Lantheus at Jones Healthcare Conference: Radiopharma Roadmap Insights

On Wednesday, April 9, 2025, Lantheus Holdings Inc (NASDAQ: LNTH) participated in the Jones Healthcare and Technology Innovation Conference 2025. The session provided a strategic overview of the radiopharmaceutical industry, highlighting both opportunities and challenges in isotope development and supply chain dynamics. The discussion underscored Lantheus’ strengths in F-18 isotopes while addressing broader industry concerns.

Key Takeaways

• Lantheus emphasized F-18's advantages in high-resolution imaging and its robust U.S. manufacturing network.
• The panel highlighted the challenges of scaling isotope production and ensuring supply chain reliability.
• Emerging isotopes like Lead-212 and Terbium-161 offer potential but face production and clinical data hurdles.
• Healthcare systems must expand PET imaging capacity to meet growing radiopharmaceutical therapy demands.
• Geographic considerations, such as Japan's focus on Astatine-211, influence isotope investment strategies.

Isotope Selection and Characteristics

• F-18: Praised for high-resolution imaging and strong U.S. distribution network; limited by short half-life.
• Gallium-68: Suitable for small-batch production; challenges in large-scale efficiency.
• Copper-64: Centralized production benefits from longer half-life; lower emission rate requires adjustments.
• Lutetium-177: Proven clinical success with a robust supply chain.
• Lead-212: Easier production compared to Actinium-225; limited clinical data.
• Terbium-161: Combines therapeutic and imaging capabilities; precursor availability is a concern.
• Actinium-225: Strong alpha emitter; production difficulties and safety concerns noted.

Supply Chain Dynamics

• Reactor Usage: Transition to power reactors expected to enhance supply stability.
• Enriched Isotopes: Western companies invest in isotope enrichment; potential need for centrifuge systems.
• PET Cyclotrons: Increased investment supports PET isotope availability.

Healthcare System Capacity

• PET Imaging: Growth in PSMA PET scans requires expanded capacity.
• System Adaptations: Pharmaceutical companies can aid by developing efficient agents like F-18.
• Radiopharmaceutical Integration: Changes in therapy delivery necessary to accommodate new demands.

Conclusion

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - Jones Healthcare and Technology Innovation Conference 2025:

Justin Walsh, Healthcare Analyst, Jones Trading: Alright. We'll, we'll get things, started now. So thank you all for, joining for today's panel, which is, titled Radiopharma Isotope Roadmap Clinical and Logistical Considerations. My name is Justin Walsh and, for those of you who don't know me, I'm a covering healthcare analyst here at Jones Trading. With respect to the format, we're going to start by allowing the panelists to introduce themselves.

I'll then ask each panelist a couple of directed questions before diving into questions for the entire panel. So to kick things off, John, can you introduce yourself?

John Wiggins, VP of Isotope Strategy, Lantheus: Hi, I'm John Wiggins. I'm the VP of Isotope Strategy at Lantheus. Lantheus is the leading radiopharmaceutical focused company and excited to be here today to answer some questions. Alright. You, Sumit?

Sumit Verma, CEO, Tag One: Hi. I'm Sumit Verma. I'm the CEO of Tag One. I've been involved in radiopharmaceuticals for almost twenty five years

Justin Walsh, Healthcare Analyst, Jones Trading: And Ricardo?

Ricardo Canevari, CEO, Radiopharm Theranostics: Hello, everybody. I'm Ricardo Canevari.

Justin Walsh, Healthcare Analyst, Jones Trading: I'm the CEO of Radiopharm Theranostics, a company that is listed in Australia and now also Nasdaq. Great. So we'll just jump right in here with with an easy question for for John. So obviously, Lantheus has demonstrated the clinical and commercial viability of branded F-eighteen imaging agents with Polarify, but the company also has Gallium 68 and Copper 64 agents in your pipeline. So can you just comment on the relative advantages of agents, based on each of these isotopes?

And assuming that the images generated by these are comparable and you can correct me if I'm wrong on that point, how important are the differences in availability, production capacity, path life and chemistry?

John Wiggins, VP of Isotope Strategy, Lantheus: Yeah, we obviously have a huge interest in F-eighteen and we think that that's a wonderful isotope for a number of reasons. One is that it has a very short positron range, and that translates into a higher resolution image. So that's sort of a a technical wonky aspect of this, but it has a real impact on the quality of image that's produced, and that's a big reason to favor f 18. F 18, of course, also we benefit from the decades of work in building up manufacturing and distribution, particularly around The US. So having this PET manufacturing facility network across The US and therefore wide availability of very high volumes of f 18.

And those factors together make f 18 an exceptional isotope. It does have a couple of either limitations or or constraints on it. One is that because it has a short half life, two hours, so longer than gallium 68, but significantly shorter than copper 64, Distribution is primarily local. So we have to have a manufacturing center or several manufacturing centers within each metro area or region in order to supply cuts in that area. If we go to a longer half life isotope like copper 64, then we can centralize production, and that makes the the management of the manufacturing network significantly simpler.

