Lantheus Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 26, 2025

There are 11 speakers on the call.

Operator

Good morning. Welcome to the Lantheus Fourth Quarter and Full Year twenty twenty four Conference Call. All lines have been placed on mute. This call is being recorded and a replay will be available in the Investors section of the company's website approximately two hours after the completion of the call. It will be archived for at least thirty days.

Operator

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

Speaker 1

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 and A. This morning, we issued a press release, which was furnished to the SEC under Form eight K reporting our fourth quarter twenty twenty four results.

Speaker 1

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.

Speaker 1

I will now turn the call over to our CEO, Brian.

Speaker 2

Thank you, Mark, and good morning, everyone. 2024 was a groundbreaking year for Lantheus as we achieved a number of important milestones and enhanced our capabilities as the leading radiopharmaceutical focus company. I am immensely proud of our team and the meaningful difference we have made in the lives of over 7,000,000 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.

Speaker 2

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 radio diagnostic for Alzheimer's disease, expand our capabilities with an Alzheimer's commercial franchise, as well as an enhanced R and D and clinical development capabilities and grow our pipeline. Evergreen Theragnostics has the potential to add Octavie, a registrational stage pet radio diagnostics that complements our therapeutic registrational stage candidate PNT-two thousand and three, strengthen our clinical and commercial manufacturing capabilities, add multiple clinical and preclinical assets to the pipeline and enhance our early stage R and 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.

Speaker 2

We are excited about these potentially best of first in class agents for Alzheimer's disease and oncology and plan to advance them during the year. Operationally, we grew Polarifei to over $1,000,000,000 in sales, making it the first ever radio diagnostic blockbuster and the clear number one utilized PS-ray PET imaging agent. We also grew our market leading ultrasound enhancing agent, Afiniti, double digits in its twenty fourth 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 long term radiopharmaceutical diagnostic innovation.

Speaker 2

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?

Speaker 3

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 $1,000,000,000 in sales, Polarifi 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. Polarify sales for the quarter were $266,000,000 up 15.7% year over year.

Speaker 3

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 plus billion in 2025, up from $2 plus billion in 2024, while the total addressable market could exceed $3,500,000,000 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 segments 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.

Speaker 3

We took an almost 6% WACC price increase earlier in 2025 and expect Polarifi's clinical and commercial differentiation to continue to support its clear market leadership and premium pricing. As Brian mentioned, we are pleased with CMS's 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 Polarify following expiry of transitional pass through payment status for the approximately twenty percent of patients with traditional Medicare fee for service insurance coverage who are treated in the hospital outpatient setting. Clarify OPPS Medicare fee for service payment rates are in a significantly better position than they would have been absent CMS's 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 Clarify's ASP since launch and we believe other radiopharmaceutical diagnostics can as well, which would facilitate CMS's ability to establish ASP as the basis for separate payment in the future.

Speaker 3

More broadly, we believe this rule represents significant progress for the long term potential and sustainability of our existing diagnostic pipeline, including MK6240 and NAV4694, as well as those agents that would be included in our recently announced strategic transactions. We continue to invest in Polarifai, including assessing the benefits of PSMA PET imaging with Polarifai in intermediate favorable patients via the MIRROR study, which continues to enroll as well as in PSMA expressing tumors beyond prostate through additional Phase four studies. We look forward to sharing more about our progress throughout 2025. DEFINITI continues to be the number one utilized ultrasound enhancing agent delivering fourth quarter net sales of $86,200,000 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.

Speaker 3

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 U. S. AD Radio Diagnostics total addressable market has the potential to grow to $1,500,000,000 by the end of the decade, driven by the increasing number of treatment options expected to become available, as well as increasing prevalence.

Speaker 3

This is supported by third party research, which estimates there to be over 100 therapies in clinical development targeting either beta amyloid or tau. 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 ninety percent 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 MK6240 and NAV4694 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 F18 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.

