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On Tuesday, 17 June 2025, Lantheus Holdings Inc (NASDAQ:LNTH) presented at the 2025 Truist Securities MedTech Conference, offering a strategic overview of its current market position and future outlook. The discussion highlighted both the company’s robust product performance and the challenges it faces within the competitive radiopharmaceutical landscape. Management outlined growth prospects driven by innovation and strategic acquisitions, while also addressing pricing dynamics and market stabilization efforts.
Key Takeaways
- Lantheus aims for double-digit top-line growth by 2026, focusing on product launches and market stabilization.
- Flagship products Polarify and DEFINITY are key growth drivers, with DEFINITY’s TAM expected to reach $600 million in the US by decade’s end.
- Strategic acquisitions, including Evergreen and Life Molecular Imaging, are pivotal for future expansion.
- The Alzheimer’s disease and neuroendocrine tumor programs are progressing, with significant market potential.
- Financial strength is underscored by a solid revenue forecast and cash on hand.
Financial Results
- Lantheus discussed its current revenue forecast, emphasizing a solid financial position.
- Fully adjusted diluted EPS and cash reserves were highlighted as indicators of financial strength.
- The divestiture of the spec business is expected to unlock additional growth potential.
Operational Updates
- The pipeline includes MK 6240, involved in numerous academic studies and partnerships.
- NAV agent shows promising conversion rates, with significant therapeutic potential.
- Octavy and 20 o three are on track for regulatory reviews and expected launches next year.
- GRPR’s diagnostic agent is advancing to phase two, with therapeutic trials beginning early next year.
- LORC fifteen is set to begin phase one trials by the end of the year.
Future Outlook
- Lantheus anticipates a return to double-digit growth by 2026, driven by new product launches.
- The PSMA market is projected to grow 15% to 17% this year, with DEFINITY contributing steady growth.
- The company plans to prioritize effectively following the Life Molecular Imaging transaction.
- Upcoming regulatory filings and product launches are expected to drive growth.
Q&A Highlights
- The PSMA market continues to evolve, with Lantheus poised to capitalize on changing dynamics.
- Polarify’s market stabilization is crucial for achieving growth targets.
- The addition of NeuroSeq and other products is expected to contribute to future growth.
For further details, readers are encouraged to refer to the full transcript below.
Full transcript - 2025 Truist Securities MedTech Conference:
Rich, Host: Great. Alright. 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 two joining.
And this format is gonna be a little heavier on the presentation side as believe Lantus is in the quiet period now. So Brian, I’ll let you take it away and maybe a brief introduction and you can jump into your slides.
Brian Markison, CEO, Lantheus: Yeah, terrific. Good morning. I’m Brian Marcus, I’m 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. So I’m gonna dive right in.
We have a lot to cover. Please note the, safe harbor statement. And, for those of you who are not that familiar with us, Lantheus is a leading radio pharmaceutical 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.
Polarify, 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. And as we look toward the very near future, we’re positioned for success not only in the PSMA market, but also in the neuro neuro injury consumer market, in our Octavvy 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.
And 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’ Lutathera. You can note our cash balance at the end of the first quarter. This is prior to the acquisition of Evergreen. And in the second quarter disclosure, hopefully, 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 spec business, but we’ll also shed more color on that in our upcoming second quarter disclosure.
So looking at our market leading portfolio, starting of course with Polarify, a true blockbuster agent achieving $1,580,000,000 in sales last year. First quarter sales were exceptionally strong. And I think 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.
And we clearly cover most of the country, but especially the high concentrated population areas as you could see, from our heat map of our PMS locate 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 could take away from the TAM is it’s definitively growing. We’re recommending perhaps 15% to 20% per year. This year, we’re looking more at the lower end of that, so 15% to 17% to make Rich happy.
And 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. And I think Novartis has done an excellent job in expanding the label for Plavicto. If we turn to DEFINITY, again, first quarter sales of nearly $80,000,000 modest growth rate coming out of a year of incredible growth due to short supply from our competition. And I think we lose sight of DEFINITY because it’s been 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. And I think you could see the highlighted image on the screen, and DEFINITY really does shed a light on suboptimal echocardiograms.
