Transcript : Lantheus Holdings, Inc. Presents at Goldman Sachs 46th Annual Global Healthcare Conference 2025, Jun-10-2025 02

Published: 2025-06-10 17:48:02 ET LNTH

Published on 06/10/2025 at 17:48 - Modified on 07/17/2025 at 17:46

Okay. Good afternoon, everyone. I'm Paul Choi, and I cover the biotechnology sector here at the firm at Goldman Sachs. It's my pleasure to welcome Lantheus. Joining me on stage to my immediate left is Brian Markison, CEO; and Bob Marshall, to my far left. What I'll do is turn it over to Brian maybe for some introductory or overview comments, and then we'll get into Q&A after that.

So I think a lot of people are familiar with Lantheus. We've been in the nuclear medicine business for many years, actually since 1956. And lately, we've become quite well known for our blockbuster agent, PYLARIFY, PSMA imaging agent for prostate cancer. But I think if you look more broadly at the company, we're participating in some of the biggest growth markets. We're in cancer. We're in neuro with Alzheimer's dementia, a particular focus, and also therapeutic oncology, diagnostic oncology and cardiology to some extent. So we're in big markets, highlighted by our molecular imaging expertise and also as of late, therapeutic oncology with a fairly broad collection of assets.

Okay. Great. Thanks for that. Maybe we'll start with the commercial side and PYLARIFY. And maybe at a high level, Brian, you guys can characterize what's happening in the PSMA PET imaging market. What are some of the impacts or recent reimbursement changes and so forth that have been happening as well as some of the -- some color in terms of the competitive dynamics.

Yes, sure. So I think overall, you have an extremely healthy market. You've got a PSMA imaging market that's growing somewhere between in the range of 15% to 20%. I think what you're seeing as of late with new entrants, [ Illuccix ] with a gallium generator and kit and then POSLUMA with a different F-18 construct. You're seeing more competitive dynamics shake out, if you will, in the marketplace. I think the reimbursement environment has been a little bit lumpy, if you will, where we lost our pass-through status at the end of last year and went to MUC pricing for the traditional Medicare outpatient population right after that, and we're living through that at the moment.

And there's also a lot of speculation with CMS, what are they going to do? What are they going to publish in July? Are they going to go to ASP right away? Are they going to go at the end of the year? I think right now, through various conversations, there's a lot of positive momentum, but no one can really play the odds one way or the other on how that's going to break because there's a few other things going on with our government these days that can be quite distracting.

So I'm not quite sure where that's going to go. But I think what -- if you boil it all down to the impact on Lantheus and PYLARIFY, we're seeing the volume growth. We're being very careful because we're in our second quarter, so I don't want to comment on the quarter itself. I think this year is going to be a bit lumpy until things settle down. I think there's been [indiscernible] I think that's kind of interesting. And I think with all the different things happening in the marketplace, this year will be lumpy and then we'll sort of settle down a bit. And I think we're already seeing signs that the market is beginning to settle a bit. So Bob, would you add anything to that?

I think that that's pretty spot on.

Good.

Okay. Great. So as you think about the outlook for maybe PYLARIFY pricing, as you mentioned, some of your competitors have passed through pricing, yours expired at the end of last year. Maybe you've characterized the rest of this year maybe potentially as lumpy, but maybe a little bit on the forward when some of your competitors don't have pass-through pricing, depending on what happens potentially with ASP and pricing, how would you sort of characterize the outlook maybe starting in '26 and beyond, it should be more of a level playing field for all the competitors?

Yes. I think wherever the share settles out, I think we're going to return market level growth. We're over-indexed in high decile accounts because that's where the majority of our volume is. And I think we've mentioned before that the smaller accounts, which were not our major focus, there's a fair amount of growth there. And that growth is really driven by the fact that there's a bit of a bottleneck in the very large institutions. So that bottleneck creates an opportunity for folks to go more out to drive further to get their scans. And that's where you'll see the growth. But it's accounts that were previously doing 1 or 2 scans a week with us now maybe they're doing like one a day. So it's a very different landscape.

