Lantheus Holdings, Inc. (LNTH) Earnings Call Transcript & Summary

Thank you all for coming. Welcome to the Morgan Stanley Healthcare Conference. Just a quick note on disclosure. For important disclosures, please see the Morgan Stanley research disclosures website or please contact your Morgan Stanley sales representative. So thank you for attending the Lantheus fireside. I'm here with the CEO, Brian Markison; and the CFO, Bob Marshall. Welcome, Bob. Welcome, Brian.

Good morning.

Good morning. Nice to be here very, very early with a nice cup of Starbucks.

Great to have you.

So for those in the audience who aren't familiar with the Lantheus story, can you mind just giving me a quick background on the company?

Yes. So a quick background. Also, please note our safe harbor and forward-looking statements, please. Background on the company, founded coming out of the Manhattan project, had a number of different names over time, but always been in the nuclear medicine business, always leadership going back in time with products like Cardiolite, which are pretty well known and our Technetium Generators. And then now most recently, the launch of PYLARIFY has really reshaped the nuclear medicine business quite a bit with the first true blockbuster PSMA agent. So we're dedicated to nucmed. Also, we have a great product in our microbubble technology, DEFINITY, which continues to turn along very nicely for us, and it's a great agent. And we've got a fairly strong investment in a deep pipeline. And hopefully, we'll get into some more of that as this conversation goes on.

Yes. That's great. And then so around the commercial portfolio on PYLARIFY, last year, for the first time surpassed $1 billion in sales. But there's been some recent headwinds around the competitive pressures and reimbursement. Can you just go into some of that?

Yes. Well, at the beginning of the year, PYLARIFY lost pass-through status, and that meant that we went to separate payment for traditional Medicare. And now we fall into a category where we're being reimbursed at mean unit cost or MUC, if you will. That was a big hit to that portion or segment of our population. Rough justice across our total population that gets PYLARIFY, it's about 20% of our patients. So that was a meaningful discount. Also, we have a competitive environment, 2 other players that we're competing with as well. And being the leader in the market right now, we're really focused on delivering our product, delivering service, growing the market and also being very disciplined in our approach to pricing.

And maybe just around more of the broader competitive dynamics are evolving within the PSMA PET space. Do you mind just going into kind of what the field is evolving to, what your expectations are?

Well, right now, we're a 3-player market. I continue to see that remaining like that for a short period of time. I think in the not-too-distant future, there'll probably be 1 or 2 additional Gallium competitors. There'll also be another copper competitor over time, not in the very near future. But I think for '26, '27, '28, you're looking at a market that's hopefully relatively stable and will exhibit significant growth due to the increasing demand for prostate cancer patients.

Yes. And so you've effectively maintained a significant leadership position within the space for years now. How do you expect to maintain that with the rise in competitive pressures?

Well, I think, number one, PYLARIFY is perhaps the best agent out there. The F-18 signature is superior to Gallium. That's not a mystery, nuclear medicine knows it. The question is how much better is it? And then a lot of that comes down to our outstanding field team, our resources, our customer service, our ability to deliver reliably over and over again. We take a lot of pride in that. The other F-18 agent is having a little bit of difficulty in real use in the marketplace with the exhibiting of false positive lesions. It's in their package inserts in their label. If I was a patient going for a scan, I would demand PYLARIFY.

And maybe just to that point, how do you kind of think about the clinical differentiation around these assets, whether it's F-18, Gallium, as you see?

I think Gallium has done a great job in being there to deliver sort of off-peak, if you will, early, late in the day, where with PYLARIFY, we're best delivering sort of en mass where there's scale. So for the, call it, 9:00 a.m. to 3 in the afternoon window, we're terrific. I think we can improve a bit in the earlier or later times. But I think we share the market now with Gallium and don't see an issue there. So I think that will continue.

And then with the recent CMS OPPS rule in '26, what do you think about the potential impacts there on PYLARIFY in the broader market?