Speaker 3

NeuroSeq has shown clinical differentiation from other approved beta amyloid agents and we plan to use our experience and capabilities in F18 based radio diagnostics and those of Life Molecular's team to grow this business. We believe that our radio diagnostic portfolio including NOW4694 and MK6240 are highly complementary to Life Molecular's portfolio, including NeuroSeq and PI2620. We remain on track to submit an NDA for MK6240 in 2025 and an NDA for NAV4694 in 2026 and to close the Life Molecular transaction in the second half of twenty twenty five. We are excited about our pipeline, including the pending addition of Evergreen's registrational stage net radio diagnostic Octevi, which would complement our therapeutic radio equivalent candidate PNT2002 and could deliver a Theranostic like pair. Pending the acquisition of Evergreen, receipt of FDA approvals and positive resolution of the PNT-two thousand and three patent litigation, we expect to launch both products in 2026 and could offer near term revenue potential and diversification.

Speaker 3

We are also excited about the potential of Evergreen's clinical and preclinical theranostic payers 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 Bombacin for prostate, breast and other cancers, which we plan to advance to an IND later this year and our VARK15 targeted radiotherapeutic for the treatment of osteosarcoma and other solid tumors as well as our TROPE-two targeted radiotherapeutic. I will now turn the call over to Bob.

Speaker 4

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 $391,100,000 an increase of 10.5% and revenue for the full year was $1,534,000,000,000 dollars an increase of 18.3%. Now turning to the details beginning with Radon Pharmaceutical Oncology, which contributed $266,000,000 of sales in the quarter, up 15.3% due primarily to the continued strength of Polarify with sales of $266,000,000 an increase of 15.7%. The difference in growth rates is due to a nominal amount of AZEDRA sales in the prior year results.

Speaker 4

POLARIFY posted full year sales of $1,058,000,000 an increase of 24.3%. Precision Diagnostics fourth quarter revenue of $117,500,000 was 16.8% higher driven by DEFINITI at $86,200,000 or 17.9% higher and TektonElite at $25,100,000 was up 16.7%. For the full year, DEFINITI revenue was $317,800,000 up 13.6% and TektonElite revenue was $95,500,000 up 9.3%. Lastly, strategic partnerships and other revenue was $7,700,000 down 66.2% for the fourth quarter due to the inclusion of a RELISTOR royalty milestone receipt in the prior year. Full year revenue was $38,200,000 led by sales of MK-six thousand 240 for investigational use in third party clinical trials.

Speaker 4

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 Relystore 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 six seventy 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 and 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 and L for these types of expenses unless the specific transaction is signed within the same quarter.

Speaker 4

Other income and expense was $4,400,000 of income for the quarter and $17,600,000 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 $151,800,000 a decrease of eight point four percent and $643,300,000 for the full year, an increase of 7.7%. Total adjustments in the quarter totaled $157,000,000 of expense before taxes. Of this amount, $22,200,000 and $11,800,000 of expense is associated with non cash 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.

Speaker 4

The company recorded an unbanked guidance loss of $119,100,000 attributed to its equity investment in Perspectiv and Radiopharm Theragostics. The remainder is related to acquisition, integration and other non recurring 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 $11,800,000 and a profit of $115,400,000 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%.

Speaker 4

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 $157,700,000 as compared to $112,000,000 in Q4 twenty twenty three. Capital expenditures totaled $16,400,000 or $300,000 more than the year prior. Free cash flow, which we define as operating cash flow less capital expenditures was $141,400,000 an increase of 41,100,000 During the full year, the company generated $493,100,000 of free cash flow. Additionally, the company repurchased approximately $100,000,000 or $1,200,000 of its own shares during the quarter, leaving $150,000,000 of buyback authorization outstanding.