One thing I would add to that, though, is that it also provides [ the market ] to think through expanding hours in the day, cameras that are available 24/7. So a rate-limiting factor could be just literally staffing. But at the same time, we are seeing extended hours during the workday and even now bridging into the weekend on Saturdays and so forth. That's not everywhere. But that certainly is something that the market. And the other part of this as well is the investment that can exist from expanding camera capacities and so forth throughout the country is certainly something that the market will recognize with PET imaging is going to be an opportunity for investment.

Great. You actually bring up a very interesting point, which is that centers are not necessarily running at 24/7 capacity, but there are also some centers that have more or less full use of the boxes [indiscernible] growth driver.

Well, there's going to be more cameras because they're on order now. And all the [indiscernible] is they can basically tell you what the pipeline looks like for their business. So that's pretty clear. And I think hospitals and the imaging centers, freestanding imaging centers that are largely financially driven, they've already made adjustments. They're open Saturdays all day. I think the hospitals -- look, I was at a major teaching institution the other day and at 5:00, I was walking in the door and almost got ran over. So with everybody cleaving to get home. So they're a little slower to adjust and have staff work later hours or even open on a Saturday. So it's a little more difficult. But they're going to adjust and then they'll get the schedule straight down. And of course, they're all trying to put in new cameras. All of them have new cameras on order.

Great. And then in terms of other drivers such as share gains and adoption of PET, let's say, versus some of the older modalities like CT or other technologies?

Well, we're seeing almost a one-for-one drop in bone scans with the increase of PSMA scans. And I think CT will become a little less relevant. MRI for prostate is here to stay. I think you -- when you're diagnosing prostate cancer, any urologist would tell you, you have to have an MRI of the prostate. So I think that's here to stay. And I think as you move out in time, I think PSMA scans and other targeted scans are going to become very important.

I want to maybe briefly touch on other drivers of market behavior potentially over the near to intermediate term as well, which is the penetration of therapies into earlier line settings, including recent label changes for Novartis' asset. How much of that is a factor in the near term versus longer term in your view?

In the very near term, not that much because it takes time. There's an incidence and a prevalence and these patients aren't falling out of trees. So I think it's going to take time for adoption. We think, again, the early adopters of the major cancer centers and from there, it's going to trickle out to the community. A lot of these patients are really treated in the community. So it's a trickle-down effect. However, the data supporting radioligand therapy after one hormone therapy in the Novartis trials is really quite strong, not only for efficacy, but quality of life.

So the ability to get hormone therapy and then upon failure switch to Pluvicto is a compelling case versus another hormone therapy trial or anything else. So I think as you look out between now and the end of the decade, PYLARIFY scans with -- as a complement to RLT are going to be the major growth driver, that and also on initial diagnosis because I think people are now getting more comfortable with the fact that PSMA is way more sensitive than PSA. So as you're looking at very early-stage prostate cancer with low PSA, you're going to want a PSMA scan anyway.

And so to build on what Brian was saying because he's absolutely right in the sense that moving into earlier stages RLT scanning ahead of to prove avidity, the single largest driver, if not the driver of how we used to describe the TAM from going from $2-plus billion to $3.5 billion market opportunity by the end of the decade. And that is the numbers of scans that we would see eligible. Right now, it makes up sort of mid-single-digit type of market at the moment, but then expanding significantly from here.

Yes. Maybe on the subject of the TAM, the TAM, I think you have described as largely U.S.-based, where your revenues are overwhelmingly U.S.-based. That could change a little bit with some of the deals you've done recently. But I just wanted to ask how you think about the international opportunity for PSMA PET. There are some European and Japanese approvals happening near term or fairly soon. And so just curious thinking about the potential revenue mix and expanding your geographic footprint down the road.

