Lantheus Holdings, Inc. (LNTH)
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May 1, 2026, 11:41 AM EDT - Market open
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M&A Announcement

Jan 28, 2025

Operator

Good day. 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 will now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Mark Kinarney
VP of Investor Relations, Lantheus Holdings Inc

Thank you and good morning. Joining me today are Brian Markison, our CEO, Paul Blanchfield, our President, Bob Marshall, our CFO, and James Cook, Founder and CEO of Evergreen Theranostics. We will begin with prepared remarks and then open the call for Q&A. Today, we issued a press release announcing our agreement to acquire Evergreen Theranostics. The release and today's slide presentation can be found on 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 transaction, please see today's press release. I will now turn the call over to Brian.

Larry Solow
Analyst, CJS Securities

Thank you, Mark, and good morning, everyone. We're thrilled to have you with us today to discuss Lantheus' acquisition of Evergreen Theranostics. This is an exciting milestone for both Lantheus and Evergreen. This transaction, alongside our recent agreement to acquire Life Molecular Imaging, is in line with our stated strategy to expand our talent, portfolio, and capabilities to accelerate growth. We have specifically focused on, first, enhancing our capabilities across the radiopharmaceutical value chain, including in Alzheimer's diagnostics and oncology therapeutics. Second, entering new radiopharmaceutical markets with significant growth potential that diversify our portfolio and make use of our existing capabilities. And third, expanding our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs that take advantage of our expertise.

The acquisition of Evergreen aligns with this strategy as it strengthens our clinical and commercial manufacturing capabilities in therapeutic oncology, adds a registrational stage PET diagnostic agent that enhances our growth profile and complements our therapeutic candidate, PNT2003, which is under review with the FDA, expands our pipeline with multiple clinical and preclinical theranostic pairs, while also adding Evergreen's exceptionally talented team to Lantheus, unlocking the full potential of our combined companies. Evergreen has advanced radioligand therapy manufacturing capability that will improve our ability to advance assets from early-stage development all the way through commercialization and is more efficient than relying exclusively on external manufacturing partners. And importantly, we are excited to add Evergreen's highly skilled team, enhancing our expertise and ability to deliver new solutions for patients.

This transaction solidifies our capability as a fully integrated radiopharmaceutical company and positions us to address radiopharmaceutical production complexities, continue innovating, and deliver on our purpose to find, fight, and follow disease to deliver better patient outcomes. Before we dive into the clear financial and strategic rationale of this acquisition, I'm going to hand the call over to James Cook to provide some background on Evergreen. James.

James Cook
CEO, Evergreen Theranostics

Thank you, Brian. I'm thrilled to be here today with you and the Lantheus team and to speak about the innovative platform we've created at Evergreen. We founded Evergreen in 2019 based on a simple vision to improve treatment options for cancer patients through radiopharmaceuticals. Since then, our company has established a reputation as a pioneer, leading the way in precision medicine supported by a talented workforce of nearly 100 team members. Evergreen serves patients by developing and manufacturing radiopharmaceuticals from our production facilities. Our operations are supported by a state-of-the-art GMP radiopharmaceutical facility equipped with cutting-edge research and development capabilities, rigorous quality assurance and control systems, and a strong logistics and supply chain network. We are proud of the reputation we've built and our best-in-class team of industry experts. As we considered Evergreen's future, we quickly realized that partnering with Lantheus presented the best path to future growth.

Brian and his team have a clear vision that offers a compelling opportunity to enhance Evergreen's growth trajectory and enable our people to thrive as part of a broader platform with a greater ability to serve even more patients. I want to express my sincere gratitude to the Evergreen team for their dedication and hard work, which have been essential in helping us reach this point. Our job isn't finished. We still have a lot of work to do, but this is an important milestone. With that, I'll hand it over to Bob to walk through the details of the transaction.

Bob Marshall
CFO, Lantheus Holdings Inc

Thank you, James. Under the terms of the agreement, Lantheus will pay $250 million upfront, payable in cash at closing, and up to $752.5 million in potential milestone payments. Evergreen shareholders are provided with immediate and certain value, along with a mutually beneficial sharing of upside. The transaction is anticipated to close in the second half of 2025, subject to customary closing conditions, including regulatory clearances. This transaction is expected to contribute modest near-term revenue through OCTEVY, which expands Lantheus' presence in neuroendocrine tumors, as well as through Evergreen's CDMO operation. By internalizing Evergreen's scalable manufacturing infrastructure, Lantheus has the opportunity to accelerate and de-risk critical pathways that otherwise would have to be outsourced.

