Lantheus Holdings, Inc. ($LNTH)

Okay. We'll continue with the next session. I'm Paul Choi, and I cover SMID-cap biotech sector here at the firm. It's my pleasure to have Lantheus here for our next panel. To my left is John Wiggins, who is VP, I think, formerly of Isotope Strategy, but I think he's in a slightly new role here, if I recall. What we'll do is let John kick it off maybe with some high-level comments, and then we'll get into Q&A. If there are any, please feel free to raise your hand, and we'll try and get a mic to you during the session.

So maybe to kick it off, John, if we can talk about what are Lantheus' strategic priorities for the remainder of 2026 and as the company goes into 2027?

Yes, absolutely, Paul. So Lantheus is a leading radiopharmaceutical focused company. We are particularly focused on diagnostic radiopharmaceutical agents. And really, when we think about what we're doing for the rest of this year and then going into next year as well, number 1 is PYLARIFY. And we know that PYLARIFY is the most widely used prostate cancer imaging agent. We see tremendous value and continued value in that franchise. And a big effort ahead of us is rolling out PYLARIFY TruVu. So today, PYLARIFY is made in almost 70 manufacturing facilities around the U.S. And we have strong demand for PYLARIFY, and we want to be able to provide that to more and more patients and be able to reach further and further. And a big tool for us in achieving that is the rollout of the TruVu formulation, which allows us to put more Fluorine-18, more activity into each batch, get more doses out, potentially deliver those doses further. And that will start happening at the end of this year. So that's a tremendous focus for us. As we look at rolling out that new process to almost 70 different manufacturing facilities, to customers across the U.S. and ensuring that everything is in place for that. Second is Neuarceq. So when we acquired Life Molecular Imaging last year, they brought with them a commercial beta amyloid agent Neuarceq. And again, we see strong uptake and increasing demand for amyloid imaging agents as the anti-amyloid therapies have come to market and there's now a clear need to have amyloid imaging, both at that initial sort of patient screening, confirming the presence of the amyloid pathology. And then looking at response and how do those drugs clear amyloid out of the brain, when can a patient either go to a reduced level of therapy to a maintenance therapy or potentially stop the therapy altogether. The amyloid agents provide value in making those decisions. And Neuarceq is the fastest growing of the 3 approved amyloid tracers out there. And one of the things that we saw when we acquired Life Molecular was that Neuarceq had very strong market share in the markets where it was available, but it was only available in about 30% of the U.S. And of course, we know that with the PYLARIFY manufacturing infrastructure, we can expand nationwide in relatively short order. And we've done that. We've increased the number of manufacturing facilities for Neuarceq by about 50% in the last year, and that's increasing the availability quickly, and we will continue to do that and continue to make it more and more widely available. And we are also across neurology, I would say, looking at what our neurology franchise looks like. We have tau imaging agents available. We have second-generation amyloid imaging agent available. So even beyond Neuarceq in neurology, we see a lot of future potential for Lantheus. As we look generally at our pipeline that, that third strategic pillar for us really is development of our late-stage assets. So we have a number of diagnostic agents that are with the FDA for review right now. That includes MK-6240, OCTEVY, PNT2003, which is actually a therapeutic equivalent to LUTATHERA. And then we have agents that are in Phase III or entering Phase III as well. So we're doing additional studies with Neuraceq in cardiac amyloidosis. We're about to start a pivotal trial for our RM2 agent that targets the Gastrin-Releasing Peptide Receptor initially in prostate cancer, although that's broadly expressed, so we may well go beyond prostate cancer. And then we have GP1, which just won Image of the Year at the Society of Nuclear Medicine Annual Conference out in Los Angeles. The image was for deep vein thrombosis. We think the initial indication may be cryptogenic stroke, but we have a lot of potential for where we could go with that blood clot imaging agent. So as we look at that pipeline and advancing those late-stage assets in a way that, that keeps the real business case in mind for each of those agents and understanding how we prioritize those and how we make decisions on where to allocate our money for product development. That's certainly another focus for us. And generally, I would say, capital allocation and how -- what are we spending our money on making smart decisions about where we put that over the remainder of this year going into next.

Great. Thanks for that recap, John. Maybe since you focus primarily on supply chain and manufacturing, we can start there. And as you think about sort of the parts that go into -- and processes that go into manufacturing PYLARIFY currently, how does Lantheus manage this? And how do you, I guess, at the end of the day, make it easier for customers, particularly your radiologists and hospitals and stand-alone imaging clinics to or chains to utilize your products?

