Lantheus at Leerink Global Healthcare Conference: Strategic Growth Plans

On Tuesday, 11 March 2025, Lantheus Holdings Inc (NASDAQ: LNTH) presented its strategic vision at the Leerink Global Healthcare Conference 2025. CEO Brian Markison outlined ambitious growth prospects, highlighting both opportunities and challenges. Lantheus aims for double-digit growth by 2026, driven by products like Polarify and DEFINITY, while addressing concentration risks.

Key Takeaways

• Lantheus targets double-digit growth in 2026 and beyond, focusing on diversification.
• The company plans to expand in Alzheimer’s diagnostics with innovative tracers.
• Acquisitions of Life Molecular Imaging and Evergreen are expected to close in 2025.
• Lantheus is advancing several pipeline assets, including Point 2003 and LLRC 15.
• Strong free cash flow is projected for 2025, with Polarify as a key driver.

Financial Results

• Lantheus forecasts double-digit growth starting in 2026.
• Strong free cash flow is anticipated in 2025, driven by Polarify.
• DEFINITY is expected to maintain a market share of over 80%, acting as a steady growth engine.

Operational Updates

• Lantheus has established around 62 PET Manufacturing Facilities to support Polarify.
• The acquisitions of Life Molecular Imaging and Evergreen are set to close in the second half of 2025.
• Progress is being made on the gRPR theranostic pair and LLRC 15.
• Tentative approval for Point 2003 is awaited.

Future Outlook

• Lantheus aims to lead in molecular imaging and radioligand therapy.
• The focus is on developing best or first-in-class theranostic pairs.
• Key 2025 milestones include closing acquisitions and advancing pipeline candidates like GRPR and LLRC 15.

Q&A Highlights

• Early detection and tracking of Alzheimer’s disease are major focuses.
• Blood-based biomarkers could potentially reduce the need for PET scans.
• The FDA shows enthusiasm for LLRC 15, currently in development.
• Octavi and PNT 2003 are viewed as a theranostic pair for neuroendocrine tumors.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - Leerink Global Healthcare Conference 2025:

Brian Markison, CEO, Lantheus: We’re good.

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: Thanks everyone for joining us. My name is Roana Ruiz. I’m one of the senior biotech analysts here at Leerink Partners, and it’s my pleasure to introduce, Lanthius to the podium. And with me today, I have the CEO, Brian Markison. So, I guess without further ado, I’ll just let it hand the mic to you and because I know you have a little bit of a presentation to go through.

Brian Markison, CEO, Lantheus: Yeah. Well, I appreciate that. Thank you. Thank you for having me this afternoon. Before I dive into the corporate presentation, please note the safe harbor.

I won’t bore you and read the whole thing, but maybe I’ll start at the beginning. No. So for those of you that are not that familiar with the story, Lantheus is a leading radiopharmaceutical focused company. And our raison d’etre, if you will, to find, fight, and follow disease to deliver better patient outcomes is kind of why we wake up every morning. And I’ll take you through a little bit of our journey, a little bit of our history, and then where we’re going when we wrap up this presentation.

So we’ve said in our fourth quarter and full year ’twenty four earnings call that we’re planning for we’re setting the stage, if you will, for double digit growth, in 2026 and beyond. And I think we have a number of near term catalysts, but clearly, our big drivers, Polarify, followed by DEFINITY. And then when we’re fortunate enough to close on Life Molecular Imaging, we certainly anticipate the addition of NeuroSeq to our portfolio as another driver of the business. You could see in the column that’s marked number two on the slide, MK 6,240, NAV 4,694, Octavi and point PNT 2,003, all in late stage development and all planning for near term launches in the 2627 time period. And of course, I can’t leave out Evergreen, which we’re very excited about that brings Octevi to the portfolio and a pipeline of very interesting early development compounds.

And we hope to close on both Life Molecular Imaging and Evergreen early in the second half of the year. So we’re very excited about that. So here’s a depiction of our historical sales performance, adjusted EPS and free cash flow. And what I’d like to do is bring your attention to that black box or rectangle in the middle of the slide where we projected cash flow, free cash flow for 2025. And obviously, a very strong performance in the wind for us, strong tailwinds for the business, and we’re we’re quite quite motivated to get this done.

