Good morning. Welcome to today's conference call. All lines have been placed on mute. This call is being recorded, and a replay will be available in the investor section on the company's website approximately two 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.
Thank you, and good morning. Joining me today are Brian Markison, our CEO, Paul Blanchfield, our President, and Bob Marshall, our CFO. We will begin with prepared remarks and then open the call for Q&A. Today, we issued a press release announcing our agreement with Life Molecular Imaging. The release and today's slide presentation can be found in the investor section of our website. Today's call may include forward-looking statements such as comments about our plans, expectations, and projections. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Please note that we assume no obligation to update these forward-looking statements except as required by applicable law, even if actual results or future expectations change materially. For more information on the risks associated with the proposed acquisition, please see today's press release.
I will now turn the call over to Brian.
Thank you, Mark, and thank you all for joining us this morning to discuss Lantheus's acquisition of Life Molecular Imaging, or LMI. It's an exciting day for Lantheus and LMI. We see a multi-billion-dollar market opportunity about to emerge in Alzheimer's disease radiodiagnostics, and this deal positions us to be there when it does and make a difference for the millions of people and their families facing this disease. Early last year, our management team aligned on our strategy to enhance our radiopharmaceutical leadership by expanding our capabilities and selectively acquiring assets in high-growth markets that diversify our business. With operational excellence, financial discipline, and prudent capital management, we have been investing in and developing innovative diagnostics and therapeutics to benefit patients and clinicians while creating shareholder value.
We have specifically focused on enhancing our capabilities across the radiopharmaceutical value chain, including in Alzheimer's diagnostics and oncology therapeutics, entering new markets with significant growth potential that diversifies our business and makes use of our existing capabilities, and expanding our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs that take advantage of our expertise. Our acquisition of LMI aligns with this strategy as it establishes a commercial franchise in Alzheimer's disease, expands our growth profile with an approved Alzheimer's disease radiodiagnostic, enhances our R&D clinical development capabilities, and strengthens our innovative radiodiagnostic pipeline. This acquisition accelerates our entry into the Alzheimer's disease and dementia space with a particular focus on beta-amyloid. As we have shared, Alzheimer's represents a significant growth opportunity with a U.S. market potential of approximately $1.5 billion by the end of the decade and aligns directly with our strategy and existing capabilities.
LMI's globally approved F18 beta-amyloid radiodiagnostic Neuraceq, or Florbetaben F18 injection, provides near-term revenue, significant growth potential, and diversification to our commercial portfolio. Importantly, this also enhances our broader radiodiagnostic platform with the addition of LMI's talented team, pipeline, and R&D capabilities, all of which will further augment our ability to positively impact those living with neurodegenerative diseases. Today's announcement marks a natural step in our partnership with LMI. We've worked closely with LMI's exceptional team since we acquired worldwide rights to RM2, their novel clinical-stage theranostic pair that targets the gastrin-releasing peptide receptors, or GRPR, for prostate cancer, breast cancer, and other tumor types. This acquisition brings LMI's differentiated pipeline to Lantheus, including multiple radiodiagnostic product candidates and expands and complements our existing portfolio. It also broadens our molecular imaging commercial portfolio with LMI's flagship product, Neuraceq, an F18 PET imaging agent that has been marketed in the U.S.
Since 2014 and is used to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment. It is approved by health regulators in the U.S., Canada, EU, Canada, Switzerland, Japan, China, Taiwan, and South Korea. In these markets, LMI has established relationships with manufacturers, hospitals, imaging centers, and neurologists. The LMI team has successfully grown Neuraceq since launch, and with our combined company's operational and commercial expertise, we plan to accelerate that growth by expanding availability and increasing promotional efforts while simultaneously benefiting from the continued adoption of disease-modifying therapies. We're especially excited to have LMI's talented team of employees join Lantheus, to learn from them and to enhance our combined capabilities in the development and commercialization of innovative radiodiagnostic and therapeutic solutions. Now, I'd like to hand the call over to Bob, who will talk us through the details of the transaction.
