Participants

Mark Kinarney; Vice President, Investor Relations; Lantheus Holdings Inc

Brian Markison; Chief Executive Officer, Director; Lantheus Holdings Inc

Paul Blanchfield; President; Lantheus Holdings Inc

Robert Marshall; Chief Financial Officer, Treasurer; Lantheus Holdings Inc

Amanda Morgan; Chief Commercial Officer; Lantheus Holdings Inc

Roanna Ruiz; Analyst; Leerink Partners

Anthony Petrone; Analyst; Mizuho Financial Group

Richard Newitter; Analyst; Truist Securities

Paul Choi; Analyst; Goldman Sachs

Matt Taylor; Analyst; Jefferies

Yuan Zhi; Analyst; B. Riley Securities Inc

Larry Solow; Analyst; CJS Securities

Justin Walsh; Analyst; JonesTrading Institutional Services

Andy Hsieh; Analyst; William Blair

John Vandermosten; Analyst; Zacks Small-Cap Research

Kemp Dolliver; Analyst; Brookline Capital Markets

David Turkaly; Analyst; Citizens JMP Securities

Presentation

Operator

Good morning. Welcome to the Lantheus fourth quarter and full year 2024 conference call. (Operator Instructions) This call is being recorded, and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call. The call 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

Thank you. Good morning. With me today are Brian Markison, our CEO; Paul Blanchfield, our President; Bob Marshall, our CFO; and Amanda Morgan, our Chief Commercial Officer. We will begin with prepared remarks and then open the call for Q&A.
This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our fourth quarter 2024 results. The release and today's slide presentation are in the Investors section of our website. Any comments made could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website.
I will now turn the call over to our CEO, Brian.

Brian Markison

Thank you, Mark, and good morning, everyone. 2024 was a ground-breaking year as we achieved a number of important milestones and enhanced our capabilities as the leading radiopharmaceutical focus. I am immensely proud of our team and the meaningful difference we have made in the lives of over 7 million patients in 2024.
Our strong performance in the fourth quarter and throughout all of 2024 was driven by our commitment to operational excellence. We remain focused on further expanding our radiopharmaceutical excellence through a leading commercial portfolio, innovative pipeline, and differentiated capabilities. Last month, we announced two strategic transactions that have the potential to, first, enhance our capabilities across the radiopharmaceutical value chain, including in Alzheimer's Diagnostics and Oncology Therapeutics; second, allow us to enter new markets with significant growth potential that diversify our business; third, expand our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs that make use of our existing expertise and fourth, help to drive sustained double-digit revenue growth beginning in 2026.
Life Molecular Imaging will support our future growth with the addition of Neuroseq, an approved radiodiagnostic for Alzheimer's disease, expand our capabilities with an Alzheimer's commercial franchise as well as an enhanced R&D and clinical development capabilities and grow our pipeline. Evergreen Theragnostics has the potential to add OCTEVY, a registrational stage PET radio diagnostics that complements our therapeutic registrational stage candidate, PNT2003, strengthen our clinical and commercial manufacturing capabilities and multiple clinical and preclinical assets to the pipeline and enhance our early-stage R&D capabilities quite significantly. Both acquisitions are subject to customary closing conditions and are expected to close in the second half of this year.
Throughout 2024, we also executed a series of asset and in-licensing deals to expand our pipeline. We are excited about these potentially best or first-in-class agents for Alzheimer's disease and oncology and plan to advance them during the year.
Operationally, we grew PYLARIFY to over $1 billion in sales, making it the first ever radiodiagnostic blockbuster and the clear number one utilized PSA PET imaging agent. We also grew our market-leading ultrasound-enhancing agent, DEFINITY, double digits in its 24th year on the market. In November, CMS issued its calendar year 2025 rule, which enhanced payment from specialized diagnostic radiopharmaceuticals for covered products. This was a significant step that will support lower-term radiopharmaceutical diagnostic innovation.
We entered 2025 focused on leading the renaissance in radiopharmaceuticals, growing both our flagship diagnostic agents, advancing our pipeline, closing our two recently announced transactions and delivering value to our patients, customers, employees and shareholders.
With that, I'll turn the call over to Paul to provide an update on our operational performance. Paul?