Back one. We there we go. So this is the TAM for DEFINITY. We believe right now that we’re about halfway through the TAM at around $350,000,000 annually heading towards 600 in The US by the end of the decade. And this is with a return to steady low to mid single digit growth, probably possibly higher single digit growth next year.
And we also enjoy an exceptional, position in the market built on a track record of efficacy, safety, and outstanding manufacturing and delivery. So from there, we’re gonna bridge to the pipeline. And 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, particular when 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 good acquisition.
I think it’s a matter of when, not a matter of if, and we do anticipate it in the near future. So the first up on the pipeline conversation this morning is there we go. Is a focus on Alzheimer’s disease dementia. And I think look, if you take away nothing else from this particular slide, is that this is a growing global crisis. And 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 65.
And certainly, I can’t think of a family that that I’m familiar with and friendly with that has not dealt with this in some shape, size or form with another family member. And it’s a terrible disease. This is the TAM as it is today. Roughly 1,500,000,000.0 for the imaging market, molecular imaging market by the end of the decade. And 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.
And I won’t spend time on the therapy side of this, but there are over a 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 three clinical trials. So m k sixty two forty 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. And you can look at the images.
I don’t have the time to get into it in this particular presentation. But what we’re looking at is m k sixty two forty 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. And what does that really mean? I’ll get into that in one second. But I think people need to understand the difference between a beta amyloid imaging agent and a tau agent.
And I’m bringing up a cross section of the brain here. And 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. And 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. So what does all this really mean?
We’re in approximately a 109 academic studies across 39 academic institutions in the world with m k sixty two forty and with 15 pharmaceutical partnerships where they’re using our MK sixty two forty to help with their therapeutic. And that number on the 15 is certainly growing as more people come to us and wanna use this agent. This slide is data from doctor Tharek Pascal at Pittsburgh. He’s conducting the head study, which is NIH sponsored. We’re not sponsoring the study.
We are making m k sixty two forty available. And here he’s looking at a comparison to the other tau agents that are either in development or the one agent from Lilly on the market. And what we’re basically showing is greater sensitivity and a greater dynamic range. And the whole game is going to be in the future for treating these patients earlier with as little disease as you could possibly detect. And 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. And 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. And this is a sineloid conversion chart. And essentially what we’re showing here is NAV, when compared to the other commercially available beta amyloid treatments, has the single best conversion to centaloid count.
And it’s on par with carbon 11, which is really the gold standard in this setting. But from the ability to manufacture at scale, it just simply isn’t feasible. And then 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. And again, this is from doctor Derek Pascal as well from the head study where he’s looking at all of these tracers. And 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.
And also for patient number one, you know, when you look at it on grayscale, you can truly see that’s a negative. But 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. And clearly, the sensitivity of this agent will be enormously helpful, in the treatment and monitoring of Alzheimer’s disease and the also the diagnosis. Here’s a comparison chart. And essentially, at the end of the day, what you’re getting with DAV 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. And 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 a a 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’s not dissimilar here. And let the neurologist determine, what would be the appropriate next step. But certainly, if there’s a strong suspicion of AD, then a beta amyloid scan at a minimum today would certainly be required. So we believe punch line that ubiquitous blood based biomarkers will help build the TAM and build the TAM for imaging in particular and not have the opposite effect. So sliding over to a catalyst that we hope to launch in the middle of next year, Octavy, l n t h twenty five zero one.
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 300,000,000. We believe we can certainly take a a fair slice of this, Tim, 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. And also, Octavy, is a differentiated agent and should perform extremely well in the market.
And it’s a perfect tuck in acquisition for this company. And we will not need to spend huge amounts of resources to launch this asset into what 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, 20 o three, is, on track to be finished with, review by the agency, certainly before the wax rashment expiration. And also we hope that the litigation with Novartis will conclude at about the same time. And we would plan to launch this asset after the middle of next year, probably in the early third quarter, but certainly what we’re not in the first half of the year due to the timing and Hatch Waxman time clock.