Now it may not it may not be noticeable to customers in the end how we do that, but we do look for operational efficiencies on our side as well. The the last piece on f 18 that I'll say is the chemistry is different, the way that it attaches to the molecule from metals like copper and gallium. So when we have a molecule that's been developed to to attach metals to it, fitting f 18 into that is it's not impossible, but it's a a little bit more challenging, so that might be a reason to favor other isotopes. And in fact, where we've worked with Gallium 68 and Copper 64 in particular, part of the consideration there is chemistry, and with with a Gallium agent, you can easily take the Gallium out, replace it with Lutetium, for example, and switch straight over to a therapeutic product, so that can make development of new molecules a bit easier because you have a few more synergies between the diagnostic development and the therapeutic development. I would say that gallium is also well suited for markets where there's lower demand because you can make it efficiently in small quantities.

If you only need one or two doses, that's easy to do with gallium. You you elute that much off of a generator. You make those couple of doses, ship them again within a a local area, and and you're good. If you need to make 40 or 50 doses, that's harder to do efficiently with gallium, and in many cases even to do at all depending on the the resources there. So that's a big reason to favor F 18.

And finally, to go over to copper 64, we do like that advantage of centralized distribution. Copper 64, like F18, has a very short positron range, so high resolution images compared to gallium 68. It it has it doesn't give off as many positrons or doesn't give off a positron as often when it decays, and that could mean that you need to administer more activity or have a longer scan time to get the same amount of information for an image, so there's some trade offs to look at there clinically when we think about how those isotopes work. Certainly, the the clinical aspect of it is is very important to us, and I do think there are differences in the in the image quality that we get off of it, but supply chain, depending on the stage of development we're at, could be even more important. And when we look at at, assets where we are either in late stage or we think we have an accelerated path to approval, then we may wanna look at isotopes that that have capacity available, gallium 68, f 18.

When we have an asset like our FAPI agent that has a little bit more time before it's likely to be approved, then looking at something like copper that's a new isotope where we still need to build the robust manufacturing infrastructure around that, we think we have that time and can then take advantages of the, supply chain efficiencies that we get with copper.

Justin Walsh, Healthcare Analyst, Jones Trading: Great. Thanks for that. Very, very informative. So, Sumit, your your first question, Tag1 is is looking to become a supplier of lead two twelve generators. So how does the current landscape look with respect to to lead two twelve supply?

And and where do you see the opportunity for TAG one?

Sumit Verma, CEO, Tag One: Sure. As you think about lead two twelve, it's one of the more newer isotopes coming into the space from a targeted alpha therapy. Certainly, have had players who have been working on it for a long time, but the popularity, especially because of what's happening in the Actinium two twenty five space, has triggered a more demanding aspect of the supply side of things. We have very good therapeutic innovators who've done a great job looking at new products and initiatives coming into the clinical market and then ultimately as providing their own supply of lead g twelve. So as you think about this market, it's kind of unique comparatively to most of the other isotope suppliers where most therapeutic developers are trying to do two complex things.

They're working towards getting therapeutic product to the market, and at the same time they're trying to bring an ISO to the market. For those who have been in the industry a long time, that's a really challenging endeavor, especially as you think about the supply side and how you have to build out that technology and the scale up effort that's required to it. So the way we see it is as there's a pivoting taking place between Actinium Inlet and also new modalities that are providing better targets outside our typical markets from PSMA and new endocrine tumors, there's an influx of the need for lead t twelve. And today, there's not that many suppliers of lead t twelve itself. In fact, in The US, most therapeutic developers are very focused on providing their own supply chain needs, but they can't really offer it up to the others.

DOE has been traditionally a good supporter and cheerleader of bringing in new isotopes, but there's only so limited efforts that they can do as well. And just thinking about the future, think that's gonna be even further constrained. That's kind of where Tag1 really comes in. Our view is we wanna be a radioisotope supplier. We this is our kind of niche that we're really good at.

We're building on the backbone of what we've done in various isotope products, everything from copper 64 to molybdenum, and using that platform to bring in a portable generator. Our view is that if you can get that generator right to the point of care to radiopharmaceuticals, hospitals, and different places where the compounding effect can be done and bring new therapeutic products to the market faster, we just think that's a good place for lead T12 generator to resume.

Justin Walsh, Healthcare Analyst, Jones Trading: Got it. Now on to you, Ricardo. So despite out licensing some assets, Radiopharm has maintained a broad pipeline, especially considering the size of the company. So what do you look for when evaluating a potential radiopharmaceutical asset and determining which to prioritize for clinical development? Are there major similarities or or differences when thinking about imaging versus therapeutic opportunities as well?

Ricardo Canevari, CEO, Radiopharm Theranostics: Yeah. No. Thank you, Justin. Yeah. Let me start from imaging.

I think that's that's what we started here, and I believe it's a very interesting part of the business even if we as a company are more focused on therapeutic. But from an imaging point of view, I really see three main value from an imaging agent. The one is the the one that we are discussing now is being the companion of the therapeutic. If you want to give Lutathera to a patient, you need to have NADSPOT. If you want to give a PROVICTOR to a patient, you need to have Pillarify or another PSMA imaging agent.

So the companion diagnostic value is is is is huge, and we've continued to grow. The second aspect that is probably less discussed at the moment is if I do not have a companion therapeutic, can I still have value with a with an imaging by itself? And in this specific case, for example, we do have experience with a PET agent with f eighteen for brain metastasis. Now the value is not because we have a therapeutic radiopharmaceutical, because we don't, but we have the imaging itself that can help to better qualify the type of metastasis that you have in the brain. Are they active?

