Great. All right. For the next fireside, welcome to everyone who's joining us on the webcast and everyone in the room. We now have Lantheus, and we are privileged to have the CEO of Lantheus, Brian Markison, and CFO, Bob Marshall. Thanks for both of you joining. This format is going to be a little heavier on the presentation side, as I believe Lantheus is in their quiet period now. Brian, I'll let you take it away and maybe a brief introduction, and you can jump into your slides.
Yeah, terrific. Good morning. I'm Brian Markison, the CEO, and to my left is Bob Marshall, the CFO. We're happy to see all of you this morning and pleased to be here today at the Truist Conference. I'm going to dive right in. We have a lot to cover. Please note the safe harbor statement. For those of you who are not that familiar with us, Lantheus is a leading radiopharmaceutical-focused company, and we are committed to find, fight, and follow disease to deliver better patient outcomes. I think, you know, as you look at Lantheus today, we're building on our foundation, PYLARIFY, which I'll cover in a few moments, a true blockbuster in molecular imaging, DEFINITY, a very stable growth asset for the company over many years. I'll spend some time on that as well.
As we look toward the very near future, we're positioned for success not only in the PSMA market, but also in the neuroendocrine tumor market, in our OCTEVY diagnostic that we recently acquired with Evergreen. We have a fairly heavy commitment in Alzheimer's dementia, and I'll spend some time on that as well. We have a therapeutic that we hope to launch around the middle of next year that I'll cover as well as a radio equivalent to Novartis's LUTATHERA. You can note our cash balance at the end of the first quarter. This is prior to the acquisition of Evergreen. In the second quarter disclosure, hopefully we will have Life Molecular Imaging closed, as well as Evergreen, and be able to give you a full profile of what the new entity with all of its combined acquisitions looks like.
We will also not spend time in today's presentation on our recent divestiture announcement for our SPECT business, but we'll also shed more color on that in our upcoming second quarter disclosure. Looking at our market-leading portfolio, starting, of course, with PYLARIFY, a true blockbuster agent achieving $1.058 billion in sales last year. First quarter sales were exceptionally strong. I think, you know, what we've done is built a market. We were the first PSMA imaging agent to be commercially available, and we think we have, and we believe we have the best agent. We've got a very strong manufacturing network with a number of partners: SOFIE, PharmaLogic, PETNET, and Jubilant. We clearly cover most of the country, but especially the high-concentrated population areas, as you could see from our heat map of our PMF locations.
The TAM here has been a topic of late and could be understated if one takes into account recent news from other folks in the field. However, I think what we can take away from the TAM is it's definitively growing. We are recommending perhaps 15%-20% per year. This year, we're looking more at the lower end of that, so 15%-17% to make Rich happy. I think the largest growth area of the TAM that we're seeing right now is in the advancement of radioligand therapy into earlier lines of prostate cancer therapy. I think Novartis has done an excellent job in expanding the label for PLUVICTO. If we turn to DEFINITY, again, first quarter sales of nearly $80 million, modest growth rate coming out of a year of incredible growth due to short supply from our competition.
I think we lose sight of DEFINITY because it's been in our portfolio for some time, but it's a fantastic diagnostic imaging agent, really used to opacify the left ventricular chamber or improve delineation of left ventricular border. I think you could see the highlighted image on the screen, and DEFINITY really does shed light on suboptimal echocardiograms. Back one. There we go. This is the TAM for DEFINITY. We believe right now that we're about halfway through the TAM at around $350 million annually, heading toward $600 million in the U.S. by the end of the decade. This is with a return to, you know, steady low to mid single-digit growth, probably possibly higher single-digit growth next year. We also enjoy an exceptional position in the market built on a track record of efficacy, safety, and outstanding manufacturing and delivery.