And again, there’s a very interesting TAM here as it grows right now. The markets lutathera. But 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. RaiseBio with Bristol Myers Squibb.
Perspective, our partner, in many respects has an excellent program with lead based therapy. So this tail 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 step in our pipeline, a little further out, is our g r p r peptide receptor or what we call r m two, another nice Lantheus number here. The diagnostic will be, a gallium product and the therapeutic will be lutetium based. And here, you can see the expression profile for g r p r and it does meaningfully express in prostate cancer, particularly in early prostate hormone sensitive disease.
So while the world is, you know, evolving around PSMA, you know, there’s very good reason to look at other receptors like steep two, h k two, etcetera, and certainly g r p r. We have our diagnostic agent is in phase two right now. And in the beginning of next year, we plan to be in the clinic with our therapeutic. We’re now negotiating a IND with the FDA, and that seems to be on track. So 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. And on the far left, as you’re looking at the slide, you could see the immense overexpression in prostate cancer for PSMA and relatively, you know, sort of modest expression in normal tissue, which makes PSMA diagnostics and therapeutics an excellent candidate for therapy. Now and diagnostics. Now if you look at g r p r in the the orange and red, you can see the overexpression in orange. The first big orange bars happens to be prostate cancer.
And then you can look at it in a variety of other tumors. There’s broader expression here than PSMA. So Novartis has a program looking more more at breast cancer than prostate. Lilly is entering the fray with a similar asset. And 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.
But this needs to be borne out in the clinic. Here, we’re looking at the diagnostic for r m two. This is from, doctor Agaru out on the West Coast, and, it’s a sort of comparison in the same patient compared to Polarify. And, we will never say that Polarify is perfect, but we will say it’s an outstanding and best in class PSMA imaging agent. And I think what’s interesting here is you can see on the left side of the screen on letter a, that g r p r does pick up a lesion.
Now, a small percentage of prostate cancer patients, maybe fifteen to twenty percent, do not overexpress for PSMA, but they would express for g r p r potentially. So there’s a very interesting role for g r p r, again, in earlier disease, and hormone sensitive disease, but also in later disease settings, when p s m a is down regulated due to therapy, gRPR begins to upregulate. And in our phase one trial that we’re planning, for the first of the year, we’re going to be looking at the population that under expresses, PSMA and over expresses gRPR. We think we have a very unique path to the market with this agent.
Rich, Host: 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?
Brian Markison, CEO, Lantheus: I think on the diagnostics 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 one. 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 one study where you’re looking for a maximum tolerated safe dose, you’re not necessarily looking for efficacy. So it could be further out.
So, 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.
Rich, Host: But earliest isn’t is it ’27 plus at earliest?
Brian Markison, CEO, Lantheus: I would go further than ’27. I would say end of the decade into the early part of next year. And I think, you know, 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. And we’re not gonna then turn around and spend hundreds of millions of dollars on a phase three program. We would look, to partner the assets, if it made sense, if the profile was correct.
And 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, and we would be proud to be a partner, with many of the bigger focus companies that are focused in therapeutic space. Makes sense? Makes sense. Okay. So the next one up, this one, LORC fifteen, we are extremely excited about it.
This is an agent that overexpresses in a number of malignancies and also is internalized. It’s a humanized antibody and we’re going to link it to lutetium one hundred seventy seven. And we hope to get our first patient treated, phase one, at the end of this calendar year. We’ve had excellent interactions with the FDA, and we do have very high hopes for this particular agent. Now, I apologize for the slide, it’s a bit of an eye chart.
But I want to drive home a couple of things here. Many people are familiar with expression profile for FAP, our fibrogen activated protein. And also looking at it compared to LLRC fifteen here, what you’re seeing in green are healthy tissue expression, and what you’re seeing in red is the cancer tissue expression. And 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 one trial is gonna start in osteosarcoma. It’s a devastating disease without a tremendous amount of advancement.