Well, I think at some point, all signs point to average selling price becoming the norm. However, getting there is a different matter. We're not exactly clear what it will take to get CMS over that final hurdle. We've communicated with them quite frequently, and we're asking them now, what do you need to know from us specifically? We report ASP. We know that a lot of other companies are reporting ASP. We don't see the difficulty there, but we know a lot of the older products, particularly those delivered by radiopharmacies, do not report ASP. And perhaps that's the hang up with CMS. However, we're waiting for their feedback and we're asking for it. So we think we're going to move to ASP, maybe not in '26, but I think '27 would seem good, but I'm not going to handicap it.

Yes, that makes sense.

And we're just continuing with innovation. So as we deliver more innovation like our new formulation, there'll be another one and another one. And so if that's what we need to do, it will be good for the industry, good for patients. So we'll just keep going on that track.

Yes. So we've heard a lot about -- or a little bit about, rather, the new formulation of what you're pursuing around PYLARIFY. Can you go into a little bit of that and maybe some of the time lines with the FDA?

Well, we filed -- our PDUFA date is March of next year. And we anticipate getting approved on time with our PDUFA date. We're in active review. It seems to be going quite well. We are engaged with the agency. Getting approval in March, we're going to go for the [indiscernible] codes and then pass-through and then hopefully be on the market as soon as practical. But the new formulation has a number of advantages. And the foremost is it will be able to increase our batch size at least by 50%. So with a lot of new agents coming for [ cardo ], certainly the explosion in the amyloid space, being able to deliver a formulation that can really boost our efficiency and batch efficiency, not only that but gross margin.

Gross margin expansion?

Yes. So that will be a good look for the company and also potentially a chance to reset some pricing.

Yes. And then maybe thinking more long term on that point, as you look at PYLARIFY beyond '25 into '26 and beyond, how do you -- how should we kind of think about that? How are you focusing on that internally?

I think '26 could be a tale of like 2 halves. I think the first half of the year will continue. As the market right now, it's exhibiting signs of stabilization, if that continues, then we plan to hopefully grow with the market. But when we launch the new formulation, I think we're going to see rather explosive growth out of the product.

That's very helpful. Maybe shifting gears a little bit to around business development. You've been very busy over the last year or so around BD. And so you've acquired 2 companies being LMI and Evergreen. You've also sold the SPECT business. Can you just explain some of the strategic rationale for these deals?

Yes. I think the SPECT business for us was very important years and years ago. But as we're looking forward, that business is probably better off in somebody else's hands. It is not a great margin contributor, not a great cash contributor, but it has been a hallmark of our history over time. And I think it's like a natural business cycle to move on and basically trade up where you can. So we closed on Evergreen before LMI. Evergreen gives us great capability in the radionucleid space where now we have a manufacturing facility that's built for today for radioligand therapies with a very nice discovery unit that comes with it under Dr. Tom Reiner's leadership. So that's -- you have to own it in this space in order to work it and deliver the market products to the marketplace. And then with LMI, we made a strategic bet that they've got great capability, great people, number one. Number two, they're in the amyloid space right now with a great agent in Neuraceq, which is growing extremely well. And they have a very interesting pipeline as well. So we're looking at a combination of these 2 other companies with Lantheus and really upping our game and our capability. So we have end-to-end capability now and across the board with radio diagnostics as well as therapeutics. And our hallmark is nuclear medicine.

And maybe on Evergreen and LMI, those have recently closed, how is the integration going? And how's that going?

Really well. I think Evergreen is sort of ahead of the curve on the integration because what we don't want to do is integrate them too hard and mess them up, if you will, because they're really doing a great job running on their own. But we are beginning to feather in our own assets into the plant. So that's really quite rewarding, quite frankly. We have LRRC15, RM2, both RLTs that are moving very fast towards the clinic. And we're working now with the team to bring those in-house. So we'll be able to make them in our own facility, which is terrific. With LMI, we're beginning to sync up their commercial team and our commercial team. We're finding that a lot of our PYLARIFY customers would love to have Neuraceq come from the same place. And so we're working quite aggressively to expand their PMF network so that we can deliver Neuraceq across the board. And then hopefully, we'll have that team ready to go when MK-6240 gets approved. I'd love to have a brand name for it, but we don't yet. And that will be the home for MK-6240, our tau agent.