So Lantheus has essentially a fairly lengthy history in nuclear medicine and the radiopharmaceutical market. But I’m not going to drag everybody through the, you know, beginning of old New England nuclear, but what I’m going to focus on is some of the more recent transactions and happenings in the company. So you could see in twenty o two, we acquired Progenics, and that was really the beginning of sort of this new renaissance at Lantheus. Shortly thereafter, Polarify got approved. In 2022, we did the deal with Point Therapeutics, which now is Lilly.

And then in ’23, we picked up MK $62.40 from Servo. We also looked at the approval of Plarify in Europe, our work with Curium to be our partner there to distribute Plarify in Europe. And then 2024 became really busy. We acquired a number of assets that I’ll talk about. We were working on Life Molecular Imaging at Evergreen during that period of time as well.

I do want to thank all the team members that worked at Lantheus to get these deals done over the finish line, and I know how hard it’s been, but it’s also been a lot of fun on this journey. So I’ll cover some of the more interesting things here on the slide as we go through the presentation, but I’m not going to drag everyone through it. So PolariFi is clearly our leading workhorse, if you will, and sustainable business driver. And we anticipate a very strong cash flow from PolariFi over our planning period, and we do anticipate it to grow with the market. So we’re quite excited about Polarifi, and I think for people to really understand what’s happening in the market, you almost have to go back and look at the data and the basis for approval where you could see the two grayscale images are conventional imaging and then the two images in color are polarifi images.

And what we’re finding versus conventional imaging is metastases that would normally have not been found, and that has led to the change in therapy. And that’s a sea change in this market that everybody is now sort of taking for granted. But this fuels the TAM. Right? Now what is Polarify exactly?

Polarify, we need to start with a f 18 cyclotron. The cyclotron is then fed into the TRACES box, and what you see in the second picture is the Polarify kit. So as the f 18 line comes into the TRACES box, all of these different things get admixed and out comes a Polarify vial, and it then put into patient ready doses through pharmacy. And you could see in the third box, there’s the little pig that they’re called, which is a lead lined tube that the patient ready dose goes in, and then lo and behold, it makes its way to the patient. We have spent since launch bringing up the largest network of pet manufacturing facilities with strong partnerships with Sophy, PharmaLogic, and PetNet and others.

And right now, we have about 62 PMFs around the country. A lot of duplicative PMFs or coverage in high service areas where there’s a lot of prostate cancer, obviously. But for example, in the state of Montana, we may have a little bit of trouble delivering doses, so we’ll fly them in if we need to. But this is a kind of look at the TAM as we’re looking at it today, and then also what we’re projecting out in the future. And I think the segment that we’re projecting the most growth for is the dark black box, which is radio ligand therapy driven.

The middle box, which is suspicion of recurrence, obviously continues to grow. But that upper box, which is initial staging, I think that may grow even more than our TAM suggests, and we’re developing data now to basically substantiate it. So this is a slide of the MIRROR study, which is looking at favorable intermediate risk prostate cancer. And this is basically people who you’re assuming based on MRI, etcetera, biopsy, that the prostate cancer is confined to the prostate bed. And what we’re looking at with Polarify is do we find metastases when according to conventional imaging you would not.

And the answer to this study is going to be yes. They’re already using it there. So what’s even more interesting though was a poster that we presented at ASCO GU where we looked at a zero change in PSA or undetectable all the way down to less than point two nanograms per ml, and we were finding lesions in a large percentage of the population. So I think as the future unfolds, you’re gonna see PSMA being far more interesting and predictable than PSA, but PSA is clearly the lead indicator that gets you to the urologist. So that’s pretty exciting.

Afiniti, our second driver, has been a real steady growth engine for the company. We did project a slowdown in that growth because our competition was out of the market last year. They’re back in the market, and we were relatively comfortable with a very consistent 80 plus percent market share, and we plan on it resuming that and not being much higher unless our competition can’t really stay in the game. So what does DFINITY do? You know, on the left image, which is the unenhanced or without contrast, you know, it’s a very poor picture of the heart valve.