Definitely. Availability of the product is key. There are so many physicians out there who will tell you that the best PSMA imaging agent is the one you can get your hands on. So we want to be sure that, that it is readily available for our customers. I mentioned that we have this network of almost 70 different manufacturing sites around the country, and that's a big part of that availability. The TruVu formulation of PYLARIFY that has been approved by the FDA and that we will launch starting later this year is going to be another element of that, and that we can make more doses available and again, make them available further away potentially from the manufacturing facilities by essentially putting more activity on the dose when it's made and then allowing it to ship further. One of the tricks of these things for folks who aren't intimately familiar with radiopharmaceuticals is that you're shipping an ice cube. So it's melting, it's decaying away all the time, and you need to have a PYLARIFY dose, an activity level of about 10 millicuries at time of administration. But every 2 hours, the amount you have gets cut in half. So if you want to back up say, 6 hours, about 3 half lives, you need to start with 80 millicuries to get that 10-millicurie dose available 6 hours later. So that amount of activity that you can put in a batch to begin with is really critical in making those doses available. And what we've seen in the PSMA imaging market is that there is such demand for these products that imaging centers are facing some bottlenecks in certain areas, and they're addressing that by expanding the number of hours in a day and days in a week that they do scans. And in order to service those kind of shoulder times, those later hours in the day, or earlier hours in the day of weekends, all those sort of things, we need to be able to make more batches, but also we need to be able to ship doses from those batches further into the day. So being able to put more activity on a dose, being able to make a bigger batch upfront is very important for reaching those expanded time slots, where imaging is performed. One of the other advantages, I would say, for -- or areas that we are hearing more and more from customers about F-18 versus Gallium-68 agents, that goes to that kind of capacity question and dose availability question to some extent, really, it's about their throughput for patients is how long a scan takes. So with an F-18 agent with PYLARIFY, depending on the scanner, you might get a scan done in, say, 15 minutes or something like that. And that within that 15 minutes, you've got these radioactive atoms that are decaying, and they're giving off positrons and that's providing information to the scanner. And when the scanner looks to produce an image, it's really all about the amount of information that it has, the number of counts that it gets from those decaying isotopes. And with gallium agents, you really only get about half the rate of information because the half-life of gallium is shorter. So it decays away more quickly. There's less of it administered upfront. And therefore, a lot of these imaging centers are taking longer to do gallium scans than they are F-18 scans. And when we think about that capacity question, that's a big incentive for them to look at PYLARIFY instead of gallium agent.

Great. Just on that capacity and demand that you've spoken -- just spoke about, can you maybe help us triangulate what is the sort of market size right now? We can sort of look at the published numbers for sales for you and some of your competitors to think about that, but just how many scans are being done, I guess, at this point? And sort of what fractional share is that of the sort of prostate market, I guess, at this point? And what is driving that growth?

Yes. We think that [indiscernible] PSMA PET scans done -- and that's about 80% penetration of the market. So the total addressable market was maybe a little north of $500,000 for last year. And we do expect that to increase significantly, looking at a total addressable market of about $3.5 billion by 2030. The use cases for PSMA PET agents today are broken down into 3 different categories. We have the initial staging biochemical recurrence and then selection for PSMA targeted therapy. And of those, the BCR, biochemical recurrence is far and away the largest followed by initial diagnosis, initial staging of diagnosis. And then there's a pretty small slice that's patient selection for PSMA-targeted therapy.

Referenced, you're talking about Pluvicto here for the most part.

Yes. It is Pluvicto today. There are other agents and even non-radiopharmaceutical agents that are in development for the target PSMA. So PYLARIFY is potentially useful for those as well. So we see the largest as a percentage growth, the biggest chunk of growth in that market coming from patient selection for therapy, especially as these other products came to market as Pluvicto expands earlier and earlier in the prostate treatment in the course of disease there. But we do see healthy growth from, number one, just the incidence of prostate cancer, which is 2% to 3% per year growth that we're seeing there. But two, use in the BCR setting, use in initial staging and diagnosis. Today, when you look at the label for PYLARIFY, it's very broad. And in that initial staging and diagnosis setting, it's patients at risk of metastases. So that's, that's not well defined in the label, but in the guidelines and in what's reimbursed, there's more strict definition around that. And today, it's really unfavorable intermediate risk or higher where there's a clear guidance that PSMA PET imaging is appropriate. We do have a Phase IV study going on called MIRROR [indiscernible] intermediate risk, which would be kind of the next step -- and expanding the guidelines potentially that wouldn't be a label change. So just looking at a potential guideline change that might follow from that study. And that study should read out in the relatively near future.