Yes. In some ways, Europe is a more mature market, but the competitive dynamic is already there, but the pricing dynamic is much less favorable than the U.S. So we're partnered with Curium. They're selling PYLARIFY in Europe, and they're doing a very good job. And they're ramping country by country. We have plans for Japan, and we also are in discussions around China as well. So we do see -- we see PYLARIFY as a global brand for global growth, but the main market is the U.S. Japan, by sheer population numbers will never be as big as the U.S. And then -- but China is something that's a little bit longer down the road, but could be a tremendous market opportunity.

In terms of those other markets, you talked about your partner in Europe. And how do you maybe think about going direct versus partnering with a local company?

Well, after we close on Life Molecular Imaging, we'll have much more of a European infrastructure. So it will be easier for us to decide on whether we go to market ourselves or go with a partner. But I think we're always going to evaluate that decision. And as our pipeline matures, I think certainly for NEURACEQ, we would probably want to scale that ourselves in Europe. And I think with our [ AD ] portfolio in general, we'll probably think about doing that ourselves in Europe. But we'll cross that bridge when we get to the approvals.

Sure. As we think about some of the points you mentioned earlier, just government and policy changes here, one of the questions that frequently comes up is just thinking about what's happening with regard to Medicare payments, pass-through and other dynamics like that. So can you maybe just remind us what is your government versus commercial exposure currently, your rough mix for PYLARIFY? And then as you mentioned earlier, if the government does go to an ASP type pricing model perhaps as early as July, maybe later this year, how does that affect your franchise?

Well, if we -- whenever we get the ASP, it's basically a leveling effect. And then I think you have more even footing for the best molecule to win, and that would be us. As far as our government exposure in general, right now, we're living it, and that's the change from ASP to MUC reimbursement. That's roughly 20% of our patient population on average in any account. The rest is fee-for-service and Medicare Advantage. So right now, our strategic contracts are in place to basically keep the account whole on that segment of the population that has that change of reimbursement.

Bob, you want to jump in here?

No, I was just going to -- because you talked about government reimbursement more broadly in the sense that there are other elements in terms of the VA or 340B which is not what we're talking about in that -- in this particular sense in terms of MUC, it's a different pricing dynamic. But still, it's the 20% for the intersection of Medicare fee-for-service and hospital outpatient fee-for-service is the 20%.

Okay. Great. In terms of the level playing field that you described that could come with ASP, I guess, would that potentially change or maybe alter your commercial strategy now that...

Our prostate cancer referral team, what do you want them to do, build up the waiting list to another week to it? Like it's not going to help us in the short term. And I do think we want to drive adoption out into the community. So we're heading into the fifth year since product launch. So that's quite a bit of time actually when you think about it. So we always reevaluate the commercial strategy on an ongoing basis. And -- but I think we're also harmonizing that with our clinical strategy. And I think we're going to do a number of things in the clinic that will demonstrate PYLARIFY as a superior asset.

Okay. Great. I want to turn to Evergreen, which you guys recently closed on. And maybe can you just remind us what sort of, first of all, manufacturing and product capacity you inherited with this acquisition? And then one of the questions in terms of realizing cost and other synergies that we always focus on is analysis, how quickly can some synergies start to be generated here you integrate?

Yes. I think the synergies are going to happen rather quickly because we're already working with -- now keep in mind, we closed on Evergreen. So that's one. So #1 synergy is launching OCTEVY, which is a diagnostic agent for neuroendocrine tumors. And OCTEVY will be probably -- we're looking at midyear next year, approval and launch. So that's #1 synergy, if you will, revenue synergy. I think the other synergies that are going to come is when our radioligand therapy pipeline begins to take shape, we're going to want to put our own assets in our own plan. It's very difficult to use contractors for the whole value chain. So that's very exciting.