Thank you, Brian. This transaction immediately adds a commercially approved product that diversifies our commercial portfolio, enhances our R&D capabilities, and provides a risk-adjusted opportunity for upside. Notably, we expect this addition to advance our entry into the Alzheimer's disease radiodiagnostic market by approximately one year and the beta-amyloid market by approximately two years. This platform will drive an increase in consolidated organic annual revenue growth by approximately 200 basis points to 300 basis points over the next three years while expanding our commercial and operational footprint outside the United States. The transaction is expected to be accretive to adjusted earnings per share within the first 12 months post-close. This combination will also allow for future synergy opportunities as we take advantage of LMI's existing neurology commercial infrastructure to launch our own complementary neurology products and by expanding the availability of Neuraceq through Lantheus's strong PMF network relationships.
The deal structure was an important consideration for this transaction. The all-cash, debt-free transaction includes an upfront payment of $350 million payable at closing and up to $400 million in potential earnout and milestone payments, as well as up to $30 million towards sellers' retained future contingent liabilities under certain contractual arrangements, all of which are largely related to the future commercial success. Similarly to how we structured the Progenics acquisition, if Neuraceq or certain of LMI's pipeline candidates exceed the milestone thresholds, both company shareholders stand to benefit even more. Lantheus expects to fund the transaction entirely with cash on hand, and as such, closing is not contingent on external financing. With that, I'll hand the call over to Paul.
Thanks, Bob. Neuraceq is currently used to evaluate patients who are being assessed for treatment eligibility with newly approved anti-amyloid drugs and for enrollment in clinical trials to support drug development in neurodegenerative diseases. With Lantheus's operational and commercial expertise, most notably in F18-based radiodiagnostics, combined with LMI's existing and complementary commercial and development capabilities, we are well-positioned to expand patient access to Neuraceq for the millions of individuals living with Alzheimer's around the world. We believe that Neuraceq and NAV-4694, our beta-amyloid diagnostic candidate in phase III clinical development, are differentiated from one another, with NAV-4694 having potential applications for detection in earlier stages of AD. We are also excited to add two pipeline programs.
First, LMI's radiodiagnostic tau agent PI-2620, currently in phase III clinical development, which we believe is complementary to MK-6240, our phase III tau diagnostic, with each offering unique advantages and applications in the diagnostic landscape. PI-2620 is in phase III development and shows potential for tauopathies where MK-6240 does not, including progressive supranuclear palsy, corticobasal degeneration, and dementia with Lewy bodies. Secondly, Neuraceq Indication Expansion is currently in phase III development for the detection of cardiac amyloidosis. These agents have the potential to provide precise, real-time insights into function and pathology, which we believe are critical for diagnosis, staging, treatment planning, and ultimately patient outcomes. This will become even more important with the increasing availability of disease-modifying therapies. Furthermore, the utilization of beta-amyloid detecting agents has demonstrated remarkable year-over-year growth, reflecting their expanding role in advancing Alzheimer's disease diagnostics.
Monthly claims data reveal a steady and substantial increase in patient scans and claim submissions for diagnostic agents like Neuraceq across sites of care. This underscores the growing reliance on beta-amyloids for the early detection and monitoring of cognitive decline. Finally, the National Institute on Aging and the Alzheimer's Association, as well as the SNMMI, continue to update their guidelines and use criteria, recommending both amyloid and tau PET imaging for diagnosis, staging, and treatment monitoring. Based on current analyst forecasts of therapeutic uptake and inferred scan volumes, we believe the U.S. AD PET radiodiagnostics total addressable market has the potential to grow to $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s. This represents a significant growth opportunity and one that our combined organization and portfolio is well-positioned to address.
Headquartered in Berlin, the LMI team has high-caliber research and pharmaceutical development capabilities, specifically chemistry and manufacturing expertise, that will enhance and complement Lantheus's existing resources, enabling us to better advance our diversified pipeline and ultimately deliver better patient outcomes. In addition, LMI has a global presence that provides additional opportunities. We plan to utilize LMI's existing U.S. infrastructure to accelerate our entry into the incredibly promising AD radiodiagnostic market by approximately one year and the beta-amyloid market specifically by approximately two years. We will utilize this infrastructure to launch our combined Alzheimer's radiodiagnostic pipeline, including MK-6240, NAV-4694, and PI-2620, while LMI's international presence affords us the option to commercialize our portfolio in markets where we have previously opted to partner or out-license. These R&D capabilities, commercial infrastructure, and established international presence will help accelerate the development, advancement, and commercialization of our combined portfolio and pipeline.
