United Therapeutics Corporation (UTHR) Earnings Call Transcript & Summary

June 12, 2024

NASDAQ US Health Care Biotechnology conference_presentation 39 min

Earnings Call Speaker Segments

Unknown Analyst

analyst
#1

Okay. Let's get underway. Thank you [indiscernible] Healthcare Conference. We are thrilled to have United Therapeutics join us this year. And here joining us on stage Pat Poisson, Executive Vice President, Technical Operations; and of course, the ever familiar, Dewey Steadman, veteran of the investor conference road circuit here. I appreciate you both surviving the weather down here, which is torrential, and I think this is a really exciting opportunity. The United Therapeutics story is one of my favorites, just for the sheer variety. I think if there was a single stock, I could make a career out of trying to cover might be you guys, not because I would do it well, but there's just so much fascinating cool stuff to go to. And it always seems to originate with a certain degree of passion in terms of solving big problems that probably a lot of people said, not sure that, that can be done. And a lot of big organizations going back decades couldn't get done very well. So tell us about you, how long you've been at United, why you're still here and what your aspirations are?

Patrick Poisson

executive
#2

Sure, sure. So before I do that, just let me state that today, I may make some forward-looking statements.

Unknown Analyst

analyst
#3

Very well trained.

Patrick Poisson

executive
#4

If any one wants to learn more about our risks and uncertainties, they should check out our SEC filings. So about me, I've been at United Therapeutics for 15 years, and I've been in the industry for 33 in operations. I started at Genentech. At that point, it was still Genentech and really has grown a passion for pharmaceutical, manufacturing and serving the patient community. As far as what keeps me going is really, Martine, her leadership and her own passion for serving the community and solving big problems really excites me. And I know it excites all of the employees at United Therapeutics. So the organ manufacturing and the opportunity to participate in that has been amazing. And it's really science that 20 years ago was really science fiction at that point in time. So the fact that it's becoming a reality and then we're about to embark into a clinical study, which I'm sure we'll talk about later, is really amazing.

Unknown Analyst

analyst
#5

Yes. No. And a title called technical operations feels very -- I don't know, Clark Kent. I'm sure there's a lot more under the cover of what technical operations mean. So what's the average day like for you at United Therapeutics briefly?

Patrick Poisson

executive
#6

Well, it's a long day, and it's usually an exciting day.

Unknown Analyst

analyst
#7

As a shareholder one here.

Patrick Poisson

executive
#8

My responsibilities reside in overseeing all of our manufacturing quality assurance and regulatory affairs. So there's a lot going on at the company. I get to participate in all of it to varying degrees. And I don't have very many boring days, put it that way.

Unknown Analyst

analyst
#9

Okay. No, that's excellent. I suppose, Dewey, you and I know that a lot of investors have signed on to get the latest in terms of the United Therapeutics story and the stock. So let's state those desires because there's a couple of things. We're not going to tell the whole story, but you and I have known each other for a very long time. Tyvaso is very much the center of gravity here just tremendous transformation for the stock, for the story when the INCREASE study read out here. And then we live in the land of worry in the investment community about why won't it go to the sky and all these different things. Certainly, the PH-ILD opportunity and thinking about the DPI. Let's address some of the basics here before transitioning. But I do intentionally just my forward-looking statement is I do want to capitalize on your presence here and talk about some of the organ business here. But let's just touch that I don't get hate mail. Tyvaso, Dewey, tell us about what we should be understanding. And you have conversations with investors post the call afterwards all the time here. ILD growth transition for DPI to nebulizer, what's the right way to be thinking about direction of how those are going?

Dewey Steadman

executive
#10

Yes. So we had made comments on the first quarter earnings call that Tyvaso is now in a period of inflection upward following the PH-ILD launch. And I think some of that is due to more acceptance of the fact that there's a treatment for PH-ILD out there. And it's also the recent expansion of our sales force where we now have field reps, MSLs, which are medical science liaisons, nurse specialists and reimbursement specialists in the field dedicated to PH-ILD. We extended the to reach these community practices that aren't necessarily center-based. And we're starting to see roots of that even in the first quarter after this expansion. And so this is something that we've been looking forward to in terms of really reinforcing Tyvaso's place in the PH-ILD landscape. And on top of that, the DPI provides a lot of convenience for patients and you can use it on the go. I think we've lost our inhaler device like 4 times today because it's so small. And Pat will pull it out if we have lost already. And we want to give patients choice. And so providing the utmost choice for patients in inhaled therapy is important to us, whether it's the nebulizer, whether it's the DPI, we give them that choice. And we're also seeing inroads in PH-ILD where the nebulizer can be used to titrate patients up to an efficacious dose in 1 breath increments versus the DPI, which is 3 breath [indiscernible] You can titrate the patient up and then transition over to DPI. And so we are seeing elements of that in patient prescribing.