The other thing is we're probably going to pop a cyclotron into that facility as well to really take [indiscernible] other venues for the F-18 franchise or [indiscernible] whatever it is that you want to spin off a cyclotron. So there's a lot of R&D synergy, early development synergy, manufacturing synergy to come. But right now, what we acquired was a highly skilled team manufacturing everything from actinium to, unfortunately, iodine because no one loves to manufacture iodine. And we can make our own lutetium if we need to.

So we're basically at scale, running a CDMO business with multiple customers, multiple skill sets -- so over time, we're going to commit to a few strategic customers because we want the plant utilized, and we're going to begin to feather in our own assets. So right now, we're looking to get RM2 in there, LRC15 in there. CCK2R is being manufactured there. That's an evergreen asset. And we're in the clinic right now in Phase I in small cell lung cancer in Europe. We opened up that trial for recruitment, I think, last week, we covered all the regulatory barriers. So hopefully, you'll be hearing from us soon that we have a couple of responses in small cell, which will be really cool.

Maybe one other question on Evergreen is, as you think about the portfolio that you've acquired here, is there anything particular on the diagnostic side or the therapeutic side that is sort of potentially your favorite new toy here or that stands out as sort of your favorite thing that you're most enthusiastic about?

I think the standout is really Tom Reiner, who runs the development group there and some of the key talent underneath him like Thomas Lindner, and he actually discovered and developed the first [ FAP ] compound that went to [ Sophie ] and now was with GE. So there's a really small but very talented team that is working on developing a number of RLTs that we plan to move through the pipe. They have a very interesting little vivarium, so they can do their own animal studies.

And I think what we're looking at is when you combine that with what Life Molecular Imaging can do in their core labs in Berlin, we will have one of the best development chains in the planet. for radioligand therapy, whether it's imaging or therapeutics, it won't matter because right now, Life Molecular Imaging is in 2 major Phase III programs and also an early Phase I, Phase II in imaging. So they've been in the imaging business for a very long time, just like Lantheus.

So when we pool our skill sets, I think what we're looking to do is develop new leads at evergreen developmental stage assets and then move them into the full pipe that we have, get them developed and either win fast or fail fast. So we're looking for novel targets that are only suited for radioligand therapy.

Right. It sounds like you're happiest about the human capital you acquired with...

I think people make it work, right? Assets come and go, but people are priceless.

Great. I'll just briefly touch on your internal radio RLT pipeline and just -- which is -- has some little bit of litigation going on. Can you maybe just remind us sort of what are the next milestones and/or timing roughly that we should expect on that front?

Well, the one with litigation is our radio equivalent to Lutathera, which we call [indiscernible]. It is basically an [ ANDA ] that's been filed against Lutathera. I really won't comment on our legal case, but we're hoping and planning that 30-month stay is up at the middle of next year. And we know that we're working with a judge that would like to harmonize the timing of all of the patent litigation to sync up with the 30-month stay expiration. So we kind of like where we are. We know we have a formidable component across from us in litigation, but we also -- we like our case.

Okay. Great. Maybe turning to the rest of the internal pipeline and just thinking about -- is there a clinical program or aspect of the company that you feel like is just sort of under followed either by the sell side or the buy-side community that you think is just maybe potentially either a bigger intermediate or longer-term driver?

I think the whole pipeline is undervalued by everybody because really, it's only been over the last year that we've been able to assemble it and advance it in a way that can really -- where you could see value. So let's start with the Alzheimer's dementia portfolio that we have. We're filing MK-6240 in the third quarter. Behind it, we have NAV, which is a second-generation beta amyloid, and also running neck and neck with NAV is another tau agent at Life Molecular imaging called 2620.

And that tau agent is very interesting because it expresses -- it highlights the other tau pathologies other than AD, other than dementia. So that's very interesting. So when you look at [indiscernible] team and expertise. So the cost avoidance for Lantheus is tremendous. So that neuro portfolio team, assets, people in one bundle, we view that as a real meaningful short-term growth driver. Then you have next year, the combination of OCTEVY and 2003, again, 2 pipeline assets launching next year potentially that look very exciting and could be meaningful growth contributors and a very efficient sale for us.