Are they necrotic? How much active they are? And when we detect that, assume the phase two is going to be successful, physician can use SRS, gamma knife, to treat patient. So the patient can have better PFS and overall survival, not because we have a therapeutic radiopharmaceutical, but because the PET agent is helping to use other modalities to support patient. And this is the second one.

The third one that probably is even less discussed is the so called side effect of therapeutic isotope. They emit gamma. But is gamma bad? Well, it depends. Sometimes gamma is very positive because you can capture gamma emission, and you can do with a SPECT camera, you can assess where your products is going and where it's not going.

And I think that using some isotope like lutetium or terbium one sixty one allow you during the clinical development of a therapeutic to really understand where you are. And this is unique, and it's a great opportunity for our sector. You cannot have that with an ADC. You cannot have that with a CAR T. You cannot have that with a with a naked molecule, but you can have with a radiopharmaceutical.

So you dose the patient with objective of a therapeutic dose, but you can image the patient after, and you know how much it went to the tumor, how much it went to the kidney, how much it went to the bone marrow, how much it went to the spleen. And you know exactly how successfully you can run your dose escalating trial faster because you have all this information. So I think these are the three major value of of imaging agent. And back to your question about selecting one molecule versus the other, That's all it's exactly the combination. It's it's there is the unmet medical need that that I can solve with the therapeutic.

Are there other modalities or not? And our focus has always been in trying to expand the use of radiopharmaceutical where there is no current development ongoing. There are great ongoing results with PSMA, with with SSTR two, with FAPI, but there is still so much to do in other modality. We are focusing, for example, on PD L1. We are focusing on HER two.

We are focusing on b seven h three. So three modalities where we see presence of immuno checkpoint inhibitor of ADC, but not yet as radiopharmaceutical. So that's where we are trying to go.

Justin Walsh, Healthcare Analyst, Jones Trading: Yeah. I I think your your second point on the, sort of the the imaging opportunity is is quite interesting, particularly in the context of of Clarify given that so much of the value of Clarify is is outside of Plugicto in and of itself. It's the prognostic case capability, which is why I think PSMA is is has been such a a great proof of commercial viability for both imaging and therapeutic because you have these this sort of great setup for that. So so maybe jumping here into our our second specific question for you, John. So related to therapeutic isotope selection, how do you think about the interplay between scientific rationale, current isotope availability, projected isotope availability, and clinical evidence.

So for context here, I understand that Lantheus' current therapeutic pipeline is dominated by lutetium-one hundred seventy seven, unsurprisingly, but the company has exposure to lead two twelve via partnerships with with prospective therapeutics. And I'm sure that you're actively evaluating other therapeutic isotopes of interest.

John Wiggins, VP of Isotope Strategy, Lantheus: Yeah, certainly. And, you know, it's a great question that all of those factors and more come into play selecting a therapeutic isotope. Lutetium has the advantage now that it checks all of those boxes, right? It has demonstrated success in products that are out there, have abundant clinical data showing that it's effective, and at this point the supply chain is quite robust for Lutetium, so it's an easy isotope to work with and fits well as a first step in developing a new product in most cases. You're right, though, that we do look beyond that and at things, not only other beta emitters, but also alpha emitters or maybe low energy electron emitters, as bringing the potential for greater clinical effect, and therefore the potential to displace lutetium at some point, or other beta emitters as standard of care.

I I would say that we are we are balancing both the supply chain interest there and the clinical evidence, and the clinical is ultimately most important. If there's clinical evidence there, the supply chain will develop. We know that some isotopes have maybe easier supply chains than others, so lead two twelve seems to be more readily produced than actinium-two twenty five, and that's no surprise with the sort of science and engineering behind that, and therefore we're very excited about LEAD-two twelve and our partnership with Perspective there. Where, you know, I think we have a bit more work ahead of us as an industry, is in demonstrating the potential of alpha emitters, because if you haven't changed the therapeutic index, if you haven't changed that kind of ratio of tumor dose to healthy organ dose, then whether that energy is delivered via an alpha emitter or a beta emitter, you're still basically getting the same dose to the tumor versus the healthy tissue, and you have the same constraints. So there are some potential mechanisms by which alpha emitters could prove more effective even with the same therapeutic index, and those, you know, those have to do with things like antigen expression and immune activation, or maybe the range of the particle, and that if, you know, if a drug is excreted through the kidney, does it really does an alpha particle damage the kidney, or is it such a short range that it doesn't even reach critical tissue in the kidney?

But those are still a bit theoretical. We haven't yet seen at least abundant clinical evidence of those, and I think that that's a major need for us, as we go forward with our research and development effort. But it is something that we're very excited about, and we certainly are believers in that. We are big believers that alpha therapy and LEG-two twelve especially will be effective. It's just not quite the slam dunk that lutetium is today based on demonstrated success.

Justin Walsh, Healthcare Analyst, Jones Trading: Great. And I think this is a great tie into the next question for you, Sumit, which is what preclinical and or clinical evidence really has you excited about the potential of lead two twelve targeted alpha therapy? Because, obviously, you have, I think, high expectations that it it it will, be favorable and and see continued uptake in use.

Sumit Verma, CEO, Tag One: Yeah. No. I I think John's right. From a continuum perspective, Letitium, as you think about just the time spent towards development of their drug therapeutic journey, their clinical pipelines, and ultimately the supply side, we've seen a big impact recently, but it was the same challenges done in 2018. So now if you take a step forward and say, hey.