Paul Blanchfield

Thank you, Brian. I'm incredibly proud of our team's performance in 2024 and excited about the opportunities in front of us in 2025. With over $1 billion in sales, PYLARIFY remains the clear number one utilized PSMA PET imaging agent. We plan to build on this success by growing both volume and net sales in 2025 and are confident that we will maintain our market leadership and relative price premium, even amidst competitive pressures.
PYLARIFY sales for the quarter were $266 million, up 15.7% year over year. Growth was driven by volume as net price was up approximately 1% year over year, even after taking a mid-single-digit price increase at the beginning of 2024. Quarter over quarter, we grew volumes just shy of 2%, with net price essentially flat.
Fueling this growth is the continued expansion of the PSMA PET current addressable market, which we estimate to be $2.5 billion-plus in 2025 up from $2 billion-plus in 2024, while the total addressable market could exceed $3.5 billion by the end of the decade. Year over year market growth is expected to be driven by the continued conversion of bone scans in the initial staging and BCR patient segment, and we expect our customer base to grow their PSMA PET volumes accordingly, as the vast majority of our hospital and freestanding imaging business are now under long-term strategic partnership agreements. We took an almost 6% WACC price increase earlier in 2025 and expect PYLARIFY's clinical and commercial differentiation to continue to support its clear market leadership and premium pricing.
As Brian mentioned, we are pleased with CMS' new payment policy, which recognizes the value of and ensures access to innovative radio diagnostics. The rule provides separate payment for innovative radiopharmaceutical diagnostics like PYLARIFY, following expiry of transitional pass-through payment status for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting.
PYLARIFY OPPS Medicare fee-for-service payment rates are in a significantly better position than they would have been absent CMS' adoption of separate payment, and we plan to continue to engage CMS as well as other stakeholders to establish a payment based on average sales price, or ASP. Lantheus has been reporting PYLARIFY's ASP since launch, and we believe other radiopharmaceutical diagnostics can as well, which would facilitate CMS' ability to establish ASP as the basis for separate payment in the future.
More broadly, we believe this rule represents significant progress for the long-term potential and sustainability of our existing diagnostic pipeline, including MK-6240 and NAV-4694 as well as those agents that would be included in our recently announced strategic transactions. We continue to invest in PYLARIFY, including assessing the benefits of PSMA PET imaging with polarity and intermediate favorable patients via the MIRROR study, which continues to enroll as well as in PSMA expressing tumors beyond prostate through additional Phase IV studies. We look forward to sharing more about our progress throughout 2025.
DEFINITY continues to be the number one utilized ultrasound-enhancing agent delivering fourth quarter net sales of $86.2 million, up 17.9% year over year. DEFINITY exceeded our expectations in the second half of the year due to competitor supply chain challenges that led to higher-than-anticipated market share. DEFINITY's long-term success continues to be driven by its established clinical and commercial value, strong history of clinical application and our ongoing commitment to operational excellence.
In neurology, we continue to progress our pipeline of radio diagnostics for Alzheimer's disease or AD. We believe the US AD radio diagnostics total addressable market has the potential to grow to $1.5 billion by the end of the decade, driven by the increasing number of treatment options expected to become available as well as increasing prevalence. This is supported by third-party research which estimates there to be over 100 therapies in clinical development targeting either beta amyloid or TAP.
Furthermore, the Alzheimer's Association Work Group and SNMMI, recently updated their guidelines to expand the appropriate use of both beta amyloid and tau PET imaging for diagnosis, prognosis, eligibility, response prediction and monitoring of select patient groups. Finally, a recent Alzheimer's and dementia Journal survey found that 90% of the nearly 300 dementia experts surveyed thought tau PET tracers will add value to clinical practice in a cognitively impaired memory clinic population. We believe we are well positioned to aid in the diagnosis, staging and monitoring of AD with MK-6240 and NAV-4694 as well as with the agents we expect to acquire via Life Molecular Imaging.
Life Molecular Imaging would add an existing commercial AD franchise, accelerating our entry in the AD and dementia space with Neuroseq, a globally approved F-18 PET imaging agent that estimates beta-amyloid plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Neuroseq has shown clinical differentiation from other approved beta amyloid agents, and we plan to use our experience and capabilities in F-18-based radio diagnostics and those of Life Molecular's team to grow this business.
We believe that our radio diagnostic portfolio, including NAV-4694 and MK-6240 are highly complementary to Life Molecular's portfolio, including Neuroseq and PI-2620. We remain on track to submit an NDA for MK-6240 in 2025 and an NDA for NAV-4694 in 2026, and to close the Life Molecular transaction in the second half of 2025.
We are excited about our pipeline, including the pending addition of Evergreen's registrational stage, net radiodiagnostic, OCTEVY, which would complement our therapeutic radio equivalent candidate PNT2003 and could deliver a theranostic-like pair. Pending the acquisition of Evergreen, receipt of FDA approvals and positive resolution of the PNT2003 patent litigation, we expect to launch both products in 2026 and could offer near-term revenue potential and diversification. We are also excited about the potential of Evergreen's clinical and preclinical theranostic pairs targeting novel molecular oncologic targets.
Finally, we continue to advance our other clinical radiopharmaceutical programs that have the potential to be first or best-in-class in areas of significant unmet need. These include our RM2 novel theranostic pair targeting GRPR, otherwise known as bombesin, for prostate, breast and other cancers, which we plan to advance to an IND later this year. And our BARK-15 targeted radio therapeutic for the treatment of osteosarcoma and other solid tumors as well as our TROP-2 targeted radiotherapeutic.
I will now turn the call over to Bob.