We estimate the transaction to be low single-digit % dilutive to Lantheus' standalone EPS, due mainly to anticipated R&D investment in the acquired pipeline, as well as pre- and post-launch investments to prepare OCTEVY for commercial success. Taken together with our other recently announced deal with Life Molecular Imaging, we estimate these two deals will be accretive approximately 18 months post-close. Lastly, as we look forward to hosting our fourth quarter earnings call next month, at this juncture in our financial close and audit process, we are comfortable with the prior financial guidance for full year 2024 and implied fourth quarter financial guidance. With that, I'll hand the call over to Paul.

Paul Blanchfield
President, Lantheus Holdings Inc

Thanks, Bob. The acquisition of Evergreen is a natural next step in Lantheus' evolution, with its manufacturing infrastructure and proven capabilities expected to support our early development, clinical trials, and commercialization efforts. Evergreen's GMP radiopharmaceutical facility is licensed to work with a broad range of diagnostic and therapeutic isotopes and consists of seven manufacturing suites. We believe this will enable us to drive innovation and target diverse indications across oncology, neurology, and other disease areas. When combined with our resources and market-leading platform, as well as the capabilities provided by Life Molecular Imaging, Lantheus will better address the complexities of radiopharmaceutical production with greater efficiency and precision. We are especially excited that by internalizing manufacturing, we can scale production of our own radiopharmaceuticals in both clinical trials and, if approved, commercially.

We also expect to accelerate development and lifecycle management, expand our portfolio of IP, and reduce the costs and risks associated with outsourced production. The acquisition of Evergreen provides these benefits years before we could do this on our own through a greenfield or brownfield approach. Evergreen's CDMO business provides a platform for further expansion while helping us manage utilization and absorption at the facility. We look forward to investing further into the site and the team to scale our capabilities and better serve our CDMO partners. We are also excited to add OCTEVY, which enhances our growth profile and complements our therapeutic radio-equivalent candidate, PNT2003. OCTEVY and PNT2003, if approved, could deliver a theranostic pair to support HCPs in the diagnosis, staging, and treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or SSTR GEP-NETs .

OCTEVY aligns with Lantheus' existing expertise, and we are well-positioned to drive the growth and adoption of these complementary agents. Finally, Evergreen provides early-stage development capabilities driven by a highly skilled team and a platform designed to efficiently generate novel radiotherapeutic programs. We're excited to work with them to advance their pipeline and provide hope to patients in need. This combination of advanced manufacturing infrastructure and early-stage development capabilities will be instrumental in driving Lantheus' next phase of growth, ensuring we remain at the forefront of radiopharmaceutical innovation. It's clear the combined acquisition of Evergreen Theranostics and Life Molecular Imaging solidifies our capabilities across the value chain. From early drug development to manufacturing and commercialization, it puts us in new radiopharmaceutical markets, including Alzheimer's and neuroendocrine radiodiagnostics, and expands our pipeline with potentially best or first-in-class product candidates.

By combining our teams, infrastructure, and capabilities, we are confident that we will continue leading in this exciting space. Let me turn the call back over to Brian.

Brian Markison
CEO, Lantheus Holdings Inc

Thanks, Paul. As we look to the future, we will be focused on closing these two recent transactions in the second half of the year and then maximizing their potential, exploring opportunities to optimize our portfolio, and continue to execute balanced capital allocation strategies that maximize shareholder value. I'd like to take a moment to thank the employees of both Lantheus and Evergreen, including those that worked on the transaction over the holidays. This would not have been possible without their shared commitment to advancing innovation in patient care. We're excited to bring our teams together, unite our cultures, and continue to work on behalf of patients. And with that, we'll now open the call for questions. Operator.

Operator

Thank you. 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 one one again. One moment while we compile our Q&A roster. Our first question is going to come from the line of Roanna Ruiz with Leerink Partners. Your line is open. Please go ahead.

Roanna Ruiz
Analyst, Leerink Partners

Hi. Good morning, everyone. So given that you gained some interesting RLT infrastructure and ability to work with many other isotopes with this acquisition, I was curious if you could talk about which isotopes you might want to work with first out of the acquisition? And also, how does the CDMO business of Evergreen help expand and build your presence in the radiopharma space?

