into a little bit of the Lantheus pipeline assets. And starting with PNT2003, this came along with that agreement with Point that I mentioned much earlier. Now Point is owned by Lilly. And this is a radio equivalent to Lutathera.
And I think when we look at 2003, we look at not spending a tremendous amount of time and energy to encroach in the market and take share, but also a great opportunity for the Evergreen asset, Octave, to be a theranostic pair with this asset 2003. And Octave is not limited to 2003, but can be used across the spectrum for Alpha NETs and also any alphanet competing therapy that will get approved that could compete with Lutathera. But meanwhile, I think this is very graceful and sort of low glide path for us to enter the market and compete on our excellent service, which we are by far the leader. So I'm going to switch gears a little bit to Alzheimer's.
I think when you look at our emerging pipeline in Alzheimer's dementia, the best analogy I can give you is we're placing a bet and we're skating to where the puck is going to be. So that's a famous Wayne Gretzky line. That's exactly what we're doing here. And as I'm standing at the podium now, we know that beta amyloid imaging is growing in leaps and bounds in response to the available therapies that have come of age. Finally, you have two therapeutics that are actually making a meaningful difference in early AD. All the associations, all the surveys, all the experts deem it reasonable that both a beta amyloid and a TAU scan should be done for confirmation of Alzheimer's dementia. So I'm going to spend some time here on MK-6240, which we're very excited about.
This is our experimental TAU agent that we hope to file this year and hope to launch next year. The bottom line with MK-6240 and with our other agent, NAV, is chemistry. We have a second-generation TAU agent, which has less off-target binding, is more specific, and can determine disease much earlier than all the available TAU agents, whether they're in the market like Lilly's Tauvid or in development. I'll show you some data in a little bit that will basically support what I'm saying. I think the world recognizes that MK-6240 is an exquisite molecule because we are in 103 academic trials. We are in 15 partnered major pharma studies. We are there on the sidelines hoping to facilitate and help pharma get to another TAU therapeutic that will make it to the market. We'll be there waiting for it.
And that's where the puck's going to be. There's certainly enough programs in development right now that you have to believe one of them will make it to the finish line. So Dr. Tharick Pascoal at the University of Pittsburgh was kind enough to let me use this slide and the next slide. And these are direct publications taken from his January presentation at the Amyloid Meeting in Puerto Rico. And what he's embarked on is an NIH-funded trial that is comparing all of the available tracers in Alzheimer's disease. Now, his goal is a little different at times because he's looking for harmonization to develop standards for interpretation. And what we're after, quite frankly, is differentiating our asset, proving that MK is the best. And through the effort of Dr. Pascoal and this funded study, what we're finding is he's actually making our case.
Certainly, MK, compared to the other tracers, and these slides are available, so you can all look them up online later, it certainly has the least amount of off-target binding. It is the most specific. And it does pick up disease much earlier than the other TAU tracers, including the blood test p-Tau. And I'll show you a slide on that in a second. I think what's very interesting with TAU, unlike beta-amyloid, not only does it aid in diagnosis and staging, but also longitudinal management. And TAU depositions are very closely related to the parts of the brain that affect memory, speech, vision, etc.
You can see clear areas of tau encroachment into the brain and have a very strong line of sight, if you will, as to what part of the brain function is going to be compromised with the encroachment of these tau tangles or neurofibrillary fibers. It's a very exciting time. It's evolving. And then here on the slide, I know it's not great to read from the back of the room, but you can look it up later. On the left side of the slide, as you're looking at it, is the exquisite sensitivity of MK-6240 relative to the other tau tracers and also relative to the p-Tau, the blood test. Now, I would never suggest that a molecular imaging scan should replace a blood test, which is quite simple, although I would love it commercially.
But I think it gives you a sense that for those patients that you can affect with treatment are much earlier in the disease progression cycle. And the earlier you can detect it with the more sensitive agent, that's the agent you're going to use. And I think that's really the same story for NAV. NAV is also a second-generation agent, beta-amyloid in development. We would hope to file that next year. And we're, again, very enthused by what we're seeing with this agent because NAV has the ability to distinguish itself from the other beta-amyloid tracers by its ability to pick up very low Centiloid counts in early AD. So again, very strong binding, very little off-target, highly specific, and another strong dynamic range. So quite frankly, it's a natural second-generation agent. And again, out of Pittsburgh, Dr.
