All right, so we'll get started. Welcome, everybody, to our 44th Annual Growth Stock Conference. I'm Andy Hsieh, one of the Biotech Analysts here. I'm very pleased to have the President of Lantheus, Paul Blanchfield, with us today to provide an update on recent progress. Just briefly, Lantheus is one of the last remaining publicly traded radiopharmaceutical-focused companies in the U.S. The company has a lead asset, PYLARIFY. It's a PET imaging agent for prostate cancer, expected to achieve over $1 billion in sales this year. So before we get started, it's a fascinating story. For a full list of conflicts and disclosures, please visit our website at williamblair.com. So Paul, thanks for joining us today for the very first time.
Thanks for having me, Andy.
Yeah, so maybe as a good background, let's talk about the history of the company, how did it get started, what are some corporate aspirations, and how do you intend on executing on these initiatives?
Sure. First, I may make some forward-looking comments. Please refer to our appropriate disclosures on lantheus.com. Lantheus is a fascinating organization. We've been around for over 65 years. If many of you have seen the Oppenheimer movie last year, we actually came out of the Manhattan Project, where one of our co-founders was a member of that. And we were the organization that actually had the first nuclear licenses to use for health care. So a long history in radiopharmaceuticals. Indeed, some of our products are still on the market from the 1960s and serving physicians who treat and diagnose cardiology and other neurology conditions. We've gone through a number of permutations over the years. But where we find ourselves now, as Andy mentioned, is we would characterize ourselves as the leading radiopharmaceutical-focused organization.
We have a very strong leadership in PET imaging and overall radiopharmaceutical diagnostics, led by our lead asset, as was mentioned, PYLARIFY, which we have provided guidance will be the first PET imaging agent to deliver $1 billion in sales this year. It's third full year on the market, growing mid-20% year-over-year. We have a number of other exciting assets in diagnostics, including DEFINITY, an ultrasound-enhancing agent that does a couple hundred million dollars and still grows double digits even in its 23rd year on the market.
So an exciting base and long history in radiopharmaceuticals to build from, but increasingly opportunities to expand with the overall radiopharmaceutical space, both continuing in diagnostics, including in Alzheimer's, where we have a phase II asset for the diagnosis and staging of Alzheimer's disease in advance of therapeutic treatments, which will be coming on the market hopefully in the next couple of years, as well as a pan-cancer FAP agent to be able to diagnose cancer. We're also increasing our exposure in radiopharmaceutical therapeutics, where we have two late-stage phase III assets, one for prostate cancer, PNT2002, and another for neuroendocrine tumors, and PNT2003. We'll talk probably a little bit more about them. But we believe that we can continue to have the opportunity to be that leading radiopharmaceutical-focused company.
That's what we come in as an organization and do every day, thinking about the manufacturing capabilities, the supply chain necessary on that last mile, while leveraging our commercial and R&D capabilities to continue to bring those products to market at scale, and then continuing to be the partner for many of the R&D-focused radiopharmaceutical organizations that are looking for somebody to partner with to bring that expertise and to leverage our balance sheet while continuing to provide an attractive financial profile.
That's a great overview. All right, so this is a Growth Stock Conference. So maybe delineate us from a short-term growth trajectory perspective. What are some drivers you want to highlight? Maybe 1 year-2 years, and then growing longer term, 3 years-5 years, what are some other growth factors? Maybe I think you mentioned about the tau imaging agent, which is very exciting in 90+ clinical trials. So maybe you can also talk about how that fits into near-term or longer-term growth trajectory.
Fantastic. So when we think about some of the near-term drivers, and for that, I'll focus really on 2024 and 2025, this really comes down to continued execution for PYLARIFY, the PSMA PET imaging agent, as well as DEFINITY, our ultrasound-enhancing agent. PYLARIFY, as we've said, will do over $1 billion in sales this year. We've highlighted an addressable market of $2 billion this year, growing to over $3 billion by the end of the decade. The actual market, that's potential, will be a little north of $1.5 billion, we would estimate this year. And so there's still an opportunity for that market to double over the next five years, which is a significant opportunity.