Speaker 4

During the fourth quarter, the company refinanced its revolving senior credit facility, increasing borrowing capacity to $750,000,000 from $350,000,000 and extended the maturity date to 2029, enhancing our strong liquidity position. Lastly, cash and cash equivalents net of restricted cash now stand at $912,800,000 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 form a 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 a range of $1,545,000,000 to $1,610,000,000 an increase of 1% to 5% over 2024.

Speaker 4

We expect Polarify 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 stack 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 twenty twenty four, which favors R and D investments. Overall, sales and marketing and G and A expenses should be flat to down year over year with R and D investment up 100 basis points to 150 basis points, all as a percent of net revenue.

Speaker 4

Interest income given heightened cash balances and the forward curve should provide $40,000,000 of income, though offset by $19,500,000 of interest expense. Therefore, for the full year, we expect fully diluted adjusted earnings per share to be in a range of $7.2 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 $550,000,000 to $600,000,000 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 $15,000,000 and $41,000,000 respectively, generally spread evenly throughout the year. Fully diluted shares outstanding should be approximately $71,500,000 which takes into account the share repurchase executed in Q4.

Speaker 4

With that, I'll turn the call back over to Brian.

Speaker 2

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 Clarify 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 for 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.

Speaker 2

With that, we're ready to take your questions. Operator, please go ahead. Thank

Operator

Our first question comes from the line of Roanna Reiss from Leerink Partners.

Speaker 5

Hi, good morning everyone. I was curious, could you give us a status update on the MIRROR study that you mentioned briefly and talk a bit about more its implications on PLARIFY? And I was curious if the timing is still on track or a little bit delayed versus what you thought before?

Speaker 3

Rana, thanks for the question. So the MIRROR study is our study to assess the use of PSMA PET with Polarify in the intermediate favorable setting. As a reminder, this is not necessarily, if you will, a registrational study, because Polarify 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 FMMI and other guidelines agencies has effectively recommended use of PSMA PET with Polarify in their intermediate unfavorable and the high and very high risk patient population. We began studying PSMA PET with Clarify in intermediate favorable patients last year.

Speaker 3

That continues to enroll. We would expect to have the last patient in sometime in the fourth quarter of twenty twenty five than 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 update in the coming years, which that 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

Thank you. One moment for our next question. Our next question comes from the line of Anthony Petrone from Mizuho Financial Group.

Speaker 6

Thanks and congrats on just a strong year overall getting clarified to $1,000,000,000 in the recent transactions. Maybe just to stick on The U. S. 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 a market shifts as this new reimbursement code has come in.

Speaker 6

And then secondly, the competitors out there looking at basically a re engineered 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? Thanks again and congrats on a strong year all around.

Speaker 2

Yes. 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, pardon the question anyway. With regard to a new product entrant, I think it's gallium. The images are not as good as Polarify images.

Speaker 2

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 Polarifi. So they're doing what they're doing, good for them and we're going to keep on and executing our game plan.

Speaker 3

So Paul? Yes. No, Anthony, thanks for the questions. 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 path to payment status.

Speaker 3

And this is clearly a benefit for Polarify, but I think more broadly as the clear leader in radiopharmaceutical diagnostics with Polarify, an incredibly strong pipeline with MK6240 of NAV4694 of our FAP agent earlier in development, as well as some of the pending acquisitions with the addition of Octavi, of NeuroSeq and earlier stage seranostic 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.

Speaker 5

Yes. Thanks, Paul. So as we shared on our commentary during the call that we've secured the vast majority of hospital and freestanding imaging centers with multi year 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.

Speaker 5

We expect to continue to capitalize on Polarife'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 Polarify. We have a longer half life, which is a distribution advantage and that enables us to optimize on our multi partner manufacturing facility network. This makes Polarify widely available through a diverse supply chain, ensuring convenient and reliable supply in over 48 states.

Speaker 5

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 Polarifi both in volume and net sales in 2025.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist Securities.