Bob Marshall
CFO, Lantheus Holdings Inc

Thanks for the question, Roanna. Good morning. I think there's a lot of dimensions to the questions you asked. I think starting with the CDMO, clearly they're working with a number of different isotopes and products and compounds. And having that skill set basic to now what will be a combined Lantheus company, I think, is essential for us to grow as we go forward. Clearly, our own portfolio of early candidates, we're looking at Lutetium. But as you know, we have an interest in all the other isotopes, and we're quite frankly agnostic to some extent. I think it all depends on the target and what can get to the target safely with the least off-target binding. So there's a lot of work to do there. This field is still fairly young, I would say. I think that's really, Paul. You want to expand on that?

Paul Blanchfield
President, Lantheus Holdings Inc

No, Roanna, thanks for the question. Maybe just expanding on your CDMO question, I think this is a great opportunity to continue to learn the business, to work with some great partners, as Brian mentioned, to work with a variety of isotopes, whether that's copper, whether that's gallium, whether that's indium, lead, zirconium, actinium, astatine, copper, right, Lutetium. There's a whole list of isotopes that can be worked with at this advanced manufacturing facility. We're excited to continue to work with our CDMO partners. It provides utilization of the facility while we ramp up our own therapeutic pipeline and continue to work with our partners and to be able to continue to advance what is an incredibly exciting portfolio.

Roanna Ruiz
Analyst, Leerink Partners

Great. Super helpful. And could I squeeze in one more? I was just curious for OCTEVY. Do you have any guidance on what the TAM might be for OCTEVY in terms of PET diagnostics for NETs and where it might be most useful in different imaging segments there?

Bob Marshall
CFO, Lantheus Holdings Inc

Absolutely, Roanna. And so when we look at the GEP-NET diagnostic market potential, there's naturally two agents on the market today, one from Novartis and one from Curium. We would look at the current addressable market today, meaning kind of end of 2024, coming into 2025, approaching $200 million or approximately 50,000 patients. When we look at the beginning of the next decade, we expect that to grow to about $300-$400 million in addressable market or 65,000-85,000 patients. Note that that's really just use in the SSTR population. The TAM could certainly get bigger if we were able to convert where FDG is being used for neuroendocrine tumors as well as CT/MR, which are other modalities. I think we're incredibly excited about OCTEVY as the ability to deliver a theranostic pair, launching approximately the same time as 2003, our radio-equivalent registrational stage therapeutic.

These could pair nicely together to be able to work with physicians to be able to diagnose, stage, and treat SSTR-positive GEP-NET patients.

Operator

Thank you. And we'll move on to our next question. Our next question is going to come from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead.

Paul Choi
Analyst, Goldman Sachs

Thanks. Good morning, team, and thanks for taking the questions. I have two. The first is just with regard to OCTEVY. Can you maybe elaborate a little bit more on the differentiation versus the existing commercial-stage products, just either in terms of convenience or use of the physicians or manufacturing? And my second question is, I think Evergreen has existing distribution agreements for OCTEVY. Can you maybe just update us on what will happen to those if they're still valid versus internal distribution going forward here? Thank you very much.

Bob Marshall
CFO, Lantheus Holdings Inc

Yeah, absolutely. So I think, as I alluded to, we're very excited about OCTEVY and the ability to pair it to deliver a theranostic pair. There are naturally two agents on the market, one from Novartis, one from Curium. One uses Gallium-68. The other uses copper-64. OCTEVY would be a Gallium-68 agent. We're not ready to share commercially how we plan to differentiate that on the market given the competitive dynamics. But we are excited about the ability to bring both a radio-equivalent therapeutic as well as a PET diagnostic to be able to work with referring physicians as well as treating sites. From a commercial go-to-market perspective, we think this is a very natural fit. The call points are the same.

When we think about our promotional activities of activating patients in what is still an underpenetrated space, especially as we look to some of the data that has been released by some competitive therapeutic companies to potentially expand the market, we're incredibly excited for what that looks like. With regard to the distribution play, absolutely, OCTEVY does have distribution agreements in place to be able to work on a radiopharmacy basis to activate the kit that would be provided by Evergreen, now Lantheus, and then pair that with a Gallium-68 generator to deliver an active agent to the imaging facility. Those contracts will carry over with the agreement, and then naturally, we'll work with our new Evergreen colleagues to assess whether we can expand that to really ensure that we have the best patient access overall to grow this market together.