Are we seeing that gets us excited? I think at a preclinical level, we've seen significant amount of work being done without generating itself. You know? Right now, not a lot of information is public, but what we've seen at doctor Caroline Anderson's labs with University of Missouri is super exciting. You know, the chelator chemistry, not from your traditional DOTA and TCMC, but even more innovative key leaders are showing good successes in that space.

That that gets us excited. And then we've been working with Priserics. Priserics has had an interesting compound called CAMH two from a single domain antibody, you know, taking a step away from monoclonal antibodies, and we've seen that also do very good in the radiochemistry side and initial mice studies. So we we're somewhat bullish that as more supply comes into the market, as more clinical trials done you know, we we have only seven out there, so it's not the same vigor as Actinium, which has over 54 clinical trials out there. But we think as you build out those databases, the data will speak for itself.

Lastly, on the clinical side, I think some of the data is super exciting that's already published. Right? I mean, if you take doctor Del Pason's study for Alphamedics and seeing the FDA give them also a breakthrough designation, it's primarily because of the data. Yeah. As compared to Lutathera, compared to RACE bio one zero one results, they are showing some very promising data at a very initial phase.

I mean, it's too early to bet big on it, but at least as you look at the landscape and some of the success stories on what's been published today, I think it's super exciting.

Justin Walsh, Healthcare Analyst, Jones Trading: Great. Now, last last one focused on on you, Ricardo. So I'm wondering if you could tell us a little bit about rad four zero two and how terbium one sixty one could be differentiated from from lutetium one seventy seven. And then sort of assuming that we end up having favorable clinical data there, how much effort would it take to to scale up production and and supply of of terbium one sixty one?

Ricardo Canevari, CEO, Radiopharm Theranostics: Yeah. Sure. So first of all, each isotope in isolation cannot solve the problem. You need to have an isotope attached to the right molecule to go after the right the right target. In this specific case, of course, Pluvicto is the leading agent.

You know? It was post chemo, now got approval pre chemo, potentially can be also earlier in the in the treatment line. It's likely that Pluvikto will be the leading the first line radiopharmaceutical for a number of years. Somebody might try to go head to head with a large trial. I don't know.

But the reality is if you take the VISION trial data and the new data, there is around thirty, forty percent of the patient that respond very well. The same time means there are patients that are not responding to And when you give the four to six doses of Probicto, eventually, the pay the patient will progress. So you need a post Probicto agent. Now for this reason, we thought about how can be that market is can be significantly commercially attractive, and, of course, the answer is yes. So how can you go postprovicto?

You can go with different approaches. We personally believe that changing target is a better option than just changing isotopes. So going with the PSMA with another isotope can work, but equally can work to go with another target. So we focus on KAK three because KAK three is expressed in ninety eight to ninety nine percent of the patient when the disease is not metastatic and probably around ninety percent of the patient when they are metastatic. You need to exclude neuroendocrine part of prostate, but all the other expressed k l k three.

So we think that is a good target to go after. The second approach is that I think is equally interesting. Pluvicto is a peptide. So it's it's kind of a small molecule. That means that one patient who receive four doses, that's the average, of ProVicto, they already consume sixteen, eighteen grays in the kidney.

And the limit for from FDA is 23 grays. So any postprovictal therapy need to consider that they only have six to seven or eight grades before they cannot give more products if the 20 grades will remain. I mean, there are a lot of discussion that that can change. But for the time being, that's the situation. So you might not able to maximize the therapeutic impact because you can give maybe only two or three doses.

So we thought that for this reason, going postprovictor is better if you go with a monoclonal antibody instead with a peptide because a monoclonal antibody is going to be excreted by liver, not get by kidney, and so probably you can manage the route of excretion without getting to the 23. And the third point that is what you ask is Turbium one sixty one. Why Turbium? Again, we go to the discussion that we mentioned before. Turbium not only is a therapeutic isotope but also has gamma emission, so we like the idea that we can do SPECT for every sing after every single dose to see exactly how the clinical development is is going.

Terbium has a unique characteristic of not only having beta emission with an half life similar to lutetium. It's like a week, so you can distribute easily. But also, he has a second emission that is Auger. And Auger is interesting. Now Auger doesn't work for everybody because Auger, in order to works, need to get internalized and get closer to nucleus.

But so some target, like k l k three, is it is internalized, so works well. And Auger is interesting because it's alpha like, so it's high energy short distance. So you have a nice out of where you are combining the beta last DOSJ, and there are some early papers that are interesting. Too soon to say if Turbium is going to be a better lutetium or not, but there are some emerging data. So we said that in order to complete the differentiation in a post pluvictal setting, so different target, different route of excretion, also different isotope might bring to a solution that can add additional value.

On the supply chain, I think we go back few years, and we see that when there is early sign of therapeutic evidence, the supply chain comes. You know? That was the example of. A lot of money went to Artenium and and are going to to lead because people start thinking that is going to happen. So that might be the same situation for Turbium one sixty one.

The production is not difficult. The challenging part is the precursor. You need gadolinium one sixty in order to do Turbium one sixty one, and this is not widely available. So that's the supply chain that you need to build.