Robert Marshall

Thank you, Paul, and good morning, everyone. I will provide highlights of the fourth quarter and full year financials, focusing on adjusted results with comparisons to the prior year period, unless otherwise noted.
Revenue for the fourth quarter was $391.1 million, an increase of 10.5% and revenue for the full year was $1.534 billion, an increase of 18.3%. Now turning to the details, beginning with radio pharmaceutical oncology, which contributed $266 million of sales in the quarter, up 15.3% due primarily to the continued strength of PYLARIFY with sales of $266 million, an increase of 15.7%. The difference in growth rates is due to a nominal amount of AZEDRA sales in the prior year results.
PYLARIFY posted full year sales of $1.058 billion, an increase of 24.3%. Precision diagnostics' fourth quarter revenue of $117.5 million was 16.8% higher, driven by DEFINITY at $86.2 million or 17.9% higher. And TechneLite at $25.1 million was up 16.7%. For the full year, DEFINITY revenue was $317.8 million, up 13.6%, and TechneLite revenue was $95.5 million, up 9.3%. Lastly, strategic partnerships and other revenue was $7.7 million, down 66.2% for the fourth quarter due to the inclusion of a RELISTOR royalty milestone received in the prior year.
Full year revenue was $38.2 million, led by sales of MK-6240 for investigational use in third-party clinical trials. Gross profit margin for the fourth quarter was 68% and in line with the full year result of 68.3%, but down 130 basis points year over year due mainly to the RELISTOR royalty milestones embedded in the prior year quarter, offset in part by favorable product mix, with strong volume contributions from across the commercial portfolio.
Operating expenses at 29.1% of net revenue in the quarter were 670 basis points unfavorable from the prior year but within previously guided spending levels. Increases in research and development were planned investments to advance our innovative clinical stage portfolio. G&A was notably higher in the period with significant expense tied to business development activities relating to the potential acquisitions of Life Molecular and Evergreen Theragnostics, including, but not limited to, due diligence and legal expenses. The company does not adjust the management P&L for these types of expenses unless the specific transaction is signed within the same quarter.
Other income and expense was $4.4 million of income for the quarter and $17.6 million for the year, derived through interest income earned on invested cash balances offset by interest expense on the company's debt. Operating profit for the quarter was $151.8 million, a decrease of 8.4% and $643.3 million for the full year, an increase of 7.7%.
Total adjustments in the quarter totaled $157 million of expense before taxes. Of this amount, $22.2 million and $11.8 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization, respectively. A portion of the stock compensation expense is related to headcount optimization, which took place last November.
The company recorded an unrecognized loss of $119.1 million attributable to its equity investment in prospective in Radiopharm Theranostics. The remainder is related to acquisition, integration and other nonrecurring expenses. Our effective tax rate was 26.1% in the quarter and 26.7% for the full year. The resulting reported net loss for the fourth quarter was $11.8 million, and a profit of $115.4 million on an adjusted basis, a decrease of 5.9% from the prior year period.