Yes. And as you think about the near-term and longer-term composition of the company with these 2 deals behind you, how do you think that changes over time? And maybe what do you expect some of the synergies to be coming out of this?

Well, I think PYLARIFY and DEFINITY are going to continue to be great workhorses for the company. they will continue to throw off meaningful cash, and we will continue to support and grow PYLARIFY where we can. That's very, very clear. I think as we look forward in time, the Alzheimer's dementia space is clearly undergoing a complete transformation. We have 2 therapeutics on the market now, both of them very good, but nothing is perfect. As the knowledge base rises with neurology and it becomes increasingly clear that catching patients early can have a very meaningful difference in their dementia profile, I think we're positioned ideally to be right there for that market explosion. So beta amyloid has grown -- basically year-over-year, it's doubled. And we -- given our pipeline, we know we have the most significant pipeline in the Alzheimer's dementia nuclear medicine space, period. And so whether it's beta amyloid or tau, when a tau agent gets approved, and there's a whole bunch in development, we'll be sitting there ready to go with the best tau agent. So we're making a pretty big bet on AD. It's not a tomorrow thing. But next year, as we look forward, we have high growth expectations for Neuraceq. So the acquisition of LMI was very strategic. It's cost avoidance on our part. We don't have to build a commercial organization. They have a great one. They have a great R&D base, great talent. They're now -- Ludger who ran LMI is now our Head of R&D and we've begun integrating a lot of their top scientists into the company. So a lot of work happening in Berlin. It's going to stay there and also as we build out more on campus in Bedford, Massachusetts.

And then on the -- sticking with BD for a second. As you think about those deals being up behind you now, the next 12 to 18 months, how do you think about future deployment around BD and how you prioritize?

Well, I think the team is asking me to calm down. So I think we've got our hands full right now on integration. We are actively looking at a number of things. We're going to be very selective as we have been, very strategic. We're not looking at anything super large, but we are looking for very good tuck-ins that could fit with the company. And we're looking across the board. So clearly, BD is the bread and butter of this company. If you look at PYLARIFY, it came from Progenics. So we will continue to do that, but I think we're going to be a little more cautious as we go forward and more selective and make sure that our shareholders see a really early return for whatever we pick up. But there's very interesting also very early targets that we're looking at as well because now we've got this great science team. So we think we can make really good assessments. So we're going through a portfolio prioritization right now. We're hoping to have an R&D Day in the not-too-distant future, perhaps before the end of the year. And we can showcase a lot of our talent, a lot of our capability, but we'll let the world know if we're ready to do that yet. We have to get through the integration first.

And maybe just quickly on a follow-up point. How do you kind of think about the 2 worlds being a diagnostics and therapeutics earlier stage, later stage and how you do the funnel there?

Yes. No, it's a great question. I think with diagnostics, that's our bread and butter. And we are always going to be what I would hope is preeminent in molecular imaging. I think when we look at the therapeutic landscape, we have a capability to really be highly selective, look for potential best-in-class, first-in-class assets and use our combined nuclear medicine expertise and experience to bring forward some very interesting candidates. Now if these candidates show immense promise, we'll either, a, develop them on our own or go partner them. We're certainly open to partnering on the therapeutic side. We understand completely. Many of us come from big pharma, I've spent years in big pharma. I'm not going to wreck the Lantheus P&L to do a $1 billion Phase III program. But if the asset has that kind of potential, we're certainly welcome to talk to other people about it and see where we can take it. But we will develop them early. We'll identify them. We'll show the potential and see where it goes.

And maybe for Bob, can you just remind us what the guidance is for the 2 recent acquisitions and also the divestiture of the SPECT business?