Pascoal, again, if I could just draw your attention to table one, the reference standard with him is Carbon-11, which is not really all that useful, but it is the reference standard here when looking at beta-amyloid. If you look at NAV, which is right there next to Carbon-11, our ability with NAV to detect earlier disease is really quite substantial. That's the whole ball game with the recent beta-amyloid therapies is how early can you detect it. Because many patients have beta-amyloid, but not all of them have AD, right? Then the presence of tau definitely confirms AD. We need to be able to detect it early and then determine through a whole host of other factors the stage and then whether or not to bring in an agent for therapy. It's very exciting, but still early.
Now I'm going to switch gears a little bit to our therapeutic pipeline. And earlier in 2024, we licensed and acquired RM2 from Life Molecular Imaging, which targets the GRPR receptor. GRPR is very interesting, and we're not alone in working on it, but we think we could be best in class. The expression profile is summarized in the middle, where there's a number of tumor types where it does express quite strongly. But I think right now we're focused on prostate cancer. And what's very interesting with prostate cancer is in early prostate cancer, GRPR expresses just as much as PSMA. So that's a very interesting finding, and we're very excited about that. And then as treatment would progress and a patient progresses with prostate cancer, as PSMA decreases or declines, GRPR begins to overexpress. And if GRPR is suppressed, then PSMA overexpresses.
You could see at the end of the road where Pluvicto is currently being used. You have patients that are high expressors for PSMA, and they're the ones that do the best in that setting post-chemotherapy, right? There are also 20% plus or minus patients who do not express at all for PSMA. Again, that's a population that's purpose-fit for this particular product. I think we're going to work it up. Our gallium imaging agent for RM2 is in the clinic already. We've got plenty of data on that. The therapeutic, we're writing the R&D IND as we speak. We want to get into the clinic as soon as possible. We're partnered with Dr. Andrei Iagaru, who's one of the founders in this population.
And just like with Pylarify, what we're seeing here with gallium RM2 is on the A side of the scale here with the patient has basically no visible mets with conventional imaging, RM2, high GRPR expression, and you get patients or patient B and C, and right away you could see tumors where there was none before. So we've got some work to do. I think the others that are working in the field, such as Novartis and Clarity, and I believe Orano Med, are all chipping away at it a little bit differently. And we think we have perhaps the best in class from our tumor to healthy organ toxicity ratios. So again, very interesting compound and a lot more to follow on this. The next one up, which perhaps is really close to my heart here, is LLRC15.
You can see the antibody construct conjugated to lutetium, a very strong expression profile, again. But anyone in radioligand therapy is going to show you expression profiles like this for the targets they're working on. I think if you look at healthy to malignant tissue on the bottom right of the slide, you can see that malignant tissue way overexpresses compared to healthy tissue. Our first target for LLRC15 is osteosarcoma. We've already met with the FDA on a pre-IND meeting. It was quite successful. We hope to be in the clinic at the end of this year or early next year. We think we can make a real difference here for patients with osteosarcoma who are unfortunately being treated with chemotherapy that was approved and marketed possibly 20- 30 years ago. So it's a very difficult disease.
We've picked a really tough target, but we want to make a difference. And clearly, if there's a sign of life here, then all the accelerated pathways become open to us. But our primary mission is to get in the clinic at a reasonable dose, get into phase one, and try to make a difference. And by the way, the diagnostic or theranostic pair for this agent will be our FAPI agent. And FAPI is the last of the pipeline that I'm going to talk about today. And this is a very interesting potential pan-tumor target. But what's got me even more interested, as you're looking at the slide on the bottom left, is the potential in lung fibrosis, cardiac fibrosis, MASH or NASH. There's no end to potential applications here.