We naturally have the lead asset there with mid-60% market share, but come to work every day really focused on how we can up the experience of our customers to ensure that they continue to prefer our agent versus anyone else. In our cardiac imaging agent for DEFINITY, it's continuing to educate hospitals on what is an appropriate echo and what is suboptimal and where the benefits of DEFINITY, which has an 80%+ market share, can continue to add value to the health care system, an incredibly durable franchise that's been around now for 23 years and continues to grow quite nicely as the market leader. Those are the real near-term drivers of products approved on the market and growing substantially in 2024 and 2025. As we look more to the midterm horizon, we would expect potential launches of PNT2002 in metastatic castrate-resistant prostate cancer.
This would go up against PLUVICTO, which did just shy of $1 billion in sales last year in its first full year on the market, even with some supply challenges. We read out top-line data in December. We met our primary endpoint. We were pleased with the overall safety and tolerability profile, but do need to wait for some more mature overall survival data that we would expect in the third quarter of this year. We estimate that market could be a $5 billion-$10 billion market by the end of this decade, of which PNT2002 could have a meaningful role. And then we look at PNT2003, which is our radio equivalent for Novartis's LUTATHERA. We submitted our package to the FDA in the fall of last year. That was accepted. We were granted first-to-file status.
After the expiry of the 30-month stay, we would expect to launch that sometime in 2026. So those are really, if you will, the near-term growth drivers, if approved, to launch 'PNT2002 and PNT2003. Then as we look there and shortly thereafter, there's an exciting pipeline coming behind it, including, as I mentioned, MK-6240. This targets tau tangles for Alzheimer's disease. With all of the therapies coming to market, both targeting amyloid and tau, we believe, as does many in the market, that the need to correctly select patients and monitor treatment is going to be paramount for the health care system. With 6.5 million Americans living with Alzheimer's and now treatments coming down, the same way we pair PSMA PET imaging as a patient selection tool for PLUVICTO, we believe the same thesis will hold for Alzheimer's agents.
We have some other partnerships earlier-stage, including with Perspective Therapeutics, another public company that has exciting assets in both neuroendocrine tumors as well as prostate and other areas. Then we remain active on the business development front, given the tremendous amount of innovation. So PYLARIFY and DEFINITY today, more catalysts with PNT2002 and PNT2003 data in the coming months, and then potential launches in 2026, hopefully followed by MK-6240 and Alzheimer's to continue to round out the radiopharmaceutical portfolio.
Excellent. Yeah, it's a great kind of lining up all the catalysts in the next couple of years. So let's talk about the PSMA imaging market, right? You kind of talk about the longer-term growth trajectory, but let's dig a little bit deeper into the individual opportunities that PYLARIFY has gotten approval for, opportunities to expand on that in terms of more labels, scans per patient. And so maybe let's put it in the perspective of patient journey. Where does PYLARIFY fit in as a patient who gets diagnosed and then travels through the prostate cancer journey?
Sure. So with three million men in prostate cancer, we're incredibly privileged to have a very broad label. And so the label for PYLARIFY is for staging of patients who have a risk of metastases and for assessing those with rising PSA, a serological test of prostate cancer following definitive therapy or prostatectomy. And so what this really means is that PYLARIFY can be used in those initial stagings of a patient where the general journey would be after a man reaches a certain age, likely 50, they would start to go annual PSA tests when they do their hopefully routine physicals. They would monitor PSA.
If PSA begins to rise significantly enough, there could be a risk of prostate cancer, at which point you may conduct an MRI to take a look at the prostate bed and to assess it, and then do a biopsy where you would put in a series of needles and pull out samples to test whether or not there is indeed localized prostate cancer. That is all done standard of care right now. What's been novel with PYLARIFY is the ability to have a prostate-specific targeted imaging agent for those patients that are deemed at risk. Now, guidelines would currently say that's very high-risk patients, high-risk, and intermediate unfavorable, as measured by something called the Gleason Score, which is a combination of your PSA test and your biopsy.