Okay. You mentioned MIRROR, and just sort of thinking about what could that do in terms of expanding the addressable population. And does that also figure into your -- the $3.5 billion number that you talked about earlier?

Yes. We do have some growth in that initial staging of diagnosis that we attribute to use earlier use in lower-risk patients rather, in that initial staging of diagnosis. I would note that it's relatively modest. Again, the biggest chunk of growth is coming from that patient selection for radioligand therapy or for PSMA-targeted therapy, but there is some in there for increasing use in lower-risk patients. And to some extent, we see that already. We know there are a lot of physicians out there who want to use PSMA PET imaging, want to use PYLARIFY in those favorable intermediate risk patients. But the MIRROR study should help us with potential guideline changes.

Sure. Probably the #1 question we get from investors is just on TruVu. And first, can you talk about where you are from a positioning perspective to provide supply? And then second, can you talk a little bit about how you're thinking about fostering either adoption or penetration conversion, whatever you want to call it, to TruVu from the current formulation? And lastly, just on that point, how does pass-through in TPT payments sort of figure into how you think customers might adopt your view over time?

Yes, certainly, certainly. So TruVu was approved by the FDA back in March. But we have, I'd say, 2 major areas of work to accomplish to complete before we roll it out, before we really launch it. One of those is getting approval in all of the different manufacturing facilities. So when we submit an agent to the FDA, we don't necessarily have to include every facility that we ultimately plan to manufacture it in. We can include a small subset, and that allows us to get the submission in more quickly, get approval more quickly and then we can roll that out with relatively simple changes from a regulatory standpoint. So we're in the process of doing that right now. We're well along the pathway of submitting and receiving approval from the FDA for all of the PET manufacturing facilities in our current network for TruVu. The other piece of it is on the reimbursement side, and we need to have coding coverage and payment in place before we can roll that out to -- roll the product out to customers and have their reimbursement goes smoothly as well as prior authorization and those sort of things. So that means submitting for a HCPCS code, which we've done already and then submitting for pass-through payment, which we've also done already. And we expect to have feedback from CMS shortly on those things with issuance of our code and confirmation of pass-through payment. And that would -- those would be effective October 1 of this year. So October 1 will be then the earliest date that we could potentially launch and have that kind of low friction on the customer side of knowing they've got the coding coverage and payment in place. Except that, it takes some time for all of the payers to get those things into their system. So we want to be sure that all the payers, our customers -- that our various customers use have updated their systems, have the new HCPCS code in there, have pass-through payment where appropriate, identify so that the customers will have the reimbursement ready to go there. So, and that's going to lead us to wait a little bit longer on the actual commercial rollout of TruVu, but we'll start making it available to the first tranche of customers at the very end of this year, and then we'll continue that rollout into early next year and Q1 of next year. And the way that we're going to do that is to make it available on a regional basis. So, we'll start with a relatively low volume region for us, make it available over the course of a weekend basically. So if the last -- if all of the PET manufacturing facilities in this region, kind of implement that process over the weekend and Monday morning, they can make TruVu. Then that allows us to make it available across that region. We can verify then that all of those reimbursement mechanisms are working smoothly. And this is low friction from a customer standpoint, that they're not having to jump through any hoops or have any challenges with reimbursement for those scans. And that all of that goes smoothly. And then once we've confirmed that, that transition plan is working well, we'll expand availability to other geographies. And ultimately, we'll have the whole U.S. covered, we expect Q1 of next year.

You talked about making the experience frictionless from a reimbursement and approval perspective. Just in terms of like the workflow, any other aspects of the product for the actual imaging tech or radiologists who may be using it that are different? And how does it integrate into their current workflow?

Yes. We expect that to be very similar to the current version of PYLARIFY. It's based on the same clinical trials, ultimately, OSPREY and CONDOR. So we don't expect a difference in what the image looks like, how that's read by physicians, any of those sort of things. It's the same administered activity. It's the same type of kind of dose format at the end -- that the healthcare providers would receive for administration to the patient. So that should be essentially transparent to the customers.

Okay. I'm going to stop and take a minute and see if there are any questions from the audience. If so, please raise your hand, and we'll be happy to get them live to you. While we're waiting for that, maybe last thing, I guess, is on TruVu is, you highlighted a little bit on the differences versus the current version. Are there any benefits or differences that the customer would notice? Or is it more in terms of like sort of, as you mentioned earlier, more product available in terms of -- in terms of the yield that you mentioned before?