Unknown Analyst

analyst
#11

Since you brought the show in talent, you're the technical ops guy, let's do a little bit of a detour here because there's a little bit of a debate. Some of it intentionally scripted in terms of how Dewey is trying to help educate the Street about your devices, your DPI and then also other modalities for delivering from a competitor that is attempting to do so. And navigating some of the legal domains here. But what is it that you would say is the way to think about the profile and why this is the right device for patients?

Patrick Poisson

executive
#12

Well, I think as I look at the data from really a scientific standpoint, it's not so much how the device operates. It's what is the result of the device delivery, which is really measured in the PK. And this is a very efficient device. The potential competition product requires a lot more API to get to the same PK values that we show with this device. So the efficiencies are very good with this device. We anticipated when we developed this product that it would be more efficient than our nebulizer, which it is by about 10%. So this product requires about 10% less API than the nebulizer to get to the same dose, whereas the competitive product requires quite a bit more. So that tells you a little bit about device performance. And that's what we really focus on is it's not so much the design, it's what is the outcome of that design. And it's intentional that we're trying to improve the patient experience. The reality is, is that the less API you need to get an effective dose is better. That's what we believe that's what we strive for.

Unknown Analyst

analyst
#13

People use these devices. People have various different competencies and also circumstances. So I think there's another message as well in terms of the elegance of the device and how the consistency of the patient experience is a valid differentiator as well.

Patrick Poisson

executive
#14

Absolutely. And I want to acknowledge the contributions that our partner made with this device MannKind.

Unknown Analyst

analyst
#15

MannKind, right.

Patrick Poisson

executive
#16

Who spent 10 years really developing this device for the diabetes insulin market. And we've been able to leverage that. That design experience is invaluable. And you can see, just as I hold this up, this weighs about an ounce. You literally cannot feel it when you're carrying it. And the -- it's easy to load and use, you pop the cartridge in, close it and inhale, it's very quick. Whereas the nebulizer, it's a process to use it. And there's some benefits to the nebulizer, which is why it still exists, and it really is beneficial that we can offer 2 minutes to inhale treprostinil. To the medical community and to the patients, it gives them options and they can choose their the most preferred one, the one that works best for them.

Unknown Analyst

analyst
#17

And so patients are voting with their feet what they like, what they can do, et cetera. What is the -- what do you think is the right study, say, in the mix of nebulizer versus DPI doing?

Dewey Steadman

executive
#18

And the 2, we've now see roughly a 60-40 split revenue-wise for Tyvaso DPI versus Nebulized Tyvaso. We probably will continue to trend upward a bit, but there will always be a base use of nebulizer either for the titration benefits for PH-ILD patients. Some patients prefer the nebulizer over the DPI for various reasons and also reimbursement reasons some patients may prefer the nebulizer. So there'll always be some base use. And I think we -- early on, we had said a 70-30 split is a good way of looking at it. I'm not ready to commit to that, but I think it will trend upward from the 60-40 that it is now.

Unknown Analyst

analyst
#19

And just to be clear, and you crossed over a little bit the economic reasons in terms of when the invoice comes there's a difference in terms of the payer backdrop for the nebulizer versus the DPI. Can you just be explicit to educate everyone?

Dewey Steadman

executive
#20

Yes. So the nebulizer is covered under the Part B medical benefit, while the DPI device is very easy to remember because it's Part D is in DPI pharmacy benefit. And so there have been recent changes in the way Part D is reimbursed for some patients that have been a favorable tailwind for us so far this year with the implementation of provisions of the IRA and there's some extra provisions that will continue in 2025 that will continue to benefit us there.

Unknown Analyst

analyst
#21

Got it. And every commercial company we've been asking about this Medicare Part D redesign implications. The first answer is always drug by drug, it depends upon the portfolio, characterize what the net -- net-net is for United Therapeutics in terms of if you look at the revenue forecast or at least the 2024 experience, what is the net-net impact?

