Lantheus Holdings Inc Aktie

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.

Good morning. Welcome to Lantheus' First Quarter 2026 Conference Call. This call is being recorded, and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Thank you. Good morning. With me today are Mary Heino, our CEO and Executive Chairperson; Amanda Morgan, our Chief Commercial Officer; and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions.

This morning, we issued a press release, which was furnished to the SEC under Form 8-K reporting our first quarter 2026 results. The release and today's slide presentation are available on the Investors section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Anne.

Thank you, Mark, and good morning, everyone. We had a strong start to the year with solid performance across PYLARIFY, NEURACEQ and DEFINITY. These results reflect our ongoing commitment to focus and discipline across the organization. As we said last quarter, 2026 is a year of commercial execution and regulatory milestones. We're making deliberate choices about where we focus our commercial efforts and deploying capital so we're positioned to deliver solid results in 2026 and accelerate growth in 2027. Our corporate focus is centered on radio diagnostics and our priorities for 2026 are clear.

First, maintain our market leadership in PSMA PET while preparing for a seamless transition to PYLARIFY TRUVU, our newly approved PSMA PET formulation beginning in the fourth quarter. Second, continue to build momentum for NEURACEQ through deeper penetration within existing accounts, leveraging the breadth of the Lantheus portfolio to unlock incremental growth opportunities and expanding our manufacturing footprint, increasing supply availability. Third, advance our late-stage clinical portfolio through key regulatory milestones and ensure launch readiness aligned with coding, coverage, payment, customer preparedness and market opportunity. And finally, allocate capital with discipline, prioritizing radio diagnostics while evaluating value-maximizing alternatives for our radiotherapeutic assets.

In addition to effective commercial execution, we advanced several key programs during the quarter that support our long-term growth strategy. On March 6, the FDA approved PYLARIFY TRUVU, our new PSMA PET imaging agent. PYLARIFY TRUVU offers the same proven diagnostic properties as PYLARIFY with a similar safety and efficacy profile. The value add of this product will be the larger batch sizes that can be enabled at manufacturing sites with high energy cycle times. This creates the potential to serve more patients and support a broader geographic reach. We estimate that more than 70% of PYLARIFY supply today is produced at PMF sites equipped with high energy cycle times, giving us confidence that through our broad PMS network, we are well positioned to optimize the benefit that PYLARIFY TRUVU can provide.

We also announced during the quarter, the FDA extended the PDUFA date for Actinium by 3 months to June 29, 2026, to allow additional time to review manufacturing-related information. Similar to our efforts with PYLARIFY TRUVU, we remain focused on advancing launch readiness, including securing coding, coverage payment and customer preparedness through the second half of 2026 with the objective of a full commercial launch in early 2027. On March 2, we announced that the FDA had offered tentative approval for PNT2003, the first radio equivalent to Lutathera for the treatment of gastro entero pancreatic neuroendocrine tumors or Gep/NET. Tentative approval confirms that the FDA has completed its substantive review and that our application meets the requirements for approval.

The timing of our launch will consider the following factors: timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings as well as manufacturing and commercial strategy to ensure launch success. As outlined last quarter, our strategy and related investments are centered on radio diagnostics and the progress we made this quarter reflects that focus. We are selectively prioritizing first and best-in-class PET radio diagnostic assets that complement our existing commercial portfolio and align closely with our nuclear medicine customer base.

I will highlight a few key pipeline updates. MK-6240, our registrational stage tau-targeted PET radio diagnostic for Alzheimer's disease represents an important asset within our Pharma Solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's disease-modifying therapy or DMT development. It is currently the most widely used imaging agent in beta amyloid and tau-targeted therapeutic candidate clinical programs. MK-6240 serves as an imaging agent for treatment eligibility in 17 current pharma-sponsored AD therapeutic programs and has a PDUFA date of August 13 of this year.

Lantheus 2401, our gastrin-releasing peptide receptor or GRPR targeted PET radio diagnostic for prostate cancer is advancing towards its planned registrational program this year. GRPR is a differentiated target from PSMA and Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal, extending this addressable prostate cancer population while fitting naturally within our existing prostate cancer franchise. Across the pipeline, we remain disciplined in strategically deploying investments based on stage gate and long-term opportunity. With robust mid- and long-term revenue drivers, a promising late-stage pipeline and a clear strategic road map, we are confident in our ability to drive meaningful performance gains that support a compelling outlook for our shareholders, and we're executing against that plan.

Our strong first quarter results reinforce that 2026 will be a year of commercial execution and regulatory progress, laying the groundwork for growth acceleration beginning in 2027. I also want to provide a brief update on our CEO search. The Board's process is progressing well, and we have narrowed the search to a small number of highly qualified candidates. In the meantime, our leadership team and I remain fully focused on execution as the first quarter results fully demonstrate. I will now hand the call over to Amanda to provide additional detail on commercial performance across our oncology, neurology and cardiology assets.

Thank you, Mary Heino. First quarter performance demonstrated continued commercial execution across our portfolio with solid volume growth and disciplined performance across each of our three core products. PYLARIFY, our market-leading PSMA PET imaging agent, delivered a solid quarter with U.S. volume increasing approximately 5.8% year-over-year. Performance was driven by consistent demand across our established customer base and continued pricing discipline in a highly competitive environment. Net ASP and volume for PYLARIFY remained stable sequentially despite ongoing competitive activity, we are well positioned as we continue to execute on our portfolio-based strategy.

This evolution strengthens our presence across sites of care and our PMF network and reinforces our market leadership in PSMA PET. Together, these factors support a seamless transition to PYLARIFY TRUVU, accelerate NEUROCEQ growth and prepare the organization for future launch opportunities. Overall, PYLARIFY remains a core contributor to our radio diagnostic strategy, supported by disciplined execution, deep customer relationships and continued usage and expansion of PSMA PET. The FDA approval of PYLARIFY TRUVU marks the next chapter of our flagship PSMA PET portfolio and reinforces our ability to serve the market reliably and at scale.

With approval secured, we are now executing against our transition plan with meaningful revenue contribution expected in 2027. We have submitted our application for a HIC6 code and are preparing to apply for transitional pass-through status. In parallel, we are working closely with our PMF partners to secure necessary FDA approvals for each manufacturing site ahead of the planned conversion, targeted to begin in the fourth quarter of this year. Our approach is deliberate. We will initiate conversions only once reimbursement coding is in place and customers and payer systems are ready to submit and process claims.

Our PMF partners are preparing to transition to the new formulation and recognize the operational advantages that PYLARIFY TRUVU offers, including enhanced stability at higher radioactive concentrations, which provides greater supply flexibility. This creates the potential to serve more patients within a given market or support delivery to sites that are further from the manufacturing location or potentially both, depending on demand in a particular area.

Now turning to the rest of our commercial portfolio. NEUROCEQ, our beta amyloid PET imaging agent for Alzheimer's disease, generated $35.4 million in the first quarter revenue, representing 14.3% growth compared to the fourth quarter of 2025. As the second most utilized and fastest-growing beta amyloid PET imaging agent in the U.S., NEUROCEQ addresses a large and expanding market opportunity. Growth was driven by increased utilization within existing accounts, supported by broader adoption of Alzheimer's, DMTs and clinical guidelines that favor earlier diagnostic use, particularly in patients with mild cognitive impairment and early Alzheimer's disease.

We are leveraging our existing nuclear medicine relationships across the Lantheus portfolio, supported by continued expansion of our NEUROCEQ PMS footprint, which is now up to 22 sites to drive execution and incremental growth as additional locations come online. Together, these factors further build on the momentum exiting 2025 and reinforce our confidence in NEUROCEQ's long-term growth potential. DEFINITY, our market-leading ultrasound-enhancing agent, remained a steady contributor to our overall performance and delivered $84.6 million in first quarter revenue, representing year-over-year growth of approximately 6.8%. Growth was primarily driven by increased volume demand.

With more than 80% market share, DEFINITY continues to demonstrate the durability of a long-standing market preferred product supported by deeply embedded clinical workflows and consistent utilization across sites of care over its 25-year history. I'll now turn the call over to Bob to provide more detail on our first quarter results.

Thank you, Amanda, and good morning, everyone. I will provide highlights of the first quarter 2026 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Revenue for the first quarter was $377.3 million, an increase of 1.2% compared to the prior year and increased 8.6% when adjusted to exclude $25.2 million of spec revenues from the same period prior year, which was divested on January 1.

Before I begin with the details, I would like to note that we have reconfigured our revenue reporting into new categories to reflect the diversity of our portfolio. The 4 main groupings include oncology, neurology, cardiology and strategic partnerships and other as well as one additional for the divested spec business to reflect prior period results. Our SEC filings reflect this change, and we have grouped prior period comparisons accordingly.

Now starting with oncology. Consisting of PYLARIFY, it contributed $240.9 million of revenue, down 6.5% from the prior year. Neurology revenue, consisting of NEUROCEQ was $35.4 million for the quarter. Cardiology revenue consisting of DEFINITY was $84.6 million, up 6.8% year-over-year. Strategic partnerships and other revenue was $16.3 million, up 52.1% due to the strength of our Pharma Solutions portfolio in addition to adding the Evergreen CDMO business. MK-6240 represented over half of the revenue in this category.

Gross profit margin for the quarter was 67.0%, flat to first quarter 2025, favorably impacted by the SC divestiture, PYLARIFY and DEFINITY volumes as well as DEFINITY price. offset by a decrease in PYLARIFY net price and inclusion of the Evergreen manufacturing facility and a near-term margin dilution of NEUROCEQ relative to the company average, both of which were not in the comparative period. Operating expenses at 32.8% of net revenue were 455 basis points unfavorable from the prior period, but favorable to previously guided spending levels. This increase was mainly due to the acquisitions of Evergreen and LMI operations across each spending category, which are not reflected in the prior period.

Increases in research and development expense, which was due largely to planned investments to advance our expanded clinical stage portfolio. Sales and marketing increases reflect the inclusion of the NEUROCEQ sales team and launch activities, mainly focused on PYLARIFY TRUVU. G&A was up slightly in the period due to higher professional fees and employee-related costs in the quarter. Operating profit for the quarter was $129.1 million, a decrease of 10.5%. Other income and expense was $0.8 million of expense.

Total adjustments in the quarter were $28.1 million of net adjustments before taxes. The company recorded a gain on the sale of SPC of $59.3 million and unrecognized gain of $16.6 million attributed to its equity investment in Perspective Therapeutics, offset by an unrecognized loss of $1.7 million on Radio pharm Theragnostic. Also offsetting these gains, the company incurred $16.0 million and $16.7 million of expense associated with noncash stock and incentive plans and acquired intangible amortization, respectively. The company recorded $6.4 million of other acquisition, integration and divestiture costs. The remaining $7 million is related to other nonrecurring expenses.

Our effective tax rate was 25.3% in the quarter. The resulting reported net income for the quarter was $118.4 million and a profit of $95.8 million on an adjusted basis, a decrease of 12.5% from the prior year period. GAAP fully diluted earnings per share for the first quarter was $1.80 and $1.46 on an adjusted basis, a decrease of 4.6%.

Now turning to cash flow. First quarter operating cash flow totaled $125.1 million as compared to $107.6 million in the prior year quarter. Capital expenditures totaled $3.2 million, $5.5 million less than the prior year quarter. Free cash flow, which we define as operating cash flow less capital expenditures, was $121.9 million, an increase of $23.1 million from the prior year period. Taken together, cash and cash equivalents net of restricted cash were $498.6 million as of the end of Q1. We have $200 million remaining on our Board authorized buyback program and have access to our $750 million undrawn bank revolver.

Now turning to expectations for full year '26. The strong start to the year across the portfolio reinforces our confidence to deliver on the outstanding guidance for both revenue and adjusted EPS. We remain steadfast in our strategies to protect the long-term value of our PSMA franchise, especially ahead of launching PYLARIFY and TRUVU beginning later this year and also remain ever mindful of potential competitive dynamics. As such, our full year forecasted revenue remains at $1.4 billion to $1.45 billion for 2026.