GAAP fully diluted earnings per share for the fourth quarter were a loss of $0.17 and a profit of $1.59 on an adjusted basis, a decrease in the prior year of 9%. On a full year basis, GAAP fully diluted earnings per share were a profit of $4.36 and a profit of $6.76 on an adjusted basis, an increase of 8.6% over the prior year.
Now turning to cash flow. Fourth quarter operating cash flow totaled $157.7 million as compared to $112 million in Q4 2023. Capital expenditures totaled $16.4 million, $4.3 million more than the year prior. Free cash flow, which we define as operating cash flow less capital expenditures, was $141.4 million, an increase of $41.1 million.
During the full year, the company generated $493.1 million of free cash flow. Additionally, the company repurchased approximately $100 million or [1.2 million] of its own shares during the quarter, leaving $150 million of buyback authorization outstanding.
During the fourth quarter, the company refinanced its revolving senior credit facility, increasing borrowing capacity to $750 million from $350 million and extended the maturity date to 2029, enhancing our strong liquidity position. Lastly, cash and cash equivalents net of restricted cash, now stand at $912.8 million.
Turning now to guidance for 2025 full year. And recall, we are only providing full year guidance this year. Additionally, this guide does not include the pro forma impacts of previously announced transactions expected to close later this year, namely Life Molecular Imaging and Evergreen. The company will update financial expectations after each transaction is actually closed.
We estimate full year net revenue to be in the range of $1.545 billion to $1.61 billion an increase of 1% to 5% over 2024. We expect PYLARIFY to grow low to mid-single digits on a net basis. DEFINITY with a low to mid-single-digit growth profile, will face headwinds from opportunistic sales in 2024, but maintain a two-year stacked growth rate of high single digits.
For modeling purposes, gross profit margin should be materially similar to 2024 levels at approximately 68%. Operating expenses should be reflective of the second half of 2024, which favors R&D investment. Overall, sales and marketing and G&A expenses should be flat to down year over year with R&D investment up 100 basis points to 150 basis points, all as a percent of net revenue.
Interest income, given heightened cash balances and the forward curve to provide $40 million of income, though offset by $19.5 million of interest expense. Therefore, for the full year, we expect fully diluted adjusted earnings per share to be in the range of $7 and $7.20, an increase of 3.5% to 6.5% over 2024.
Lastly, the company expects free cash flow to continue to expand through 2025, with an anticipated amount of $550 million to $600 million, providing the company along with current cash balances, more than sufficient liquidity to execute its business development priorities as well as returning a portion to stockholders through buybacks.
Finally, for modeling purposes, depreciation and amortization for the full year 2025 should be approximately $15 million and $41 million, respectively, generally spread evenly throughout the year. Fully diluted shares outstanding should be approximately 71.5 million, which takes into account the share repurchase executed in Q4.
With that, I'll turn the call back over to Brian.