If you are considered intermediate unfavorable, high or very high risk, to then undergo a PSMA PET scan with PYLARIFY, which is a whole-body scan and will specifically bind to prostate cancer to understand if indeed that prostate cancer is just localized or indeed it has metastasized to other parts of the body. The beauty of this is that through our study data, 2/3 of patients scanned with PYLARIFY have a change in intended management, meaning that physicians are actually taking a different course of therapeutic action based on their PYLARIFY scan, either potentially upgrading treatment or downgrading treatment to ensure that patients get the best treatment and payers are appropriately paying for the best treatment. That's all in the staging bucket.
Over time, we would expect PYLARIFY and PSMA PET to be used in lower-grade assessments, including intermediate favorable, where we have a phase IV study to assess PYLARIFY's benefits in that added population. The product is already being used there. It is on label, but is not necessarily in guidelines. So it is not as widely adopted in that patient population as elsewhere. If we look more to the biochemical recurrence, this refers to after you've had definitive therapy, frequently a prostatectomy or other castration means. If your PSA is still rising, that's a sign that you likely have metastatic prostate cancer because you don't necessarily have any localized because you've had a prostatectomy. But we need to monitor that and understand what that is. That would first be done with a PSA test, which would be done regularly after you've been diagnosed with prostate cancer.
If that is rising, then you would undergo a PSMA PET scan with PYLARIFY to virtually image where you may have that cancer and to understand based on a man's age and health and what type of interventions would be needed. And so incredibly broad labels. I would note that within that second bucket, we also use it for patient selection. So as radioligand therapy, in this case, specifically PLUVICTO, which I referenced earlier, in order to be eligible for a PSMA therapeutic, you need a positive PSMA PET scan. And so PYLARIFY captures currently about 2/3, 65% of the overall market. And so this is used in that early stages. It's using following definitive therapy to monitor rising PSA, and it's also used for patient selection. We would expect continued adoption in all three of those, as well as continued expanded scientific use as technology continues to evolve.
There's many investigator-initiated trials out there to assess PSMA PET with PYLARIFY's use elsewhere. Then I would note lastly, the frequency with which men will be scanned is also something that continues to evolve. We're finding that physicians will note a PSA score but may not want to have an interventional treatment at that point. If a gentleman, for example, is in their mid-80s and has a recurrence but has a PSA of 0.4 or 0.5, they may choose to come back and get a scan again in six months to determine whether or not that prostate cancer is actually aggressive and requires interventional treatment or not. So we're seeing what that frequency of scanning also increases, and that creates added opportunity for us to add value to the health care system.
So I guess in terms of each of the buckets, do you have a sense of the scans per patient? What are the biggest levers from those different buckets?
So the biggest lever overall is really just continued education of the referring physician community. And by that, I mean urology, medical oncology, and radiation oncology. While ourselves at Lantheus and many within nuclear medicine talk about PSMA PET on a daily basis, urology, medical oncology, radiation oncology still have a long way to go to more fully adopt this technology. I'll note that of all the prostate cancer imaging scans that are done on an annual basis, PSMA PET only makes up about 25%. The other 75% are still non-prostate-specific scans, whether they're bone scans, whether they're CT, whether they're MR. That's a significant opportunity for us to continue to educate referring physicians. The next big lever, to your point, is naturally as physicians become more comfortable with the frequency with which you get scanned. What's historically been known as the watch and wait see.
I'm not going to treat everything I see, but I'm going to monitor it to see the progression and speed to progression and then understand what I want to do. That's really in the biochemical recurrence space, and that's where we start to see an increasing volume of scans. In the initial staging piece prior to definitive therapy, we would expect it's generally going to stick at one scan. You're really staged once you've been diagnosed with prostate cancer. There are instances where if you were low risk, you may want to be monitored to see what that looks like. I think more likely we're going to see the increasing scan volume and particularly repeat scans because fortunately for men with prostate cancer, they are more likely to die with prostate cancer than from prostate cancer.