Dewey Steadman

executive
#22

Yes. So we mentioned on the first quarter earnings call that our prior rate of free drug that was given out because of Part D provisions in 4Q was about high -- in the high teens percent. We're seeing it in the low double digits percent after 1Q. And so that's a pretty substantial portion of patients that have transitioned to paid drug for us. And we expect that to continue down over time. And the other Part B drugs that we have in our portfolio, it's generally mid-single-digit percent that are on the patient assistance program. So we could see a continued trend down through this year as patients come to us throughout the year, they're generally on some other high-cost drug and they probably have met their co-pay obligation for 2024. So they come to us as a paid patient with 0 co-pay to them, so much like our commercial program. And then in 2025, because the provisions of the IRA allow for it and even lower co-pay throughout the year, and you can spread it through 12 months as opposed to paying it upfront, you'll probably have more patients that will be able to afford that out-of-pocket early on in the year. So we could see an additional step down then.

Unknown Analyst

analyst
#23

Topical has also been making these things, manufacturing facilities, et cetera. Capacity, anything to know about where you are relative to the anticipated demand for these devices? It sounds like we've built up some capacity. Any things that still are going to make progress for? Or have we addressed that?

Patrick Poisson

executive
#24

So we've been working hard with MannKind on a capacity expansion at their site up in Danbury, Connecticut. And we're now at the point the capable of supporting 25,000 patients annually with their capacity. In addition to that, about a year ago, we kicked off a capital program to build a facility on our RTP campus and that facility is being designed to support 50,000 patients. In addition to that, there's other things we can do with the process to further expand that. But ultimately, our plans are to be able to manufacture product for up to 75,000 patients. And if we get to 75,000, I think we've got a good problem on our hands. and we'll have other capacity expansion discussions at that point.

Unknown Analyst

analyst
#25

Got it. And part of the bridge to getting to that 75,000 number is thinking about additional indications. This brings to mind IPF and the TETON trial. Dewey, just a quick update. I think we previously had you comment that you expect to complete trial enrollment by year-end '24? Are we doing still on track?

Dewey Steadman

executive
#26

Yes. So on the last earnings call, I think we mentioned that the TETON 1 study, which is in the U.S. and Canada was, I believe, 75% enrolled and increasing. For TETON 2, I believe we said it was 80% enrolled. I'm happy to say today that TETON 2 has been closed for screening. So we have the patients in the pipeline to be able to fully enroll that study in the next month or 2. And so that obviously meets our goal of enrollment by the end of the year. We would expect TETON 1, obviously, to be enrolled by the end of the year as well. This has a 52-week study would position us for data in 2025.

Unknown Analyst

analyst
#27

Cool. Very exciting. And then finally, in topics that are not organ manufacturing related, PAH and the introduction of Merck where we had Rob Davis and Dean Li talk about how the initial commercialization has gone. They are very pleased. There's a backdrop of enthusiasm, which we're familiar with. You've been asked this question in terms of being basically the franchise position with PAH therapies across different modalities. What kind of commentary can you share with what your commercial and clinical people are seeing out in the field during this first couple of months?

Patrick Poisson

executive
#28

Yes, I mean it's early on. So we haven't seen really the impact yet. But it's our expectation, and we've discussed this before that it will complement treprostinil and prostacyclin therapy. So we're expecting to see that. We've -- a survey done by Wells Fargo was published today, and the physicians are backing that up and validating that belief that it's complementary. So I think it's all good for the PAH community thinking back 20 years ago when there was really very few options for them. The fact that they have now 16 or 17 different products to treat. It's an amazing outcome.

Unknown Analyst

analyst
#29

Okay. Awesome. Let's turn to the next chapter, very much a part of the United Therapeutics story going forward. And actually, I've always thought of this as a little bit of a Google moonshot -- initiative kind of for the company, and this is going back because I've been paying attention to you guys for so many years, but without a doubt, with all sorts of [ silly little ] metrics when I looked at the deck that you guys showed up in San Francisco with -- very clearly, this is what you guys are putting a great deal of emphasis. You are revealing more here, might have been like 40% of the slides or something. So let's talk organ manufacturing, I think most people on the street have to do work. And as they begin to dive in, it's fascinating. 25, 30 years ago, I was a clinician sitting there running the Igloo cooler into the operating room, doing organ transplants. There's a fundamental dilemma here. There's shortages -- and there's kind of a construct here that is looking for a solution, [indiscernible] Martine, United Therapeutics kind of the right crew to go in there and again, do badass difficult things. So investors can be fascinated, but probably won't give you necessarily credit. They like tangible things like clinical data and revenue models. And you've begun to tease. You've thrown out some big round numbers, et cetera. But come on man, help us out. Give us some step tools, which is what we need to become a little bit smarter about this. So I think I laid sort of the introduction, I think about the structure. There's organ assist and organ manufacturing dealers' choice, which one should we do first? And again, with a mindset of I'm hungry for potentially more advanced programs first to talk and spend more time there. Where do you want to go?