Brian Markison

Thank you, Bob. We are pleased with our strong performance in 2024 and excited about our momentum in 2025 and beyond. We are well positioned to grow PYLARIFY and DEFINITY, advance our existing pipeline and close out two recently announced strategic transactions to become a fully integrated radiopharmaceutical company.
These pending transactions will enable us to concentrate 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 diversify our business, and expanding our pipeline with potentially best or first-in-class radiopharmaceutical theranostic pairs, including the potential for multiple commercially approved products in 2026.
In closing, we are confident that our strategy will enhance our radiopharmaceutical leadership, drive growth, build long-term shareholder value and bring innovative products to patients.
With that, we're ready to take your questions. Operator, please go ahead.

Question and Answer Session

Operator

(Operator Instructions)
Roanna Ruiz, Leerink Partners.

Roanna Ruiz

I was curious, could you give us a status update on the MIRROR study that you mentioned briefly? And talk a bit about more it's implications on PYLARIFY. And I was curious if the timing is still on track or a little bit delayed versus what you thought before.

Paul Blanchfield

Roanna, thanks for the question. So the MIRROR study is our study to assess the use of PSMA PET with PYLARIFY in the intermediate favorable setting. As a reminder, this is not necessarily, if you will, a registrational study because PYLARIFY has a very broad label in the staging where it identifies the risk of metastases but it doesn't distinguish the level of risk. And so the NCCN and the SNMMI and other guidelines agencies has effectively recommended use of PSMA PET with PYLARIFY in their intermediate unfavorable and the high and very high-risk patient population, we began studying PSMA PET with PYLARIFY in intermediate favorable patients.
Last year, that continues to enroll. We would expect to have the last patient in sometime in the fourth quarter of 2025, then to be able to follow those patients, do the right clinical trial analysis as well as publishing with the hopes of having guidelines from NCCN and SNMMI updated in the coming years, which then could influence payer policies and overall expand the addressable market for the staging population. And I think you'll note that in our total addressable market we would expect that staging population to increase from approximately 145,000 scans annually potential today to approximately 175,000 by the end of the decade.

Operator

Anthony Petrone, Mizuho Financial Group.

Anthony Petrone

And congrats on just a strong year overall, getting PYLARIFY to $1 billion in the recent transactions. Maybe just to stick on the US PSMA PET dynamics. So maybe one, just a little bit on the competitive dynamics with the new reimbursement change that's effective January 1. I know you mentioned most of your customers are now contracted, but just anything you're seeing competitively of market shifts as this new reimbursement code has come in?
And then secondly, the competitors out there looking at basically a reengineered reformulated version, if you will, of their PSMA PET agent. Just expectations on that on whether or not that's baked into the guide. And what you think that does for the competitive landscape. And congrats on a strong year all around.

Brian Markison

Yeah. Thanks, Anthony. I'll start with the back end of your question and then turn it over to Paul and Amanda for the second half -- or the first question -- part of the question anyway. With regard to a new product entrant, I think it's Gallium. The images are not as good as PYLARIFY images. There's been a little bit of noise about it. I don't really see a big sort of influx to anything that's happening with PYLARIFY, so they're doing what they're doing good for them, and we're going to keep on executing our game plan. So Paul?

Paul Blanchfield

Yeah. No, Anthony, thanks for the question. Maybe I'll just tackle some of the MUC kind of CMS piece, and then I'll turn it over to Amanda to talk about some of the competitive dynamics that we're seeing in the marketplace.
So I think as we said, I think we're incredibly excited about the CMS shift to MUC versus where we were previously expected to be from the expiry of transitional pass-through payment status. And this is clearly a benefit for PYLARIFY. But I think more broadly, as the clear leader in radiopharmaceutical diagnostics, with PYLARIFY, an incredibly strong pipeline with MK-6240, of NAV-4694, of our FAB agent earlier in development as well as some of the pending acquisitions with the addition of OCTEVY, of Neuroseq and earlier-stage theranostic pairs, I think we're incredibly pleased for the long-term growth potential, sustainability and payment dynamics related to MUC.
And so I think we think this is a big win. We're naturally going to continue to work with the agency to shift to ASP over time. But I think we're really pleased overall with the market and what this does to the growth and sustainability of the radiopharmaceutical diagnostic space.
Maybe I'll turn it over to Amanda to talk a little bit more about the competitive dynamics.

Amanda Morgan

Yeah. Thanks, Paul. So as we shared on our commentary during the call that we secured the vast majority of hospital and freestanding imaging centers with multiyear contracts. This will enable us to continue to leverage our strategic partnerships. What I'll say is that I'm very pleased with the evolution of this strategy and the partnerships. We expect to continue to capitalize on PYLARIFY's clinical and commercial differentiation to support its clear market leadership and pricing premium even with the current competitive market dynamics.
So just kind of talking a little bit more about our commercial differentiation and our clinical differentiation from a commercial differentiation perspective, we have the largest dedicated commercial team. Additionally, we have broad payer access with more than 90% of lives having access to PYLARIFY. We have a longer half-life, which is a distribution advantage, and that enables us to optimize on our multipartner manufacturing facility network. This makes PYLARIFY widely available through a diverse supply chain, ensuring convenient and reliable supply in over 48 states.
And then from a clinical differentiation perspective, there's really three things. There's clarity from a diagnostic perspective, meaning accurate detection rate without the high false positive rate. We have clarity in intended patient management, which is based on robust pivotal clinical data and clarity from consistency and reader interpretation or high inter-reader agreement. So by driving differentiation through clinical and commercial differentiation, our long-term strategic partnerships and an optimal customer experience, we plan to continue to grow PYLARIFY both in volume and net sales in 2025.