Yes. We would certainly hope that they will notice that availability improvement and that we can expand the number of available doses and the hours of the day that it's available. And part of that is as we look at the partnerships we have with our manufacturing facilities, is getting earlier and earlier manufacturing times during the day, so that the morning doses are available. But then ideally out of that same batch they make for those earlier times, still being able to service late day doses and potentially even later in the day than they do now based on the amount of activity that they can put into a batch. So that's something that we would -- yes, we would very much hope that the customers can see that ultimately.

Okay. Great. I want to turn to Neuraceq and the Alzheimer's market. And maybe you can sort of give us -- help us understand or maybe mark-to-market, what are sort of the current use cases for PET scans in Alzheimer's? How much of it is clinical trial or academic use driven versus actual sort of real-world treatment, treatment or diagnosis of patients? Maybe starting there.

Yes. Let me talk about 2 different Alzheimer's agents that we have. One is Neuraceq, which is a commercially available agent and see, as we discussed earlier briefly, solid use today and very good growth. And the other is MK-6240, which is our tau-targeted agent that's with the FDA for review right now and we expect a decision in August of this year on that. So on the amyloid side, the currently approved therapies for Alzheimer's disease require confirmation of amyloid pathology before starting administration, starting patients on these therapies. And then there's some difference between the 2, but regardless of the differences in label, what we hear from neurologists, from physicians is that best practice and I would say, routine practice is to monitor the patient response to those therapies and to look at amyloid levels and how quickly they're being cleared and then change the patients over as the amyloid levels drop, either to reduce dose to a maintenance therapy or perhaps discontinued therapy. So those are those are major use cases in regard to the therapies. But there is also a fair amount of use in just diagnosis and confirmation that Alzheimer's is the type of disease that's causing the patient's symptoms. So really, I would say it's that, it's those 3 things together of the diagnosis, the screening or selection of patients and then the monitoring of response. And what we see is that for a typical patient, there would probably be 1 scan done upfront and that could serve both purposes of diagnosis as well as determination of eligibility for therapy. And then some number of additional scans. And the therapies are relatively recently approved. So we don't have a great sense yet of exactly how many scans per patient that's going to be in the end. But we expect that most patients would get at least 1 additional scan and might get multiple additional scans depending on whether they've responded at the time of the first scan. And then once that -- once the patients' amyloid pathology has cleared, if they stop the dosing of those therapies, then amyloid tends to build back up over time. So there is further potential depending on the patient's life span of additional scans further out for that patient. On the tau side, MK-6240 is actually very widely used today, of course, not in clinical practice because it's not approved, but in trials, and in a lot of the Alzheimer's therapeutic trials that are going on, MK-6240 is used in some combination of patient screening eligibility for the trial as well as response monitoring. And the reason for that is that the tau protein that it targets is much more closely correlated with disease progression. And what we hear from many physicians today is that they would -- they're excited about a product like MK coming to market because, one, there's a lot of evidence that's superior to the one currently available tau agent. And two, that decision of whether to put a patient even on anti-amyloid therapy can be driven by presence of tau and the level of tau. And there is evidence in the trials of approved therapies today that lower tau burden at initiation of therapy is correlated with better outcomes, better response for the patient. So in essence, we may be looking at the ideal case for selecting a patient even for anti-amyloid therapy is, yes, they have amyloid because there has to be something there to target but that they're also below some level of tau. And essentially, what that would represent is confirmation that they are early enough in the stage of disease that we expect the anti-amyloid treatment to be effective. Of course, we think that the major push for use of tau imaging in clinical practice is going to be anti-tau therapies, and there are many that are in development now. And we're excited, for example, about the BIIB080 product that Biogen looks at to be taken to a pivotal trial soon. So once there is an anti-tau therapy, then that's a clear case for an agent like MK-6240. But even in advance of that, we do hear some interest from physicians and the utility of those agents for current therapies.

Great. The time lines for those potential tau therapies is a little further out as you noted. But I guess, if MK-6240 comes to market in the not-too-distant future, how do you see that being utilized in advance of the therapeutics becoming available?

As I said, I think there are physicians out there who see a use case for it today. But where we see the tau market today based on claims data, for example, is very small. And in that environment, we're going to be careful about decisions that we make around MK-6240 and exactly what that looks like post approval, assuming it is approved.

Okay. Maybe looking forward and outside Alzheimer's, you mentioned earlier you're developing multiple agents, most notably for PET. Can you maybe help us understand based on your roughly 70 current facilities where you are from a supply and manufacturing capacity perspective? And will you be able to sort of support not just clinical development, but ultimately, commercial supply down the road? Or does that require incremental infrastructure build-out?