Patrick Poisson

executive
#30

You pick. We're ready to talk about all of it. First of all, you call it a moonshot. And it's not a moonshot because it's possible. So therefore, it's an earth shot to us.

Unknown Analyst

analyst
#31

Yes. No, I said I contemplated it years back, and we're going back -- the first time we've heard about this over half a decade ago, it was -- again, this whole notion -- and it's not meant to be pejorative, but more sort of the standpoint of experimenting with what might be possible. And the fact that it is such a front-and-center presence in your corporate presentation suggest that it is possible. And just bringing to bear my own history as formerly as a clinician in the prior century, it was this question of what could make sense here. So okay, let's go with Organ ASSIST, right, lung perfusion, liver assist product. This seems a little bit more the natural glide path because all of a sudden, we're sort of saying, what is available and how can we make what available better, right? Is that fair? Tell me what's the right way to educate the investors about Organ ASSIST?

Patrick Poisson

executive
#32

Well, So there's two things there. One is the lung perfusion service that we have. That's a commercial service that we offer today. We have 2 facilities in Silver Spring and in Florida that do that work. And what they do is they take lung -- donated lungs that were deemed unacceptable for transplant. They run a process on them that allows them to become acceptable. And so those lungs are handled and put through that facility, and that's been going on for some time now.

Unknown Analyst

analyst
#33

And give us a sense, how many lungs are harvested on an annual basis in the U.S. and what percentage of them are unacceptable? There's all sorts of reasons. People weren't riding motorcycles without helmets and they aspirate and they bring it into the [indiscernible] usable.

Patrick Poisson

executive
#34

As far as these lung transplants go, I think the data I saw from '23 is around 2,400 transplants. So a very small amount.

Unknown Analyst

analyst
#35

Out of a total denominator of what because I think this is a magnificent unmet need.

Patrick Poisson

executive
#36

Yes. I mean it's pretty challenging for people that are looking for a lung transplant. Many of them don't even go on the list because the supply is so few. But with this service we offer to date and this is after running for a few years, we've been able to recover close to 500 lungs that would have been discarded and those have been transplanted. So that's made a nice dent, but it's not enough. In addition to that, we're working on a process to improve the perfusion process. We recently completed a clinical study involving that, and we're going to file a PMA later this year to be able to implement that new process. So a lot...

Unknown Analyst

analyst
#37

To go backwards. So that we're talking about -- the product actually has an acronym, I believe, when I did a little bit of homework, EVLP, right?

Patrick Poisson

executive
#38

Yes.

Unknown Analyst

analyst
#39

Ex vivo -- outside the body?

Patrick Poisson

executive
#40

Yes.

Unknown Analyst

analyst
#41

lung perfusion. We're really talking building blocks here. We're trying to be clever element resistant here, but the strategy was to establish our presence in the transplant community in which we've done that. And the promise is these lungs are we going to -- you're going to give longer durability, you're going to have higher yields. What's the pitch?

Patrick Poisson

executive
#42

I think it's going to just result in an improved -- an improved lung outcome for patients.

Unknown Analyst

analyst
#43

So it won't necessarily change the percentage of accessible lungs.

Patrick Poisson

executive
#44

Well, it could. I think we'll have to wait to see what the long-term impact is. But the fact is that there's 400-plus people walking around today that may not have lived because we were able to recover these lungs. That's a tremendous impact. So that's one piece of the puzzle. Of course, our acquisition of Miromatrix, late last year, and this is on the liver side, they've got an IND approved for their bioengineered liver. And they'll be kicking off a clinical study there. Now that's an external liver that's really meant to be a bridge. So that's exciting progress there as well. So we're seeing immediate returns on that investment. So there's a lot happening.