Sure. Brian has already touched on the fact that the deals were not based on synergistic values, even though that they bring tens of millions of dollars in terms of LMI in terms of the cost avoidance from a sales channel perspective. But combined, I said it would be 18 months sort of combined. And the assumption there was that they would both close midyear. Obviously, with Evergreen closing in April and then you have LMI closing sort of toward the end of July, it's sort of like a little bit of a disparate math there. But I had said $0.25 diluted. That is mainly due to the R&D investments and so forth that Evergreen brings in the manufacturing infrastructure, but LMI being accretive out of the gate. And so just given the nature of where we are in the balance of the year, I had called out in the last earnings call that it would be about $0.04 accretive. So you take the 2 combined, you normalize them for the timing, and it gets to that low single-digit dilution that I had stated back at the beginning of the year from our expectations. So those are the 2 acquisitions. The divestiture of the SPECT business is $120 million effectively roughly of revenue that would go with the deal. But as Brian has already pointed out, at the bottom line, it's marginal at best. And -- but for the benefit for us then becomes a gross margin. So one, it unlocks some growth on the top line. But it also, from a gross margin perspective, adds about 200 basis points that gives us additional leverage as we move forward, particularly in the environment that we're working in.

Yes. No, that makes sense. And then, Brian, you mentioned you briefly went through the Alzheimer's and neurology space as we're kind of thinking about it. Can maybe discuss some of the opportunity set as specifically around Alzheimer's and how that's growing out?

Yes. Well, I think the immediate opportunity is certainly with beta amyloid and with Neuraceq. Right now, their PMF footprint is less than half of our national coverage with PYLARIFY. So for us to work with our partners like Sofie, PharmaLogic to expand the network is pretty much a no-brainer. Our deep relationships with nucmed make it a perfect fit with our PYLARIFY franchise. And also in all these institutions, we, for the most part, have DEFINITY under contract as well. So I think we want to expand the neurology team that we have with LMI, expand our footprint nationally. And I think that's the immediate opportunity for Neuraceq. It is an excellent agent. And I think we said we would file MK-6240 in the third quarter. That's on track. So therefore, an approval sometime next year. That market build will be slower. Essentially, while it's a great agent and perhaps best-in-class -- Again, it's going to be meaningful -- more meaningful when a therapeutic that affects tau directly gets FDA approval. And again, there's a number of them in the pipeline. So behind MK-6240, we have the LMI tau asset 2620 in the middle of Phase III right now. We also have NAV, which is another beta-amyloid agent that we partnered with Enigma in Phase III development right now. And something that doesn't really get a lot of attention is right now with Neuraceq, LMI is in -- or we are in Phase III with a cardiac amyloidosis study. So we anticipate expanding our label for Neuraceq or launching a separate agent. We haven't really diced that strategy yet. But we're in the middle of Phase III. We hope we'll be done with the program by the end of the year into next year and again, put a filing together for cardiac amyloidosis, which is really becoming quite an interesting area, again, driven by newer and better therapeutics for that space.

That's great. And then on Alzheimer's for a second, there's been recent data and then approval on the blood testing side. How do you see the PET and blood testing?

I welcome it. I think it's very analogous to the prostate market and PSMA. You go to your primary care physician, you get a PSA test, blood test. And if the markers, the guidelines are extremely well known, if you're seeing an elevation and it's consistent, they run you right to urology. With primary care, I'd love to see a ubiquitous blood test where you're showing certain signs, certain levels in the wrong direction, they refer you right to neurology. And then neurology can then work -- do a proper workup and get someone to a PET scan.

Maybe just shifting gears to the neuroendocrine tumor pipeline. Can you just give a quick update on 003 and how things are going right now?

Yes. With 2003, again, that's our radio equivalent to LUTATHERA. We are in review with the generic division. It will be an AB-rated product should it get approved. We believe we are finished with review. We're waiting on the agency now. And we're also in pretty extensive litigation with Novartis. So right now, we're in the middle of it. We are planning to have the litigation conclude by the end of the Hatch-Waxman 30-month stay, which will be the middle of next year. The judge that's presiding over the case seems to be on that track. So we're kind of encouraged by what we're seeing. But again, when you're in front of a judge, you really can't make strong predictions. Like our case, otherwise, we wouldn't be spending money on it.