From there, we're going to bridge to the pipeline. Everything in green is currently under the ownership of Lantheus, which includes the Evergreen acquisition. The orange, or the diagnostic assets under LMI, are going to become green, particularly after we close the transaction. We're waiting for a relatively minor South African sign-off, and we should be good to go to close on that acquisition. I think it's a matter of when, not a matter of if, and we do anticipate it in the near future. The first up on the pipeline conversation this morning is, if I can get there we go, a focus on Alzheimer's disease, dementia. I think, look, if you take away nothing else from this particular slide, it's that this is a growing global crisis.
If you look at our aging population and you look around the world, especially even in China, where the demographics are a little more severe, we will have a huge portion of our population over the age of 65. I can't think of a family that I'm familiar with and friendly with that has not dealt with this in some shape, size, or form with another family member. It's a terrible disease. This is the TAM as it is today, roughly $1.5 billion for the imaging market, molecular imaging market, by the end of the decade. We do expect this TAM to significantly change to the good, if it's not good enough anyway, when other therapeutic agents make it to the market.
I won't spend time on the therapy side of this, but there are over 100 beta-amyloid and tau agents, therapeutic agents, in development today around the globe, and many of them are advancing into later stages of phase III clinical trials. MK6240 is a tau agent. It is a second-generation agent that is more specific than the first generation, which in this case would be Tauvid. You can look at the images. I don't have the time to get into it in this particular presentation. What we're looking at is MK6240 has the unique ability to detect neurofibrillary fibers much earlier and more clearly than other available and also in development tau agents, and also has significantly less off-target binding. What does that really mean? I'll get into that in one second.
I think people need to understand the difference between a beta-amyloid imaging agent and a tau agent. I'm bringing up a cross-section of the brain here. If you look at the left side of the slide, where we have the blue, green, and red box and the particular areas of the brain that are associated with it, tau has the unique ability to give you geography in the brain for where exactly the tau deposition is. Tau deposition and its location in the brain is directly correlated to how the brain reacts to Alzheimer's dementia and its progression. The other thing of note is that in the recent therapeutic clinical trials, if you really peel apart the data, patients with advanced tau deposition clearly are not great candidates for anti-amyloid therapy. What does all this really mean?
We're in approximately 109 academic studies across 39 academic institutions in the world with MK6240 and with 15 pharmaceutical partnerships where they're using our MK6240 to help with their therapeutic. That number on the 15 is certainly growing as more people come to us and want to use this agent. This slide is data from Dr. Tharick Pascoal at Pittsburgh. He's conducting the head study, which is NIH-sponsored. We're not sponsoring the study. We are making MK6240 available. Here he's looking at a comparison to the other tau agents that are either in development or the one agent familiarly on the market. What we're basically showing is greater sensitivity and a greater dynamic range. The whole game is going to be in the future for treating these patients earlier with as little disease as you could possibly detect.
Having the most sensitive agent and one that you can use to track longitudinal progression and link to symptoms, I think, and I think many of the KOLs we work with would agree, is critical to the future of understanding this disease better, monitoring therapy, and tracking patients longitudinally. Now, not necessarily what I would call a companion product, but certainly a great fit for us strategically is NAV, which is a second-generation beta-amyloid product. I think I'll move rather quickly here. What I want to do is bring your attention to the table one, the first green box. This is a Centiloid conversion chart. Essentially, what we're showing here is NAV, when compared to the other commercially available beta-amyloid treatments, has the single best conversion to Centiloid count, and it's on par with carbon-11, which is really the gold standard in this setting.
From the ability to manufacture at scale, it just simply isn't feasible. I think if you look at gray matter to white matter signal ratios and dynamic range on the bottom charts, you can certainly see that NAV outperforms the other agents. Again, this is from Dr. Tharick Pascoal as well from the head study where he's looking at all of these tracers. I think when you look at grayscale on the bottom row and you look at the nice colorful images that NAV can produce, you know, for the extreme positive patients five and six, you know, you don't really need a whole lot of guesswork here. Also for patient number one, you know, when you look at it on grayscale, you can truly see that's a negative.