Unknown Analyst

analyst
#45

Sure. Okay. And I'm trying to organize the thoughts because I think it's a big marathon a mosaic and acronyms here. So to keep it so that people come away with something that they can grab hold up. So Organ Assist 2 products, EVLP ex-vivo lung perfusion. We've talked what that is about, and that is to enhance sort of the viability of harvested lung tissue. You talked about 400 patients. And that was over what period of time have you accrued 400 patients? 1 year, 5 years?

Patrick Poisson

executive
#46

It's been 5 years at least.

Unknown Analyst

analyst
#47

Got it. So we have some sense for sort of like the [crescendo ] the efforts here regulatory clinical data -- are we ever going to have clinical data that sort of demonstrates how good is EVLP?

Patrick Poisson

executive
#48

Well, as I said, we just completed the clinical study.

Unknown Analyst

analyst
#49

When do we learn it? When will you show us the data?

Dewey Steadman

executive
#50

At an upcoming medical conference.

Unknown Analyst

analyst
#51

Yes. Okay. During the next 12 months?

Dewey Steadman

executive
#52

To be determined.

Unknown Analyst

analyst
#53

Okay. Again, I have to ask these questions, right? And then milestones then, once you have the data, then you go to the regulators, et cetera. So what is the potential time line for this that we have...

Patrick Poisson

executive
#54

PMA filed before the end of the year.

Unknown Analyst

analyst
#55

PMA. Okay. Good to know.

Patrick Poisson

executive
#56

Yes, yes, premarket approval and approval expected in 2025.

Dewey Steadman

executive
#57

And at the same time, for us, we do have an approved service called XPS that we use that is from ex vivo perfusion. So this data that we're talking about in the PMA is for what we call CLES, Centralized Lung Evaluation System. It's very similar to the XPS, but it uses different consumable components. So we are on the market with an approved product. Obviously, it's not our approval, but we do provide the service as an approved service to transplant centers.

Unknown Analyst

analyst
#58

Okay. It makes sense that Organ Assist is this further along in terms of ultimately being a product that's FDA approved and becomes a revenue generator as opposed to organ manufacturing, the science is still further behind or no.

Dewey Steadman

executive
#59

No, it's revenue generating for us now, the XPS services are. It's not going to be the core revenue driver for United Therapeutics.

Unknown Analyst

analyst
#60

Of course, not. Yes, this again, it's like contemplating what stage you're at. You actually have prospect for revenues coming from this over the next couple of months. So [ Street bidders ] are sharpening their pencils and thinking about this type of opportunity, which I think they are not, which is part of the benefit, hopefully, of this discussion here. So key risks to Organ Assist from an enterprise standpoint, like what could make this not happen?

Dewey Steadman

executive
#61

So I think with the liver program, so our ELAP, miroliverELAP, it will be the first bioengineered organ to enter a clinical study. And that is for acute liver failure. So patients that have a liver toxicity event and need -- either have hours or days to live or desperately need a liver transplant can go on this circuit that it perfuses -- I'm sorry, it doesn't perfuse, but it's assist -- uses a bioengineered organ, so a pig liver with allogeneic human cells in it to perform basic liver functions to allow the recipient native liver to recover from this acute toxicity event. So the idea is to increase the supply of transplantable livers by reducing the need for transplant in these patients that can be served with an external product for up to 48 hours.

Unknown Analyst

analyst
#62

Okay. So conceptually, it's almost like a metaphor for dialysis or...

Patrick Poisson

executive
#63

It's dialysis...

Unknown Analyst

analyst
#64

Got it. Okay. Very cool. Very logical. Organ manufacturing. Okay. Here's where things get a little bit Unitarian, right? Multiple approaches are being taken, artificial organs, natural or synthetic materials also. And this is just broadly in terms of those people who are thinking of like let's make organs, right? We're generative medicine-based approaches for which the underpinning is kind of like let's reduce the chance of having the complications of rejection risk because the immune system is really useful but can be annoying. 3D organ printing, right? 3D tissue printing is you can start with all sorts of stuff like the cartilage around the ear that's very cute, but like we're really talking about complex biological processes here. So the level of sophistication is getting exponential. And then xenotransplantation. And this is where all the said and I think you get a lot of clicks, topic does, certainly, New York Times, just the media is curious and fascinated by some of these dimensions here. So walk us through each of these in terms of organ manufacturing and what United Therapeutics cares the most about.