And And I think when you look at the DFINITY image and that line in the middle, for those of you that are not that close to this, that is an excellent picture of the heart valve. And to see a dynamic image, you can see the heart valve in motion and really understand what’s going on, in an echo with DEFINITY. So again, very interesting, excellent science. And our TAM here for DEFINITY is really defined by the contrast market size, not so much the sort of non contrast ultrasound market, which is enormous. So here we have the three agents that are in the market today, and that really defines our TAM.

So I’m going to switch now to our pipeline a little bit. And this is a view of the pipeline with the potential closing of evergreen in blue and Life Molecular Imaging in the brown. And ultimately, all of this is gonna be in green, and you could see how it layers in with the current Lantheus pipeline. And I’ll talk about some of the more exciting components of this, right now. But I think when both these businesses close, you’re going to see a company with a lot of very interesting shots on goal, both diagnostically and therapeutically.

So first up in the pipeline is Point two thousand and three, our partnership with Lily Point, and that is the radio equivalent to Lutathera. So essentially, we will be competing in the Lutathera market for market share, and we will be launching with our two thousand and three Octavi, which will be the diagnostic or if you will, we’ll be introducing a theranostic pair into the marketplace. And I think we’ll compete quite nicely for the full range of neuroendocrine tumors with Octavi and also for the Lutathera market with 02/2003. And I think it’s sort of a soft entry for for us, if you will, in being able to enter the radioligand therapy market with a known asset in a known place with a very interesting diagnostic agent as a as a precursor to the therapeutic. Now we made a pretty big bet on Alzheimer’s disease, and I think what what I call this is a Gretzky move, which is we’re skating to where the puck is going to be.

So you sort of have to believe that Alzheimer’s is going to become a big market in order to get your head around this opportunity, which we think, when you look at the portfolio that we’re amassing in Alzheimer’s, that is just gonna be a similar scale, to what we’re seeing now with Polarify. I don’t think one single agent, but I think the portfolio. So, you know, what we have on this slide is a very distinct amyloid plaque signature and also tau tangles and how they appear. And also on the right is basically the prevalence and the growing incidence of Alzheimer’s disease. This is a population that is certainly far in excess of what we’re seeing with prostate cancer, unfortunately.

And, you know, I think there’s no doubt that all the, you know, associations that are behind, the tau tracers, the beta amyloid tracers, they basically concur that you need both for a positive diagnosis of Alzheimer’s disease. And here’s a rough cut of the TAM that we see for 02/1930 in terms of market size, on the left side of the slide, which is monitoring, staging and screening. And clearly, all of this is driven by therapeutics. So we’ve got two beta amyloid therapeutics in the market today, and you’re essentially seeing amyloid scans double, over in a very short period of time with the advent of Lilly’s new therapeutic into the market. So we are really excited about MK6240, and I’m gonna describe in the next few slides why it’s so interesting to us.

So MK is a second generation tau agent, and it is perhaps more specific, more sensitive than the other tau tracers, and also has much less off target binding. So we’ve got a fair amount of data from the head study, which is being conducted by doctor Pascal at Pittsburgh, and I’ll explain that in a second. But right now, MK sixty two forty is in over 103 academic studies and 15 major pharmaceutical trials looking at tau therapeutics. And so this is a, I think, a significant recognition of how valuable this tracer is. And we sell MK sixty two forty in this setting.

We don’t give it away for free. Right? So people are buying our tracer to use in these studies, but we do make it affordable. So we try to make it easy. And of course, we want the data.

I mean, that’s part of the price. So this is data from the head study where doctor Prescao, under an NIH grant, is the first person to really look at comparing all the tau tracers that are currently in development. And, you know, I think what you could see here head to head in the same patients is the four different tracers. And MK sixty two forty, if you look at the nice images of the brains, clearly picks up early tau the earliest and also the most pronounced imaging, and a lot of that is driven by the sensitivity of the tracer. And again, here’s just a much better view of the four different tracers in the same patient, relatively same timeframe, and you can see the performance of MK sixty two forty versus the other tau tracers.