That makes sense.

Now the other thing we also have with the acquisition of Evergreen is OCTEVY, and that's a diagnostic molecular imaging agent for neuroendocrine tumors as well. That's unencumbered. We plan to launch that towards the -- probably the third quarter of next year, early third quarter. And we're very excited to bring that to the market. So we'll have a theranostic pair, if you will, in the neuroendocrine space. The diagnostic to us is full steam ahead. The therapeutic product is sort of like option value for us. We preside well in the lawsuit. We go forward. We believe we have -- the product is imminently approvable, but we'll see. And it's great upside for the company if it hits.

Yes. Yes. That makes sense. And then if there is the approval of 2003 and OCTEVY is launched, how do you see that fitting in with the competitive landscape in SSTR and neuroendocrine?

Yes. I think it's again, if it gets approved, it will be rated as equivalent to LUTATHERA. So I don't think the competitive landscape for us is going to be all that difficult considering our deep relationships with nuclear medicine and the field. So we'll be bringing a portfolio to nucmed with PYLARIFY, Neuraceq, et cetera. This is an easy conversation to have. As I've talked to our customers today about the potential for this product, it's not going to be a heavy lift. So I think we just want to be cautious. We want to get through the FDA. We want to get through litigation, see where we go with Novartis. If they want to settle. We've certainly said we're open to that. I think it would be in their best interest, but we'll see where it goes.

Yes. And then you mentioned briefly, for example, label expansion amyloidosis. Are there -- what other programs that are within the pipeline that are worth highlighting, I guess the milestones coming out?

Well, yes, we have -- with Evergreen, we're in the clinic right now in Phase I with a targeted agent for small cell lung cancer. Right now, the trial is open in Europe. We're engaged with the FDA to open that study up in the U.S. and also potentially in India. It's targeting CCK2R, which is a pretty good expression profile in small cell and also in other tumors. So we want to see what we get here, get to a reasonably good dose and then evaluate the compound. We also plan to be in the clinic by the end of the year with LRRC15, which is a very exciting product that we have, radioligand therapeutic for osteosarcoma, tagged with Lutetium. That agent from now, all the preclinical signs, early animal models look phenomenal. So we're gearing up right now to treat our first patient. We're working with Dr. Noah Federman out in the West Coast, who is one of the preeminent doctors in pediatric oncology. And that program we got our fingers crossed. It's very exciting and we would love to bring something new to the treatment for osteosarcoma where it's been really difficult. And then right behind it, we have RM2, a diagnostic and therapeutic, theranostic pair. We're trying to go full speed in prostate cancer. We know we're competing with a Novartis agent and a Lilly agent and a few others, but we think we have a competitive advantage, and we're going to explore it. But certainly, we will bring the diagnostic RM2 full gear. And that's targeting GRPR, which is also expressed quite heavily on prostate cancer, particularly early hormone-sensitive prostate cancer. So while we love PYLARIFY and PSMA, not everybody expresses PSMA to a high degree. And also what we find is a very interesting dynamic where GRPR can overexpress when PSMA is underexpressing and vice versa. So there's a very interesting opportunity to make sure, particularly in early prostate that if people are going for definitive therapy that we catch all the mets. And the RM2 diagnostic agent that we have should really be helpful there.

And then maybe just taking a step back around the capital allocation strategy. And we touched on BD earlier. How do you kind of balance the internal versus external BD?

Well, I mean, it's...

In terms of external capital allocation, sorry.

Well, you know pretty well because you work closely with us. But it's a constant balance, right? And you're looking at -- essentially, it's all about shareholder return. So we've also disclosed an authorized $400 million buyback. In our last quarterly disclosure, we have been active in the marketplace on the buyback. We'll disclose in the third quarter release exactly how much we've been doing. And we plan to continue that. However, it's all a balance. And if we feel that there's an external opportunity that has greater return for the shareholders, then we'll explore it. So it's something that you look at every day. If something pops up that demands our attention, we'll take a look at it. But we're running a balance, and we'll deploy capital where we need to and optimize shareholder return.