Yes. It does, I would say, it requires infrastructure growth but we see healthy investment in these PET manufacturing chains. We've seen a lot of capital flowing into them, a lot of investment there in either upgrading existing cyclotrons or building out new sites with multiple cyclotrons on site, putting in additional hot cells, all these sort of things. So largely, as we've assessed that market, we see that at a gross level at a national level, there will be adequate PET manufacturing capacity for the agents that we and others are bringing to market and for the growth of current agents as well as those future agents. That said, it's very much a local game and there may well be specific sites where we see bottlenecks coming and need to take some action to prevent that and work with partners to ensure additional availability, and we are watching those sort of things closely. But we don't expect manufacturing overall to be a constraint on availability of our PET agents. There are a lot of things that we can do in our -- and are doing in our product development work to ensure that those agents are easy to manufacture. And that's things like TruVu, where we can now put more activity onto a single batch and reduce the number of batches that one of these facilities has to make. It's also being careful about how many different PET agents we bring to market and ensuring that we're not asking these facilities to make too many different products in 1 day or a particular time of day. So we're being careful about our selection of where we place products, how many products we place there, what we use time slots for, all with a view to maximizing availability. But the short answer to that is we don't expect manufacturing to be a bottleneck ultimately in availability of our products even with the view of our and others' pipeline agents. The other important piece, though, of PET imaging is the imaging side of it and not just the product availability, but the scanner availability. And again, there, we see healthy investment in new scanners. And as we discussed earlier, expanding hours of the day, days of the week for those scans, and we think that that's going to help to grow the capacity we see. But again, the push to F-18 agents like PYLARIFY for many customers because of that faster throughput and the ability to increase their patient volume that way. We see staffing as an important issue there. So when you have those additional hours of the week ultimately, that you're going to run those -- to operate them to handle the patients during that time. And that's something that we work closely with various industry and academic societies in looking at availability of technicians and incentives to get people into the training pipeline and have them qualified to perform those roles so that we can have adequate patient care out there for the number of patients that we expect to go through all these types of scans.

Great. As we look at the landscape, I think investors are trying to figure out sort of what is the direction of play, I guess, in this industry with regard to sort of isotope focus. You obviously are heavily invested in flourine, but there are other imaging agents that we've been discussing here, gallium and so forth. And so could you maybe talk about how Copper 64 might ultimately fit into this landscape? Is this something that's a priority for Lantheus where are you from a supply and capacity perspective? And just sort of what are the most reasonable use cases in the near to intermediate term?

Yes. Yes. Copper 64 is an interesting isotope to us. We do have an agent in Phase I in our pipeline that's targeting the fibroblast activation protein, fat, and that uses Copper 64. I would say that there -- Copper 64 is interesting from a supply chain standpoint, because it has a longer half-life than F-18 or Gallium 68. So F-18 and Gallium 68, both have to be made locally, Gallium 68, even more so than F-18. And that's why we have this network of almost 70 manufacturing facilities around the country for PYLARIFY. Copper 64 has a long enough half-life at 13 hours versus 2 hours for F-18 that it can be made more centrally. So what we envision for a product like a FAP agent is maybe 2 or 3 sites around the U.S., for example, that could supply the whole country. And because of the reach in the overnight logistics, which we had done for many decades with our SPECT products, we think we can cover the country with fewer manufacturing sites. So that's interesting from an efficiency standpoint, from an operational -- reduced operational complexity standpoint, those sort of things. And the trade-off there is that when you administer a Copper 64 agent, we talked a little bit earlier about the number of positrons that are given off in a scan. F-18 gives off a positron essentially every time it decays. Copper 64 gives one-off less than 20% of the time. So that means you need a lot more activity there to get the same kind of rate of information out of that scan. And products that are on the market today and even in development today, we don't think are using a high enough administered activity. And what we hear from the physicians who have used those products is that it takes much longer scan time to get a good quality image out of those products than with an F-18 agent, certainly. And we're being very careful about our own Copper 64 product and doing a robust dose finding study to be sure that we have the right administrated activity and that we can get a high-quality image in a reasonable scan time. I'll say that the 1 Copper 64 product on the market today is for neuroendocrine tumors. That's a relatively small market patient population. And if you're doing that number of scans, and you have to do a double or even more the time of the scan, that's manageable. For a PSMA agent, that will be a better couple [indiscernible] to swallow right? That's tough to get the level of patient throughput that you need for that market size with double the scan time for each patient. So I think that's the fundamental trade-off that we see for Copper 64 and the thing that we're being careful about in development of our own agent. But ultimately, it's an interesting isotope, and we see it having a place in our portfolio, clearly.

Okay. Great. Thanks to John and Lantheus for joining us today, and we'll end it on that note.

All right.

Okay. Thanks, John.