Our first quarter results underscore the disciplined execution of our strategic priorities and commitment to streamlining our cost structure to drive operational efficiencies, enabling us to support sustainable long-term value creation. We are making progress to evaluate alternative opportunities for the therapeutic assets to rebase the company's earnings profile and growth trajectory as was noted on last earnings call. We continue to balance strategic investments and cost management across the organization and expect to deliver solid bottom line results with EPS in a range of $5 to $5.25. With that, let me turn the call back to Mary Anne.

Thank you, Bob. In the first quarter, we accomplished what we set out to do. PYLARIFY, NEUROCEQ and DEFINITY all performed well, and we achieved two important regulatory milestones with the FDA approval of PYLARIFY TRUVU and tentative approval of PNT2003. Looking ahead, our priorities are unchanged: maintain our market leadership in PSMA PET by sustaining PYLARIFY volume growth and executing a seamless transition to PYLARIFY TRUVU, continue to build momentum for NEUROCEQ and successfully advance our registrational stage products towards regulatory milestones. All of these will position Lantheus for the growth acceleration we expect beginning in 2027. We are driving forward through the rest of 2026 with confidence in our strategy and in the Lantheus' team's ability to deliver. The first quarter was a terrific start, and we remain focused on the work ahead. With that, I'll turn it over to Q&A. Operator?

[Operator Instructions] And our first question comes from Anthony Petrone of Mizuho Financial Group. And our next question comes from Richard Newitter of Truist. Congrats on the progress this quarter.

I've got -- I guess the first one, maybe for Bob on guidance. You had a pretty nice beat in the first quarter across the board, just about every product line. I guess the reiteration of the guide assumes some step down in the 2Q to 4Q, presumably for all the businesses. I'm assuming that's just conservatism on your part. I just wanted to make sure, one, that's the case. And then was there anything -- is there anything you're seeing that would lead you to be incrementally cautious as we move forward into the remainder of the year? Or is this just good old-fashioned prudence on your part, you still have a few more quarters of transitional pass-through disadvantage to get through? And then also, if you could just comment on what your assumption is for PSMA PET imaging diagnostics market growth in 2026 for the remainder of the year? And what did it grow in the first quarter?

Okay. So I'll start with the -- obviously, with the guidance. So to your point, we had a very solid start. And we saw that in terms of volume growth, in terms of pricing dynamics, fairly steady state from what we've seen over the last number of quarters, in fact, almost delivering exactly the same number for each of the last 3 quarters in a row. But it's early in the year. And so we're going to remain vigilant to the market, the competitive environment out there. We still have one competitor who is maybe find some footing with their new products, launch themselves as well as one that will be losing pass-through later this year, call it, October 1. So for us, we're going to -- to your point, we're going to be prudent with this.

The other thing that I think that plays into this a little bit is the fact that, as Mary Anne noted in her prepared remarks, that we do see a new CEO in the near future. And I think it's right to allow that person to own the balance of the year. So our assumptions really haven't changed in terms of expecting what we had said earlier in terms of gross to net as the year progresses. And I still continue to model modest volume growth looking forward. So I wouldn't have you model Q1 forward in that sense. So our strategy remains the same. It's intact. We're watching our competitors and talking with our customers, remaining disciplined. And again, the focus for the year is on launching PYLARIFY TRUVU and protecting that franchise on a going-forward basis.

It's Maryann, and I'll step in on your second question around the PSMA PET market growth. I think the market continues to play out exactly as we anticipated. If we look back and look back to '25, we saw high teens to low 20s percent growth for the entire market over the course of the year prior -- relative to the prior year. And this year, as we -- I think we shared in our last quarter's discussion points, we were backing off and saying that we expected for '26, that growth would be in the low teens. And I think that is what we're seeing. I'm not being specific because this is a market that from a data perspective, truly has to be triangulated. Unlike the pharmaceutical prescription market, there are no clean third-party data sources to kind of bring these estimates together.

So what we do is we look at our own results We, of course, monitor what our competitors are reporting. However, as you can imagine, there's not a lot of talk track from Novartis on locomotes and PostLuma is offered by a private company. So I'm offering you that just to say, I'm not trying to avoid giving you a direct numeric answer, but it is a triangulated figure that we arrive at, and we're very pleased with what we're seeing in the market.

And our next question comes from Anthony Petrone from Mizuho Financial Group.

Sorry about that. I was muted, hopping across calls here, but congrats on the strong start to the year. Maybe just on TRUVU into the TPT ruling and just launch, how that's going to sort of work out from a contracting perspective? When do you think TRUVU will be completely adopted? And at what point does PYLARIFY Gen 1 get phased out? That will be my question. I'll hop back in queue.

Terrific. Anthony, thanks for the question. I'll take that. First, let me offer for clarity. It's not a -- PYLARIFY won't be phased out. PYLARIFY will be transitioned directly to PYLARIFY TRUVU. So in any market, only one of the products will be available at a time. And that's very purposeful on our part because as you can imagine, if our PMF partners had to run 2 different batches, which they would have to, it would take up too much of their manufacturing time, and we prefer to have a single product in each market that we can focus on. So just I wanted to offer that for clarity. It will be geographically a site-by-site conversion.

As we've offered before, I'll share again that we plan to begin that conversion in Q4 of this year. It's very carefully thought out, and I'll explain why. These products as a class, PET diagnostic products are uniformly prior authorized. You require prior authorization for insurance to cover them. We must ensure that insurance coverage is in place and that the systems are fully operational with the coding and the coverage requirements for TRUVU before we take that product into any market. In like fashion, and you're aware of this from the comments we've offered, we also have to make sure that we have our HCPCS code and that we have PPT in place, transitional pass-through payment. Those have slightly different schedules of what the application process is for applying and receiving it.

But from our perspective, the one piece that's clear is all must be in place before we ask our customers to start ordering TRUVU. -- we have worked long and hard to make sure that this will be a seamless transition, and we're really confident in it. But that's why you've seen already we got the approval date, but we're not yet in the market. This is carefully thought through and will be exceptionally executed once we take it into the market.

And our next question comes from Roanna Ruiz of Leerink Partners.

I have a follow-up question about TRUVU. I was curious what strategies do you plan to use in terms of enabling customer readiness and prepping hospitals and imaging sites to potentially switch and get really comfortable with TRUVU? And I was also curious, given what you've learned from the original PYLARIFY launch, is there anything you want to get ahead of and proactively mitigate in terms of possible hurdles to adoption?

So Ron, I'll take your question as well, and I'll kind of bounce up of what I just shared from Anthony's question. This is a master piece of preparation because before the first dose and from our customers' perspective, all we want them to see is that their dose shows up and that the coverage and payment, the reimbursement for it has already been fully approved. And so we want it to look invisible to them as to which of the Lantheus PET franchise products they're using, TRUVU or PYLARIFY. And again, they'll only be using one at a time. There's lots we can do to get ready.

And you heard Amanda and Amanda's comments her repeatedly referring to our prostate cancer franchise. It is actually in the nuclear medicine customer base, it's actually more than that. We are a full portfolio of products that we bring them in addition to our prostate cancer PET products. And all of our communications with our customers really center on one thing. Do you have the access you need? Does the product show up when you need it? And do you get fair reimbursement and coverage for it? And that is what we work continuously to ensure for our patients. We also will have some work done in order to contractually prepare our customers for TRUVU versus PYLARIFY. And that is also something that we're very experienced with. From a nuclear medicine perspective, we have been doing this for 60-plus years with the nuclear medicine department. So we're also confident that we'll be able to handle that.

I will say just operationally, there is a set of functional steps that we'll go through with each PMS to ensure that they are -- that they can manufacture and that they're approved to manufacture. As we've shared in the past, PM as a network and as an individual site are individually approved as GMP manufacturing sites by the FDA. So we also have a very carefully thought through plan as to how to secure region by region to ensure that the FDA approvals are in place for all of our PMF sites.

And as with any other manufacturing site, there's a set of steps you go through with what's called validation batches, which kind of proves out the manufacturing process and that you can consistently replicate that process. Let's remember, PYLARIFY was a first. We -- not only in PSMA PET, but in the scale of a new launch that had not been seen in many decades in a PMF network. We did it then. We're very confident we can do it again with PYLARIFY TRUVU.

And our next question comes from Matt Taylor of Jefferies.

On TRUVU, I was wondering if you could talk a little bit about the pricing strategy with TPT and how much in the initial transition period can you realize? And can you give any high-level thoughts on how that could impact 2027?

So Matt, it's Mary. Thanks for your question. I will share what I always share. We don't talk about pricing strategy. What I will say and what I think all of you from working so closely with us over the years are aware of is that transitional pass-through is a reimbursement mechanism that's available only in the hospital outpatient setting and only applies to traditional fee-for-service Medicare patients. And so we're very cognizant of how to ensure that, that the possibility and the opportunity of that coverage being available for that patient group is something that our customers are very aware of.

And I don't think I need to say that it's certainly from our learnings with PYLARIFY, it's something we're very focused on to ensure that, that reimbursement status is clear and available to all of our hospital-based customers, especially those who have larger patient populations of traditional fee-for-service Medicare. What I -- we will not give forward guidance, obviously, to 2027. Yes, you have to wait later in the year for that, Matt. But as we said repeatedly throughout our script, we do see 2027 as a year of growth acceleration. So you can probably infer from that.

And our next question comes from Yuan Zhi of B. Riley.

Maybe a question to Marianne or Amanda. On your radar, do you see any other F-18 or Gallium-68 PSMA imaging agent entering the market in the next couple of months? And which market or geographic areas do you anticipate some meaningful impact?

I'm going to let Amanda take that for you.

Sure. Thanks for the question. So as you can probably imagine, we continuously monitor the marketplace, and we're watching for all types of agents that could enter the market. We remain steadfast on the franchise that we have set up through our prostate cancer franchise and PYLARIFY and the follow-on asset of PYLARIFY TRUVU. So we will continue to monitor the marketplace, but we remain confident in the franchise that we've established, and we remain confident in the relationships that we have with our entire portfolio as well as within our nuclear medicine relationships.

So I'll just add there. I think as anyone who follows the space is aware, we follow there are 2 copper-based products that are in development, late stage that have the potential to enter the market at some point in the future. We don't see any of that occurring in 2026. And -- but we continue to follow their progress and their programs. We're also aware that there are 2 other gallium-based products worldwide, PSMA gallium-based products that could then have potential for application into the United States. But again, we don't see those as imminent on our high. We have and have purposely developed a portfolio approach to our nuclear medicine customer base, we feel that, that will keep us highly competitive and successful in our interactions with not only our prostate cancer franchise, but our neurology franchise and any other therapeutic areas that we enter with that customer base.

And our next question comes from Paul Choi of Goldman Sachs. And our next question comes from Andy Hsieh of William Blair.

Maybe just a kind of an educational one for us. Mary, you mentioned about the high-energy cyclotron that's required for Truvu. So can you give us a sense of what percentage of your PF network is equipped with such equipment? And do you foresee longer term, all of them will be transitioned to the high-energy versions? And just maybe comment as you go through the hardware transition, any sort of supply -- maximum supply versus what you expected for the original PYLARIFY. Just kind of get a sense of the ramp-up and also from a production perspective.

Sure. And it's a great question. I did address a little bit of this in my remarks. But when we look out at what the current PMF network is that services PYLARIFY and will service PYLARIFY TRUVU in the future, we estimate that already 70% of that, and I'll call it a fleet. It's a fleet of manufacturing sites. We estimate that 70% of our fleet is already serviced by high energy cyclotrons. And therefore, that gives us confidence that what we see as the value add of PYLARIFY TRUVU is directly transferable into the market.