Justin Walsh, Healthcare Analyst, Jones Trading: Got it. And that's the, the perfect tie in for my first question for the the panels, broadly, which is how has the the radioisotope supply chain evolved over the last few years, and are there isotopes that are available in in sufficient quantities for preclinical or clinical investigations now that that weren't available previously? And, and and how does this look in different geographies? Obviously, Australia is a a big hub there and tons of work done in in Europe and and The US and Canada, but love love to just hear some of your thoughts on on on this topic.

John Wiggins, VP of Isotope Strategy, Lantheus: I I think Ricardo's example of lutetium is is a perfect one of that that's kind of the path that we expect most isotopes to follow, that early on, they can be they can be scarce. And then as there is not only clinical success, but commercial success, then that supply chain will become a lot the product will become a lot more readily available. But we live through several years of lutetium not being readily available, and that transition period, that early success of the isotope is where it's imperative that the companies driving those products have their supply chain really nailed down and and know all the way back to the enriched isotope or whatever other starting materials there are, where that where those things are coming from in order to be successful. And, you know, a few a few isotopes call out there beyond the discussion that that Ricardo already gave on on terbium, you know, I think that that astene two eleven is an interesting one, where the the raw material is natural bismuth that's readily available, but it takes a special cyclotron in order to make astene two eleven. So we're seeing companies now come out with these specialized cyclotrons specific to astene two eleven.

We've had the first couple of those installed recently, so now AST-two 11 is becoming a little bit more available for at least early research stage, probably not yet all the way to a robust clinical program, but we are seeing the beginning of that growth curve there. I'll certainly let Suma talk to LEAD-two twelve, but Actinium-two twenty five to me is an example of a difficult isotope, so we've seen huge amounts of investment in Actinium-two twenty five because production is so challenging, and despite all of that investment, at this point we still see shortages that cause delays in clinical trials and challenges with getting enough supply. So I think maybe that gives you a little bit of the spectrum of isotopes that that can come up that curve more quickly versus those that are going to take a little bit longer. The last category I would touch on is the PET isotopes, which are, very short lived typically, so like Acinetwo eleven on the therapeutic side are going to require somewhat localized, maybe very localized depending on the specific isotope production route, and they're the you know, it's not so much access to reactors, but it's access to PET cyclotrons.

And PET cyclotrons, thanks to the success of products like Polarify and and probably Alzheimer's agents that are that are growing pretty rapidly now, are gonna become more and more heavily utilized. So looking at the the number of cyclotrons that are available, the capacity that those cyclotrons hold is a key piece for us as we think through what our supply chain for future products is going to look like. And then again, the enriched isotope supply of of knowing how we're going to get in the case of copper 64, where are we going get nickel 64? Is that all coming out of Russia, or do we have Western sources of that? And if usually, those raw material costs aren't a significant portion of COGS in the end, but you know, to the extent that tariffs come into play there, do we have US sources of those or whatever national national market we might be in in order to mitigate those kind of risks?

Sumit Verma, CEO, Tag One: Yeah. I I think John's right. The way I think about it is that just like lutetium story, you're gonna see huge investment wherever it goes, and you will see the supply become more robust over time just because of the need of these isotopes. In the grand scheme of things, I think there are three limiting factors. One is how is the isotope produced?

You know, the production route is rather key to this overall effort. The second being the source of the starting material. I think John's alluded to a few, and especially, like, Tim, that becomes super challenging. And thirdly, it's just now going to be this supply chain constraint. You know, when you think about these alpha cyclotrons, there's only four companies that make cyclotrons, let alone how many companies actually perfect the alpha cyclotron.

Same thing with hot cells. All these are gonna become natural constraints that are gonna impact overall processes. And then lastly, as you think about it, today, there's not a really big push towards cost of goods, but that's gonna play out very in real time when we have multiple therapeutic products in the market with different isotope as starting points. To me, that's gonna be a bit of a game changer. And then if you go back towards looking at the overall supply chain, you know, if you're starting material, things like thorium two twenty nine or radium two twenty six, having it accessible, let alone the price point to them, that just changes the cost module for products like $2.25.

You know, gallium is like one person owns it today. You know? How do you break that supply chain when you put all the pieces together? So as you think about some of the benefits that we see with some of the isotopes like lead two twelve, you know, thorium two twenty eight is not constrained today. It's it's it's very easy to follow through from a supply chain and see, hey.

As as the modality grows and the supply grows, it could follow the TCM story and get to the place where alpha is a favorite towards being more lead two twelve based than actinium two twenty five. So I I think that's a good silver lining on thinking about the raw material aspect and the production routes. While we've done a lot of investment in cyclotrons and reactors, there's still a bit of a lag in capacity. That's been rather challenging. We've seen it in the traditional imaging play out where molybdenum was rather constrained for quite some time, and now you have the same reactors trying to produce some of these isotopes, which put even further constraint to these actual infrastructure because they're so old.

So having early on investments and some companies are doing that, right, and some countries are doing that too. So so I I do think that's gonna play out in real time. But the last point that John made about the pet cyclotrons, I do think that is a worthwhile effort to look at because if you can at least get the imaging point out of the equation and move towards more PET imaging agents, I think that opens up these spaces towards targeted alpha therapies and therapeutic products much faster than anticipated.