We're already -- from OCTEVY's perspective, we're already calling on nuclear medicine physicians. So it's not a big reach to get them to look at OCTEVY and try it. And for 2003, that's a nuclear medicine call point for the most part, and PT committee. It's not -- we're not going to be running around talking to referring oncologists and talking to them about a generic Lutathera, just not in the cards.

And then I think if you look at the lineup of radioligand therapies that we have going into the clinic or in the clinic, we're looking at small cell, extremely high unmet need with CCK2R. By the end of the year, this calendar year, we'll have something to say about what we're seeing in patients real time. LLRC15, we plan to be in the clinic first -- at the end of this year in osteosarcoma. We will know rather rapidly if we've got something really to [indiscernible] therapeutic targeting GRPR is also a very exciting combination.

We're focusing on prostate cancer. Novartis has a similar program. They're in breast cancer. I believe Lilly is launching their program with a similar asset. We have a very interesting molecule with great dynamics, pharmacokinetics. And we're interested to see where it goes and GRPR expression in prostate cancer is quite interesting. It over expresses in early prostate and hormone-sensitive disease. So there is a definitive role that can be carved out for GRPR and PSMA. And I think finding where those 2 can coexist and complement each other because when one over expresses, the other one tends to down regulate.

I think that's a very exciting journey, and we're just at the very beginning of it. But our diagnostic works. We know it. We've got evidence in the clinic. It's in Phase II. And I think we're looking at a fast track approval there that we haven't really finished off the complete strategy. And then as far as the therapeutic is concerned, we plan to be in the clinic early next year, and we'll get a readout fairly quickly. And that will be in a population that would otherwise not be eligible for Pluvicto. So high GRPR expression, very low to no PSMA expression.

Okay. Great. I want to dig a little bit more into the Alzheimer's diagnostic opportunity that's potentially ahead of you here. And specifically, with LEQEMBI and [indiscernible] being slowly integrated into the treatment paradigm for Alzheimer's patients, what is the current use case for imaging agents like NEURACEQ? And sort of what is the current size of the market? And then I have a few follow-up questions.

I think we have a TAM at the end of the decade of around $1.5 billion. And that's with the current therapeutic agents that exist today. There's over 100 agents in development. We're in with MK-6240, for example, 103 academic trials and over 15 major pharma sponsored studies, everyone from J&J to Lilly to Merck. So we're working with everybody here, and they really want our tracers. I think the use case is quite strong. I think the approval of a blood test is a significant advance. And I think it can only build a more rational TAM because if you notice and if you read the FDA sort of press release when they approved the blood test, they sort of suggest that it's in place of or can be used in place of sort of unnecessary PET scans.

But what does that really mean? It means if you suspect AD and you don't -- and you didn't have a blood test available, your only real choice was to get a PET scan. However, now you have a blood test, if you're positive, then it's a very -- it's the absolute reason why you need a PET scan because you need quantification. You're trying to shrink beta amyloid, you need to know what you're starting out with and you need to know what's shrinking and you could quantify it with a beta amyloid scan.

And also with a tau scan, you can similarly -- you can track a patient longitudinally. You can see what area of the brain is affected, which would also directly correlate with symptoms, vision, memory, gait, et cetera. So there's a real paradigm here. So the blood test, I think, builds our TAM and it's more constructive...

Right. In terms of patient identification. [indiscernible].

[indiscernible] can certainly see amyloid on an MR or CT, but you can't really quantify it. And I think now what we're seeing is it's part of the initial workup. And then before patients go on a definitive beta amyloid therapy, they're getting another scan. And then they would get a scan at the end and completion of that therapy or if they're going to continue on therapy for some reason, maybe at the 1-year mark. So we're averaging in the TAM, 1.5 scans a year. But with a very good therapeutic that could go for up to 2 or 3. But right now, we're looking at 1.5 scans per year.