As Brian mentioned, this acquisition aligns squarely with our strategy to enhance our radiopharmaceutical leadership by expanding our capabilities, diversifying our business, and strengthening our long-term growth potential through inorganic actions. It adds radiopharmaceutical R&D expertise and significant commercial and international infrastructure well ahead of Lantheus's standalone expectations, enhances our pipeline with highly complementary clinical assets targeting disease with significant unmet need, and brings with it a commercially approved F18-based imaging agent with a strong growth trajectory. By combining LMI's innovative PET portfolio with Lantheus's operational and commercial expertise, we'll unlock the full potential of our combined companies, with Neuraceq immediately boosting and diversifying our commercial revenues. We expect to complete the transaction in the second half of 2025 after receiving approval from Life Healthcare Group shareholders, regulatory clearances, and other customary closing conditions. Let me turn the call back over to Brian.
Thanks, Paul. To summarize, this acquisition is a pivotal step in our strategy to expand our radiopharmaceutical leadership by enhancing capabilities across the value chain, diversifying our portfolio, and accelerating growth in high-potential markets like Alzheimer's disease and dementia. In closing, I'd like to personally thank the employees of both companies. This transaction would not have been possible without their hard work and dedication, including over the recent holidays. We look forward to bringing our two teams and shared cultures together and working on behalf of the patients we all serve. With that, we'll now turn the call over for questions.
Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Roanna Ruiz from Leerink Partners.
Hey, morning, everyone. So I was curious, could you elaborate a bit on how Neuraceq helps you quickly entrench yourselves into the Alzheimer's market, and what are some of the top assumptions that drive your $1.5 billion TAM assumption for Alzheimer's radiodiagnostics, which I think you mentioned could grow to $2.5 billion by mid-2030?
Yeah, thanks, Roanna. And I'll tag team this answer with Paul, but Neuraceq is already well-established in the U.S. and really demonstrating a fairly good growth clip, which we're pretty excited about. And the recent inflection point really was with the approval, obviously, of two therapeutics that can make a difference and the real importance of beta-amyloid scanning for monitoring, tracking, and determining the extent of disease. So, as you know, in our pipeline, we have MK and NAV, and this gives us an immediate commercial presence day one in the market where we plan to have a major role. As far as the TAM is concerned, there's a number of factors that lead us into that calculation. There's doses reported, there's camera placements, there's a number of scans reported, there's reimbursement information, and also, naturally, incidence and prevalence. But Paul, why don't you pick up the TAM question?
Yeah, thanks, Brian, and Roanna. I appreciate the question. So we've shared this before, and I think our view is very much aligned with that, quite honestly, of Life Healthcare Group and what they've put out in the past, as well as aligned with what we've seen from analysts' forecasts of disease-modifying treatment adoption. So if we look at what the general consensus out there is for the DMT market size by the end of the decade and then indeed in the mid-2030s, we're looking at a market by the end of the decade that could be $8-$10 billion from a DMT perspective and north of $15 billion by the mid-2030s. That implies roughly between 400,000 to 500,000 patients by the end of the decade and approximately 600,000 patients on therapy by the middle of the 2030s.
If we look just mathematically at the number of patients that will need to be scanned for staging to go on those therapies, we can very quickly get to a market size by the end of the decade of over 400,000 scans per year for Alzheimer's PET and really close to 600,000 by the mid-2030s. The vast majority of that, about 75%, is going to be driven by the staging for those DMTs, and then, naturally, PET is going to see increasing use in overall screening and diagnosis, as well as monitoring, given some of the challenges there.
Roanna, the other part of this, which is perhaps the most exciting, is we get an early jumpstart into the marketplace with Neuraceq in an accretive transaction, so we get to hop in with a successful team, learn as we go, shape as we go, and we're relevant in the market as soon as this deal closes so we can begin to shape it for our pipeline.