Speaker 2

Hi. Thanks for taking the questions. Just maybe on Polarify,

Speaker 4

any color you can provide on the cadence and pacing of the Polarify growth within that low single digit to mid single digit? And specifically in the first half of the year, should we expect Polarify to grow in all quarters including the first quarter? So Rich, good morning. I'll take that. So I think that our guidance actually kind of has captured sort of a range of different scenarios.

Speaker 4

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 takes consideration sort of the 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 toward 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.

Speaker 4

And it sort of is very reflective of the hard work that the commercial team has done to get these strategic partnerships put in place.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Paul Choi from Goldman Sachs.

Speaker 7

Hi, thanks. Good morning, everyone. Thanks for taking the question. My question is on SoCardo 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 the Lantheus perspective? Thank you.

Speaker 2

Yes, Paul, appreciate the question. Good morning. 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

Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jefferies.

Speaker 8

Good morning. Thank you for taking the question. 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 Folarify, how do you think that changes your growth potential for Folarify in 2026 or 2027 if it changes?

Speaker 2

Will, you want to do that or you want me to I'll probably tag team

Speaker 7

it. Great.

Speaker 3

All right.

Speaker 2

So it is a little hard to predict what's going to be happening down within the Beltway, as you know. So hopefully, 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?

Speaker 2

I think that's spot on.

Speaker 3

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 time frame to take effect in 2026. So Matt, just to be specific, I think the earliest we could potentially see this is Jan one, twenty twenty six, but we would see those draft rules in July. I think CMS remained open to adjusting for ASP.

Speaker 3

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 MUC in 2025 and beyond. And if we received ASP, that would just further support the payment dynamics of the overall PSMA PET diagnostic. So guidance and our expectations are based on MUC for the

Speaker 9

full year of 2020.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Yuan Joo from B. Riley.

Speaker 8

Good morning. Thank you for taking our questions. Although periodic file will be paid in separate payments after this pass through expires in January, the reimbursement price is lower than competitors. I heard some customers are switching from Clarify to Eluisix or OZYUMA in 4Q before the CMS policy update. I'm curious to hear how the situation dynamics have played out recently.

Speaker 8

Thank you.

Speaker 2

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.

Speaker 2

So Amanda, anything you want to add to that?

Speaker 5

Yes. 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. There's also an availability piece, right? And so that does have an important kind of piece of how this market plays.

Speaker 5

There are select markets where there is limited access to Polarify 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 F-eighteen when it's available and we've done a fantastic job of getting patients access to Clarify, getting accounts access to Clarify 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.

Speaker 2

Yes. 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're locked and loaded.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Larry Solow from CJS Securities.

Speaker 8

Good morning. I guess, I just wanted to just follow-up on Richard's question 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 you know, given guidance for '26, but longer term, this should sound like it's a one year reset.

Speaker 8

Should we expect kind of price to at least not be a headwind as we look out into 2026? And 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 impacts in the back half of this year or in Q4 was pretty muted. So I assume there will be some impact, right, going forward, at least in the front half of the year? Thanks.

Speaker 4

Yes. 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 Polarify franchise. We will see seasonality that we normally see with the DEFINITY, for instance.

Speaker 4

But as we look into 2026, as we anniversary through, yes, we do have a sense of bringing those sort of foundational products in clarifying DEFINITY back to more of a seasonally cadenced sort of flow, if you are, of revenue stream.

Speaker 3

Maybe just to add Larry on the specific kind of pricing dynamics. In the second half of twenty twenty four, we did see sequential declines. If you look at the first half of twenty twenty four pricing and you look at the second half of twenty twenty four 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 twenty twenty five because those year over year comps are now included in that. We did take a mid single digit price increase at the beginning of twenty twenty four.

Speaker 3

We highlighted that we did the same slightly earlier in 2025 this

Speaker 2

year.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Justin Walsh from Jones Trading.

Speaker 7

Hi, thanks for taking the question. You noted NeuroSeq is expected to expand your international footprint. Do you have broader ex U. S. Commercial plans for your pipeline assets?