Justin Walsh, Healthcare Analyst, Jones Trading: Yeah. I'm I'm curious if you because the Japan has made heavy investments in in Acetene, 211, I think largely because of geographic considerations and and and not wanting to have to import therapeutics. I'm I'm just curious just thoughts on if it seems like, I guess the thinking would likely be that the if the clinical data is compelling enough there, then we'll get more investments in other markets. Just curious if there's other maybe either related to Acetylene two eleven or or other sort of little geographic considerations that that might have an impact. I mean, Australia in in particular, I'm sure you you have to deal with the geo geographical considerations quite a bit.

Ricardo Canevari, CEO, Radiopharm Theranostics: Yeah. I mean, again, for lutetium is not a problem with with seven days. You know? And in Australia, you have the local institution of that is producing for entire Australia. And if you have and when we have some, you know, maintenance of of the reactor, we can ship it from everywhere.

But I think going back to the isotope, I think that finally in 2025, we will have some Actinium data. Because until now, look, we have phase one and half phase two. We don't even have a full phase two. So and that's probably what is also keeping maybe investment from isotope like astatine, a little bit on a post. Because if you have great data on Actinium, you know, long half life central distribution, expected efficacy, I think there are no questions on that, all the questions are about safety.

You know, giving that dose of an alpha. If you have a peptide, you give it to the kidney. If you have a monoclonal antibody, you likely give it to the bone marrow. It's good or not good. Until we know this, it's difficult to to have any other assumption because the interest of astatine is all based on the fact that a single emission is better than what Octaneum does.

But do we really know if these daughters are bad daughters or good daughters? Logically, it doesn't seems to be nice to have the daughter circulate, but we don't really know. So I think that based on evidence based medicine, we know that lutetium is the safe bet. Actinium is the next big isotope where we all need to see this data. And when we see this data, if the data are positive, probably why you really need astatine.

I don't know. Maybe you need for scientific interest, but does the market really need it? But if Actinium creates some area of concern, then we'll definitely the people would like to experience other alpha even more. More investment on lead, more investment on for for sure. And then there is all the element of the further unknown that are the pure Roger emitter.

No? Are these isos of that, you know, in the family of iodine? I remember if it's the iodine twenty three or 25, one of the two is a pure pure meter. There is bromine seventy seven people are looking at. I mean, that's a pure Auger.

Is is there a space for those in some specific disease? Maybe when you look at area that are more radio sensitive, like, I don't know, brain cancer or other area where you know that is highly internalized. So it's it's interesting. I think that probably in 2025, we will know more about Actinium, and this will be very helpful for the community to really go full speed in one direction versus another.

Sumit Verma, CEO, Tag One: The the only one point I would add to what Ricardo said is is just the geographical positioning of some countries and their populations, which could tip the scale in favor of acetone. You know, if you think about Japan and the density populations, it actually does make it a really good target to have high populations centered towards hospital care that can provide them these therapeutic products. I think Japan was early on to bet on that for that reason. Because if you think of the overall supply chain and the constraints that are resolved in many countries like Australia, Europe, and America, those are not there in China and India and such. You know, if if they were looking to make a long term bet, it does sound like having smaller alpha cyclotrons located in big cities and bringing the populations that therapeutic care could be advantageous.

And the piece around escitabine, which from from from just a therapeutic side, which makes it a bit exciting, is a chelated chemistry as well. You know, they they don't need that. And depending on how you look at some of the targets, that could be an interesting play as well. So I'm not ready to bet on Astatine two. I think to Ricardo's point, let's see what the clinical data comes out from Actinium this year.

But if you're looking long term geography, there may be some advantages as the clearing of others. Yeah.

Justin Walsh, Healthcare Analyst, Jones Trading: Got it. So maybe and I think we've sort of been been talking on this subject in in some respects, but I'm curious what's your thoughts on the how you see the supply evolving over the next one, five, or or ten years and and where you see the the bottlenecks emerging. And, I mean, we've we've mentioned some of this, but it's, reactor uptime is, is gonna matter, the cyclotron distribution, accelerator beam capacity, the the feedstock to to actually make the isotope, and and, of course, this will all be informed by the emerging clinical data. But where where do you guys see some of the the bigger pain points and and and how things are gonna play out?

John Wiggins, VP of Isotope Strategy, Lantheus: Well, I think on the on the reactor side, I'm really excited about the increasing use of power reactors for irradiation, of medicalized stopes because when when you look at the research reactor infrastructure that's been used for decades, those reactors tend to be up somewhere around 40% of the time. Like, they're they are not designed to run day in, day out, and therefore you have to piece together this huge network of reactors around the world to to have steady supply. And that that's worked so far, but it's not ideal. And as we see more and more companies moving to use of power reactors for radiation, where those reactors are designed to be up 95% plus of the time, now you're getting to much more stability of supply and much greater capacity, even with only a handful of reactors. So that that's a really exciting piece of the irradiation infrastructure.

I think on the on the raw material side, we have seen more and more western companies getting into the isotope enrichment basis business specifically for medical isotopes. By and large, those have been using electromagnetic separation systems, which are suited to to certain types of isotopes. They may be more limited in their ability to produce other isotopes like nickel 64, which just means that the capacity is a bit more constrained, but likely will need a centrifuge based enrichment systems for some of these isotopes. That's a longer range investment than the electromagnetic separation systems. So I think looking at the availability or dedication maybe of those centrifuge cascades to enriched isotope production is an area that I'm interested to see develop over the next couple of years.