Yep, super helpful. And if I could squeeze in one extra question, I was curious, thinking about the PI-2620 tau agent relative to MK-6240, do you have any thoughts about how both might be used in the future in clinical practice and some of the decisions between using one over the other?
Yeah. I mean, number one, MK-6240 is a bit ahead of 2620. We think 2620 could have some very interesting activity in PSP, progressive supranuclear palsy, corticobasal degeneration, and possibly dementia with Lewy bodies. So there seems to be perhaps a really good opportunity to expand the label there, while MK is much more specific, highly sensitive, has a great signal-to-noise ratio, and seems to be a very exciting compound. And what I'd like to do is just highlight at the upcoming beta-amyloid meeting in Puerto Rico later this week, there will be a lot of information presented about MK-6240 in the head study presented by Dr. Pascoal.
Got it. Thanks. Super helpful.
Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist Securities.
Hi, thanks for taking the question and congrats on the announcement and the deal. I wanted to just start off on the 200 basis points -300 basis points anticipated organic growth accretion that you mentioned. It sounds like that, obviously, this is going to turn organic in the second half of 2026. Is it right? I mean, we can get the 200 basis points of organic growth contribution just from Neuraceq alone. Is it right that that 200 basis points -300 basis points over three years is just for products commercialized already, or does that include other items? And I have a follow-up.
No, Rich, that's for commercialized products only.
Okay. And then if you could just talk to us a little bit about the margin contribution and what the—so year one, I appreciate it's accretive to earnings, but talk to us about what this does to margins. And then in 2025, what should we be thinking about in terms of dilution, if any?
Yeah. So, Rich, I appreciate that question. One, we're not giving 2025 guidance, obviously, because of the concept of we need to get to close. And when we get to close, that's when we'll really kind of fill in the blanks. We're not anticipating, by saying then the first 12 months, not trying to indicate dilution in the interim. So it's a year one accretive deal. From a margin perspective, this product will benefit from scale over time. If I look at a gross margin contribution, Neuraceq, from a cost of goods plus the embedded royalties that many products have, it's probably just below the company average at this point in time. But I do anticipate, as we grow scale, that just like with Pylarify, we've seen improvement in the overall profile.
There is going to be spend just from it comes with an R&D pipeline, and that probably adds about 100 basis points' worth of R&D spend. But again, it's all embedded. The benefit here, too, that we tried to talk about is in the sales and marketing opportunity in terms of being able to take advantage of the existing commercial infrastructure. So as we launch our own complementary portfolio in the next years, we're not going to have to build out that investment. We'll certainly supplement what they have, but certainly not to the same scale that we would have on a standalone basis. So as I look forward, this deal is accretive to earnings per share and free cash flow from year one throughout. I don't anticipate, based on our estimates, that this is a dilutive situation.
Okay. That's helpful. If I could just squeeze in one more. Just thinking about Neuraceq revenue, that was the majority of LMI's revenue. We're getting to about, I think it was $60 million. Is that ballpark correct? And should we be thinking of this as 40%-50% type growth, or would you just give us a sense on the growth trajectory there? And if any of that's wrong, please correct me.
Yeah. No, Rich, I think you're generally on the right track, right? Clearly, LMI and Life Healthcare continues to operate as an independent organization right now, but I think you're in the direction of what we would have expected 2024 Neuraceq revenues to be. If you look at their overall growth trajectory, they've noted in their public presentations from September that they've seen growth on an annual basis in the 80-plus% range from a volume perspective. So it's a pretty healthy clip. As I noted in the prepared remarks, we've been monitoring closely the utilization, specifically over those last couple of months as DMTs have really taken off. We're very pleased with the growth trajectory over the overall beta-amyloid PET market and pleased to have the opportunity to bring such a great product and, more importantly, team into the fold.
And Rich, what Paul reported in the growth rate was the LMI disclosure that they made a little while ago, and that was specific to their growth in doses in their fiscal year 2024 over 2023. So we're pretty excited about that growth trajectory. Clearly, the inflection point is disease-modifying treatments. And also, there's a much smaller part of their business, which is a pharma services type of business, very similar to the Lantheus Pharma Services business, where we sell the tracers to academic institutions and pharma companies for clinical trials.