Operator

Thank you, and one moment for our next question. Our next question is going to come from the line of Richard Newitter with Truist Securities. Your line is open. Please go ahead.

Richard Newitter
Analyst, Truist Securities

Hi. Thanks for taking the question. I just wanted to ask on the guidance reiteration. It's just about February here, and you're reiterating your guidance. Does that mean that we should expect the results to fall in line, or does that take any end-of-the-range off the table? Or, I'm just curious what you can say there?

Bob Marshall
CFO, Lantheus Holdings Inc

Yeah. I mean, again, Rich, thanks for that question. Listen, these are still preliminary results, right? You have to finish the audit. But I think we're very comfortable that probably the low end of that range is definitely off the table and that we would expect our results to meet expectations.

Richard Newitter
Analyst, Truist Securities

Okay. And then I'm just wondering if you can comment just on your go-forward acquisition and M&As and licensing and deal collaboration type strategy. Just you've done about $600 million worth of upfront cash payments that will come probably in 2025. Can you announce those in January? Kind of just talk to how much firepower you have left and the balance sheet a little bit and kind of how we should think about M&A going forward. Is this a digestion, or are you going to keep going? Thanks.

Bob Marshall
CFO, Lantheus Holdings Inc

No. Again, that's another good question. Let me just reflect back on comments that I made in November at a competitive conference over in London. And at that conference, basically, what I said was, "Listen, we had $900 million of cash on the balance sheet at that time. That continues to grow as a number. We continue to generate $100 million-$125 million a quarter on average in free cash flow. So we're continuing to add to the balance sheet." And what I said then is that we had a rich pipeline of BD opportunities in front of us. And what you're seeing is that pipeline coming to fruition.

I also noted that we had sufficient cash not only on hand, basically at that time, to do the deals plus share buyback to be able to execute our capital allocation priorities with the amount of cash that we had on hand. As you think through, as you look forward, we're going to continue to put additional cash on the balance sheet, which will allow us to continue to create and return value to shareholders.

Paul Blanchfield
President, Lantheus Holdings Inc

Yeah. And Rich, as far as future M&A strategy, in this business, no one ever stops. We are going to focus really on the near term on integration and closing these two opportunities. We've got a lot of work in front of us. We will continue, but we will be highly selective and obviously sort of capital conscious here. But as Bob mentioned, and I want to reiterate, we have plenty of cash firepower. So we're very excited about that.

Operator

Thank you. One moment for our next question. Our next question is going to come from the line of Matt Taylor with Jefferies. Your line is open. Please go ahead.

Matt Taylor
Analyst, Jefferies

Hi. Thank you for taking the question. So the first one I wanted to ask was just if you could clarify a little bit the financial impact now of the two deals. I noticed in the presentation here, you're now saying collectively they'll be accretive within 18 months post-close. Could you give us some framework to think about how these deals could impact earnings in 2025 and 2026 and how to think about the different parts in terms of their solution in the near term?

Bob Marshall
CFO, Lantheus Holdings Inc

I'll take that, Matt. I've got a nice long-winded answer mapped out here for myself on this question. On 2025, I'm going to kind of avoid that one because in terms of the timing, I'll update that for both deals when they actually close because I'll be able to give you more of a better window. But as I reflect on 2026, if we start with gross margin, obviously, the deals from a contribution perspective will be highly dependent on when products actually launch. But I'll just sort of take it for granted. OCTEVY comes with a at-scale gross margin profile that is a lot like sort of PYLARIFY and Definity. But it'll take a couple of years to get to that level. But still, that's one of the things that will drive accretion in sort of the near to medium term.

The CDMO business is on a gross margin basis below, excuse me, the company average, but on a relative scale to the overall expected sort of top line for the combined pro forma company, it doesn't really have a material impact just because of just sheer scale. OpEx, I would say from an R&D perspective, it probably adds about 50 basis points of percent of revenue-type spend. But again, we would expect over time that that level would stabilize based on not only just revenue growth from a diversified portfolio of commercial assets, but we also will prioritize and phase gate our R&D priorities. When it gets to R&D, there are other benefits as well.