Operator

Richard Newitter, Truist Securities.

Richard Newitter

Just maybe on PYLARIFY, any color you can provide on the cadence and pacing of the PYLARIFY growth within that low single digit to mid-single digit. And specifically, in the first half of the year, should we expect PYLARIFY to grow in all quarters, including the first quarter?

Robert Marshall

So Rich, I'll take that. So I think that our guidance actually kind of has captured sort of a range of different scenarios. Toward the low end, I think you would expect sort of a flattish first half with modest growth in the second half. That's how you get to that sort of the low end of the range. That piece of consideration is sort of anniversarying as we go through the strategic partnerships as more of those contracts actually come into full sort of value, if you will. But if you think towards the higher end of the range, really what that does imply, yes, is growth in the first half of the year, actually increasing to sort of the mid-single, high single-digit kind of growth in the back half of the year.
So the scenario is going to capture like a very nice growth profile no matter where we are in the whole thing and sort of is very reflective of the hard work that the commercial team has done to get these strategic partnerships put in place.

Operator

Paul Choi, Goldman Sachs.

Paul Choi

My question is on Flyrcado. And just as you're thinking about the partnership with your partnership there, can you maybe just update us on what are the inputs that are involved in the decision process of potentially going forward with the co-promote here and just kind of what has been the sort of rate-limiting step from Lantheus perspective.

Brian Markison

Yeah, Paul, I appreciate the question. At this time, we're not anticipating entering into the co-promote option with GE. They're more than capable of achieving their ambition and we're here to support them if they need it.

Operator

Matt Taylor, Jefferies.

Matt Taylor

I wanted to go back to, I think it was Paul, before was talking about the potential for CMS to go to an ASP-based methodology and all the folks now reporting that. Can you talk about the potential for that to happen this year versus next year? And if that does happen for PYLARIFY, how do you think that changes your growth potential for PYLARIFY in '26 or '27 if it changes?

Brian Markison

Paul, you want to do that? Or do you want me to --

Paul Blanchfield

I'll help you tag team it.

Brian Markison

Great. So it is a little hard to predict what's going to be happening down within the Beltway as you know. So hopefully, the doors will stay open. But look, if they migrate to ASP, we look at that as upside to the business. It's that simple. Paul?

Paul Blanchfield

I think that's spot on. I think the CMS will continue to establish draft rules this summer in July. Then they come out and collect comments throughout the fall. They come out with final rules, proposed rules in the November timeframe to take effect in '26. So Matt, just to be specific, I think the earliest we could potentially see this is Jan 1 '26, but we would see those draft rules in July.
I think CMS remains open to adjusting for ASP. Clearly, that requires the industry to report ASP for the vast majority of products that would be subject to the separate payment status. Our base case is for in '25 and beyond. And if we received ASPs, that would just further support the payment dynamics of the overall PSMA PET diagnostics. So guidance and our expectations are based on MUC for the full year of '25.

Operator

Yuan Zhi, B. Riley.

Yuan Zhi

Although PYLARIFY will be paid in separate payments after this pass-through expired in January, the reimbursement price is lower than competitors. I heard some customers are raising from PYLARIFY through MUCs or possibly in 4Q before the CMS policy update. I'm curious to hear how these ratio and dynamics have played out recently.

Brian Markison

So I'll tag team that with Amanda. But as you heard us repeatedly, our strategic contracts are in place with the vast majority of our customers, and that strategy was set in motion over a year ago. And so we're very comfortable and it anticipated essentially no change to any of the rules. So the fact that we have an MUC and have a separate payment is really upside to what we were originally thinking and planning, and we never changed our strategy and tactics all the way through. So while it's true that the competition is trying to nibble at the borders, we've kept the wall up. So Amanda, anything you want to add to that?

Amanda Morgan

Yeah. What I'll add is -- listen, it's a complex market, right? There's different factors in here in play here from the commercial differentiation that I talked about the clinical differentiation, but there's also an availability piece, right? And so that does have an important kind of piece of how this market plays their select markets where there is limited access to PYLARIFY in early mornings or late afternoon. And we'll continue to build that through our PMS network and expanding our manufacturing time slots.
But really, I would just go back to kind of what we hear from accounts and that is they prefer F18 when it's available, and we've done a fantastic job of getting patients access to clarify getting accounts access to PYLARIFY. And then just as Brian shared, really through our strategic partnerships. We really have been able to, as we shared, really secure a vast majority of our hospitals and freestanding imaging centers.