Great. I want to maybe take a minute to discuss the other side of it, which you mentioned, which is the tau side and tau opportunity. In our prior conversations, you've expressed a lot of enthusiasm for the tau side of things, even though there isn't yet an approved therapeutic on that side. And so I guess right now, you have some relatively late-stage pipeline assets for tau could be potentially in the market in 12 to 18 months, roughly speaking. And so can you help us think about what is the near-term opportunity and use case for it without a therapeutic on the market? And then maybe how do you think about it longer term?

Yes. I think in the short term, without a tau-specific therapeutic, it's a build, to be perfectly honest. But -- so we're in the Stanley Cup finals. We're going to use [indiscernible], and we're skating to where the puck is going to be. So with tau, we believe, and I think we have -- there's a lot of support for this, that eventually, it will be more important than a beta amyloid scan.

More specifically, tau deposition is directly correlated to symptomatology. And where in the brain, you can trace to exactly where the symptoms are. So for being able to follow a patient longitudinally, it's very important and very insightful. And I think the other part of it is if you have or if a subject has a significant tau accumulation, they should absolutely not get a beta amyloid therapy because it will not work. And in fact, you're exposing them to unnecessary treatments.

So I think Lilly did a masterful job of keeping tau out of the label. The one thing it should have done is put tau in the label, so people who have extensive tau deposition are probably not candidates for therapy. All of the trials for therapeutics are using MK and beta amyloid therapy in general as entry criteria to get into the trial. So I think the market -- I think it's a build. And then once there's a tau therapy, I think it becomes a whole different story. And I can only -- I could speculate on the growth, but if it's a safe product that has some effectiveness and it works against tau, it will be a blockbuster.

Okay. Great. In our remaining time, we have a minute -- a few minutes left here. I want to talk a little bit about portfolio management on the other side, you've been both in acquisition mode as well as divestment mode. And so can you maybe talk to us what was the reason as you reviewed your portfolio about selling your spec business to Shine? And how do you think about this versus sort of the broader Alzheimer's strategy that you've laid out on the imaging side and so forth?

I'll let Bob comment a little bit more on the Shine divestiture. But if you think about it, we're basically simplifying our organization around a strategic direction. So we're driving our company to more and more innovation, and we're staffing and buying and doing business development accordingly. And also, we're trying to find a home for a wonderful business that's been the core of this company that has growth potential in someone else's hands. So...

Yes. I mean this is a win-win for both companies in the sense that this is in their hands an opportunity for them to drive profitability in this part of the business. But for us -- and that's given their vertical integration into that space. But for us, this -- while we will take out $120 million worth of revenue on the topline, it's gross margin accretive by a couple of hundred basis points, as I mentioned. And even at net income, it is effectively a breakeven on an adjusted management basis. So that's just in our hands. They will be able to do much more with that. So from that perspective, it helps us refocus how our P&L is put together. And as Brian just mentioned, it's obviously our ability to focus on these new assets as well as the continued commercialization of what we have out there in the field already. So again, it's a win-win. We're thrilled to be partnered with them, and we look forward to being able to close that transaction year-end-ish.

Great. I want to maybe just squeeze in one more quick one because just on the cardiology side, which I think people are just also struggling to understand a little bit. You may or may not opt in, in the future at some point, but just sort of like how do you and your partner think about the potential here with GE?

Well, I think you'd have to leave it to GE. They've already put out some public commentary around what they see as the potential. I think through all the conversations we've had today, it's come up. And naturally, people think it's a very large and sizable opportunity, and we would agree. We're not opting in for anything. We're letting GE run the program here. The co-promote option that we have sounds interesting on paper, but it's not worth it for us. So it's their asset that they're running the show. We think it's got a tremendous amount of potential in their hands because they're able to sync up the technology of the drug, the tracer with the camera strategy, and that's perfect for them.

Great. Okay. We're out of time. So we'll end it on that note. My thanks to Brian and Bob for joining us.

Thank you.

Thank you.