One of the things that Paul mentioned in his remarks was the ability to create savings on our own R&D pipeline by actually now having the ability to manufacture clinical doses and whatnot for ourselves as opposed to outsourcing. And that's sort of an embedded synergy that's sort of deep within the numbers. Sales and marketing and G&A, I expect those to be relatively flat relative to as a % of revenue over time, mainly because we're going to be able to leverage these companies come with particularly when we talked about Life Molecular, that actually comes with accretion out of the gate as well as our ability to leverage the teams that exist and the talent that they bring to the overall organization. I did note that there is a level of interest income headwind, but then again, that's to be expected.

I would rather have the return on these investments as opposed to treasury yields on excess cash. Again, and I'll just sort of wrap it up here in terms of net income margin and EBITDA margins. Obviously, we are investing in what becomes a diversified revenue stream for both commercial revenue streams as well as a pipeline that should deliver multiple shots on goal for future viable sustainable top line growth. We do expect to return and expand on those profit margins in the near to midterm planning horizon. And again, I've always said that one of our investment criteria is accretion in a reasonable time horizon. And the combination of these deals certainly fits that criteria. It's played out well for us in the past, and it's a strategy that we see as a positive for shareholders going forward.

Operator

Thank you. One moment for our next question. Our next question is going to come from the line of Yuan Zhi with B. Riley. Your line is open. Please go ahead.

Yuan Zhi
Analyst, B. Riley

Good morning. Thank you for taking our question. I have two, maybe a quick one. Is this acquisition price $250 million contingent on the approval of OCTEVY and any regulatory update you can provide on this submission?

Paul Blanchfield
President, Lantheus Holdings Inc

Not contingent on the approval of OCTEVY to close, and also, OCTEVY is under FDA review.

Yuan Zhi
Analyst, B. Riley

Got it. And my next question is, how do you plan to make the most use of Evergreen's CDMO business since both Lantheus and Evergreen have preclinical and clinical-stage assets? Would that be a conflict with other CDMO customers of Evergreen?

Paul Blanchfield
President, Lantheus Holdings Inc

Absolutely not. We plan to nurture the CDMO business alongside the development of our own assets, and as you know, and I think you completely understand, the number of doses that are produced in early clinical trials is really quite small when you look at scale. Evergreen certainly has more than abundant scale and capability to host a number of different programs at the same time, and James, I mean, currently, you're running what, three shifts at the plant?

James Cook
CEO, Evergreen Theranostics

Correct. Correct.

Paul Blanchfield
President, Lantheus Holdings Inc

So we want to keep the plant utilized. We want to keep the skill set energized. And I think we'd love to fill it with our own assets and those that we're acquiring with Evergreen. But the reality is this is a slow build as you go through clinical trials. So we will have abundant capacity for a number of years to come. And we will run the plant at capacity.

Operator

Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Tara Bancroft with TD Cowen. Your line is open. Please go ahead.

Nick Lorusso
Analyst, TD Cowen

Thank you. This is Nick on for Tara. Just one from me. But as it currently stands, what stage of development can Evergreen's manufacturing facility support? Basically, how big can it do phase one trials, phase two, phase three? And how long will it take to scale up production to later stage trials or even commercialization? And then I guess just one follow-up on that is, what's the timeframe for a potential tech transfer for Lantheus's assets to Evergreen's manufacturing facilities once the deal does close? Thanks.

Paul Blanchfield
President, Lantheus Holdings Inc

I can start with the answer for that one, so in terms of capabilities and capacity, we're set up to produce any stage of clinical assets as well as commercial assets. All of our projects currently are clinical stage, but we're fully equipped for commercial stage as well. The second question.

Brian Markison
CEO, Lantheus Holdings Inc

I believe that was on tech transfer.

Paul Blanchfield
President, Lantheus Holdings Inc

On tech transfer.

Brian Markison
CEO, Lantheus Holdings Inc

Let me.

Paul Blanchfield
President, Lantheus Holdings Inc

Yes. Go ahead, Brian.

Brian Markison
CEO, Lantheus Holdings Inc

Look, tech transfer is an ongoing process. We're basic in that skill set. We've been doing it for years. As our programs enter phase one, we'll be working side by side with Evergreen. But we're also going to continue working with other partners as well. LRRC15 is going to be partnered externally to Evergreen. We had them take a look at it, but our timeline is more aggressive. And actually, they're running at capacity right now, so they couldn't fit us, which is actually true. RM2, we're going to begin to work with Evergreen to feather that in again. So the tech transfer process is what we do in our sleep. So I'm not really concerned about that.