I do want to address operationally something you mentioned about transition of hardware to PYLARIFY TRUVU. If you understand the operational basis of PMF, they essentially use a cyclotron to produce isotopes and the predominant isotope is obviously F-18. But then F-18 then is run through a manufacturing process that's called a synthesis box. And it is on the synthesis box that the product-specific elements are added in to form the final product. And so it is a different -- and they call them -- this is the synthesis boxes have different names, but for all intents and purposes, they call the objects cassettes that they attach to the synthesis boxes to complete the final production of the F-18 labeled isotope imaging agent.

In this case, they will use a different set of cassettes to produce PYLARIFY TRUVU compared to what they were using for PYLARIFY and compared to the other types of cassettes they use to produce other F-18-based isotopes like SEG or the other isotopes that they're producing. To the other part of your question, I'll say that the incredible success of PSMA PET imaging agents as well now as the emerging building success of PET-based Alzheimer's disease agents has incredibly invigorated the PMF network chain that service the United States medical market. And it's a clear opportunity to them and for them to invest in their operational readiness with higher energy cyclostomes.

I can't speak to their -- to what their capital plans for investment are, but I can speak to what has clearly been a renaissance of PMF-based products in the United States and what that means for their business case. Again, just to reiterate the first part of your question, the PMS that produce PYLARIFY, 70% of our dose volume currently comes from PMFs that have high energy cyclotones in place. I hope that was clear and helpful.

And our next question comes from Paul Choi of Goldman Sachs.

Apologies for fumbling the question earlier. My question is on gross margins, which looked better this quarter than it has in a little while, and this is ahead of your potential switch to Truvu down the line and getting to scale. So my question is, is this sort of a more normalized run rate? Or is this sort of a one-off for this quarter as we think about sort of the margin profile over the short to intermediate term?

Paul, I appreciate the question. When we gave guidance, I don't know, back whenever it was end of February, I think I noted that we would be between sort of 65% and 66%. We're probably going to end up trailing towards the higher end of that particular range. So there is a little bit of a one-off. I mean we did have a lot of benefit coming from PYLARIFY and DEFINITY volumes. We had the spec divestiture, which is the majority of the year-over-year change, but that was offset by the PLA pricing headwind and as well as the inclusion of LMI and Evergreen into the mix. So that was intentional that was with the spec divestiture in the sense that, that gives us sort of the tailwind to offset the PYLARIFY pricing headwinds that we see. So I would still have you model more like where I had guided, but maybe towards the higher end of the range.

[Operator Instructions] And our next question comes from Justin Walsh of Jones Trading.

I'm wondering if you can comment on the process for turning PNT2003's tentative approval into a potential full approval in June. And wondering if you can remind us if PNT2003 is included in the current guidance.

I'll start with your question about approval, and then Bob can speak to what he is included in the guidance or not. As I mentioned in my comments, PNT2003 did receive tentative approval in March from the FDA. And for them having offered tentative approval, what they convey with that is that essentially their review is complete and they find the basis of approval for the product. However, because there is a Hatch-Waxman stay with this product, the final approval will require, let's call it, 3 different things.

The first is either the expiration of or the resolution of the Hatch-Waxman stay. And what that means is that is -- it's essentially a challenge about whether the original product patents are being violated by your application. And to the extent that if it's not, if you need to have 1 or 2 things happen, the 30-month period can expire or the FDA can rule ahead of that, that they'd be finding that there is no infringement for the product. There's also then related to that, there is the disposition of kind of related legal proceedings, which again, is more of a legal issue. And we will, of course, wait for that. There was the Citizens petition also filed by Novartis and their request for reconsideration of that citizens' position, that was a 150-day period from when it was first filed.

So all of that together, I think what we're saying and what we're trying to communicate is that once we have final approval from the FDA, we can technically launch the product. And we see that occurring again, either at either the expiration of the Hatch-Waxman period or the resolution of it and then the related legal findings. Having said that, what I would also like to communicate is our decision on ultimate launch date will follow the comments you've heard me say repeatedly throughout my remarks, and that is we will ensure that there is launch readiness, customer preparedness and that all coding and reimbursement related benefits are in place for the product before we take it to market.

And with regard to what's in the guidance, I think we had said during the beginning of the year that any of the approvals that we would be getting for products this year were not considered and we should not be sort of in any material way, embedded into the 2026 total revenue expectation. So I would -- it's not in the model effectively.

And our next question is a follow-up from Matt Taylor from Jefferies.

I just had a follow-up on guidance. So I wanted to ask because of the strong start with PYLARIFY, when you guided before, you were talking about the potential for pricing pressure and baking in some conservatism. I guess I just wanted to confirm, it doesn't seem like you're seeing that, are you? And I guess, the -- it sounds like you're being conservative with the new CEO coming in, it makes sense. But would you have raised guidance if not for that?

You know what, Matt, I'm going to give Bob a break on this one and answer your question, which I think in large part, Matt, you may have answered for yourself with the way you phrased it. We're early in the year. We're really happy with our first quarter results. But we're also sitting pretty much right in front of the CEO change, which I've also been fairly transparent about. And I think for all of those reasons, we felt that the most prudent thing we could do was hang with the guidance that we had already offered, which we felt was already a great outlook for our company.

And our next question is a follow-up from Anthony Petrone of Mizuho Financial Group.

Popping back and forth, but I wanted to press again on NEUROCEQ for a moment. Maybe just a reset on NEUROCEQ and the landscape there for beta amyloid tests and where is the NEUROCEQ share today relative to competitors? I think GE is out there with Vismo and Lilly has [indiscernible] what is the expectation for a higher attach rate to the 2 disease-modifying agents going forward? And the prescription trends for Alzheimer's disease look bullish. Just an update on that market as we look into the back end of the year.

So Anthony, I'll start with this and then Amanda can jump in if I miss anything. But I think what you've heard us repeat now consistently is NEUROCEQ holds 2 places of note in the beta amyloid imaging market. First, -- it is the fastest agent growing of the 3 agents that are currently present in the market. And second, it holds the second highest share already in that market. Now I'm not going to offer specific market share, again, for the reason that these are estimated figures. We have to triangulate back into them. And I don't think it's germane. I think what's germane to hear from us is that we are investing in NEUROCEQ to ensure that it has expanded availability and availability is key in this market as it is in the other [indiscernible] market.

That is our major investment thesis for 2026 that we can accomplish 2 things -- or actually, I'll take it now to a third thing. First, we can use our portfolio approach to have our customers use NEUROCEQ as their beta-amyloid imaging agent of choice based on their relationship with Lantheus and the customer service we provide. Second, that we can drive deeper penetration in existing NEUROCEQ accounts that goes along with the great growth we're seeing in the market because of, as you referenced, the adoption of and the continued adoption of the beta amyloid therapeutic agents. And third, that we can expand the footprint of where the product is manufactured.

So that again, it serves number 2, which is deepening penetration in existing accounts, but it also gives us access to new accounts out there. And these are all benefits that we had considered as we considered the LMI acquisition because as a company at their size and their financial capabilities before the acquisition, they just did not have the bandwidth to take on some of these opportunities. We do and we will, and we see that coming back to us not only in '26 already, but certainly in '27 and beyond. Amanda, did I leave anything out of note to that?

You did a fantastic job. Maybe I'll just add a few key points that NEUROCEQ is really addressing a large and expanding market. And so it's benefiting from that market. And as Mary Anne shared, the adoption of the Alzheimer's CMT is critical. But also the other point to add in is that the guidelines favor earlier diagnostic usage. So that's an important component. And then finally, I'll just kind of anchor down on the ability for us to work with our nuclear medicine customers from a Lantheus portfolio perspective is really advantageous for us and for our customers. So I would just like to add that.

Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect, and have a wonderful day.

Good morning. Welcome to Lantheus' Fourth Quarter and Full Year 2025 Conference Call. [Operator Instructions] This call is being recorded, and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for at least 30 days.

I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Thank you. Good morning. With me today are Mary Anne Heino, our CEO and Executive Chairperson; Amanda Morgan, our Chief Commercial Officer; and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions.

This morning, we issued a press release, which was furnished to the SEC under Form 8-K reporting our fourth quarter and full year 2025 results. The release and today's slide presentation are available on the Investors section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings.

Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website.

I will now turn the call over to Mary Anne.

Thank you, Mark, and good morning, everyone. It's a pleasure to be back with you as CEO at an important moment for the company. I want to start by recognizing Brian for his leadership and for ensuring a smooth transition. While my role as CEO will be interim as we complete the search for the next Lantheus CEO, I'm thrilled to be back in the operational leadership role with the same passion and commitment that those who work with me will remember.

I have taken time to meet with shareholders over the past months and appreciate the ongoing opportunity to listen to your feedback. My intent is to seamlessly transition our strategy and the execution of that strategy to the incoming CEO. I will note the Board and I are successfully progressing our CEO search, and I am pleased with the candidates we have met thus far.

Before I offer comments about our business achievements for 2025, I would first like to share that Lantheus' products helped impact the lives of approximately 7 million patients in 2025, underscoring the real-world importance of the work our teams do every day.

Now, turning to the results, I would like to start by highlighting the important progress we made in 2025 to shape our strategic focus within the radiopharmaceutical industry. The decisive actions we took in 2025 include: We closed two complementary transactions that diversified and will accelerate our near-term revenue stream across our commercial radiodiagnostic portfolio. First, the acquisition of Neuraceq, our beta-amyloid-targeted PET radiodiagnostic, which now serves as the commercial cornerstone of our Alzheimer's disease portfolio. We are excited both about the growth potential of Neuraceq and the expanding amyloid PET imaging market. And in 2026, we expect Neuraceq growth will exceed that of the overall market. Second, our acquired product candidate, OCTEVY, a neuroendocrine PET radiodiagnostic currently under FDA review. Upon approval, OCTEVY will enter the well-established gastroenteropancreatic or GEP-NET PET imaging market. This product fully complements our nuclear medicine customer base and allows us to broaden our offering to the customers we already engage with for PYLARIFY and Neuraceq.

In 2025, we also took meaningful steps to further build out the portfolio of radiodiagnostic products Lantheus offers to the prostate cancer community. Our primary focus in 2025 was defending our leadership position in the PSMA PET imaging space with PYLARIFY, and we believe that position will serve as a key advantage as we prepare the market for our new formulation later this year. This past year, we also advanced Lantheus 2401, our Phase III-ready gastrin-releasing peptide receptor or GRPR, targeted radiodiagnostic for prostate cancer. GRPR is a biologically distinct target from PSMA and an estimated 15% to 30% of prostate cancer patients do not express PSMA. Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal, extending the addressable population while fitting within our existing prostate cancer franchise.

That transition will take place -- with these acquisitions and the other activities accomplished to build out our pipeline, we believe that Lantheus now has the broadest radiodiagnostic pipeline among our peers in the radiopharmaceutical space. Finally, we completed the divestiture of our legacy SPECT business on January 1, 2026. While the SPECT business was foundational to Lantheus' renowned reputation in nuclear medicine over many decades, our strategic intent is to prioritize investment in and the commercialization of innovative PET radiodiagnostics on a forward basis. For having narrowed our strategic focus to radiodiagnostics, we believe we can deliver sustainable and attractive revenue growth in the mid and long term.

Looking ahead to 2026, we are fully focused on commercial execution and revenue generation with our current commercialized assets as well as successfully advancing a number of approval milestones for our registrational stage products. Our top priority is to maintain and strengthen our leadership in PSMA PET by sustaining PYLARIFY volume growth while preparing the market for the launch of our new PSMA PET formulation. That transition will take place in the fourth quarter of 2026, with the material commercial impact of that launch beginning in 2027.