And then finally on the irradiation piece, I think we've mentioned a few times that the pet cyclotron piece is really interesting to see those, the increased investment in that, the number of companies within The US that are putting in new PET cyclotron capacity, and also the wider variety of isotopes that are being produced on those now, so we're seeing not only F-eighteen but also copper and gallium being produced on those. It's really exciting to see that increased availability of iced of pet isotope production as well.

Sumit Verma, CEO, Tag One: Yeah. I'll pick up from John saying, hey. That's the advantage of Lenti 12. You know? You you really avoid going through a cyclotron or reacting completely.

And and to the points John's made is if we can get to that enrichment and secure the supply long term side of things, I think that is a big game changer. And, you know, going back to the one five ten year outlay, I think for now, centralized manufacturing is gonna play a key role. That's just where we are today. But as you go forward and think about precision medicine and where we want to go with therapeutic development, there's a need to start thinking of, you know, how do we get it to point of care? How do we get the experts to provide precision medicine from a rare disease perspective oncology?

And that to me is the next phase of our product development. You know, we we're very used to, you know, a bit of a copy and paste of, hey. Seventy five kilo patient, this kind of dose, and that's what becomes your clinical trial and dose escalation. But I don't think that's gonna be the future state of what we're looking for. You know, it's gonna be based on kilos, understanding our genetic data, how we think about the patient experience itself, and all the things Ricardo has already touched on.

And that's where, you know, if you can get to a point where we move away from a centralized manufacturing and do what we did in diagnostic and bring the generator right to the point of use where you can compound products and make them to the point what's needed for that personalized medicine, to me, that's what the ten year outlook could look like with compounds like Glyde two twelve.

Justin Walsh, Healthcare Analyst, Jones Trading: Got it. We we tend to to focus on the risk of not having enough isotope. I'm curious if any thoughts on a if if there could be a risk that there's an over investment in in a given isotope and, and then the that could reflect negatively on the space. And and maybe just if we think about, like, let's say that there are safety concerns with actinium two twenty five and then investors have put in so much money to build that capacity and they feel burned by that. Do you do you think that's a legitimate concern or or not?

We're we're really still focused on we need to get enough isotope.

Ricardo Canevari, CEO, Radiopharm Theranostics: Honestly, I never thought about that, but it's a fair question. And and, you know, some investment some capital investment in infrastructure are long term. So if something doesn't go as you expect, of course, it's it's become it's becoming difficult. But at the same time, many of the company has the ability to readjust from one isotope to the other, not from everything. But I think, personally, I'm I'm more concerned of the increasing cost of gold and without going to any political discussion, but only purely cost from a cost point of view.

Today, if you let's say you like a target and you want to do a monoclonal antibody, it costs you 4,000,000, if not 5,000,000 to do in China. It costs 7 if you do in Europe, and and this is assuming zero tariffs. Now if the tariffs are a %, then the 5,000,000 become 10,000,000, would be very difficult for any biotech or institution to create a monoclonal antibody. Peptide are cheaper, but still are not are not are not zero. So the potential increase of cost of good might be a problem for for biotech company that, you know, count every single single dollar.

The same is for CDMOs. You know, you you can use today CDMOs from Canada, from US, from Europe if you have isotope that are, you know, a week of half life. Now in all our budget, we have assumed that this is zero increase cost. And two days like that, if we get the products from Canada to to US to hospital, we don't pay any tariff on that one. But it's going to stay like that or change because if it goes up 40%, of course, it's a problem.

We see now that the cost of treating any single patient in a clinical trial is going up because hospital and center realize that there is more competition. They can choose between one trial and the other. Australia is an example. Australia is becoming more expensive because everybody is going to Australia, and the phase one clinic got a limited number. So before you were doing something with hundred and 20,000 per patient, now it's get $1.80 per patient, and maybe we'll keep going up.

So I think this another element of the cost that are are personally, I'm thinking about more than the overcapacity. That is a fair question, but we need to consider this as well.

Justin Walsh, Healthcare Analyst, Jones Trading: Yeah. That's interesting. And I I'm curious. So I hadn't thought as much about the targeting vector costs, which is is considerable. Is there, I guess, or potential impact for either the the cost cost of the the feedstock or the isotope itself?

I mean, the therapeutics themselves tend to have premium pricing, but, of course, you you still have to get it through development and get there. And then when we're talking about some re like, reasonably large scales at some point, it it could be pricey. So I'm I'm just curious how, and, obviously, we're we're all sort of waiting to hear what what what exactly will be impacted in in what ways, but, wondering sort of the balance of the the risks on on the cost side for that.

Ricardo Canevari, CEO, Radiopharm Theranostics: Well, I mean, we can always say that we are still in a better shape than cell and gene or CAR T. You know? So that's that's so you always need to realize how much we want to complain. It still costs so much less, but it costs more than other targeted molecule, in particular if they are small molecules, small size. When you go to protein production, that's a big increase because we we see a lot of biologics, not in radiopharmaceutical, but in general, ADC or or or targeted therapy.

And so you always need to do with capacity. If you go to a producer, they can say, well, we are fully booked. Come back in six months. Nobody wants to lose or to lose six months, so you need to look at cost but also availability. And and that's why many company goes outside US, go to Europe, go to China, go to other area to produce proteins because you need both the capacity and the cost and the cost element.