Speaker 7

And to what degree do you anticipate remaining U. S. Focused in the long term?

Speaker 2

I think our focus really is U. S. 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.

Speaker 2

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 I 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 U.

Speaker 2

S. Focused.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andy Hsieh from William Blair.

Speaker 9

Thanks for taking our questions. So I'm curious if you can comment on your strategy in building a dataset that highlights the competitive differentiation for MK 6,240 and NAV 6,494 not 4,694 as you get ready for the regulatory submissions of these two assets? Thank you.

Speaker 2

Yes, 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 MK6240 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 MK6240 over any of the other tau tracers whether they're in development or on the market today. So we feel that MK6240 is already recognized as an extraordinary asset for its ability to detect early tau tangles.

Speaker 2

And the evidence of that is very clear as well because it's in over 100 clinical trials right now, most of the vast majority academic, but we have some real interesting partnerships already in place and developing with major pharma like J and 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 centaloid 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 MK6240.

Speaker 2

That doesn't mean it would ever replace it because a blood test is inexpensive and so cheap. However, looking at some data versus p tau and MK6240, the tracers have a distinct advantage right now, our tracers anyway. Thanks.

Operator

Thank you. Our next question comes from the line of John Vandermosten from Jax.

Speaker 10

Great. Thank you and good morning. As you mentioned, before you acquired two assets from Radiopharm Theragnostics and that was the 2,403 and February '4. 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.

Speaker 10

Does anything else look attractive at that company for you?

Speaker 2

Yes. And good morning, John. 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.

Speaker 2

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.

Speaker 2

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 LRC15 and get it into the clinic.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Kempe Dovar from Brookline Capital Markets.

Speaker 8

Thank you. I want to ask about PNT2002 in the context of the PSMA four final hazard ratio coming out at 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 2,000 prospects may look pretty appealing now?

Speaker 2

Yes. Thanks for the question. I think when you look at the population pre chemo for 02/2002 as well as Plavicto, we were under dosed 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.

Speaker 2

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 02/2002 in the near future.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist Securities.

Speaker 2

Hi. Thank you for taking the follow-up.

Speaker 4

I just, I wanted to ask the low single digit to mid single digit Polarify guide 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?

Speaker 3

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.

Speaker 3

We are focused on maintaining our revenue share going forward and maintaining Polarify 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 Clarify will maintain its leadership and its revenue shared position.

Speaker 4

Yes. 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 what gets recorded. And we're really pleased that we are growing the franchise. It's a $1,000,000,000 franchise with a very nice margin profile. It's going to help us to generate that $550,000,000 to $600,000,000 of free cash flow, which is now I had been telling people that it was about $125,000,000 on average.

Speaker 4

That number goes up to about $140,000,000 on average.

Speaker 2

Can you say that again?

Speaker 4

$550,000,000 to $600,000,000 of free cash flow.

Speaker 2

This year? This year.

Speaker 4

So I mean that's ultimately the benefit because that's going to help us to drive our long term growth profile as a company.

Operator

Thank you. One moment for our next question. Our next question comes from the line of David Turkaly from Citizens JMP.

Speaker 10

Hey, good morning. I apologize if I've been bouncing around a little, but I thought I heard a comment early on that sustained double digit growth could begin again in 2026. And I'm just wondering, is that based on sort of the current core of like Polarifi and DEFINITY? Or are there some assets in the pipeline there that you're comfortable with that will be contributing by then? And if so, could you maybe point to which ones would deliver that kind of a profile?

Speaker 10

Thank you.

Speaker 2

Right. Yes. No, great question and I'm glad you asked it. So we certainly anticipate Polarify to lead the way and DEFINITY. There's no question in our mind there at this time.

Speaker 2

Also, we have 2,003 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 Octevi, the theragnostic pair to 2,003, 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 Polarify.

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.

Remove Ads
Powered by Quartr
Earnings Conference Call
Lantheus Q4 2024
00:00 / 00:00
Remove Ads