Their fiscal year ends September, though, right? That doesn't even include maybe some of the benefits of the change in CMS on a go-forward basis, which it sounds like you saw some nice uptick in the more recent months closing out 2024. Am I reading that correct?
I think that, look, the recent change for separate reimbursement for products by CMS is just huge for the industry. So we've taken that into account as we progress this opportunity for Lantheus and for LMI. So essentially, but remember, that takes effect in January 1st. But again, it's very good news. Thanks.
Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Anthony Petrone from Mizuho Financial Group.
Thank you. Happy New Year to everyone, and congratulations on the deal. Maybe one follow-up on the $2.5 billion TAM question. A lot is focused on staging of Alzheimer's patients, but kind of curious when you think out, certainly even to the mid-2030s, how do you think these agents will be used as diagnostic agents more for drug monitoring capabilities? So in an instance where, for example, a patient's on Leqembi, they may be getting dosed for several years, how do these stack up for drug disease monitoring? And then I'll have a quick follow-up.
Yeah. Great question, and happy New Year right back at you. I think the molecular imaging tracers are going to be extremely useful for determining really the more precision around clinical syndrome stage, which is critically important, and then longitudinal monitoring. So again, MRI is being highlighted to rule out ARIA, but when you look at longitudinal monitoring, and I think over time you'll see a very interesting role for tau agents because they get much more precision on geography within the brain. So I think as this market matures, longitudinal changes are going to be the most important reason to use these tracers beyond just ruling in and ruling out dementia.
That's helpful. And then when we think about MK and NAV just in the clinical trial phase of their development, I think, for instance, MK's used in like 90 clinical trials. Bringing in Neuraceq, is that going to change any of those development pathways? Can Neuraceq be used in other clinical trials alongside drugs that are under development? How is that going to work? Will that be accelerated, or will there be some cannibalization there? Thanks again, and congrats on the deal.
I think they have to play out. I think we look at Neuraceq as a first-generation agent, and we look at NAV as a true second-generation agent, which is highly, NAV is highly sensitive, has really excellent gray matter to white matter contrast, and really favorable kinetics, which are excellent for visual reading. Neuraceq clearly is a workhorse, first-generation agent, extraordinarily good chemistry backing it up and easy to use, and a great track record in safety and efficacy right now. But Paul, I don't know if you want to add to that at all.
No, Anthony, I think in short, we are excited to continue the development of all of these agents. We think they have differentiated roles in the market to play. Clearly, when the deal closes sometime in the second half of this year, we're going to continue to support the LMI team to bring those products to market, and we think this is in the best interest of overall shareholders to have even more agents available for both beta-amyloid and for tau in their respective markets.
Thanks again. I'll hop back in.
Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jefferies.
Hey, good morning. Thanks for taking the question. I guess in the LMI materials, they talk about their potential for garnering 20%-40% market share. And so I was wondering if you could comment on that. Do you agree with that? Do you think you could do better with more agents in your size? And then also just had a question on the decision not to pre-announce today. You have in the past. Can you just talk about why you didn't?
All right. I'll take the first part of the question. I really think Bob will take the second part, but I didn't hear it all that clearly. But anyway, on the first part of the question, yeah, we've noted their projections, and we think they're really good. But I'm not going to comment on their work and their public work product. I think we see a lot of growth potential in Neuraceq, but I believe that we believe that it'll have to be driven by our operational excellence and what we've done to shape the Pylarify market and grow that market. So I think there's a lot of wood to chop, but I think it's a great place to start, and their projections are their projections.
Yeah. In terms of the pre-release, Matt, we've actually only done that one time, and that was last year, and that really had more to do with being Mary Anne's last year and then transition to Brian into the new role, so we're really sort of just sort of reverting to what historically has been our norm. Nothing more than that.
Okay. Great. Thank you for the feedback.
Thank you. One moment for our next question. Our next question comes from the line of Yuan Zhi from B. Riley.