The only thing I would add is that we are still generating significant free cash flow. We're still in that $100 million plus per quarter sort of run rate. And one of the things that I had noted is that I thought if there was a dislocation in our stock price relative to the intrinsic value of the company as we look at it on a forward basis, obviously, you always want to do that measurement that we would be active. And as Brian noted, that we have been active because we do see that dislocation.

Yes. And I guess on the capital allocation front, from an R&D perspective or from a P&L standpoint, how do you think about deploying more versus less there from an internal standpoint too?

Yes, that's a significant challenge. And right now, we're going through that prioritization process I mentioned. We will see a modest increase in R&D expense. We've seen it already and reporting it. And it all depends on the opportunity set that we see in front of us, to be quite honest. So we think we have an incredible pipeline. We have a great team that can execute on the platform. And I think if we're convinced and have conviction that some assets need to be accelerated and spend a little more money, we will do that, but it will be clear to everybody why. And the thesis will be in front of everyone. So we're not going to spend money recklessly and just to pick up widgets and say we have a pipeline.

I think historically that the company had spent something in the neighborhood of, call it, 5%, if you will, of net revenue on R&D effort, largely about sort of regulatory and so forth and moving maybe a more limited pipeline, but these acquisitions plus -- and not just the last 2, but a number of them that we've done over the last, call it, 5 years, we're now sort of marching towards more of a, call it, 9%, 10% type of investment. But to Brian's point, all of those investments come with an ROI. We have phase gating to make sure that we look at and make sure our assumptions around what these products can do commercially eventually to make sure that while the science may be interesting that we actually have a viable product longer term. And so we do study that. And as a team, we evaluate every aspect of these trials and studies that we're trying to conduct.

And then you mentioned this kind of the stock buyback strategy a little bit. You recently announced the $400 million stock buyback. You've used them in the past opportunistically. How do you kind of think about that as part of your broader capital strategy? And also maybe as a follow-up question to that, have you used any of the $400 million stock buyback yet since you announced?

Yes, we have been active in the market. So we have used some of that capacity, and we'll disclose exactly how much in our third quarter earnings release. And again, it's a balance, quite frankly. We have a $400 million authorization. It's flexible. We can always go back and get more. What we're doing with the management team, with Bob and I and Paul is constantly look at this and determine -- I think what we're seeing with this dislocation that Bob mentioned, it's a great opportunity for us to take some shares off the table. So we're looking at that all the time. It's just what's the best for shareholder return.

That makes sense. I know we have a couple of minutes left. Just figured I'd see if you wanted to share anything else with the audience that we might not have covered in the questions so far.

No, I think we are still comfortable with the guide that we gave. We've seen to see a market for PYLARIFY that is showing signs of stabilization. I think with a 3-player market right now, I think we, as the leader, are being as disciplined as we can be. And we're doing everything we can to get ready for the launch of our new formulation. So we have a number of launches coming up next year. So potentially, not only our new formulation for PYLARIFY, but we have OCTEVY. We have the expansion of Neuraceq, which we're treating like a launch, right, because for Lantheus, it is new to the table. Potentially 2003 or neuroendocrine radioligand therapy that will compete with LUTATHERA. And then right behind that, potentially MK-6240. So when we look at 2026 and potentially 4 launches, we have a lot on our plate. So we're being very mindful as to what are the big growth drivers, where should we put most of our attention, where should we put the resources and then how do we drive the market going forward. So clearly, our strategy over the last year or 2 years has been to diversify the revenue base. I think we're accomplishing that and making great strides. Our strategy has been to deepen our research and development bench with real assets that we can point to real programs. We've done that. So now for us, it's really a matter of execution, and we're going to be very prudent when we look at business development and also deploying capital for share repurchase. That's about it.

Thank you, guys. I really appreciate it, and thank you for joining us bright and early, and thank you all for joining us for this session. So just join me in thanking Bob and Brian for joining.

Thank you. Bye.