Nick Lorusso
Analyst, TD Cowen

Sounds good. Thank you very much.

Paul Blanchfield
President, Lantheus Holdings Inc

Thank you.

Operator

Thank you. One moment for our next question. Our next question is going to come from the line of Larry Solow with CJS Securities. Your line is open. Please go ahead.

Larry Solow
Analyst, CJS Securities

Great. Good morning. Thank you. Congratulations. It sounds a very complementary acquisition to me, at least. I guess question for James. I think you mentioned your business was only founded in 2019. So relatively young. Was it founded more on the contract, the CDMO side, or were you more of initially a drug development company that then got into CDMO? I'm just kind of curious how that shook out, and can you discuss maybe just the landscape of other CDMO providers in the radioisotope land?

James Cook
CEO, Evergreen Theranostics

Yeah. So we started on multiple segments of the business simultaneously from the beginning. So we were working on OCTEVY from the beginning, and we were working on CDMO from the beginning. We attracted some really great talent that helped us push forward on both sides. And we were able to leverage a lot of past experience in radiopharmaceutical manufacturing and development. So it wasn't that we were a CDMO and became a product company. We were really working on both from the beginning.

Larry Solow
Analyst, CJS Securities

Got it. And just in terms of the scope of your customers today, can you maybe just kind of discuss how that ranges?

James Cook
CEO, Evergreen Theranostics

Yes. We have about 10 customers right now that represent a variety of leading companies in radiopharmaceuticals from larger companies to smaller ones. They're valued partners that we've worked with over the last several years, and we look forward to continuing to support them.

Operator

Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Justin Walsh with Jones Trading. Your line is open. Please go ahead.

Justin Walsh
Analyst, JonesTrading

Hi. Thanks for taking the question. Are there assets in Evergreen's pipeline that Lantheus is particularly intrigued by beyond OCTEVY? I know early data for the CCK2R targeted EVG-321 was highlighted at a scientific meeting last year and looks very exciting.

Paul Blanchfield
President, Lantheus Holdings Inc

Yeah. I mean, we're very interested in that asset for small cell lung cancer. It is entering phase one this quarter, and I think already one patient on the imaging side has been accrued to the trial. Small cell has been a fairly risky proposition for a lot of companies. We're excited about it. We're excited to deliver it safely to humans and see how it goes, and there's three other assets right behind it looking at neuroblastoma, pancreatic carcinoma, or lobular breast carcinoma. We're not disclosing the exact targets at this time, but there's a team under Thomas Reiner that we're really excited about, and we want to be able to combine our efforts and create a lot more targets and learn really fast and then either win or fail fast as well, so we're looking again for first-in-class, best-in-class.

We want to build out that operation together with the LMI acquisition when it closes, so we're very excited about the capability as much as the targets that are there under review right now.

Operator

Thank you. One moment as we move on to our next question. Our next question is going to come from the line of Kemp Dolliver with Brookline Capital Markets. Your line is open. Please go ahead.

Kemp Dolliver
Analyst, Brookline Capital Markets

Great. Thank you and good morning. First question relates to OCTEVY, and it's been under review for a while, and your comments suggest that this is a 2026 launch. Am I reading too much into that such that a 2025 launch is not expected?

Brian Markison
CEO, Lantheus Holdings Inc

I don't believe expected is the way I would describe it. I'll let Paul answer the question in full, but OCTEVY is under review right now with the agency. Paul.

Paul Blanchfield
President, Lantheus Holdings Inc

Yeah. No, no. Thanks for the question. Totally accurate. OCTEVY remains under review with the agency. We've been working and assessing the situation with Evergreen. It was a focus of significant diligence to understand what that looked like. We're finalizing some CMC components of the package to better support that. We understand the communications that Evergreen has had with the agency with a specific focus on CMC on registrational batches and finalizing those to augment the package. And so we do plan on a 2026 launch of OCTEVY at a comparable timeline as launching 2003, our registrational stage radio equivalent, which, as I mentioned earlier, has the opportunity to deliver a theranostic pair, delivering both commercial synergies and common call points. So that's the latest timing and the focus that brought us here.

Operator

Thank you. One moment as we move on to our next question. Our next question is going to come from the line of David Turkaly with JMP Securities. Your line is open. Please go ahead.