In neurology, we are excited to drive momentum with Neuraceq through expansion of our PMF manufacturing network as well as the opportunity of introducing Neuraceq to our existing nuclear medicine PYLARIFY customers. Neuraceq as well as the radiodiagnostic products currently under FDA review will be offered to our nuclear medicine customer base as part of a comprehensive portfolio of Lantheus products in 2026 and beyond. We have the potential for multiple FDA approvals this year. The first, our new PSMA PET formulation; second, OCTEVY; third, PNT2003, our radioequivalent formulation of Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors, or GEP-NET; and fourth, MK-6240, our tau-targeted PET radiodiagnostic.

Assuming approval for each of these products, the commercialization plan will be thoroughly targeted to align with market and access readiness, an approach we believe underpinned our successful PYLARIFY launch. We are able to leverage our PMF network and commercial infrastructure, investing in line with the expected revenue growth opportunity of each product in 2027 and beyond. As I have already mentioned, our strategy and related investments going forward will focus on radio diagnostics. As a result, we are optimizing our cost structure to match this focus, enabling us to deliver on the EPS targets we announced today while leaving additional opportunity to further improve that profile in the future. We are selectively prioritizing first and best-in-class later-stage PET radiodiagnostic assets that complement our current commercialized portfolio and our nuclear medicine customer base.

As part of this strategy, we have decided to pursue value-maximizing alternatives for the radiotherapeutic assets in our pipeline. Given the broad portfolio we have built to date, we do not anticipate pursuing any significant M&A activity in 2026, though we remain open to opportunistic tuck-in acquisitions of portfolio aligned diagnostics. Our priority is to complete the integration of our recent transactions early in 2026 to fully capture their value. As I have outlined, 2026 will be a year of commercial execution and regulatory milestones as we focus our efforts and investments to serve our nuclear medicine customers. With strong mid- and long-term revenue drivers, a robust late-stage pipeline and a clear strategic road map, we are confident in our ability to drive meaningful performance gains that support a compelling mid- and long-term outlook for our shareholders.

Let me now hand over to Amanda, who will offer highlights on performance and commercial execution across our portfolio in oncology, neurology and cardiology. She will then provide an update on our late-stage diagnostic pipeline. Amanda?

Thank you, Mary Anne. We are positioning the business for its continued growth by driving commercial readiness ahead of multiple upcoming launches, beginning with our new PSMA PET formulation. First, let's discuss our fourth quarter results and priorities for 2026. I'll begin with PYLARIFY, our market-leading agent, which posted solid performance in the fourth quarter in a highly competitive market with volume up approximately 4% year-over-year. Our continued successful commercial execution and pricing discipline were the drivers of this performance. Notably, the vast majority of our annual volume in 2025 came from long-standing accounts, demonstrating the resilience and commitment of our customer base and the clinical value of PYLARIFY.

As a reminder, pricing concessions provided late in the second quarter of 2025 reset 340B pricing in the fourth quarter. Our best price, which determines what is offered as 340B pricing was unchanged in the second half of 2025. Therefore, there will be no further change to our 340B pricing in the first half of 2026. We believe we have the broadest end-to-end coverage of PSMA PET imaging value chain, delivering consistent availability, reliability and dependability to our customers. This level of operational excellence is a clear source of competitive advantage. We will extend this proven capability across each product we launch into the radio diagnostic market with the intent to accelerate adoption and drive both mid- and long-term growth.

Now I will highlight performance of our commercialized Alzheimer's imaging product. Neuraceq contributed $31 million for the quarter, driven by strong commercial execution. In 2026, we will further support that execution with the onboarding of 6 additional PMF sites. We are excited about the potential of Neuraceq in Alzheimer's disease PET imaging market. As the already second most utilized and fastest-growing beta amyloid PET imaging agent, Neuraceq addresses a large and expanding opportunity. With more than 7 million people currently diagnosed with dementia in the U.S., demand for amyloid PET imaging is increasing, driven both by the adoption of Alzheimer's disease-modifying therapies or DMTs as well as by guideline expansion for diagnostic use earlier in the care pathway for patients with mild cognitive impairment and early Alzheimer's disease.

Finally, DEFINITY remained a strong contributor to our overall performance and delivered over $85 million in the fourth quarter. 2026 marks DEFINITY's 25th year on the market, and it remains firmly positioned as the market leader with more than 80% share.

Now turning to our promising late-stage pipeline. 2026 is a critical and exciting year for commercial launch preparedness for several of our registrational stage assets. Specific to radiodiagnostics, it is important to align investment and launch timing with market access and value chain readiness to optimally realize the commercial opportunity. We have 3 radio diagnostic assets and 1 radioequivalent therapeutic with near-term regulatory approval time lines. First, our new PSMA PET formulation with a PDUFA date of March 6, offers the same diagnostic properties of PYLARIFY with a similar safety and efficacy profile while delivering manufacturing efficiencies that will immediately improve supply availability. And as with any F-18 radiodiagnostic, launch timing and success depends on having broad PMF network in place as our focus will be on supply continuity. A central tenet of our launch strategy is to ensure we have coding, transitional pass-through status and broad payer coverage in place before commercial launch, thereby ensuring customers have access to and coverage for the new formulation.

By leveraging our already established infrastructure and strong nuclear medicine customer relationships, our goal is to ensure the transition from PYLARIFY to our new formulation will be a seamless experience while providing what will be the only F-18-based product in the PSMA imaging category with transitional pass-through reimbursement. This approach informed by our deep experience in radiodiagnostics, we executed on a rolling regional basis in the fourth quarter of 2026, which will minimize risk during the commercial launch. We believe these actions position a new formulation for continuous sustainable growth beginning in 2027.

Second, OCTEVY, our gallium-based PET radiodiagnostic for NET with a PDUFA date of March 29, will support clinical decision-making in patients with neuroendocrine tumors. Assuming FDA approval, we will have the opportunity to launch OCTEVY as the only neuroendocrine PET radio diagnostic with transitional pass-through reimbursement. As a gallium-based agent, OCTEVY will be offered through existing radiopharmacy networks, which Lantheus has long-standing relationships with. Our team is eager to begin the launch process for both agents in the second half of this year with the expectation that they will begin to have a material impact on our performance in 2027.

Turning to PNT2003, our registrational stage radioequivalent therapeutic to Lutathera. We are awaiting FDA approval and anticipate a court ruling midyear on our Hatch-Waxman litigation. PNT2003, like OCTEVY, will be a natural addition to the Lantheus commercial portfolio of products offered to our nuclear medicine customer base, enabling portfolio leverage across this common customer. MK-6240, our registrational stage tau-targeted PET radiodiagnostic for Alzheimer's disease, currently represents an important asset within our biomarker solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's DMT development. It is currently the most widely used imaging agent in amyloid and tau-targeted therapeutic candidate clinical programs.

MK-6240 currently serves as the imaging agent for treatment eligibility in 17 pharma-sponsored therapeutic programs. The PDUFA date for MK-6240 is August 13 of this year. Collectively, our registrational stage assets will deliver on our strategy to maintain and expand our leadership in innovative PET radiodiagnostics and drive sustainable mid- and long-term growth. In 2026, our commercial priority is clear: maximize the value of our current product portfolio by navigating a competitive marketplace with discipline and executing upcoming launches with excellence.

I'll now turn the call over to Bob to provide more detail on our fourth quarter and full year results and outlook. Bob?

Thank you, Amanda, and good morning, everyone. I will provide details of the fourth quarter and full year 2025 financials, focusing on adjusted results with comparisons to the prior year quarter unless otherwise noted. Revenue for the fourth quarter was $406.8 million, an increase of 4%. Revenue for the full year was $1.5416 billion, an increase of 0.5%.

Turning to the details. Radiopharmaceutical oncology currently compromised solely of PYLARIFY, generated fourth quarter revenue of $240.2 million, flat sequentially and down 9.7%. For the full year, PYLARIFY delivered $989.1 million, down 6.5% from the prior year period. The result was above expectation with price and volume favorability as compared to our previous estimates. Precision Diagnostics delivered fourth quarter revenue of $143.2 million, representing a 22% increase. The category was driven by net sales of DEFINITY at $85.3 million or 1% lower due to the prior year competitor supply challenges, which drove higher-than-expected revenue during Q4 2024.

For full year, results were $330.2 million, up 3.9%. Neuraceq delivered $31 million in the quarter and $51.4 million since the acquisition in late July. TechneLite and other SPECT revenue for the quarter was $26.9 million for the fourth quarter and $111.4 million for the full year. Lastly, strategic partnerships and other revenue was $23.3 million, up 203.3% due to a strong quarter for MK-6240 as well as the recognition of a $6 million milestone receipt relating to an out-licensed asset. Full year revenue was $59.4 million, with MK-6240 contributing slightly less than half of that amount.

Gross profit margin for the fourth quarter was 65.1%, down 289 basis points from the fourth quarter 2024 due mainly to year-over-year decreases in PYLARIFY net price and the inclusion during 2025 of the Evergreen manufacturing facility and Neuraceq volumes, which were not in the comparative period, all offset in part by favorable PYLARIFY dose volumes. Operating expenses at 30.9% of net revenue were 179 basis points unfavorable from the prior year, but within previously guided spending levels. Increases in research and development, the majority of the year-over-year change were a continuation of our planned investments to advance our clinical stage portfolio. The sales and marketing increase was largely due to having a full quarter of the Neuraceq sales team and related activities.

G&A was flat in the period despite ongoing and a litigation expense for our PNT2003 asset and the inclusion of LMI and Evergreen operating expenses. Other income and expense was $2.3 million of expense. Operating profit for the quarter was $138.9 million, a decrease of 8.5%. Total adjustments in the quarter were $66.2 million of expense before taxes. Of this amount, $17.5 million and $16.5 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization, respectively. The company recorded an unrecognized loss of $9.5 million attributed to its equity investments in Perspective Therapeutics and Radiopharm Theranostics. Additionally, the company recognized a $5 million payment in the quarter related to the RELISTOR royalty stream sale, which was reflected in other income. Further, the company incurred $21.7 million in acquisition, integration and divestiture-related costs. The remaining $6 million is related to other nonrecurring expenses. Our effective tax rate was 19% in the quarter and 25.3% for the full year.

The resulting reported profit for the fourth quarter was $54.1 million and a profit of $110.7 million on an adjusted basis, a decrease of 4.1% from the prior year period. GAAP fully diluted earnings per share for the fourth quarter were $0.82 and $1.67 on an adjusted basis, an increase of 4.7%. On a full year basis, GAAP fully diluted earnings per share were a profit of $3.41 and a profit of $6.08 on an adjusted basis, a decrease of 10% from the prior year.

Now turning to cash flow. Fourth quarter operating cash flow totaled $90.2 million as compared to $157.7 million in Q4 2024. Capital expenditures totaled $8.8 million, $7.6 million less than the prior year. Free cash flow, which we define as operating cash flow less capital expenditures, was $81.4 million in Q4 2025, a decrease of $60 million from the prior year period. The majority of the variance lies within working capital with a $49.3 million decrease driven primarily by the acceleration of accounts payable associated with the cutover activities for the SPECT business ahead of the divestiture on January 1. Increase in accounts receivable related to timing of sales and the go-live to a direct billing model transferred from one of our significant PMF partners as well as an increase in inventory due to the timing of production runs and expansion of the PMF network. Additionally, the company repurchased $100 million or $1.77 million of its own shares during the quarter, leaving $200 million of authorization for buybacks outstanding. Lastly, cash and cash equivalents net of restricted cash now stand at $359.1 million.

Before turning to our expectations for the full year 2026, there are a number of line items I would like to clarify to put the right context on 2025 versus 2026 comparisons. Beginning with revenue, we completed the divestiture of our SPECT business effective January 1, 2026. As such, you should remove $111.4 million from the 2025 baseline year. Further, as mentioned, we recognized a $6 million milestone payment related to an out-licensed asset in the fourth quarter. Taken together, the comparable baseline would be $1.4242 billion. The EPS impact on these adjustments equates to approximately $0.16. Operating expenses also require normalization adjustments for comparison's sake as well. During 2025, the company reduced accrued bonus expense, resulting in approximately $0.14 of benefit to 2025 that should not repeat in 2026. Further, the company recognized approximately $4 million or $0.04 of employee retention credit benefits occurring in Q2 of 2025, also not likely to repeat. Therefore, the appropriate adjusted EPS comparison should be $5.75.