Patrick Poisson

executive
#65

Well, I think we care about all of it. Let's talk about xeno first because I think that's what people hear most about today because it's closely becoming a reality. So the Tianjin xeno-kidney is really what's going to lead the charge here. We've just finished the nonhuman primate studies that FDA requested of us prior to being able to file an IND. So the plan right now is we'll meet with FDA probably sometime end of Q3, early Q4 of this year. Propose a clinical study to them, get their feedback and file an IND in early 2025 and have the first team in transplant sometime thereafter, maybe mid-2025. Now in relation to that, when we talk about manufacturing, we've also talked about on our quarterly calls, the status of our clinical DPF, which is where the pigs are housed and where the lungs -- or the organs are harvested. So that facility is now up and running, and there is a population of genetically modified pigs in that facility. What's happening now is we're expanding that herd and preparing it to be ready to support the clinical study. So this is now no longer a concept. This is becoming a reality. And it's been a long journey. But it's right around the corner, and we're very excited about that.

Unknown Analyst

analyst
#66

Great. Why pigs and for which organs?

Patrick Poisson

executive
#67

So the pigs are interesting. Their organs are very similar to ours and they're easy to breathe. They're easy to genetically modify. And all these things played a role in selecting a pig for this purpose. So they're really a good, say, factory for these organs. And a lot of research has been done on that driven by Revivicor we acquired in 2011, and we've continued to develop that science. Following the kidney will be the Tianjin Heart, which many of you have heard about the compassionate use transplants that happened earlier this -- last year and the prior year. And then, of course, the most recent, the 1 gene thymo-kidney will also come out of that as well. So we have a couple of areas we're pursuing with the xeno and all that's coming to fruition now. In relation to the other technologies you mentioned, we have a regenerative medicine program, where we're taking porcine lungs, decellularizing them and then depositing allogeneic cells on those lungs or on those scaffolds to grow a functional lung. Very challenging to do that, but a lot of progress has been made by the teams working on that. So that's another option as we pursue the lung transplant, which, as we go back to the founding of United Therapeutics, Martine's goal was to cure PAH, and that remains a goal. The only care is a lung transplant. But what's holding these people back, of course, is the availability of lungs to transplant. So again, that's a priority for us. And then, of course, you mentioned the 3D printing. And that might be really the best technology in the end, although that's equally as complicated, where we print a lung scaffold and we're able to cellularize it with either allogeneic or hopefully, in the future, autologous cells, which will really eliminate the need for immunosuppression, which is one of the challenges we face with some of the other technologies with xeno. Of course, immunosuppression will always be present. So a lot of -- we call them shots on goal. And so we're pursuing a lot of avenues to try to solve really the organ shortage crisis that exists.

Unknown Analyst

analyst
#68

So within 3D printing, the reason why you think that may ultimately be the best because of the potential for juxtaposing that in the context of autologously sourced from the person themselves, reducing very materially the risk of having that biology screw things up.

Patrick Poisson

executive
#69

Exactly. Exactly.

Unknown Analyst

analyst
#70

Okay. Then the reason why this is even possible now and you kind of went through it. And again, you're assuming that we all understand what you do. And so I'm probably being a little bit of a junior high school teacher here, but it is advances to my understanding, in the gene editing that has enabled that? Or am I wrong?

Patrick Poisson

executive
#71

Well, certainly with xeno CRISPR, the -- to CRISPR, it certainly accelerated what was happening with the gene modifications. I would tell you the knowledge of managing the different cells that are used to populate these scaffolds. What's been learned over the last few years [indiscernible] that can be a successful end game for [indiscernible] and IVIVA is their knowledge of being able to manipulate these cells to do certain things. Extremely complicated science. And it's years of investment, years of knowledge that gained. So it's very complementary towards our business.

Unknown Analyst

analyst
#72

Okay. Regulatory is inevitably a gatekeeper. 2022, there was an advisory committee meeting on xenotransplantation. What's the most important thing that you think an investor should understand is a takeaway from that, that's somehow one of the rules of the road for how you're conducting your development?

Patrick Poisson

executive
#73

Yes, I mean, I think the big thing is FDA is very supportive of these efforts. They understand the need. They see the shortage. People are unfortunately dying on the waiting list. They know there needs to be a solution here. Not only people on the waiting list, but the people that can't even get on the waiting list. And if we talk about kidney, there's close to 100,000 people waiting for a kidney transplant. There's another 400,000 on dialysis to get on the list. So that's pretty dismal. We can do better. And I think with the efforts that we're making, we're going to start to see a solution here with one of these technologies.