That again, once again, highly specific with less off target binding. And then this slide is a correlation between p tau or plasma tau and MK sixty two forty. And what we’re seeing here is that MK sixty two forty has the highest correlation for p tau. So if you’re looking for a blood test to determine whether a patient should get a scan, here we have the highest correlation. And then also on sensitivity, this graph, again, taken from doctor Pascal in the head study, so I wanna thank him for his permission, to let us use these slides.

But again, directly comparable, MK 6,240 is clearly the most sensitive, and it also is more sensitive than p Tau. It picks up centilloids much, much earlier in the game than the other tau tracers. So a true second generation, and we will disclose our plans for filing a little bit later this year. So we’re very interested to see how our Phase III trials develop. So switching gears to beta amyloid, NAV is a second generation beta amyloid agent.

Again, similar hallmarks to MK6240 in improvements in chemistry and less soft target binding, more specific binding to the target itself. And ultimately, what we’re looking at with NAV is the ability to pick up centaloids much earlier. So again, beta amyloid, early AD has the the best response to therapy, and you wanna begin to pick up these patients as early as possible. The standard, if you will, for doctor Pascal was carbon 11, which is on the bottom of the slide, the bottom of the top half of the slide. And you could see that NAV is right in there with carbon 11 in the ability to pick up early centaloids.

Also, NAV has superior gray matter to white matter sort of disposition, if you will, which really leads to essentially the ability to read these images much better with more clarity. And you you really don’t need NAV for the advanced population on the far right, which is the positives that you could see they light up like a Christmas tree. But if you’re looking at the subjects in the middle that test negative, right, or positive, you could see number patient number two. Right, on conventional imaging, it’s not that straightforward. But when you’re using NAV sixty two forty, you get a startling image here.

So again, with NAV, it’s the ability to pick up very low centilloid counts or early centilloids. And, you know, here’s some of the comparison of the tracers. And I guess what we’re looking at with NAV is gray matter to white matter ratio and making visual reads much better. Again, a second generation agent, that’s going to have to sort itself out. It’s further back in development than MK.

But the first agent in for us is basically going to be NeuroSeq, right, because once we close our Life Molecular Imaging, we’re in the market right now with a beta amyloid. So the next step in the pipeline is our gRPR targeting agent, both the gallium and the therapeutic pair with lutetium. And gRPR is very interesting to us because we wanted to stay in prostate cancer, but we didn’t wanna beat our brains on the wall with another PSMA targeted agent. And so what you find in early prostate cancer, gRPR expresses practically to the same extent as PSMA. And then as you progress in the in the prostate cancer paradigm, if you will, where one over expresses, the other does not.

So for example, while PMSA is PSMA is high, gRPR is down. But with gRPR is high, PSMA is down. So there’s a very interesting role for combination therapy, but also for fifteen percent to twenty five percent of the patients that do not express at all for PSMA, but do express for gRPR. So our imaging agent’s already in phase one, and the therapeutic we’re preparing, to have a very healthy conversation on a pre IND meeting with the FDA in the very near future. And here’s against some of the scans from doctor Agarou out in California looking at RM two gallium scans, conventional imaging then with gRPR.

And again, we can see that gRPR really lights it up quite favorably when expressing for when the avidity is there for gRPR versus the subject A, which is conventional imaging. So very clear signal that we light up GRPR when it’s expressed, and we know we can deliver the therapeutic to the tumor. The next one up is LLRC fifteen, potential first in class targeted antibody, fully humanized, again, linked to lutetium in this instance. And the expression profile here is very interesting. And our first shot on goal, if you will, will be for osteosarcoma.

But the target here has an extremely healthy profile in overexpression in a number of malignancies and no expression to very low expression in basically non, you know, non cancerous, you know, the rest of the human body. So if you look at breast cancer, for example, on the bottom right, you could see the tumor over expression versus normal tissue, head and neck, lung, etcetera, pancreatic. So we’re being very careful here. We hope to be in the clinic at the end of the year, if not, at the very beginning of the year. And we already had a very successful phase, pre IND meeting with the agency.