Good morning. Thank you for taking our questions and congrats on this commercial expansion outside of prostate cancer. Maybe one quick question, Brian or Paul, what were the factors driving you to buy this asset, this Neuraceq from Life Molecular Imaging? Was it updated CMS reimbursement rule or the rapid growth of Neuraceq in 2024, or are you just looking for a new growth driver in the near term?
I think it's a combination of things that in our mind make perfect sense. You have an exploding market in therapeutics for Alzheimer's dementia, and therefore the tracers now are becoming far more relevant and interesting. I think we know the F18 market really well, and we've watched and monitored LMI and its growth and development of Neuraceq, and when you think about our pipeline and the cost avoidance to jump into the market early, okay, with an experienced, talented team that has a tremendous development track record as well, this acquisition becomes really very straightforward for us.
Got it. And maybe a quick follow-up there. For the Neuraceq, can you quickly comment on the current market share of Neuraceq in Alzheimer's imaging and your strategy to grow and compete with two other approved agents out there?
Yeah. Thanks, Yuan, for the question. So when we look at the market shares, we're looking in the 20% from an overall market share perspective. I think we're incredibly excited about coming together with LMI's proven capabilities and what they've been able to do from a commercial perspective in Neuraceq, especially with the advancements of DMTs. I think when we combine our capabilities, we think about the commercial, we think about the market access, we think about our very strong channel relationships with the PMF manufacturers to ensure that we have the right out-the-door times to meet this exciting growing market, partnering even more closely with PET imaging centers, both hospitals and freestanding imaging centers, and to really maximize the potential of this agent as well as our broader portfolio for the Alzheimer's patients in the market. I think we've seen what we've been able to do with Pylarify.
We're going to be able to leverage many of those capabilities to maximize this asset and indeed the entire portfolio. But Brian, do you want to add?
Yeah. No, I'm glad you pointed out that there's other beta-amyloid agents currently in the market. Certainly Amyvid with Lilly, Vizamyl with GE. And I think Neuraceq with the LMI team has done an excellent job competing. It's a pretty open market for competition, and I think we plan to grow with the market and compete really well with our great customer service and commercial team and then bring our pipeline along as we come.
Got it. Thanks for the helpful comment.
Thank you. One moment for our next question. Our next question comes from the line of Paul Choi from Goldman Sachs.
Hi. Thank you. Good morning and happy New Year, everyone. My question is in regard to business development strategy. Can you maybe just comment on the rationalization for prioritizing Alzheimer's disease versus a potential oncology therapeutic or something in that area? And then my second question is, can you maybe just comment on what your counsel has advised with regard to antitrust considerations here, given the late-stage clinical pipeline as well as other competing commercial-stage assets in the Alzheimer's diagnostic market? Thank you very much for taking our questions.
Right. So the Alzheimer's market for us, where we already have a pipeline presence, when you think about the explosive growth, the innovation that's taking place almost daily in that market, our commercial excellence in building out the PET PSMA marketplace, extending into Alzheimer's and the size of the population affected versus prostate cancer really lines up perfectly with our strategy to, A, diversify, and, B, drive into growth potential areas where we can hope over time that we can actually duplicate and possibly surpass what we've done with Pylarify on a franchise basis. So that's quite simple. With radioligand therapies, after you get through a lot of the hype from last year and a lot of the premiums paid, radioligand therapies really only have a few agents on the market that are extremely successful, and most of the background has been about development and deals.
We're being very careful, very selective. We want to be best in class or first in class with our radioligand therapeutic choices, and those are much longer development timelines when you think about waiting for survival data or overall response rates and then an overall survival rate data as well, so we need to be more careful there, more selective there, but also rely on our deep expertise. With regard to the regulatory issues that you raised, we have no comment on that.
Thank you. One moment for our next question. Our next question comes from the line of Tara Bancroft from TD Cowen.
Hi, good morning, and thanks for taking the questions. So I think we got through most of the market questions. So I guess mine is more of a strategy question. So I wonder how much of this acquisition decision was driven by, of course, the accretive impact on EPS versus the expertise of the commercial and development team to support the growing franchise or franchises even outside of Alzheimer's. Specifically, can this team help support growth of Pylarify and DEFINITY too? Thanks.