Brian Markison

Yeah. And the other thing to note is our service statistics and customer support, along with our PMF partnerships is just outstanding. So appreciate the question. We'll lock and load it.

Operator

Larry Solow, CJS Securities.

Larry Solow

I guess I just wanted to just follow up on Richard's question just on the cadence of the year. I guess, we can infer that the impact of price, obviously, is waning in the back half. So my question is kind of what does that mean as we look out to '26? Should we actually expect -- given the to '26. But long term, this should sound like it's a 1-year reset. Should we expect kind of price to at least not be a headwind as we look out into '26? And the second part of that question is just, I don't know if you can give us a little more concrete numbers here, but it felt like the price impact in the back half of this year or Q4 was pretty muted. So I assume there will be some impact, right, going forward, at least in the front half of the year.

Robert Marshall

Yeah, Larry, thanks for that question. I think your assessment is right that this year 2025 is going to be more reflective of the price dynamics as we anniversary through the strategic contracting with our partners. And so the normal seasonality, if you will, isn't necessarily going to be reflective within the PYLARIFY franchise. We will see seasonality that we normally see with the DEFINITY, for instance. But as we look into 2026, as we anniversary through, yeah, we do have a sense of bringing those sort of foundational products in PYLARIFY and DEFINITY back to more of a seasonally cadence sort of flow, if you will, of revenue stream.

Paul Blanchfield

Maybe just to add, Larry, on the specific kind of pricing dynamics. In the second half of '24, we did see sequential declines. If you look at the first half of '24 pricing and you look at the second half of '24 pricing from an actual realized, we did see a decline. Now that's with the overall raising prices and others that helps offset some of those. But that will normalize, as Bob has mentioned, as we get to the second half of '25 because those year over year comps are now included in that. We did take a mid-single-digit price increase at the beginning of '24. We highlighted that we did the same slightly earlier in '25 this year.

Operator

Justin Walsh, JonesTrading.

Justin Walsh

You noted Neuroseq is expected to expand your international footprint. Do you have broader ex US commercial plans for your pipeline assets? And to what degree do you anticipate remaining US focused in the long term?

Brian Markison

I think our focus really is US-based right now. Neuroseq, and once we close on Life Molecular Imaging, it will give us a much stronger international footprint. We certainly want to stop relying on out-licensing our assets. So I think we're going to look very carefully at expanding into the other markets, particularly the EU. However, we're not going to do a greenfield exercise where we're going to pour a lot of money into something and then hope we can fill it up. So it's going to be opportunity based. And I think the stronger portfolio gives us a real reason to be there. But as we look at the company today, we're US focused.

Operator

Andy Hsieh, William Blair.

Andy Hsieh

I'm curious if you can comment on your strategy in building the data set that highlights the competitive differentiation for MK-6240 and NAV-4694, as you get ready for the regulatory submissions of these two assets.

Brian Markison

Yeah, it's a great question. And I think there was the annual amyloid conference in Puerto Rico in January, which seems like ages ago. And the quality and amount of information on MK-6240, was really quite substantial and data coming out of the head study in Pittsburgh, which is a federally funded trial, where basically they're comparing all the tau agents and all the tracers in AD, demonstrated a significant advantage for MK-6240 over any of the other tau tracers, whether they're in development or on the market today.
So we feel that MK-6240 is already recognized as an extraordinary asset for its ability to detect early tau tangles. And the evidence of that is very clear as well because it's in over 100 clinical trials right now, most of vast majority academic, but we have some real interesting partnerships already in place and developing with major pharma like J&J, like Merck and others and Roche to really be the diagnostic agent for their assets in development, and we're very excited about that.
NAV is a little bit further behind. But again, NAV as a beta amyloid is seeming to shape up quite similarly to MK in its ability to detect very early or low centiloid counts. And I might add both of these agents, while not as convenient as a blood test, may turn out to be more sensitive than a blood test. We're certainly seeing that pan out right now with MK-6240. That doesn't mean it would ever replace it because the blood test is inexpensive and so cheap. However, looking at some data versus pTau and MK-6240, the tracers have a distinct advantage right now, our tracers anyway. Thanks.