And we’re looking forward to just finishing off some of the CMC and getting into the clinic. Again, if this product can show a glimmer of activity in osteosarcoma, it’ll be sort of the first time in a while that an improvement has been delivered to this population, which really is an unfortunately tough malignancy to treat. Here’s our FAP agent or diagnostic for right now being worked up in sarcoma. And we are also very interested in looking at FAP, and its potential outside of oncology. So we have experimental studies up and running in COPD and cardiac applications in NASH or fatty liver NASH.

What you know, people often call them different things, but we’re gonna go with NASH and also fibrosis. Lung fibrosis could be a major indication here. So we’re we’re very interested to see where we can take this this agent because it’s believed that if fat was available before FDG, it might have been a better pantumor agent than FDG. I think our search here is we feel very comfortable that we’ll be able to get an indication in sarcoma. But that’s a small patient population, and how can we really expand it into some of the really exciting areas?

Like, we believe right now that we’re helping with the assistance of diagnosis and management of lung cancer. The FAP agents could be much more, could deliver much more information, if you will, than FDG, which is not all that great for lung cancer. So while FDG is widely used today, we think we have a very good chance of taking some of that market with that. So kind of wrapping up looking at 2025, some of our milestones and what we’ve got to get accomplished this year, we have to close on two really important acquisitions. We have to close Life Molecular Imaging, we have to close on Evergreen, we have to advance our GRPR theranostic pair, we’ve got to advance LRC fifteen.

Point 20 o three is with the FDA. We’re waiting for a tentative approval, but we also have to wade through the Hatch Waxman exclusivity period of potential litigation with Novartis, and we have to get our tracers over the finish line and filed. So, a lot going on, a lot of catalyst for us coming up, and I think we’re kind of busy, so that’s a good thing. So we’re powering our future here. We are an industry leader.

We’re relying on our expertise to avoid the pitfalls that others have made and also improve our probability of success. We are actively diversifying the portfolio and trying to get out of the concentration risk, that we’re seeing with Polarify. I think anyone with common sense would say that’s a good move. And we’re sharpening our strategic focus. We want to be preeminent in molecular imaging, and we want to be highly selective with radioligand therapy, where we’re looking at best or first in class.

But our theranostic pair approach really will help guide us in making sure that we pick the winners in therapeutics. And that’s really it. So that’s the end of the prepared remarks. And we have how much time for questions?

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: We have about six minutes. Maybe I’ll open up if anybody in the audience has any questions.

Brian Markison, CEO, Lantheus: If

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: not, I can jump in as everybody gets warmed up. So, I know you’re focusing a lot on the pipeline. There’s a lot going on, in a good way, which I agree with. So maybe starting with Alzheimer’s diagnostics and thinking about the space there. Some questions that I’ve gotten from investors is, you know, what wins in that space among tracers?

Is it specificity? Is it selectivity? So and is there room for multiple products as well?

Brian Markison, CEO, Lantheus: Well, there’s clearly room for multiple products. There’s three of them right now. I think when you look at beta amyloid and and the future of beta amyloid, I think the game is gonna be mostly about the ability to pick up very early Alzheimer’s, and that means a low centilloid count. And that’s where we’re playing with NAV. But right now, NeuroSeq is an excellent product.

It’s a workhorse. And the three beta amyloid tracers that are available today are basically doubling year over year because of the therapeutic march from Lilly and Eastside Biogen. So that’s a market that’s growing because the therapeutics are available. And I think the earlier you can pick up the disease with a tracer, the better. Like, you really do not need a tracer if somebody is loaded with amyloid or tau and they have severe symptoms.

I mean, what is it what is it gonna tell you? That you have advanced disease. Good luck. Right? What you wanna do is you wanna pick it up early.

And again, here’s, like, MK sixty two forty versus p tau and the other tracers. If you can pick it up early, that’s the name of the game. And then you wanna track it longitudinally. You wanna know how you’re doing. And that’s where I think MK sixty two forty comes with, because with tau, what you can look at is the region of the brain that’s affected.

You can look at the relationship between that region and and basically symptoms. So correlate region to vision, speech, memory, balance, and you could track the patients longitudinally. So there’s huge benefits and the field is exploding around us, and it’s all driven by this tremendous prevalence.