I think if we're broader in F18 imaging, it could only help us. The fact that this deal is great out of the gate, I think, is just good news. I think what's more important for us is a clear head start by one year or more into a market where we plan to be. So Paul, you want to answer that?
Yeah. No, Tara, thank you for the question. I think clearly we're incredibly excited about the Alzheimer's space. We are very impressed with the LMI team and how they have been able to bring Neuraceq to market and make it available for patients. So clearly, the primary driver here is the fantastic LMI team and what they have been and continue to be able to do with Neuraceq. Clearly, there's additional benefits that we've highlighted. It does expand our overall capabilities in radiopharmaceutical leadership, specifically commercial, in their pipeline programs, which we've highlighted and are excited about, as well as their enhanced R&D and supply chain capabilities.
We think the combination of these two great organizations will allow us to continue to lead, specifically in radiodiagnostics, and expand our capabilities both in launching products in the U.S., but also, as we highlighted, selectively looking ex-U.S., where we've primarily relied on partners or outlicensing. LMI brings some of those capabilities for us to consider to maximize going forward.
The group in Berlin is exceptionally talented, and we're thrilled to have them become part of the team to build off our combined expertise and development. So there's a real synergy there, and they've done excellent work, especially on the CMC side. And let's not forget, RM2 came from this group, and we licensed that earlier this year.
Okay. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets.
Great. Thanks. And good morning. You touched on the commercial infrastructure briefly earlier, and Life has this data in their presentation. So looking forward, how do you see the pacing of the build-out? Is it something where it might be, you might make some near-term investment shortly after closing, or do you think it's just going to be more gradual from here?
Yeah. Thanks for the question. I think if you look at some of the information that LMI has put out publicly, they do plan a modest expansion in the U.S. to support their growth efforts, and we are very much in sync with that. I think we would continue to invest where appropriate in helping them build out their PMF network and also drive deeper connections to referring physicians. But we don't necessarily see a massive investment coming down the pike here.
What we see is a natural progression to help them build out and support what they're doing right now, and that leads back to Paul's and Bob's comments earlier where we described that this transaction is accretive over the life of the short-term plan for us. Great. And the second question is, since this is going to require a shareholder vote by Life Healthcare Group's shareholders, are there any wrinkles in that voting process we should understand, or is it just a straight majority vote? We do not think there will be any wrinkles. The LMI or Life Healthcare senior management team and board fully support the transaction, so we expect this to go rather smoothly.
Great. Thank you.
Thank you. One moment for our next question. Our next question comes from the line of Ed Ridley-Day from Redburn Atlantic.
Good morning. Thank you. A couple of follow-ups, please. First of all, on the Neuraceq revenue, I don't know if you can give us any color on the proportion that is clinical trial related, as with you, clearly a lot of work being done, and that is an important driver. So if you can give us a breakdown of the Neuraceq revenues, that'd be helpful. And then on the R&D service revenue that they disclose, how should we see that going forward? I mean, clearly a very stable business, a very well-set business. But can you speak a bit to your ability to grow that business?
So just to clarify the question, are you asking about their pipeline and our ability to grow that or in general?
No, specifically the R&D service revenue. I think it's about $20 million a year where they have that service business. And how should we see that growth in that business going forward as compared to the other business?
Yeah. Understood. Yep. I understand. Well, I think, look, there's some promising candidates in their pipeline. Certainly, the potential for an expansion of Neuraceq labeling in cardiac amyloidosis, and that's in advanced phase III clinical trials. Their tau agent, as we mentioned, 2620, is also in phase III. But the LMI team has been extremely efficient in deploying capital to cover these expenses. So I don't think you're going to see a dramatic increase in our research and development expense as a result of this acquisition. Remember, it remains accretive over time. So we believe that growing Neuraceq will certainly compensate for any increase in R&D spend plus some. So we're pretty excited about that component of it. And as far as the Neuraceq revenue question, Paul, do you want to ping that?