Therefore, being able to follow a gentleman's progression of disease over potentially decades is incredibly important. They benefit from the repeat scans with the same imaging agent to be able to have a true apples-to-apples comparison onto the progression of their disease.
Great. And so maybe let's talk about the competitive landscape. Obviously, there's a couple of imaging agents out there all looking at PSMA, right? Some Fluorine -18, some Gallium -68. So how do you think about the competitive moat that you have and how that market is going to evolve over time?
First, I would say we're incredibly pleased with the results of PYLARIFY and the leadership that we continue to exhibit where now 3+ years in, we have a market share in the mid-60% amidst three other commercially approved agents and two academically approved agents. So we feel very pleased with the results and the leadership we've been able to deliver. That said, we certainly do not take that for granted and work every day to ensure that we continue to meet our customers' needs. We believe that our product is clearly clinically and commercially differentiated. From a clinical perspective, I highlighted some of our change in intended patient management data where physicians really are doing things differently as a result of the scan. We believe that that is differentiated from data that our competitors have generated.
We look at the highly accurate detection rate, not just overall detection rate because some of our competitors will tout detection rate that includes false positives. We believe we are differentiated with the benefits of PSMA, our targeting moiety as well as the F-18 isotope. Then we look at the consistency of scans where readers, perhaps at different imaging centers, will interpret a scan and read it the same as someone else does. We believe that gives the referring physicians comfort that when they continue to repeat scans on patients, that they see a comparable result that they can compare and that those patients benefit. Commercially, we've worked incredibly hard to differentiate ourselves not only in the payer coverage, where over 90% of patients have access and are covered for PSMA PET with PYLARIFY.
We're the lone PSMA PET player to have a multi-partner PMF chain where we leverage multiple manufacturing sites, three national chains, 58 sites across the country to manufacture this product and allow our customers, whether they're hospitals, freestanding imaging centers, or government facilities, to procure the product where they so desire and to have what we call out-the-door times, given the half-life dynamics of radiopharmaceuticals of products when they want to procure them, whether that's an early morning scan, a late morning scan, or a mid-afternoon scan, in addition to our education and commercial efforts. So we feel we are well differentiated, but we work tirelessly to ensure that that is consistent. Thus far, we've been able to maintain a mid-60% share, importantly on a much higher growth market. So we really focus overall on what we can deliver from a revenue and a patient impact perspective.
As the market leader, an overall growing market that we're focused on disproportionately benefits us. So we're very focused on overall market expansion.
Great. Maybe a little segue from the commercial comments that you're making to one of the most talked about topics, at least from our conversation with investors, is pass-through. So a lot of investors would like to know, pass-through is coming. What are you doing to mitigate some of the impact and talk about the kind of in terms of the framing of that impact, mostly the Medicare beneficiaries? So how big is that market from a revenue perspective?
Transitional Pass-Through payment is a somewhat obscure CMS payment dynamic that applies strictly to radiopharmaceutical diagnostics. It allows for separate payment for a specific site of care with a specific payer coverage. It is strictly the hospital outpatient segment, which accounts for about 60% of PSMA PET imaging. It is strictly Medicare Fee-For-Service, meaning it is not Medicare Advantage and it is not commercial. That equates to about 1/3 of payer coverage. When you take the intersection of the 60% site of care hospital, 1/3 Medicare Fee-For-Service, you get about 20% of patients that are subject to what we call Transitional P ass-Through payment, whereby for a three-year period, the hospital is reimbursed or paid separately for the radiotracer in addition to the procedure costs of a PET scan.