Operator

John Vandermosten, Zacks.

John Vandermosten

As you mentioned before you acquired two assets from Radiopharm Theranostics and that was the 2403 and 2404. First question is, what's the -- are those completely under your control right now? And then the second part is you have a significant investment in them as well. And they have a pretty large portfolio and a presence in Australia. Does anything else look attractive at that company for you?

Brian Markison

Yeah. Number one, the answer to 100% control of the assets is yes. And number two, the whole company does look interesting. They've got a very nice portfolio in development. But our significant investment is really not that big in reality. It's kind of a foot in the door to stay close to them and support them. And we're going to stay close to them. We like the management team. We like what they're trying to do, and we want them to be successful. And if more reasons evolve to partner, we'll continue to do so. but we are leveraging their capabilities right now as we march along with LRRC15 and get it into the clinic.

Operator

Kemp Dolliver, Brookline Capital Markets.

Kemp Dolliver

I want to ask about PNT2002 in the context of the PSMAfore final hazard ratio coming out of 0.91, I know we're still waiting for your final HR data, but it strikes me that with that as the competitive bar that 2002's prospects may look pretty appealing now.

Brian Markison

Yeah. Thanks for the question. I think when you look at the population pre-chemo for 2002 as well as Pluvicto, we were underdosed in our trial, the cycles were a little further apart. And we had a suboptimal overall survival hazard ratio, which may not improve. So while the safety, the efficacy of the product is there, from our ability to get it approved by the FDA, we're not that confident. So we're going to just wait for the study to read out, see where we go and then determine if we have a play. So we're just going to learn as we go and see how it goes. But right now, we are not expecting an FDA approval for 2002 in the near future.

Operator

Richard Newitter, Truist Securities.

Richard Newitter

I just -- I wanted to ask the low single-digit to mid-single-digit PYLARIFY growth guide. Can you just talk to what your underlying market growth assumption is, or what the trend will look like in '25 to get there?

Paul Blanchfield

So I think, Rich, we continue to see growth potential in the PSMA PET market, certainly double-digit growth when we see that. We are very focused on maintaining our leadership and our share position. I think what you're seeing is the natural seasonality across quarters that Bob has alluded to many times before, and then the gross to net compression given the roll in of our strategic partnerships.
And so the overall market remains strong. We are focused on maintaining our revenue share going forward and maintaining PYLARIFY as the clear market leader. And so growth will not be sequentially the same every year or even every quarter as additional data comes out, and so we believe in the long-term potential. And we believe that PYLARIFY will maintain its leadership and its revenue share position.

Robert Marshall

Yeah. The only thing I would add to that, Paul, is that obviously, that the guide is -- we're trying to do it on a net basis because that's what ultimately gets recorded. And we're really pleased that we are growing the franchise. It's a $1 billion franchise with a very nice margin profile. It's going to help us to generate that $550 million to $600 million of free cash flow, which is now -- I have been telling people that it was about $125 million on average, that number goes up to about $140 million on average.

Richard Newitter

Can you say that again?

Robert Marshall

$550 million to $600 million of free cash flow.

Richard Newitter

This year?

Robert Marshall

This year. So I mean that's ultimately the benefit because that's going to help us to drive our long-term growth profile of the company.

Operator

David Turkaly, Citizens JMP.

David Turkaly

I apologize, I have been bouncing around a little bit. But I thought I heard a comment early on that sustained double-digit growth could begin again in 2026. And I was just wondering, is that based on sort of the current core like PYLARIFY and DEFINITY, or are there some assets in the pipeline there that you're comfortable with that will be contributing by that? And if so, could you maybe point to which ones would deliver that kind of a profile.

Brian Markison

Right. Yes. No, great question, and I'm glad you asked it. So we certainly anticipate PYLARIFY to lead the way, and DEFINITY. There's no question in our mind there at this time. Also, we have 2003 in the pipeline And pending closing of LMI and Evergreen Life Molecular Imaging, we will look to add Neuroseq which we're very excited about. And OCTEVY, the theranostic pair, to 2003, which is in our pipeline. So we're looking at potentially three brand-new launches next year that will lead to our growth profile, the addition of Neuroseq and that will pop us into double-digit growth. But I want to underscore, led by PYLARIFY.

Operator

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