When you get to the middle, you know, sometimes grayscale will be negative, but with NAV, there's an excellent gray matter to white matter ratio. Clearly, the sensitivity of this agent will be enormously helpful in the treatment and monitoring of Alzheimer's disease and also the diagnosis. Here's a comparison chart. Essentially, at the end of the day, what you're getting with NAV is better, clearer images and the ability to detect a much lower Centiloid count, so earlier disease than the other available beta-amyloid agents, including one we hope to acquire in the very near future. Again, here's a little bit on blood biomarkers. I don't have the time to really dive into it in this particular presentation, but our view of a blood-based biomarker is it's certainly an enabler and will certainly build our TAM.
We would love to have a low-cost ubiquitous test that primary care could administer that would then say, "Okay, look, let's get you to a neurologist." This is not dissimilar to PSMA tests given on an annual exam and seeing, unfortunately, a rise in PSA over baseline, whatever that baseline was for that patient, and then referring that patient to a urologist. That is not dissimilar here. Let the neurologist determine what would be the appropriate next step. Certainly, if there is a strong suspicion of AD, then a beta-amyloid scan at a minimum today would certainly be required. We believe, punchline, that ubiquitous blood-based biomarkers will help build the TAM and build the TAM for imaging in particular and not have the opposite effect. Sliding over to a catalyst that we hope to launch in the middle of next year, OCTEVY, LNTH- 2501.
We love to give these assets numbers. What we're looking at here is neuroendocrine tumors and not just limited to radioligand therapy. We have a TAM that we're calculating today is roughly 50,000 scans, growing roughly by 5% a year to the end of the decade to 60,000 scans at approximately $300 million. We believe we can certainly take a fair slice of this TAM with our agent, our diagnostic portfolio, our breadth, our scale, our great sales team in the field, our nuclear medicine team in the field, and our medical science team as well. OCTEVY is a differentiated agent and should perform extremely well in the market and is a perfect tuck-in acquisition for this company.
We will not need to spend huge amounts of resources to launch this asset into what I would consider a well-worn glove, if you will, and make a difference in the marketplace. Now, the companion therapeutic, as opposed to companion diagnostic, 2003, is on track to be finished with review by the agency, certainly before the Hatch-Waxman expiration. We hope that the litigation with Novartis will conclude at about the same time. We would plan to launch this asset after the middle of next year, probably in the early 3rd quarter, but certainly not in the first half of the year due to the timing and Hatch-Waxman time clock. Again, there is a very interesting TAM here. As it grows right now, the market's ludicrous.
I think as many of you who know the space, there's a lot of energy here, a lot of different companies, certainly ITM, fairly advanced with an excellent program, RayzeBio with Bristol Myers Squibb, Perspective, our partner in many respects, has an excellent program with lead-based therapy. This TAM will grow as it advances further into first-line therapy, but also as new indications become clear for this broad range of small, interesting tumors that unfortunately are very difficult to cure. The next up in our pipeline, a little further out, is our GRPR peptide receptor, or what we call RM2, another nice Lantheus number here. The diagnostic will be a gallium product and the therapeutic will be lutetium-based. Here you could see the expression profile for GRPR, and it does meaningfully express in prostate cancer, particularly in early prostate and hormone-sensitive disease.
While the world is evolving around PSMA, there's very good reason to look at other receptors like STEAP2, HK2, etc., and certainly GRPR. We have our diagnostic agent is in phase II right now. In the beginning of next year, we plan to be in the clinic with our therapeutic. We're now negotiating an IND with the FDA, and that seems to be on track. A little bit more about the expression profile that I just mentioned. If you look to the left in the blue and green, you could see PSMA expression. On the far left, as you're looking at the slide, you could see the immense overexpression in prostate cancer for PSMA and relatively sort of modest expression in normal tissue, which makes PSMA diagnostics and therapeutics an excellent candidate for therapy and diagnostics.