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: Yep. That makes sense. And, talking about tracking patients, I was curious, there’s been a little bit of a debate thinking about blood based biomarkers versus pet tracers, etcetera. And, you know, some some of the first Alzheimer’s therapeutics have had a slower launch than expected. So, what’s your take on those moving pieces?

And does patient monitoring, following progression sort of help, disconnect the pet tracer growth, a little bit more in certain terms of boosted over time?

Brian Markison, CEO, Lantheus: That’s a bunch of questions. Yes. That’s part. So we we want the blood test to be fairly sensitive because we wanna be able to rule in and rule out the need for a PET scan. So the best analogy I have, quite frankly, is the p PSMA market.

You have a rising PSA, you go to urology, and then you get a workup depending upon how that clinician reviews your case. I think here, we have a positive blood test. You go to neurology, and the neurologist will begin to work you up and decide whether or not you need a molecular imaging scan. So the the unfortunate thing is I think the blood test the blood biomarkers right now are not that sensitive. But as a general screening tool, we really want them out there.

It’s not practical to image everyone with a molecular imaging scan if they think you’ve got Alzheimer’s. So I I think that’s where it’s going. But what a blood biomarker can’t do is give you a region. It can’t give you how much of your brain is affected. If you look at, for example, these NeuroSeq scans on the bottom left, a biomarker, a blood marker is not gonna tell you that.

And so you really need to see. And if you’re monitoring therapy, you really need to understand if your therapy is working. And a lot of it, the current therapies are sort of, if you will, the resolution of amyloid plaques. And as that plaques go away, where is it happening? How is it going away?

How much is going away? So, but the but the current therapeutics come with some side effects that need to be managed, and the burden with the number of MRIs is not trivial. So, you know, I I think they’re gonna grow. I think, the market’s poised for tremendous growth, And I think we have very good targets to shoot for on the therapeutic side to make modest improvements to get more widespread usage, which will blow open the tracer market.

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: Got it. Interesting. And I noticed I think it’s worth $24.00 3, you just got pre IND feedback. I was curious if you could give us a little more color of what was the feedback like, how does that inform some of your next steps, and what are you excited about?

Brian Markison, CEO, Lantheus: So 2403 is the LLRC 15 agent that we have, that really has a very unique profile in terms of expression in malignant tumors versus nonmalignant. And the the one thing that we’re working with doctor Noah Federman on the West Coast as one of the preeminent thought leaders in pediatric oncology, and the meeting we had with the FDA was really nothing but collaborative. They’re very much interested in seeing this program progress. Our our big quest in the phase one study coming up is to not under dose the patients because these patients are gonna be fairly far along. They will have been administered a number of rounds of chemotherapy, and some of the drugs are are as old as I am, and they’re not very easy to tolerate.

But these patients are quite resilient, and I think we’re gonna be going in with a reasonable dose. So we’ll be very quickly able to see if this product can have an effect one way or the other in in its antitumor properties. And we’re very, very excited to get this in the clinic.

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: Yeah. Sounds good. And then, I did wanna squeeze in a question in the last minute. Positioning of Oct in PNT 02/2003, how are you thinking about that as a possible theranostic pair in the marketplace, and how could the sort of paradigm evolve at that point?

Brian Markison, CEO, Lantheus: Well, we’re thinking about it exactly as you described, as a theranostic pair. Octavi can compete across the board for all the neuroendocrine tumors regardless of what the therapeutic approach is. But clearly, when it’s paired with twenty o three or Lutathera, it makes perfect sense. So I think we’re gonna have a couple of touch points for nuclear medicine to wanna work with us. And again, radio equivalent to Lutathera in twenty o three is an AB rated generic at the end of the day.

And I think it will look like the biosimilar market in terms of uptake and market share over time because these are not easy drugs to make as everybody knows. You need expertise. You need outstanding supply chain and customer service, and those are all the things we’re really good at.

Roana Ruiz, Senior Biotech Analyst, Leerink Partners: Yeah. Sounds good. So I think with that, we are out of time. So thanks again, Brian, for coming out and joining us for the discussion.

Brian Markison, CEO, Lantheus: Yeah. Glad to be here. Thank you.

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