After three years, the PSMA PET agent, in this case, PYLARIFY, comes January 1st, 2025. Illuccix, the number two competitor in the space, July 1st, 2025. And then LOCAMETZ, the number three player in the space, October 1st, 2025. So the three clear market leaders within nine months of each other are now bundled into a broader payment mechanism. And so the fear is that with a reduced potentially payment mechanism for PSMA PET, that the business will look elsewhere given some of the potential financial disincentives. And so we've been planning for this since launch. We continue to, one, highlight that these products are not the same and the clinical and commercial differentiators that I just highlighted.
We shared earlier this year that in the middle of last year, we began entering into strategic partnerships with those key hospital customers for those that have financial exposure given their payer mix as well as financial sensitivity to help financially mitigate the impact of roughly 1/3 of their business on average, potentially seeing a reduced payment mechanism. And so we began that effort last year. We continue to make meaningful progress to financially mitigate and to enter into multi-year long-term strategic partnerships with our customers so that we can remain the PSMA imaging agent of choice and continue to activate referring physicians to drive continued growth of the marketplace. In addition to some legislative and regulatory approaches that could permanently fix the TPT or Transitional Pass-Through dynamic, CMS has proposed rules last year. They took in a number of comments.
The broader coalition that's focused on this topic continues to engage with them. They will come out with new rules for fiscal year 2025 in July, take feedback till September, and then issue final fiscal year 2025 rules in November to potentially fix this. Then lastly, the Congress has taken up the FIND Act, which would also fix this from a legislative perspective. That just cleared a House Energy and Commerce Subcommittee meeting. The next step would be for the broader House Energy and Commerce markup, as well as a CBO score to potentially be included in a future large healthcare bill in the must-pass side. So there's a number of mitigating strategies. We take it very seriously.
But overall, we've been putting these in place for some period of time to ensure that hospitals can weather this financial potential disincentive and continuing to be comfortable using PYLARIFY that they've used for a number of years.
Great. So maybe it's a good time to transition into the therapeutic side of the business, right? One of the most powerful tools that you can use as a radiopharmaceutical is you can see there's a diagnostic pair, there's a theranostic pair, right? So maybe you could talk about the therapeutic strategy that you have and how do you intend to grow 2002, 2003, and also maybe a little bit about the deal that you signed earlier this year with Perspective. How do you view that asset is going to grow?
Sure. I think we're overall incredibly pleased with the radiopharmaceutical space on the therapeutic side. Naturally, there were some early launches in the early 2000s with Zevalin, BEXXAR, and other products that didn't quite live up to potential. But as we look at the last couple of years, specifically with PLUVICTO and LUTATHERA, it's clear that these are multi-billion-dollar opportunities right now in prostate and neuroendocrine tumors. But as we look to the growth of antibody drug conjugates and other targeting approaches, we believe this will only grow. For us, our near-term entry into therapeutics would be the PNT2002 and PNT2003 assets that we licensed global rights save for a few Asian markets from POINT Biopharma, now part of Eli Lilly. I referenced those earlier. PNT2002 met its primary endpoint in its phase III data that we announced in December.
We would expect more data to come out in the third quarter of this year. And then if the overall survival hazard ratio, which for us was north of one as it was for Novartis, Novartis just shared, I believe it was on Sunday, the days are blurring, at ASCO this past weekend, an updated hazard ratio of 0.98, which effectively means there was a 2% survival benefit to those patients in the treatment arm and then the control arm. They now are going to proceed to work with the FDA to file that. We have to wait for our 75% maturity data sometime in the third quarter. And if the OS ratio gets down to one or below, then we clearly have a filable asset.
We haven't shared too much specifically on the competitive approach to be able to launch this agent in the marketplace, just given some of the competitive dynamics. Our friends down in New Jersey would like nothing more than to know exactly how we plan to launch this. We do think there is a benefit from an overall dosing regimen. Their product is six doses, ours is . There is a convenience piece there. We were pleased with the safety and tox profile, specifically the number of patients that were able to go on to subsequent therapy. While radiopharmaceuticals are fantastic in treating prostate cancer, they do not yet over the long-term cure cancer.