Now, if you look at GRPR in the orange and red, you could see the overexpression in orange. The first big orange bars happens to be prostate cancer. You can look at it in a variety of other tumors. There is broader expression here than PSMA. Novartis has a program looking more at breast cancer than prostate. Lilly is entering the fray with a similar asset. We believe that our particular construct has an excellent safety profile and will be able to deliver more radiation to the target with significantly less normal tissue toxicity. This needs to be borne out in the clinic. Here, we are looking at the diagnostic for RM2. This is from Dr. Agaru out on the West Coast. It is a sort of comparison in the same patient compared to PYLARIFY.
We will never say that PYLARIFY is perfect, but we will say it's an outstanding and best-in-class PSMA imaging agent. I think what's interesting here is you can see on the left side of the screen on letter A that GRPR does pick up a lesion. Now, a small percentage of prostate cancer patients, maybe 15%-20%, do not overexpress for PSMA, but they would express for GRPR potentially. There is a very interesting role for GRPR, again, in earlier disease and hormone-sensitive disease, but also in later disease settings when PSMA is downregulated due to therapy, GRPR begins to upregulate. In our phase I trial that we're planning for the first of the year, we're going to be looking at the population that underexpresses PSMA and overexpresses GRPR. We think we have a very unique path to the market with this agent.
Brian, can I just ask a question? From a timing standpoint, any color you can give on when this might begin to have a potential impact? Are we talking two, three years from now?
I think on the diagnostic side, we're looking at two years, sort of in a mid-range. I think on the therapeutic, a lot hinges on what we see in phase I. If we begin to see real signs of activity in a very small population, it would lead us to believe that there could be an accelerated path. However, if you just think about a traditional phase I study where you're looking for a maximum tolerated safe dose, you're not necessarily looking for efficacy. It could be further out. It really depends on what we see in the clinic.
I know it's a squishy answer, but we got to get into humans and really understand it better.
Earliest, this is 2027 plus at earliest.
I would go further than 2027. I would say end of the decade into the early part of next year. I think with these assets in our therapeutic program, we're very interested in getting to proof of concept in humans and then understanding the true TAM available to the asset. We're not going to then turn around and spend hundreds of millions of dollars on a phase III program. We would look to partner the assets if it made sense, if the profile was correct. I think if you're looking at precedent transactions, getting an exciting asset in the hands of a major company that is willing to donate a lot more money to this, I think would be very exciting.
We would be proud to be a partner with many of the bigger companies that are focused in the therapeutic space. Makes sense?
Makes sense.
Okay. The next one up, and this one, LRRC15, we are extremely excited about it. This is an agent that overexpresses in a number of malignancies and also is internalized. It is a humanized antibody, and we are going to link it to lutetium-177. We hope to get our first patient treated phase I at the end of this calendar year. We have had excellent interactions with the FDA, and we do have very high hopes for this particular agent. Now, I apologize for the slide. It is a bit of an eye chart, but I want to drive home a couple of things here. Many people are familiar with the expression profile for FAP, our fibroblast activation protein.
Also looking at it compared to LRRC15 here, what you're seeing in green are healthy tissue expression, and what you're seeing in red is the cancer tissue expression. Toward the middle of the slide in the red, the overexpression in sarcomas and osteosarcomas for both of these agents is fairly well aligned, which gives us a lot of clues as to why our phase I trial is going to start in osteosarcoma. It's a devastating disease without a tremendous amount of advancement. If we can make a difference here, it will be enormous for these patients. Since I just mentioned the expression profile for FAP, we are partnered here with Ratio on their therapeutic trial with their FAP agent [Q82] actinium. We're the diagnostic agent of choice with Copper-64.
They're looking to accelerate their program as the year progresses, and we plan to utilize that particular trial and our own ongoing studies to really explore this asset further. Getting to a last but not least financial overview. Again, I touched on this at the very beginning. We have our current revenue forecast for the year, our fully adjusted diluted EPS, also our cash on hand, which I'm very proud of, and the annual revenue over time as you look at the company and its build. The last slide, I believe in this deck, the second to last slide is our upcoming catalyst. This is extremely important as we look to the near future for Lantheus.