I think the challenge that we have as a company is to figure out the right path forward, the right non-cancerous indications. And that could be a whole different market. But meanwhile, we're focused on sarcoma. We're in phase one as we speak. And we're partnered as well with Ratio in their phase one therapeutic trial. So we know that FAP expresses or overexpresses in sarcoma. It's a really safe target for the agent. And we anticipate getting an approval, but we'll be putting out timelines that are more specific in the future. So we're beginning to wrap this up. If you look at 2025, we have a number of key milestones and drivers that we're going to be updating you all on, whether it's in prostate cancer, Alpha NETs, or other solid tumors, particularly with LLRC15, or a growing neuro portfolio in Alzheimer's dementia.
We are very anxious to close on Evergreen Theranostics and also close on Life Molecular Imaging because I really didn't spend a lot of time on it, but Neuraceq will be an amazing addition to our company and really launch our commercial platform in Alzheimer's dementia. They come with Life Molecular Imaging with a homegrown commercial expertise that's already there. We have a lot that we can bring to the table to help them expand their growth. Our future is being fueled by our pipeline. Again, we intend to remain a robust industry leader. We're diversifying our pipeline and our portfolio as we speak. We have a bit of concentration risk in Pylarify and DEFINITY. We are clearly moving well past that.
We hope to become a much more exciting story than we have been, but it's really hard to beat our success in recent history, so we've sharpened our strategic focus, and we're just moving on to the next wave of innovation, so with that, I want to thank everybody, and we have four minutes and 19 seconds for questions. How'd I do on the over/under?
Well, I was being direct now, so if there are questions in the audience, we're happy to take them. Otherwise, I'm going to ask questions on Pylarify.
Okay. Let me get that there.
I think what would be really helpful to hear is what gives you confidence in the guidance that you provided? Because I think it was very well received by the market because it was more hopeful than I think the worst-case investors were thinking. And so just a little bit more on what gives you confidence in that and what you think the probability is that you could potentially beat it this year.
Would love to beat it, but I have a high degree of confidence. I think we have, when you look at our commercial team, we've got our best boots on the ground. And we also have, I think, the best agent as well. So we command a price premium that is living through in the marketplace right now. And we are also seeing real evidence that as we advance the science, we will be growing this TAM, and it's going to be moving into earlier lines of therapy. And I think that's very interesting. So as a leader, we plan to maintain our revenue share.
We're going to rely on our very strong commercial footprint, which I think is by far the best out there. And we're going to continue to put our head down and invest in growing the business.
Okay. And another point that I think is important to emphasize is that you've mentioned that you expect prices to normalize again in 2026. So I guess what goes into that process of different institutions restating ASP prices and just the whole process? And again, what gives you confidence in normalized pricing again in 2026?
Well, I think we're going to see it at actually the second half of this calendar year. And what gives me confidence is the turn of the calendar year led to the full effect of our strategic contracts coming into effect.
And as we've noted in a previous earnings call, the vast majority of our customers are under our contracts. So I think there's been a little bit of scurrying or border incursion, if you will, at the very beginning of the year with the transition to MAC reimbursement from ASP, but that's a small percentage of our business. And I think that things will begin to stabilize as we come out of the second quarter and the full effect of our contracts begins to level off in the marketplace.
Okay. And based on that contracting, then is that what protects Pylarify's market share from new market entrants or existing products that are already on the market? I guess what I'm getting at is a little bit more color on how you're thinking about competition coming in from existing and new products.
Yeah. We have to think heavily about competition because when we launched, we had 100% market share. Obviously, you've got to give something up, and we think about it. We war-game it all the time. I'm just holding on to the fact that we have the best agent. We have the best images, whether you compare it to another F-18 or to Gallium, especially when you look at Gallium. Our signal is much stronger. It's pretty well proven that F-18 images are superior. The way I look at it, it's the whole package. It's our service network. It's our commercial team. It's our science team, and they give me a lot of confidence. I think the other thing that we're going to see is that Pylarify is going to be viewed as more sensitive than PSA.
Clinicians are going to turn to it earlier in the paradigm, even than our MIRA study in initial staging across the board. It's going to take time. I think as radioligand therapy moves ahead, I think the profile of Pylarify and its quick clearance through the kidney is going to be excellent for measuring SUV or uptake values and determining the effectiveness of therapy based on SUV values. I think we have a very strong position, and I look forward to the competition.
Okay. Great. I think that's time for us. Brian, thank you for that great presentation. Thanks to the whole Lantheus team for being here. Thank you for listening.
Thank you.