Now turning to expectations for 2026 fiscal year. While we expect several product approvals this year, given the timing of commercial launches, as Amanda discussed, we don't anticipate meaningful revenue contribution this year. Our focus in 2026 will be the continued commercial execution, assuring a successful transition for our new PSMA PET formulation, setting the stage for revenue and earnings growth acceleration exiting 2026. Now for the details, the forecast for PYLARIFY considers the annualization of pricing decisions made in 2025 and related impacts as well as the potential for renewed competitive dynamics as the year progresses, notably as the only one other commercially available F-18 agent nears the end of its traditional pass-through period as of September 30. Therefore, we see PYLARIFY net revenue declining 8% to 10% year-over-year, consisting of increased volume offset by modest price erosion.

To assist with modeling, each quarter should be fairly similar sequentially from a net revenue perspective with volumes and discounts growing throughout the year. This includes the fourth quarter during which we will undertake the transition of our PMF channel partners from PYLARIFY to our new formulation on a rolling geographic basis. We see Neuraceq growing triple digits inorganically and DEFINITY is expected to grow low to mid-single digits. Taken together, we forecast worldwide net revenue of $1.4 billion to $1.45 billion for 2026.

Moving down the P&L, gross margin continues to model at approximately 65.5%. While we have the opportunity to leverage our established infrastructure and common targeted customer base, we will continue to invest in sales and marketing in support of our new PSMA PET formulation as well as OCTEVY to ensure broad availability and access. R&D is expected to move to 10% to 11% of revenue, an increase of approximately 200 basis points across a number of phase-gated projects anchored by our GRPR diagnostic agent. G&A should be essentially flat with 2025 at 10% of net revenue. Our net interest expense and other is expected to change in 2026 to $5 million of expense from approximately $9 million, $4 million of net income in 2025. This $9 million headwind is due largely to lost interest income on funds we used on our 2025 M&A activity as well as through share repurchases executed throughout 2025. The effective tax rate is expected to increase slightly by about 1 point to 26%. Fully diluted shares outstanding should average 66 million shares for the year. Altogether, we forecast EPS in the range of $5 to $5.25.

As Mary Anne noted, following last year's considerable M&A activity, we are undertaking a full review of our pipeline portfolio and expense base. We are committed to focusing on investment and related commercial efforts largely on our diagnostic portfolio. For the therapeutic assets in our pipeline, we are contemplating alternative opportunities to advance these assets and optimize their value for the company and our shareholders. This process will take the better part of 2026, during which we are confident that there will be further opportunities to rebase the company's earnings profile and growth trajectory with annualized synergies achieved in addition to the avoidance of higher cost of late-stage R&D development often associated with therapeutic product candidates. We believe that the therapeutic pipeline has material value, and this plan is intended to unlock that value for shareholders, which is not reflected in our stock price or our guidance.

With that, let me turn the call back over to Mary Anne.

Thank you, Bob. While we focused in 2025 on the competitive dynamics experienced in the PSMA PET imaging market and our work to successfully integrate acquisitions, we are now taking purposeful steps to sharpen our focus on our strategic priorities, especially in the diagnostics space and leverage both our capabilities and portfolio in 2026 and beyond. Allow me to again state our priorities for 2026.

Maintain our market leadership in PSMA PET by sustaining PYLARIFY volume growth, execute a seamless transition to the new PSMA PET formulation beginning in the fourth quarter. Increase momentum for Neuraceq by expanding our manufacturing footprint and driving deeper penetration in existing accounts and accounts where a strong PYLARIFY relationship already exists; advance our assets currently under FDA review through regulatory approval milestones and affect fit-for-purpose launch activities with those assets that offer the earliest and best revenue return; selectively develop other pipeline assets towards key stage gates and decision points and allocate capital with discipline, prioritizing radiodiagnostics, seeking to optimize the value of our radiotherapeutic pipeline and maintaining financial flexibility while committing to a leveraged P&L that delivers value to our shareholders.

We entered 2026 with confidence in our strategy and our ability to deliver recognizing this represents a year of intentional investment and portfolio prioritization that will position the company for solid financial performance and durable value creation. As we do so, we remain focused on the patients we serve, having helped impact the lives of approximately 7 million patients in 2025. I want to thank our shareholders, employees and our loyal customers for their continued support and dedication.

With that, I'll turn it over to Q&A. Operator?

[Operator Instructions] Our first question comes from Anthony Petrone with Mizuho Cap Financial Group.

Mary Anne, welcome back. I hope you're doing well. Rob, Amanda, Mark, hope everyone's doing well. Maybe I'll start off with 2 quick ones, just I know a lot of folks are on the line here. But start with just the March 6 PDUFA date for next-gen PSMA PET imaging agent. Thanks for the updates there on a fourth quarter rollout. But when we think about taking a glass half full approach, assuming the PDUFA date goes as expected and we get clearance, what will be the timing when we do secure coding, when we get realization on what the TPT sort of reimbursement rate will be? And maybe a little bit of detail on how you will begin that transition specifically with long-term contracts that are out there? And I have one quick follow-up.

Anthony, I'll take that, and thank you so much. It is, as I said, great to be back in my operational role here. And as you noted, it is absolutely a glass wonderfully half full about our new PSMA PET formulation. Let me review some of the dates we're assuming here, and that will also then, I think, explain our strategy as we move forward. As you noted, our PDUFA date is March 6. The 2 items that Amanda -- well, 2 of the items that Amanda referenced that are important with the launch of any PET-based product is you need to ensure that you have secured a HCPCS code as well as transitional pass-through status. And those are 2 separate activities.

We would anticipate that we would have in place by October 1, our HCPCS code and after having submitted our transitional pass-through application by June 1, that, that will also be in place by October 1. And it's very important that those events precede your commercial entry into the market. That is why you hear us referring to late 2026 or specifically the fourth quarter for the operational rollout of the PMF. And as you can remember from our PYLARIFY launch and from the other launches of F-18-based assets into this category, you have to stand up or get approved each PMF separately because they each represent a GMP-approved manufacturing site. Our goal is to make sure that we never have disruption of Lantheus product availability in that market.

So we've chosen a regional rollout, allowing for duplicity so that we absolutely still have service in place to flip from PYLARIFY to our new formulation, which we will offer a name and start using as soon as it's approved. And we anticipate for making sure that, that is derisked that, that will take us the fourth quarter to accomplish. So coming out of the fourth quarter, we will have a network as broad as we have in place currently for PYLARIFY in place for our new formulation. And that is why we keep referencing to say that significant revenue related to that product will really occur beginning in '27 and not as much in '26. But we feel like we've got all bases covered here. We're all waiting for the March 6 date. It is right in front of us now. And you can certainly imagine that there will be a press release around that date to communicate what we've heard from the FDA.

Excellent. And just a quick one is just the market dynamics for PYLARIFY as is today, down 8% to 10%. We know that there's a study out there, POSLUMA versus PYLARIFY, a head-to-head study. I believe it reads out at ASCO. And so maybe what is baked into the negative 8% to 10% per share shift? How does the outcome of the study play into that? Thanks again. Welcome back.

Thanks, Anthony. And kind of interesting to talk about that study because I will be honest and say we do absolutely have some concerns regarding the study design that was used. First and foremost, there's no randomization in the study. If you read the protocol and you see how it was executed, the PYLARIFY images were always captured first. And in a fully randomized trial, you probably expect to see something different.

Also is concerning, there's no truth standard. If you look at the design of the study, you're really measuring just SUV and detection rate. And the kind of the odd thing of that is when you measure detection rate that way, you actually give yourself credit for false positives. So the high detection rate may be due to the false positives that are already noted in that product package insert. Also, is it just from a math perspective, the study was not powered to show statistical significance.

And from a clinical perspective, there's really 2 relevant comments here. First, bladder SUV values do not impact diagnostic performance. And that is what the study is really measuring. Second, and very much not in line with current clinical practice, the men in the study because, of course, it was all male patients were not allowed. They were actually prevented from voiding prior to having their scan done. And that is very much the opposite of what happens in clinical practice today. So I will say we are glad to see continued scientific investigation into this incredibly important class, but we also would very much hope that it would be rigorous scientific evaluation. And I will share with you because you referenced how does that bake into our forecast. The results of that study really do not bake into our forecast.

Our next question comes from Richard Newitter with Truist.

So I just wanted to put a finer point on what your kind of pricing and unit growth played out, how that played out in 4Q '25. You were at 3% unit growth, I think you said. In the third quarter, you had about a 500 basis point 340B driven price headwind to contend with in the fourth quarter. I'm getting to like a high single-digit unit growth rate in 4Q. And is that right? And then what was behind that? Did the market improve? Did you just call back some share, if that is, in fact, right?

And then maybe, Bob, can you give us a little more on what the market assumptions are for '26 for PYLARIFY and kind of what your unit and price assumptions kind of are within that?

Yes. So Rich, I'll take that. In terms of growth, I mean, listen, it was a great quarter from a PYLARIFY perspective, obviously, above our expectations. But it was both volume and a little bit of benefit actually coming from the gross to net price change. I think when we talked about it during kind of the fourth quarter, following our call and whatnot, we had sort of pegged it at sort of the mid-teens. And that's effectively what we saw. And that was maybe slightly more favorable than the actual teens growth that we were kind of thinking. So I think Amanda pointed out, I think it was like 4% volume growth. And it did turn out to be our single greatest sort of volume performance in the quarter. excuse me, for the full year.

When I think about assumptions going into how we're playing out 2026, so we are thinking sort of a similar, sort of low single-digit volume growth for the year, much not too dissimilar from 2025. And from a pricing perspective, what we've done is that we've -- while we've seen a lot of consistency in the market from a pricing perspective over the last couple of quarters, as we think about one of those competitors losing pass-through, that they may actually look to try to use pricing as a mechanism to drive share. And we've been really pretty disciplined, and we've been really explicit that as we think about executing our strategy that we're going to stay disciplined. We're not going to chase business that is not good for the medium to long-term value of that franchise.

So the guide assumes that we see sort of a continuation of some incremental price that would sort of move us from sort of the mid-teens of where we are now to maybe the high teens as we progress through the year from a gross to net adjustment perspective. And that's why you see sort of what I've laid out as sort of a sequentially net revenue sort of neutral outcome for each of the quarters throughout 2026.

So Rich, this is Mary Anne. Does that answer your question?

Yes, it does. So it sounds like you're not seeing any dramatic changes to the pricing environment currently. To be prudent, because this is what took you by surprise and all of us by surprise last year, you're embedding that assumption that there will be another kind of regular way price erosion situation or you'll have to walk away from that business incrementally and that's a placeholder in your guide, and you don't really assume any contribution from 2.0. So there should be -- there could be upside if those things don't play out that way and you start to get some benefit from 2.0 if all goes well next week and you can execute on the transition faster. Is that a fair way to look at these numbers?

Yes. Rich, absolutely. And I have to say it's such a great pleasure to have analysts like yourself monitoring our business where you know the market so well and also understand our strategy, but you are really spot on with how we're thinking about the market.

Our next question comes from Roanna Ruiz with Leerink Partners.

So I was curious, could you elaborate a bit more on one of your comments about pursuing value-maximizing alternatives for radiotherapeutic assets to support long-term growth? And maybe think about -- are you thinking about different features of products that you're looking for? Could this be part of near-term BD? I know you mentioned on the comments possible tuck-ins this year. So I was just curious if you could explain a bit more there.