David Turkaly
Analyst, JMP Securities

Thanks. I appreciate the comments on the balance sheet today and the firepower. But obviously, you've got some significant milestones here from these last two deals, but also others out there. I was wondering, Bob, maybe if you could talk to how that's going to proceed or when you expect some of those to hit. It's a sizable amount, so I'm just trying to think through, will you have the cash flow to cover all that?

James Cook
CEO, Evergreen Theranostics

No, Dave, that's a great question. We structured these deals, I mean, very much like sort of taking out of the playbook of what we did with Progenics in terms of structuring deals that sort of reward for the upside achievements from a milestone perspective. So obviously, it's a risk-sharing, if you will, opportunity. But if we are achieving the milestone levels, we're pleased to be able to pay them out. So achieving the, because like I said, these are largely commercial-driven, particularly with the Life Molecular deal that was very much tied to commercial. This has a little bit more around some clinical milestone payments embedded, but those are sort of modest relative to what then we would achieve from a commercial milestone perspective.

The numbers we haven't disclosed, but the level of sales that are required to pay these out would more than pay for, by themselves, independent of our existing cash flow profile, pay for these milestones.

David Turkaly
Analyst, JMP Securities

Thank you for that. And then you mentioned the seventh suite at the GMP. I was just curious, how does that compare to some of your partners? Is that larger or smaller? I know the company has only really been around for like six years, but I love your thoughts there.

Brian Markison
CEO, Lantheus Holdings Inc

Yeah. It's really hard to compare. I think there's all ranges, sizes. And also, when you look across the industry, utilization is very different. So it's really difficult to answer that question.

David Turkaly
Analyst, JMP Securities

I had to try. Thank you.

Brian Markison
CEO, Lantheus Holdings Inc

Good job.

Operator

Thank you. One moment as we move on to our next question. And our next question is going to come from the line of John Vandermosten with Zacks. Your line is open. Please go ahead.

John Vandermosten
Analyst, Zacks Investment Research

Great. Thank you. And good morning. With the LMI acquisition in Evergreen, you've increased your exposure to fixed assets. And does it make sense to own the means of production? Because I know this is a little bit in contrast to the legacy businesses with the outsourced PMFs pretty much. What are your thoughts there on the different approach to the different sides of the business?

James Cook
CEO, Evergreen Theranostics

Thanks for the question, John. I think we're excited about the ability to vertically integrate in the radiotherapeutics space. I think if we look at the overall market, you've seen that this is a source of significant investment for other players given the complexity and advanced manufacturing. We're incredibly excited about that as it helps us do the clinical trials to have greater control over those programs. We've always been focused on the clinical development, but now even more so on the CMC, where we otherwise would have had to outsource those capabilities at not only significant cost, but perhaps less efficiently and speed to market as we can do when we can take a more integrated approach. I think from a diagnostic perspective, we believe that we will leverage the Evergreen facility to be able to do more lifecycle management formulation work for our radiopharmaceutical diagnostics.

Given the half-life dynamics of the therapeutics and the diagnostics, we don't believe we need to own all of the production facilities for diagnostics. As we've shared, we've got over 60 PET manufacturing facilities to make Pylarify. We have great partners around the country and indeed around the globe beyond just Pylarify, but for MK, for NAV, as does Life Molecular Imaging for Neuraceq. And so I think that makes a natural approach for the radiopharmaceutical diagnostics when you're speaking about shorter half-lives to be owned independently and to develop great partners like we do. But the ability to scale up radiotherapeutic manufacturing specifically from a trial and then contributing commercially, we think that makes sense. We are certainly not the first to do that as we've seen in the market.

We think that's a core capability that a leading radiopharmaceutical company makes a lot of sense to own.

John Vandermosten
Analyst, Zacks Investment Research

Got it, and looking ahead to 2026, how much of the commercialization cost is shared if you combine the marketing of 2003 with OCTEVY? I mean, and just in general, is it a lot more efficient to commercialize and market a theranostic pair than it is to just do them independently?