Yeah. No. Thanks, Richard. I think we view this primarily from a Neuraceq perspective as commercial sales over time, right? This is a little bit different, if you will, than what we see with our own MK-6240 or NAV, recognizing that those are still in clinical development. There will certainly be an opportunity for continued use of Neuraceq as well as their other agents as well as Lantheus's agents in clinical trials. But those can be procured more on the commercial market, given those are approved products that, well, Neuraceq is an approved product. And as products become approved and reimbursed, they can be utilized in clinical trials more broadly as a commercially available product.
Thank you.
Thank you. One moment for our next question. Our next question comes from the line of John Vandermosten from Zacks.
Good morning. Given that this is a global product and there are both business and nuclear material considerations, what regulatory clearances do you need?
Beyond the customary shareholder vote that's required in South Africa and the regulatory clearances here where we're really referring to antitrust, there really are no other clearances that are required to close this transaction.
Okay. And in a few years, you may have two beta-amyloid and two tau agents. And how will the Life Molecular Commercialization team change to accommodate that?
That will certainly shape over time. And remember, the market in general is fairly competitive with three currently marketed beta-amyloid agents, one currently marketed tau agent. But we see distinct differences in these agents. On the amyloid side with Neuraceq, we view that as a first-generation workhorse, if you will, beta-amyloid tracer. While NAV, we look at a second-generation tracer, which is very highly sensitive, again, great gray matter to white matter contrast, and could be an excellent drug for visual reading. And with tau, MK-6240 is certainly ahead of 2620. And I think our MK-6240 offers distinct advantages and differences, while 2620 could be very relevant in other tau pathologies. We do see differences here that are quite distinct. But again, that'll be shaped over time, and there's a lot to play out in the marketplace with currently competitive agents. Paul?
Maybe just a bit more to add on the expansion of the LMI commercial team. I think you've already seen expansion. LMI has shared publicly them expanding not only their U.S. team, but their PMF sites or PET manufacturing sites to increase the availability of Neuraceq, enhancing the relationships that they have with hospitals and imaging centers. Clearly, we think they're doing a fantastic job, and as we've done in the past, we will continue to invest when we come together, commensurate with the opportunity, but are incredibly pleased with the great work that the LMI team has and continues to do, and we're looking forward to working with them, bringing our combined capabilities to better serve patients going forward.
Thank you. One moment for our next question. Our next question comes from the line of Andy Hsieh from William Blair.
Oh, great. Good morning. Thanks for taking our question. One is Eli Lilly's Kisunla, it allows patients the flexibility of having a drug holiday. So I'm just wondering Paul's commentary before about this longitudinal tracking. Is that a part of that assumption already, or this could present as upside going forward? And the second question has to do with R&D. I'm curious about LMI's R&D capability and how would that help you in terms of generating the next wave of radioligands? Just maybe highlight some of the differentiation that they can provide with your pipeline. Thank you.
Yeah. I'll start with the second part of your question first and share the first answer with Paul. But the development team of LMI is really a core group of outstanding folks, great chemistry, certainly clinical trial expertise, great radiolabeling expertise. They've got a cyclotron on-site, access to a terrific animal lab on the Bayer campus. So there's a real synergy there in adding complementary skill sets in the drug development value chain as we sort out the pharmacokinetics and positioning of different radioligand therapies, but more importantly, other diagnostic candidates that are in the pipeline that we're exploring currently. With regard to the first part of your question, Paul?
Yeah. Thanks, Andy. We're certainly aware of the drug holidays associated with certain of the DMTs. I think that's generally factored in overall to the general monitoring and patient selection, recognizing that payers as well as physicians are going to want to understand the presence of beta-amyloid and potentially tau in continuing disease-modifying therapy as well as restarting. And so I think we're still at the very early stages of what is an incredibly promising market overall. We do believe that the staging is going to be the primary driver today. And it will still say the majority, but the monitoring piece will continue to expand in importance, especially as we think about longitudinally. And so very pleased with the overall upside of the market.
I'm going to continue to monitor and naturally cheer on the success of the DMTs and look forward to Neuraceq as well as the expanded portfolio playing an increasing role in the screening, diagnosis, staging, and monitoring of this very important condition.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.