Absolutely. I'm glad that everyone is kind of picking up on the comment that both Bob and I made about this intentional focusing of our strategy. We really see it as the natural outcome of all the activity that we had in '25 and even '24. We have now a very broad portfolio of both diagnostic and therapeutic assets. And our intent is to and we think our obligation to our shareholders is to make sure that the value of each of those is considered. But we certainly could not handle or accomplish the advancement of that entire portfolio. So we've chosen to focus in on the diagnostic assets.

And as you'll see, I had a pipeline slide in the middle of my presentation and also showed again at the end. It really is a very broad portfolio there. When we refer to the therapeutic assets, what we're referring to is, and we have undertaken a full review of our whole portfolio, but looking really at what are the stage gates for the therapeutic assets that really define value for them so that as we consider how they should be then driven further, and it will be through external alternatives or partnered alternatives, how is it best for us to present the value and the clinical utility of these products.

And so a lot more to come on that as we talk throughout the year. I will mention, and it really comes back to what you mentioned with tuck-ins, further tuck-ins for diagnostic opportunities. If we find them and they fit, then yes, absolutely, we'll consider them. But even as we talk about the therapeutic assets, I probably should be clear to say that when I talk about that, I'm not talking about PNT2003. That product is right before us as far as regulatory approval opportunity. It's a natural fit into our portfolio of products and again, our customer base. So we are already committed to what we believe will be a very successful launch of that product.

Our next question comes from Matt Taylor with Jefferies.

I guess I'll ask one on Neuraceq. It came in nicely in Q4 and your guidance, you said was, I think, at least triple-digit growth. I guess not that that's a bad growth rate, but why couldn't it actually be higher than that given the momentum that you have and also the sequential growth that we're seeing in some of these Alzheimer's therapeutics?

Matt, we absolutely do see. Triple digit is pretty good to hear, Matt. And I think what you're also hearing from us again, we inherited that product as of, we'll call it, midyear last year. And one of the things and again, this comes back to F-18-based products in this market, you have to have the manufacturing footprint to be able to bring your product broadly to patients. And I will say, I think the numbers have been discussed before, but the number of standing PMF for Neuraceq at the time we acquired it was, call it, mid-20s.

We added a few and someone might correct me if I'm wrong there, but we added a few and then our intent is to add 6 more this coming year. Therefore, we will start to approach having what we consider a broad geographic footprint for that product. And I'm sorry, I've been corrected. The starting number of PMF when we inherited the product was 16. And again, we will continue to add. That really is our -- the way that we measure how far we can take the product into new areas. And then the other part of our -- what we think is a very promising forecast is our ability to take the product deeper into the accounts where it already is based on some changes in guidelines and the broadening that we saw in the PIs last year as well as by also leveraging the relationships that we have in accounts with other Lantheus products. So again, happy to be wrong here and have it even further exceed what we have, but I think we've been very practical -- optimistic but practical with our forecast. And Bob, do you want to add something there?

I do because I just -- I mean while people can figure this out from a mathematical situation by triple digits, we're talking something in like, call it, the 140% to 150% range of inorganic growth off of what was a very good fourth quarter, which was the first full quarter that we actually had the asset in the portfolio commercially.

Our next question comes from Paul Choi with Goldman Sachs.

This is Karishma on for Paul. If the upcoming BIIB data does show meaningful tau reduction, but no benefit on cognitive measures, how does this affect your go-forward investment in your tau program?

I'm sorry, could you repeat what you're referring to? No, the study. Could you repeat the first part of your question, please?

Yes, sorry. If the upcoming Biogen data shows meaningful tau reduction, but no benefit on cognitive measures, how does this affect your go-forward investment in your tau program?

Okay. I'm sorry, there was -- we just didn't hear the first part of your question, but it makes perfect sense. We will, of course, are very eagerly awaiting those data, but I think there's very, very strong scientific evidence already that the presence of tau and the quantification of tau is aligned with cognitive performance of patients. And that really is something that's slightly different than the role that amyloid plays. Amyloid and if you think about it, I guess, bluntly, amyloid comes early, but it doesn't always match to cognitive change in patients, where there is a much stronger correlation between rise of tau, especially in certain areas of the brain and unfortunately, related cognitive defects for patients.

So I think what we're seeing in this market, and we're kind of all seeing it in real time because that's a wonderful thing that's happening around us. There really is now a market that is willing and acting on taking these products that are disease-modifying and starting to use them in patients and the kind of complementary use, increased and increased use of imaging both amyloid and tau will come along with that. But I won't speculate on data that are not out yet other than to say we are -- from a scientific perspective, we are fairly confident in the role of tau in the market. As you heard Amanda mentioned, in our biomarker business, tau is the our product, MK-6240 is the #1 product that's used in what we see as the 17 ongoing studies in the market.

Our next question comes from Larry Solow with CJS Securities.

Great. And I echo the welcome back, Mary Anne. It sounds like the CEO search is progressing though. So is this going to be like -- do you feel like a 6-month, 12-month type of thing? Any thoughts on just timing?

So it is progressing, Larry. It's good to be talking with you again. I want to say 2 things that I think are in our favor. I think this is an incredible opportunity for someone to step into what the future of our company and where we're going to be taking this company. And so I think as exciting as that is to me, I think it's also something that is exciting to the candidates we're talking to.

And the other thing I will say is, as everyone knows, we sit fairly adjacent to what is an incredibly active market in the United States, and that is the life sciences market in Cambridge. And so that has also, I think, been very much a boom for us in our search. I will say, and this will not be a surprise to anyone that there -- the potential slate of candidates for us who are purely radiopharmaceutical or have radiopharmaceutical is very narrow. This is just not a large industry.

From a history perspective, there haven't been a lot of CEOs in this industry. And as you can imagine, those of us who are here probably have competitive blocks from going to competitors in a role as significant as the CEO. But having said that, I will reiterate what I said, I'm very pleased with the candidates that we've met. And to me, it's also a declaration or a demonstration of how far radiopharmaceuticals have come and what they mean and represent in overall life sciences now.

Our next question comes from Yuan Zhi with B. Riley.

Maybe to Mary Anne, when comparing Neuraceq with the #1 leader in that space, where do you see improvement opportunities to catch up in market shares? Is it availability guidance difference or pricing? Any additional color would be appreciated.

Sorry, your voice was actually very muffled while you asked your question, and we're going to have to ask you to repeat it.

I'm sorry. When comparing Neuraceq with the #1 leader in that space, where do you see improvement opportunities to catch up in market shares? Is it availability or guidance or pricing? Anything you see opportunities?

Yes. Very well understood now. Thanks so much. Let me first start by correcting. Neuraceq is the second most utilized amyloid beta imaging agent in the space. The product with the highest market share in the space right now is actually Lilly's product, Amyvid. As far as where we see the growth opportunities for Neuraceq in the market short, mid and long term is, first and foremost, there have been some changes to the guidelines regarding use of amyloid imaging for diagnosis of patients with different levels of Alzheimer's disease. So that's the first.

And very much a testament to that, I think the launch and now what we see is continued uptake of the DMPs, the drug-modifying therapies for Alzheimer's disease come with what will be associated imaging not only to validate that the patients will be eligible for those therapies, but then there's also the potential to monitor those patients during therapy. And all of those, both of those activities would add volume to the amyloid imaging market. Finally, very specific to Neuraceq, this is not a price play. You mentioned is this going to come from -- purely from price growth? And the answer to that is no. It really is driven by 2 factors. The first is, and most important, broadening the geographic footprint from which Neuraceq is available for distribution to all of the centers that do amyloid-based PET imaging.

And the second is that within those accounts and especially accounts where there's already a PYLARIFY relationship, deepening the penetration of Neuraceq use in those areas. You heard me refer several times throughout my comments to the nuclear medicine customer base. we feel very strongly that we have a key advantage in our relationship there, long-standing history. That has been the central focus of Lantheus' commercial efforts since we were essentially launched as a company back in the late '50s. So it's a long relationship. It's a deep relationship, and it's a very trusting relationship for having brought them all the products before, but certainly PYLARIFY.

So where we find ourselves now very fortunately, which we absolutely intend to take advantage of is that we have the ability to bring a portfolio of products into this customer space. And one of those will certainly be Neuraceq. I'd also like to clarify a comment that I made before regarding the POSLUMA versus PYLARIFY head-to-head study about the final point about patients not being allowed to void. That is not an accurate statement. I should have -- what I should have said is that while patients were encouraged to drink and they were encouraged to drink, they weren't instructed to void or did not -- were not made to void. So I apologize for that error in how I presented it.

Our next question comes from Justin Walsh with Jones Trading.

In the medium to long term, can you comment on your expectations for the relative revenue contributions for your product portfolio segments? Just wondering how important prostate cancer is versus other solid tumors versus neurology and PET imaging.

I absolutely am happy to comment on that. And I hope also that kind of came through in our comments to say that while we are incredibly fortunate to have up to 4 approvals this year, I think I was repetitive as with Bob and even Amanda in sharing that we expect revenue uptake to begin significantly in 2027. And that really is related to the nature of how these products come out into the market and the very important considerations of ensuring that you have access and coverage as well as insurance coverage. But here, we're talking about market coverage as well in place before you put your commercial effort really behind it. It doesn't mean we're not getting ready for the launches. It just means that we won't execute the launches and see the return for them. We're seeing largely in '27.

From a revenue perspective, I hope you appreciate how much effort we did throughout end of '24, all through '25 to diversify our revenue base. But going forward, it's safe to assume that revenue derived from our prostate cancer franchise of products will be the main driver. We see lovely, lovely contribution from Neuraceq. We absolutely have strong expectations for contribution from our other launch products that we will be taking to market. But fair to say that the cornerstone and the majority of our revenue will be from PYLARIFY. That's why for 2026, and we've again repeated this several times, we are laser-focused on the transition to and introduction of our new PSMA PET formulation.

Our next question comes from Andy Hsieh with William Blair.

So like Neuraceq, you're going to be launching into markets with incumbents with OCTEVY and the therapeutic 2003. So can you outline some product-specific and commercial infrastructure differentiation that you can leverage to gain an upper hand as you launch these 2 products in the future?

Yes. Very good question. Just to clarify, of course, Neuraceq is already in the market. We didn't launch Neuraceq. It's been -- those products have been in the market for over a decade. But I will say that Neuraceq is the second most utilized product in what is a 3-product market. Important notes about the other products that you mentioned, and we'll put 2003 aside because that's therapeutics.

But as Amanda mentioned in her comments, OCTEVY, one of the important considerations of OCTEVY is that it will have transitional pass-through status and reimbursement as will our new formulation of the PSMA franchise. And so that will be an important consideration and is an important consideration for many customers, especially given that the OCTEVY market is approximately 80% hospital-based. And as everyone is aware, the concept of transitional pass-through payment is really applicable for traditional Medicare patients who are seen in the hospital setting. So we see that as a key advantage as we take that product to market.

From MK-6240, which also has an approval and a PDUFA date later this year, that is a product that is already well established through our biomarker solutions business. And there, we will continue to support its role as being the #1 tracer used in what are the wealth of clinical trials being undertaken by pharma in the study of tau and amyloid-based Alzheimer's disease.

[Operator Instructions] Our next question comes from Kemp Dolliver with Brookline Capital Markets.

Quickly for Bob, could you go through the comments again on the sales and marketing guidance for '26?

All right. That's fine. I can manage that. So more or less what we're thinking in terms of like total OpEx, you're going to see 2 of our sort of 3 sort of OpEx categories sort of increase in spend. I did note specifically that we would see R&D up around that 10%, 11% mark. But with regard to sales and marketing, and I do think that this is when I look at consensus files, this is, I think, the one sort of like underappreciation for the work that we need to put in front of 20, the different products that we're hoping to launch going into 2027 and the work this is -- and it mirrors almost what we did with PYLARIFY back in, when was that, 2021.

So from that perspective, I think you're going to model it somewhere in, call it, the 12-ish, 12.5% range of revenue. And that, I think, together with a flat G&A, again, keeping some leverage in those functions that are supporting, but really kind of putting the money in the investment where we hope to see a solid return for shareholders. That's how you should model things.