James Cook
CEO, Evergreen Theranostics

Yes. I'm going to provide a little more color, but absolutely. Right when we think of going to market, these are the same treating sites. The vast majority of PET/CT centers that we'll be working with, many of them do have therapeutic capabilities when you're thinking about the hospital. There naturally are some standalone freestanding imaging centers that we will continue to work with. We already work with all of them. When we think about PYLARIFY, Life Molecular Imaging works with many of them from a Neuraceq perspective. And so from an imaging treating site, it's a very common call point across radiopharmaceutical diagnostic imaging. The therapeutic space, from a referring physician standpoint of those treating neuroendocrine tumors, it is many of the same physicians that are going to be doing the appropriate diagnosis and staging as well as the treating.

So yes, we think as a theranostic pair, we will have revenue synergies. We believe that we will have commercial synergies in being able to utilize the same teams to go to market both in the treating site as well as the referring site. And then naturally, working with radiopharmacies is something that we've been doing with for decades. And so that's also a natural build-on on what we've been doing from our core capabilities. So long-winded answer of saying yes.

Operator

Thank you. One moment.

James Cook
CEO, Evergreen Theranostics

Long-winded answer.

Operator

One moment as we move on to our next question. And our next question is going to come from the line of Andy Hsieh with William Blair. Your line is open. Please go ahead.

Andy Hsieh
Analyst, William Blair

Well, great. Thanks for taking our questions. One on OCTEVY. So a question has to do with the percent utilization from a diagnostic side. So I'm curious if you can make a side-by-side comparison with the PSMA. So specifically, in terms of NET patients, what percentage of them actually get a PET versus all the other conventional imaging or other diagnosis methodologies? And just to really understand how you came up with the numbers that you provided TAM-wise. And then from an R&D perspective, obviously with the Life Molecular acquisition, and now with Evergreen, I'm curious about your refined thinking on R&D, first on the synergy that can be brought by all three parties, and also whether you're thinking about adding, using now acquired capabilities for new molecular entities and new RLTs in the pipeline going forward. Thank you.

Paul Blanchfield
President, Lantheus Holdings Inc

Thanks, Andy. So I think maybe if we break that into two parts, I'll answer the OCTEVY market potential piece, and then I'll turn it over to Brian to address some of the R&D plans we have going forward to leverage these three great organizations ourselves, Life Molecular Imaging and Evergreen. So on the GEP-NET diagnostic market potential, we see around 50,000 patients currently utilizing the current agents on the market from Curium and Novartis. At the same time, more patients actually leverage or utilize FDG, which is far less specific for neuroendocrine tumors, but it is taken up by glucose with solid tumors processing more glucose, and so you do see some light up of there. We also see somewhat substantial use of CT/MR with contrast for NETs well over 100,000.

When you look at what the current market is, what we've really focused on, those that are using neuroendocrine tumor SSTR-specific agents, that's a little over 50,000, as I mentioned now, has the potential to grow somewhere between 65,000 and 85,000 by the early part of the 2030s. There would naturally be additional upside if we're able to convert some of the FDG use that's non-specific for NETs as well as CT/MR. But we want to be cognizant that this is a market that has existed for some time. One agent came out in 2016. Another on the market came out in 2020. So it's not necessarily the same growth trajectory that we saw with PSMA, with PYLARIFY being the first agent out and significant unmet need in no other PSMA agents. There are other GEP-NET SSTR PET imaging agents.

OCTEVY would be the third to market, but provides significant commercial and revenue synergies, as I talked about, of delivering that theranostic pair. Let me turn it over to Brian to answer some of the R&D future plan strategy.

Brian Markison
CEO, Lantheus Holdings Inc

Yeah. Thanks, Paul. When we look at the R&D future strategy, we get really, really excited here. First, the Life Molecular Imaging group based out of Berlin has been in this business for quite some time, focusing obviously on diagnostics, but their chemistry and capability to evaluate early compounds is really extraordinary. When we combine that with what Lantheus can do and some of our great scientists here and also Thomas Reiner, we hadn't mentioned previously, but also from Evergreen, Thomas Lindner, who was at Heidelberg previously, is well-known in the industry. We're just excited to bring all these folks together, get the collective going, and ultimately, our goal is to create more targets, more shots, build this capability out both diagnostically and also therapeutically, and drive as fast and hard as we can. We're students of the industry, as you know, so assembling the right team is critical.

I think this is going to be a world-class team when we're done assembling all the parts.

Operator

Thank you. And this is going to conclude today's question-and-answer session. Ladies and gentlemen, this is also going to conclude today's conference call. Thank you for participating, and you may now disconnect. Everyone, have a great day.

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