And if we can make a difference here, it will be enormous for these patients. And since I just mentioned the expression profile for PAT, for FAP, we are partnered here with Ratio on their therapeutic trial with their FAP agent, chelated to actinium. We’re the diagnostic agent of choice with copper sixty four. They’re looking to accelerate their program as the year progressive, and we plan to utilize that particular trial and our own ongoing studies to really explore this asset further. So 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. And the last slide, I believe, in this deck. Second to last slide is our upcoming catalyst. This is extremely important as we look to the near future for Lantheus.
MK 6240 filing the new drug application in the third quarter, filing NAV next year, getting, the JEPNET diagnostic approved, launched middle of next year, twenty o three potentially approved and launched middle of next year. And further out in the pipeline, we have our copper 64 FAP agent, GRPR, both diagnostic and therapeutic that I just mentioned, LLRC15 and, TROP2 in very early development, which I really don’t have enough time to get into. And finally, we’re looking to strengthen our position as a leader in the radio pharmaceutical 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, but 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 wanna be part of the Lantheus journey, and we’re really proud to be here. So thank you.
Rich, Host: Great. Maybe just a couple of questions here with the time remaining. Know, Brian, just thinking about 2026, because you guys have talked about a pathway back to double digit top line growth, ’25 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 digits? DEFINITY was on the slide.
That’s a high single digit growth asset, I think normalized. You know, what are the other or Bob too. What what are the other kind of levers?
Brian Markison, CEO, Lantheus: 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. How’s that?
Bob Marshall, CFO, Lantheus: Alright. So, I mean, the basis of of the question really gets into the stabilization as we get through 2025 with Polarify and getting through the pricing dynamics as we go through the balance of this year and then into early next year. So really having a stabilization of that product on a go forward basis. The divestiture of the spec business, that’s $120,000,000 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.
But when you take that out of the base, it does unlock a couple of 100 basis points of growth potential. Now you put into that all of the launches that Brian just went through, the addition of NeuroSeq 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, twenty four, 2025, you do average to high single digit growth and that was literally because of the comps in 2024 were exacerbated by a competitor out of the market. But we do see that also just returning to its normal growth rate. And then you have the launches of Octavy, you have the launch of three, you have the launch of MK6240.
Those will be more incremental. But when you add those incremental adds to a Neuroseq, to a high single digit DEFINITY, to a, you know, a more sort of stabilized Polarify situation, that’s how you get there.
Rich, Host: And, I mean, I think the key is is you’re not necessarily committing or do we expect you to to what the definition of normalized Polarify is. But, know, you know, because we have a model, you know, we we model a mid single digit Polarify growth rate as the placeholder, and then build around that, and we can get to, you know, and call it a eight to 12% organic kind of growth rate next year depending on, you know, upper end and lower end of all those drivers. Is that a reasonable framework to be thinking?
Bob Marshall, CFO, Lantheus: That’s exactly what I think we’re getting at.
Rich, Host: Okay.
Brian Markison, CEO, Lantheus: And I think the Polarify 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. But what’s very interesting with Postluma in particular, we are seeing customers who are experiencing Postluma because of the disruption with MUC pricing, and they’re coming back to us. And if you look at the labeling for post luma and the false positives that are called out in their label, it’s a real thing. And so many times people look at labeling, they don’t really, you know, think about it the way we do anyway.
But now it’s becoming obvious in the marketplace. People are trying it. They’re seeing it. And it’s it’s a problem, and they’re coming back to us. So this market has yet to go.
There’s a lot to take shape. I think, you know, we’re gonna see what happens with the other agents in the field, what happens with their pass through status. And we believe eventually that ASP for all of these agents is gonna be on the near horizon.
Rich, Host: Great. I think we’re right at time here, but thank you.
Brian Markison, CEO, Lantheus: Thank you. Thanks, Rich.
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