Ladies and gentlemen, there are no further...

Sorry, I just did want to add a comment there that kind of finishes out Bob's thought. I think also what we were also trying to communicate that's important here is that we have leverage as we take these new launches through, and certainly sales and marketing expense is part of that, as we take these new launches out to the market, one of the great opportunities we have is leverage as we've already got a full voice and presence with that customer base. So you heard me say and I'll repeat it again, fit-for-purpose investments commensurate with the opportunity, but also with the investments we've made prior in those same customer bases and I would say, overall in the channel.

Thank you. Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect, and have a wonderful day.

Good morning. Welcome to Lantheus' Third Quarter 2025 Conference Call. [Operator Instructions] This call is being recorded, and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Thank you. Good morning. With me today are Brian Markison, our CEO; and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions.

This morning, we issued a press release, which was furnished to the SEC under Form 8-K reporting our third quarter 2025 results. The release and today's slide presentation are available on the Investors section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to our CEO, Brian.

Thank you, Mark, and good morning, everyone. In addition to the earnings press release issued this morning, we announced a leadership transition plan to guide Lantheus into its next chapter of long-term growth. As a part of this plan, I will retire from Lantheus at the end of this year and transition into an advisory role. Mary Anne Heino, our current Board Chairperson and prior CEO, will assume the role of Executive Chairperson now and serve as interim CEO following my retirement. This structure allows Mary Anne and me to work closely together with our leadership team to ensure a smooth transition over the coming months. Mary Ann led Lantheus as CEO for 9 years, driving significant growth throughout her tenure before becoming Chairperson in early 2024. With her extensive industry experience and deep knowledge of Lantheus, Mary Anne is well-positioned to continue executing our strategy and driving momentum while we prepare for the expected launch of our new F-18 PSMA PET formulation.

The Board has initiated a comprehensive CEO search led by our Lead Independent Director to identify and appoint our next CEO, who will build on our strong foundation. We also announced that our President, Paul Blanchfield, will be leaving Lantheus for a new opportunity. We thank Paul for his many contributions and wish him continued success in his new role. I would also like to note that Amanda Morgan will return from leave and continue in her role as Chief Commercial Officer, reporting directly to Mary Anne.

Before Bob and I review the business performance, I want to express what an honor it has been to serve on the Board and lead such a talented and purpose-driven group of employees at Lantheus. I am proud of our collective achievements and the remarkable progress we've made to strengthen Lantheus' position as the leading radiopharmaceutical focused company. We executed a series of strategic transactions, including the acquisitions of Life Molecular Imaging, Evergreen Theragnostics and Meilleur Technologies, along with key licensing agreements. These transactions diversified our revenue streams, expanded our capabilities across the radiopharmaceutical value chain and positioned us for successful regulatory submissions. Most importantly, they enabled us to build a robust and innovative pipeline of radiodiagnostics, including advancing our position in the growing Alzheimer's disease imaging market and our early-stage radiotherapeutic products.

Now turning to the Lantheus results. In the third quarter, our top priority was and remains executing our commercial strategy to maximize the long-term value of our prostate cancer franchise. Our PYLARIFY results for this quarter reflect our ongoing efforts to maintain a disciplined approach to pricing and to raise awareness of PYLARIFY's clinical differentiation. The pricing stabilization across our accounts that began early in the third quarter has continued and actions we implemented in the second and third quarters to maintain our market leadership will continue to play out over time. Looking ahead, we are preparing for the potential approval of our new F-18 formulation in 2026. We anticipate this will qualify for 3 years of transitional pass-through payment status, supporting our PSMA PET franchise growth beginning in late 2026 and into 2027.

Now turning to PYLARIFY. Sales were $240.6 million during the quarter, down approximately 7% year-over-year, with U.S. volumes up 3.3% and down slightly sequentially due to seasonality, both consistent with our expectations. And further to that point, large institutions continued to diversify their PSMA agents across PYLARIFY and gallium-68 agents, while smaller accounts grew in line with market rates. Importantly, our educational efforts and customer feedback reflects increasing recognition of PYLARIFY's clinical value. And anecdotally, we are seeing some sites return after trialing alternatives. As I mentioned earlier, signs of pricing stabilization persisted throughout the third quarter and into October. We are preparing for the expected launch of our new F-18 PSMA PET formulation, which optimizes the manufacturing process to potentially increase batch size by approximately 50%, which could enhance production efficiency, supply resilience and enable increased patient access.

We plan to introduce this new agent to the market following the receipt of coding, coverage and reimbursement, including a HCPCS code and transitional pass-through payment status. We expect this plan to level the reimbursement playing field. For the remainder of '25, we expect low single-digit volume growth offset by further price compression as 340B or best price resets in the fourth quarter as a result of the 2-quarter lag in government price reporting, reflecting price concessions offered in the second quarter. Importantly, we do not anticipate any material changes to 340B from the fourth quarter into the first quarter of 2026 as PYLARIFY's in-market best price remained consistent from the second quarter to the third quarter of this year. These resets are factored into our guidance, and we are actively mitigating the impact through targeted commercial strategies. Our focus remains on preserving the long-term value of our PSMA PET franchise.

DEFINITY continues to deliver consistent performance, growing more than 6% year-over-year despite experiencing slight unfavorable customer mix in the quarter. We remain confident in DEFINITY's market leadership and the continued growth of the ultrasound-enhancing agent market. DEFINITY's success continues to be anchored in its proven clinical and commercial value at 24-year track record of clinical application and continued customer satisfaction.

Turning now to our neurology franchise. We see significant growth potential in the U.S. Alzheimer's disease radiodiagnostic market, driven by rising prevalence, expanded PET imaging guidelines and increasing use of amyloid beta and tau PET imaging agents alongside disease-modifying therapies. Today, there are 2 approved therapies and more than 100 in development, including approximately 30 tau-directed therapies and 40 beta-directed amyloid therapies, underscoring the critical role PET imaging can play in diagnosis and treatment selection.

In the third quarter, Neuraceq delivered sales consistent with expectations. Neuraceq is our F-18 PET imaging agent used to detect beta amyloid plaques in patients being evaluated for Alzheimer's disease and select patients for amyloid beta-directed therapy and is already enhancing the depth of our relationships with nuclear medicine customers and our manufacturing partners. Our strategy for Neuraceq focuses on 3 main priorities: first, expanding geographic coverage to ensure broad access across leading Alzheimer's centers and community practices, including with the recent addition of 2 new PMFs in Southern California and Illinois. Neuraceq, has growing geographic coverage in the U.S. across 20 PMFs, and we plan to launch 6 additional PMFs in '26. Second, improving availability and scheduling flexibility; and third, leveraging revised appropriate use criteria or AUC, and updated benefit manager guidelines, which recommend repeat scanning. We are advancing MK-6240, RF-18 PET imaging agent for detecting tau in adults being evaluated for Alzheimer's disease, and the FDA has set a PDUFA date of August 13, 2026.

Our NDA submission was supported by data from 2 pivotal Phase III clinical trials, which evaluated MK-6240's performance in detecting tau pathology in early Alzheimer's disease. These studies met their co-primary endpoints of sensitivity and specificity to detect tau tangles. MK-6240 previously received fast track designation reinforcing its potential to address a significant unmet need in Alzheimer's disease diagnostics. We believe PET imaging is foundational to the diagnosis and management of Alzheimer's disease. The recent FDA approval of blood-based biomarkers is an important advancement, enabling earlier identification of patients. We believe these tests will expand the readily addressable market over time and complement, not replace the critical value PET imaging provides in visualizing and quantifying disease. In addition to our work progressing our new F-18 PSMA PET formulation and for MK-6240, we also are planning for potential approval of LNTH2501 which is also known as OCTEVY, which is a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors or as we commonly refer to them, NETs. If approved, LNTH2501 may complement Lantheus' therapeutic candidate, PNT2003 as part of a theragnostic pair, advancing the company's strategy to deliver integrated diagnostic and therapeutic solutions for patients with cancer.

These 4 products strategically diversify our business and further solidify Lantheus' position as the nuclear medicine partner of choice. As we execute our strategy and advance our leadership in radiopharmaceuticals, we remain focused on delivering strong financial performance and disciplined capital allocation. To provide more detail on our third quarter results and outlook, I'll now turn the call over to Bob.

Thank you, Brian, and good morning, everyone. I'll provide details of the third quarter 2025 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted.

Turning to the details. Consolidated net revenue for the third quarter was $384 million, an increase of 1.4%. Radiopharmaceutical Oncology, currently PYLARIFY, contributed $240.6 million of sales, down 7.4%. U.S. volumes were up 3.3% year-over-year and down slightly sequentially due to seasonality as expected. Precision Diagnostic revenue of $129.7 million was up 25%. Highlights include sales of DEFINITY at $81.8 million, 6.3% higher, along with TechneLite revenue of $21.1 million, up 3.2% Additionally, Neuraceq contributed $20.4 million in the abbreviated quarter. Lastly, strategic partnerships and other revenue was $13.7 million, down 10.1%, driven mainly by our investigational product candidate, MK-6240 at $6 million of revenue, down 39.9% due mainly to the timing of milestones received in the prior year quarter not repeated. Gross profit margin for the third quarter was 53.5%, a decrease of 471 basis points. The decrease is mainly attributable to unfavorable pricing impacts to margin, the inclusion of Evergreen and LMI margin profiles and E&O charges, which accounted for approximately 50 basis points of gross margin headwind in the quarter.

Operating expenses at 32.4% of net revenue were 775 basis points higher than the prior year rate, but generally in line with previously guided underlying spending levels with the inclusion of both Evergreen and LMI as well as additional investments in our R&D pipeline. Operating income for the quarter was $119.6 million or a decrease of 27.6%. Other income and expense were $2.4 million of expense. This is slightly lower than expected due to a decreased cash position from the $100 million of shares repurchased during the quarter that resulted in lower net interest income to offset interest expense. Total adjustments in the quarter were $74.8 million of expense before taxes. Of this amount, $24.5 million and $14.6 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization, respectively. Nonrecurring expenses tied to closing and integrating our announced acquisitions and divestiture totaled $34.8 million. Our effective tax rate was 26.9%. The resulting net income for the third quarter was $27.8 million and $85.7 million on an adjusted basis, a decrease of 30.9%. GAAP fully diluted earnings per share for the third quarter were $0.41 and $1.27 on an adjusted basis, a decrease of 25.3%.

Now turning to cash flow. Third quarter operating cash flow totaled $105.3 million, down $69.8 million from the prior year. The variance is driven in part by M&A fees and integration cash costs incurred in the quarter of $35.1 million. Capital expenditures totaled $10.6 million, down $5.2 million. Free cash flow, which we define as operating cash flow less capital expenditures, was $94.7 million, $64.6 million lower than the prior year period. During the quarter, the company invested $100 million in its own shares at an average price of $56.94 for 1.756 million shares. Also, the company completed the acquisition of Life Molecular with an outlay of approximately $309 million net of cash acquired. Taken together, cash and cash equivalents, net of restricted cash now stand at $382 million. We have access to our $750 million undrawn bank revolver and are comfortable with our strong liquidity position.

Turning now to our updated guidance for the full year of 2025. We are narrowing our view of full year revenue to the higher end of the range to reflect recent trends we saw throughout Q3 as well as quarter-to-date. Principally, we estimate that PYLARIFY will come in towards the higher end of the prior range of $940 million to $965 million. Neuraceq's contribution should also trend to the higher end of the prior range. Taken together, full year revenue is now expected to be in a range of $1.49 billion to $1.51 billion from the prior range of $1.475 billion to $1.51 billion. We are also narrowing our estimates of adjusted EPS to a range of $5.50 to $5.65 versus the prior guide of $5.50 to $5.70.

With that, let me turn the call back over to Brian.