MK6240 filing the new drug application in the third quarter, filing NAV next year, getting the [JEPNET] diagnostic approved, launched middle of next year, 2003 potentially approved and launched middle of next year. Further out in the pipeline, we have our Copper-64 FAP agent, GRPR, both diagnostic and therapeutic that I just mentioned, LRRC15, and TROP2 in very early development, which I really do not have enough time to get into. Finally, we are looking to strengthen our position as a leader in the radiopharmaceutical industry. Our portfolio is very diverse. We have, in essence, an embarrassment of riches. We need, upon close of the Life Molecular Imaging transaction, to be ruthless in our prioritization.
It's a wonderful position to be in to have such a strong cash-generating company, the ability to fund your programs and attract some outstanding talent, not only with our recent acquisitions, but also in the marketplace. Many people are coming to us from other companies that really want to be part of the Lantheus journey, and we're really proud to be here. Thank you.
Great. Maybe just a couple of questions here with the time remaining. Brian, just thinking about 2026, because you guys have talked about a pathway back to double-digit top-line growth. 2025 is a transition year as you work through transitional pass-through dynamics. Can you just maybe help us think through the components to getting to that double-digit? DEFINITY was on the slide. That's a high single-digit growth asset, I think normalized. What are the other or Bob too?
What are the other kind of levers? Yeah, I'll let Bob start off with the answer because he really unpacks it pretty well, if you will, and then I'll top it off with that.
All right. I mean, the basis of the question really gets into the stabilization as we get through 2025 with PYLARIFY and getting through the pricing dynamics as we go through the balance of this year and then into early next year. Really having a stabilization of that product on a go-forward basis, the divestiture of the SPEC business, that's a $120 million business that hasn't really grown very much. It's been a very stable and a very important part of the legacy of the company. When you take that out of the base, it does unlock a couple of hundred basis points of growth potential.
Now, you put into that all of the launches that Brian just went through, the addition of Neuraceq into our commercial bag, if you will, right out of the gate as we go into 2026, is going to be a very key catalyst. DEFINITY, obviously, this year, when you normalize it over the last two years, 2024 and 2025, you do average to high single-digit growth. That was literally because the comps in 2024 were exacerbated by a competitor out of the market. We do see that also just returning to its normal growth rate. You have the launches of OCTEVY. You have the launch of O3. You have the launch of MK6240. Those will be more incremental.
When you add those incremental adds to a Neuraceq, to a high single-digit DEFINITY, to a more sort of stabilized PYLARIFY situation, that's how you get there.
I mean, I think the key is you're not necessarily committing, nor do we expect you to, to what the definition of normalized PYLARIFY is. Because we have a model, we model a mid-single-digit PYLARIFY growth rate as the placeholder and then build around that, and we can get to, and call it an 8-12% organic kind of growth rate next year, depending on upper end and lower end of all those drivers. Is that a reasonable framework to be thinking?
That's exactly what I think we're getting at.
Okay.
I think the PYLARIFY market or the PSMA market is going to continue to evolve.
I think what we're seeing with the pricing disruption going to MUC at the beginning of the year, it has created an opportunity for the competition to receive a trial, if you will. What's very interesting with PLUVICTO in particular, we are seeing customers who are experiencing PLUVICTO because of the disruption with MUC pricing, and they're coming back to us. If you look at the labeling for PLUVICTO and the false positives that are called out in their label, it's a real thing. Many times people look at labeling, they don't really think about it the way we do anyway. Now it's becoming obvious in the marketplace. People are trying it, they're seeing it, and it's a problem, and they're coming back to us. This market has yet to go. There's a lot to take shape.
I think we're going to see what happens with the other agent in the field, what happens with their pass-through status. We believe eventually that ASP for all of these agents is going to be on the near horizon.
Great. I think we're right at time here, but thank you.
Thank you.
Thanks, Rich.