Sumit Verma, CEO, Tag One: I might be a bit more bullish on that. I I I do believe that there's not adequate capacity today. If you go and take the lessons learned from the launch of Lutathera and Plovicta, it would have been nice we had all that lutetium one seventy seven capacity. Today, you know, it being such a big blockbuster, to me, it's all about the patients that desire. You know, reasons why cell and gene and CAR T and some of the monoclonal antibodies are not working is because we're not getting that kind of response that we're looking for unlike radioligand therapy.

And today, we are very focused on PSMA and GAPNETs. You know, those are just the two indications that are out in the market. Once you start flooding it, so to speak, with all the clinical trials coming out from breast cancer and other modalities, I do think you're gonna see some signs of hope that, hey. We do need to be ahead of the curve and try to get this capacity out there. And then just from a reimbursement perspective, it's still a better option than CAR T and cell and gene.

So if we it shouldn't be, you know, build it and they shall come, but it should be a bit of a phased approach of building it as you see political data favoritism coming out from each of these isotopes.

John Wiggins, VP of Isotope Strategy, Lantheus: Just one thing for me on the on the, I guess, the cost question. You know, I I think that the the enriched starting materials that we that we work with in producing isotopes are usually not a significant component of the of the ultimate cost of the drug product. So I I'm not terribly concerned about about those. I think the where I see a a bigger risk of cost increases from tariffs is maybe in the irradiation area where we're to use research reactors, a lot of which are overseas, but there's a question there of whether you're whether you're buying a good or a service. And if the thing that you're doing is taking an ampoule of this enriched isotope, shipping it off to someone to irradiate, and then getting that back and processing it yourself all within The US, and there are robust there's a robust infrastructure in The US to do that, then I think that tariffs are at least a bit less of a concern.

So, you know, I think overall it's a very manageable thing for the for the industry, not to say that there's zero risk there, but I I think that it's it's something that's I don't know. I do it's not it's not existential by any stretch. Got it. So we only have a

Justin Walsh, Healthcare Analyst, Jones Trading: couple of minutes left, but I I I'm just curious if you could speak a little bit to whether or not you you think that we're gonna start seeing some fault lines emerging in terms of the capacity of the the health care system because we have a very large amount of imaging already done, but there's increased interest in the the the neuroscience space. And and if some of these large, pan cancer targets prove effective as as we hope, then we're we're gonna start seeing a lot of, like, a large demand. So just curious what how how you're sort of seeing things shaping up if if you think that the building of theranostic centers or if hospitals will will have enough space for these patients, just how you think about that.

John Wiggins, VP of Isotope Strategy, Lantheus: Yeah. You know, maybe I could start there because we're we're very much on the forefront of that with the volume of of Polarify, and and we love to see the success of that product. But it does start to to push the boundaries of what's available in terms of PET imaging. I would note for PET imaging, though, that we're starting from a base of 2,000,000 doses, 2,000,000 scans a year of FDG. So when we add on hundreds of thousands of doses, which is fantastic, of PSMA PET, it it's still a relatively, modest growth of the overall, PET imaging business.

Nonetheless, we do see, areas where specific sites where there are constraints on camera capacity and folks are starting to add, weekend hours, evening hours to do more scanning. There there is a need for growth in the health care sector. I think there are there are also a lot of areas where the pharmaceutical companies can help with that. So we look at things like with Polarify talking to the earlier advantages of F-eighteen, can we shorten the scan time because it's a better isotope and then enable higher throughput of patients with our product versus others? Do we have the as we look to neuro, we use the cardiology market that Lantheus as a predecessor created for Cardiolite twenty five years ago, where nuclear cardiologists came into being, and cardiologists would have SPECT scanners to do Cardiolite scans in their office.

Can neurologists do the same thing with Alzheimer's and having the head only, brain only PET scanners, you know, on the market now in their offices to do, neurology scans? And I think that's a great, that evolving the neurology market where the where the cardiology market went is a great analog for us as we think about how to increase that capacity on the provider side and ensure that we can handle the volume of scans that we're expecting.

Ricardo Canevari, CEO, Radiopharm Theranostics: Maybe a different perspective on this is how we need also the evolution of the health care system from a physician point of view. And we if we stay in oncology, that is the area where most of the trial are. Still, we see some discussion in some center where the tumor board decide who is the right patient for the trial, allocate the trial, and then you have the nuclear medicine physician or the radiation oncologist that is doing the dose. And then and then all the question open. Is my patient?

Is your patient? If a side effect that nonradiation related happens, who is managing? Cannot be the nuclear medicine physician. It's not their experience, but cannot be only so I think we need a shift now that more therapies are becoming available on the approach on how to use radiopharmaceutical therapy and an alignment in the patient journey on how that is the best way to allocate patient trial and managing the patient after they have their number of doses. Because at the end of the day, this is not a chronic treatment.

If you are lucky, you give four, six doses, and then the patient will need something else again. So I think we the system is not % functioning in in in this new approach that before was only neuroendocrine tumor, so it was simple to manage with prosthetics becoming now more difficult, and with new indication potentially is is going to be a big topic.

Justin Walsh, Healthcare Analyst, Jones Trading: Alright. Great. Well, we are just about out of time, so I'd like to thank you all again for for participating and and the audience for for tuning in. If all of you would like to stick around, we have the the next presentation will be with, with Shomit Roy and a fireside chat with Nuvation Bio, titled reshaping an established market. So, that should just get underway in a few minutes.

So thank you all again for your time.

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