Thank you, Bob. As I mentioned earlier, I look forward to collaborating with Mary Anne and the Board over the coming months and supporting Lantheus in an advisory role after retiring. In the meantime, I remain committed to advancing and executing our strategy. This includes continuing to build on Lantheus' strong leadership position in radiopharmaceuticals. We're staying laser-focused on driving PYLARIFY commercial execution as we prepare for the next chapter of our prostate cancer franchise. We're also advancing our strategic diversification plan, including the ongoing integration of our recent acquisitions and preparing for 4 near-term product approvals that we expect to fuel our next wave of growth. The talented teams from Life Molecular Imaging and Evergreen significantly strengthen Lantheus' ability to execute operationally and commercially and ultimately allow us to expand our patient impact. And we're advancing our innovative investigational assets across oncology, neurology and cardiology and expanding our commercial portfolio that enables clinicians to fight follow disease to deliver better patient outcomes.

It's been a privilege to lead Lantheus as CEO. Together, we have built a robust radiodiagnostic and radiotherapeutic pipeline, position Lantheus for successful regulatory submissions and strengthened our capabilities and expertise in the growing Alzheimer's disease radiodiagnostics market and across the radiopharmaceutical value chain. I'm confident that Lantheus is well positioned to drive long-term growth and enhance value for all our stakeholders. And with that, operator, I'll now turn it over to questions and answers. Thank you.

[Operator Instructions] Our first question comes from the line of Roanna Ruiz from Leerink Partners.

I want to extend my best wishes to you, Brian, on your next endeavor. So, a quick question for me. I noticed on -- you were talking about the PYLARIFY and Neuraceq likely being in the higher end of range of guidance based on trends in the quarter and to date. So, I was curious if you could elaborate on those, what strategies are getting traction here? And how could those continue into 2026?

Thanks, Roanna. And I'll take the beginning of it and then flip it to Bob. And by the way, welcome back, and congratulations to you. I think what you're seeing with PYLARIFY is, as we reflected in the prepared remarks, the stabilization in the PSMA market, we have, I would think, weathered the storm appropriately with execution as we changed from an ASP reimbursement environment to one of MUC. And we're seeing customers that are trialing different agents actually come back to PYLARIFY, and that's quite rewarding. So, with Neuraceq, it's really all about expansion and availability. It's a great amyloid tracer under the Life Molecular Imaging umbrella. It has not had the resources to expand in a way that we have with PYLARIFY. So, it's all about for us, availability, expansion, being there for our customers and also driving our portfolio. Bob, do you care to comment?

Yes. I mean to kind of tack on to that, the visibility that we have as we look to the balance of this year, obviously, our focus is on executing the strategy that we've had in place. which we'll continue to do. But it's still a competitive market. And so, we will continue to monitor that extremely closely, particularly as we go into the new year. So, I'm not going to comment on '26 as we're not in a place to provide guidance. But when we do, it will take into consideration all the different market and environmental dynamics that we see at that time.

Our next question comes from the line of Richard Newitter from Truist.

I wanted to just ask actually a couple. I know you're not giving '26 guidance but is there -- I think investors are definitely focused on the possibility of any major resets coming. So, anything you can highlight relative to where you see consensus? I think consensus earnings is around $575 million for next year. And PYLARIFY is hovering a little over $900 million. It sounds like with the step-up in visibility today around PYLARIFY, that might not be a bad place to be. But anything you can comment on '26, even if it's just directional relative to consensus, that would be helpful.

Yes, Rich, I appreciate the question. We're not going to comment on '26 guidance. I think what we can tell you and what we're seeing in the market right now is the stabilization of our account base. We're also seeing continued year-over-year and sequential volume growth for PYLARIFY. So, we're seeing a lot of promising signs as we focus on growing the market, preserving the growth and preparing for our launch of our new formulation.

Our next question comes from the line of Matt Taylor from Jefferies.

I was hoping just because there's a lot of significant management changes, you could talk a little bit more about why now in terms of retiring, why Paul is leaving? I guess, what you're looking for in a new CEO and how long that process could take?

Yes. Thank you. I appreciate the question. Well, first, let's uncouple the 2 management changes with Paul and Brian. Paul is going to a great opportunity. It's wonderful. We're excited for him, and it's also gratifying to Lantheus that we continue to turn out some great executives into the marketplace. As for me, my decision is personal. I've got 9 grandchildren. And actually, I think # 9 was the tipping point for me. So, when I came into the role, it was not with any expectation that this would be a long-term assignment, and that I came in to rebuild a pipeline, rebuild an R&D organization and position this company for sustained long-term growth. And I feel really, really good about doing that. So, it's time for me to step aside. But the other thing that's really good here that we should take note of is that Mary Anne is very close to this business. She was the CEO for 9 years. She has been part of it as a Board Chair for the past 2 years, and we have worked very closely together for the past 13 years. This is a seamless transition with an expert who's coming back in on an interim basis as we've also announced a CEO search.

Our Lead Independent Director is heading up that search. It will be comprehensive. And obviously, we're looking for outstanding individuals that can take this company to the future. How long the process will take, I can't determine that. And right now, it's very early in stages. So, you can look at industry averages from announcements like this, the time of new placement and you can figure it out for yourself. But this is a very attractive role for an up-and-coming rising CEO candidate. And I have no question that we are going to find an outstanding person to come in here and build for the future.

Our next question comes from the line of Paul Choi from Goldman Sachs. Our next question comes from the line of Yuan Zhi from B. Riley.

One advantage of F-18 label PYLARIFY is they are produced in 20 or 40 doses per batch. Since competitor Gozellix come to the market, do you notice that they are producing in cyclotron with a similar number of doses per batch and taking market shares away from your high-volume customers?

Thanks, Yuan. I appreciate the question. We're not seeing a lot of impact from Gozellix produced by the cyclotron. We're seeing actually, as I mentioned in the prepared remarks, very good and consistent growth with our smaller accounts that have more capacity and they are growing with the market. But we are seeing in our much larger accounts, those sharing, if you will, with Gallium-68, but those are the accounts that have a tremendous amount of volume. But we are not seeing any real impact that I can measure right now from Gozellix on a cyclotron. So, I'm not at the moment concerned about that.

Our next question comes from the line of Larry Solow from CJS Securities.

It's Pete Lucas for Larry. Just one question. If you could give us a little more color on the competitive landscape in the Alzheimer's imaging market, particularly on the tau tango side of the market and how MK-6240 is positioned against other products?

Yes. Thanks, Pete. Great question. So again, MK-6240 has been filed with an expected PDUFA date of August 13 and 26. I think we look at MK-6240 as a second-generation tau agent. Tau is the only agent commercially available today. There is a lot of interesting information out of different clinical trials, one notably the head study out of University of Pittsburgh, where they directly compare these tracers, all the tau agents, whether they're investigational or the one commercially available head-to-head, if you will. And the superiority of MK-6240 is in evidence and reported in these studies, and we've discussed it in previous earnings calls. I think the major thing to look for here as the marketplace evolves and guidelines evolve, clearly, the role of tau is going to become increasingly more important as you look at staging, longitudinal management and tracking. And also what tau gives you the ability to do is look at where in the brain the tangles are, if you will, and what parts of the brain are they affecting -- and how does the patient with AD really behave, whether it's memory, whether it's balance, whether it's speech, all of these things come into play when looking at tau and assessing its disposition in the brain of an Alzheimer's disease patient. So, we feel that MK has a significant competitive advantage. However, I would like to point out that the market is relatively immature for tau and the beta amyloid market is really exploding right now in front of us.

Our next question comes from the line of Tara Bancroft from TD Cowen.

So, I'm wondering if you could tell us more about the various factors and maybe feedback that you're hearing from your partners that are leading the market to reach this pricing stabilization exactly? And then along that line, do you believe that this will remain kind of a 3-player market in the near-term, like into 2026, given the various pass-through dynamics that are expected next year for you and for others?

Yes. In the near-term, I expect it to be a 3-player market. I think in a competitive market like ours and given the success we've had simply looking at the revenues we reported for PYLARIFY, you naturally do attract competition. We think the stabilization we're seeing and our description of our strategy to be disciplined on price has played through in the marketplace with our accounts and our customers. The other thing to note is our service is top notch. Our ability to deliver doses on time in full is unparalleled. And I think that service quotient and our team in the field, along with our PMF partners needs to be recognized as part of our success. So, it's not simply introducing another agent. It's also having the feet on the street and the knowledge that we have to really execute. The other part of this, though, is the clinical differentiation of PYLARIFY is really beginning to shine, if you'll excuse the pun. I think in patients with low-volume disease where they're suspected of a recurrence or even on initial staging and diagnosis, PYLARIFY has a very clean and distinct signal and its sensitivity and specificity are really unparalleled. And you can just look at the other competitors' package inserts to compare them. So, in all, I believe this market stabilization we're seeing now is healthy. I think that customers are making the right decision for their patients. And I think our team in the field is really rocking it, and I expect continued growth out of this franchise.

Our next question comes from the line of Justin Walsh from Jones Trading.

What are your thoughts on the potential dynamics that could emerge in the PSMA imaging market as other clinically differentiated products enter? I know one potential competitor has a copper 64-based agent in late-stage development, and it would be great to hear how Lantheus will maintain your edge in the space.

Yes. I think the copper 64 agent is certainly of interest to us, and we are monitoring their progression carefully. I think when you look at real differences in the clinic, that will have to play out, but we're highly confident that our sensitivity and specificity at our network will continue to be the major force in the marketplace. So, we're watching it very carefully, and I really don't have too many concerns at the moment about that.

And Justin, I'll just tack on. I just think that you're also talking about it launching into what is we believe will be a continuing market opportunity. So, a rising tide lifts all boats. Certainly, if there's a carve-out share for them, it would be into a market that is going to approach $3.5 billion plus by the end of the decade. A lot of that predicated on the growing use from an RLT perspective. I'll leave it at that.

[Operator Instructions] Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets.

Brian, what are you thinking regarding the pending Medicare hospital outpatient rule, which, a, is overdue and then also the possibility that they will transition to ASP from MUC.

Yes. I think when you look at the end of last year, there was a moment in time where we had ASP, then we didn't, then we had it again and then we didn't. And now we're in the MUC environment. I think the hill is a bit in disarray at the moment. However, we continue to lobby. We continue to work with CMS, and we're continuing to educate them. I think the belief out there, and certainly, we share this is that moving to ASP eventually is the right move for all parties involved. It simplifies everything from both our end and from CMS. However, I think at the moment with a bit of a disarray, it's hard to break through and have your voice heard. So, I think for '26, I'm not anticipating much change, but certainly for '27, we are predicting that there could be meaningful change to ASP.

Our next question comes from the line of Yuan Zhu from B. Riley.

A follow-up from us. So now Neuraceq acquisition is complete, can you provide additional color on the growth trajectory from the past and looking forward as well as your plan to gain market share there?

Yes, I appreciate the follow-up question. I would love to talk about the historic trend line for Neuraceq, but those sales were not our audited numbers. So, I really can't really report on them too much. However, what I can say is we're seeing terrific growth from Neuraceq. October was an all-time high, and we expect that growth to continue.

Yes. I mean -- and even to take it from an inorganic perspective, we do -- they have been healthy growth rates. I mean, let's just put it that. They've had a great year in 2025. We expect them to continue to grow from a market share opportunity perspective as we grow our PMF network, as Brian outlined in his prepared remarks and as well as bolstering the U.S. sales team that came with the acquisition who have all done a great job. We expect the opportunity from an expanded geographic presence to drive not only just the annualization of their contribution, but also to drive added value beyond that.

And I think what gives us a lot of confidence is the team from Life Molecular Imaging has been in the neuroscience space for quite some time. And their expertise is immediately grafted into our organization, and that gives us the ability to really hit the ground running and not lose any -- there's no real downtime with them. It's been a seamless transition and integration with them, and we really cherish a lot of our new employees.

Thank you. Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect, and have a wonderful day.