The ability to maintain future treatment options, whether that's chemo, whether that's future RLTs, means that to be able to have an appropriate tox profile, meaning xerostomia, bone marrow, other pieces is going to be important. There could be some advantages there. For PNT2003, this is ultimately a radio equivalent or an ANDA to LUTATHERA. There's natural levers that we can play there. But we do believe that we're going to be able to lever our existing experience with all of the nuclear medicine departments that we've been serving for decades and that are frequent users of PSMA PET with PYLARIFY. We believe there are opportunities for us to compete in what could be sizable markets. We've noted the PNT2002 market could be $5 billion-$10 billion.
Even with not a leading share, it could be a meaningful contributor to the business. We're incredibly excited about radiopharm therapeutics. That led us to partner and license options for Perspective Therapeutics. Perspective Therapeutics is also a publicly traded company. They have focused on the development of lead, both diagnostically and therapeutically. That is an alpha, an alpha versus a beta. An alpha has a higher energy, a shorter length of treatment, and double strand breaks of DNA. So some advantages potentially versus betas. We were very pleased with some of the early data we've seen there of their targeting moiety of their linker and then of their chelator specifically, which is proprietary to them to contain lead as it treats neuroendocrine tumors, which is their lead asset. So much so that we also took an equity stake in the organization. Just shy of 20%.
They continue to do some raises. And so that may be a little bit lower than that right now. But I think the future in radiotherapeutics and radiopharmaceutical diagnostics is incredibly strong. And so we'll continue to lever our strong cash flow generation and balance sheet to make appropriate bets, both diagnostically and therapeutically.
All right. So maybe for the last minute, maybe some comments on BD. I think you mentioned about business development opportunities. It'll be more aggressive during the first quarter call. Just kind of share your latest thoughts on BD and inorganic growth opportunities.
So I think we're very pleased with the amount of opportunities that are out there on the marketplace. I think what we've really demonstrated, I know in many one-on-ones, we've talked about our specific focus on ensuring that any type of deal is going to meet our return metrics in a reasonable timeframe, recognizing there has been some significant frothiness in the market and multiples or rather just prices paid. There are some very early stage assets in the market on the therapeutic side. We think there is continued opportunity, first and foremost on the diagnostic space, where we clearly have leadership capabilities and the ability to add value, add revenue and cost synergies to bring markets to products sooner, products to market sooner, and do so well by levering our installed base. Therapeutically, we continue to be active as well through creative options.
If I look at some of the deals we've done over the last couple of years, there's been a number of different approaches. When we acquired Progenics, that was a large deal for us at the time. That was an all-equity deal with some CVR payments that we were very happy to pay out given the success of PYLARIFY. We were able to license in the PNT2002 and PNT2003 assets from POINT for $260 million with no other milestones due until approval, which was a great option for two late-stage assets. We brought in MK-6240, our Alzheimer's asset, which already had revenue-generating capability in our pharma solution space. And then earlier this year, we took two options on the Perspective assets as well as an equity stake. And so we're willing to be creative depending on what the solution calls for. We are not of the size or scale or willingness to write some of the large pharmaceutical checks that have gone out to acquire a platform of multiple billion dollars. But we don't believe we need to do that because we already have a platform and a history in radiopharmaceuticals. We do need to continue to expand some of our capabilities as we go into therapeutics, expanding, for instance, in the medical affairs space, inpatient services, in some of these other areas. But we believe that we already have the capabilities in many respects to in-license or acquire other assets to continue to fuel the leadership that we've had going forward. And so we'll continue to be active there. Brian Markison, our new CEO, as of March, continues to spend a significant amount of his time assessing the space and ensuring that we continue to have a robust pipeline that fuels growth well beyond PYLARIFY, DEFINITY, PNT2002, PNT2003, MK-6240, and for us to continue to be the leading radiopharmaceutical-focused company.
All right. I think that's a wrap.