Unknown Analyst

analyst
#74

We love numbers. We live for numbers. You guys started to introduce market opportunity, the fundamental building blocks. The most simple equation is n times price. You started to give some market numbers. Prevent me from going the wrong direction, what are the inputs to these market projections that you gave? And just so I can understand that.

Dewey Steadman

executive
#75

So the inputs, I mean, the primary driver would be pricing, obviously, and that's driven by the alternatives for these patients. And so dialysis is $150,000 a year. Patients are on dialysis 8 to 10 years. What's the cost of the system in terms of dollars, but also patient productivity, patient satisfaction, patient ability to not be tied to a dialysis center. And then on the corollary to that would be are these curative and then gene therapies are curative and they're also very expensive. And -- so that represents the two kind of the wide range that we gave for pricing. I think as we get to a clinical program and we determine the right patient for xenotransplantation [indiscernible] because we can look at the alternatives for these patients.

Unknown Analyst

analyst
#76

Just very simplistically, think about the glorious margins that pharmaceutical companies can have. I do not understand what the margins could look like for, let's say, a stand-alone business in the organ manufacturing business. You said the word PMA, which is sort of like a device modality path from a regulatory standpoint, how the margins compare? And how should we think about margin progression for United?

Patrick Poisson

executive
#77

Yes. I mean we're expecting the margins to be very similar to what we see for drugs.

Dewey Steadman

executive
#78

Yes, the ultimate margin will be determined by the end pricing. So I mean [indiscernible] Martine gave the $300,000 to $900,000, that [indiscernible] pretty greatly depending on where we end on that.

Unknown Analyst

analyst
#79

Okay. Like people want to be smart and learn more often, it's that much more compelling for public equity investors to be able to pay attention to somebody else's [indiscernible]. We love Coke versus Pepsi, et cetera. But I think this is a scenario where the advancements are progress for anybody who lifts all boats when the tide comes in. Any other entities, hopefully, public so that they can disclose, but if not, who are the leaders in this field that you bump into other meetings who are doing good work?

Dewey Steadman

executive
#80

So primarily, it's eGenesis. So eGenesis had a patient at Massachusetts General, who received a 69 gene edit kidney. Their ultimate construct is very similar to ours. Just the 59 of -- the 69 [indiscernible] with endogenous retrovirus that they have eliminated with a genome. We have done it through breeding. So we just had a natural selection to our gene editing for us. And then 9 of the 10 edits that remain are identical between the 2 constructs. So it's very similar. We don't look at them as a competitor and they don't look at us as a competitor, we're peers. And we're trying to advance this to help patients. And at the end of the day, it's not a net zero game because there's not enough supply. There won't be enough supply for the massive demand that's out there for kidney.

Unknown Analyst

analyst
#81

Okay. No, that makes sense. Then we'll close this out with a little bit of Wall Street stuff because your last quarterly call intentionally had Martine rescripted commentary that talked about capital allocation priorities and shareholder returns, et cetera, including the share repurchase. Where are we with that? And I was intrigued by that attention to capital allocation priorities as sort of like this is the message...

Dewey Steadman

executive
#82

[indiscernible] next question on the accelerated share repurchase, when is the next one. So [indiscernible] Yes. So our -- this accelerated share repurchase, obviously, we received the shares, but -- or 80% of the shares. But our agent is still purchasing shares, and we'll do that through the end of September. And then that program will expire. I think we've had a very, very good reception for it. And my team loves positive reinforcement. And I'm still employed, which is wonderful. But it is -- it's something where capital allocation is always part of the equation for us. And I think with a successful execution of it, it continues to be something we think about, but our ultimate goal is to help patients. And the way we can help patients is through organs and investing in ourselves and looking at technologies in rare disease that can help patients. So those -- that's why investing ourselves and business development come ahead of return on capital. But as capital is available, it's something we consider on a regular basis.

Unknown Analyst

analyst
#83

Okay. No, that totally makes sense. It sounds really adult. So good for you guys. Patrick, thank you so much for telling us a little bit more about the story. We look forward to more conversations. Dewey, always great to see you.

Patrick Poisson

executive
#84

Thank you.

Unknown Analyst

analyst
#85

Thank you so much.

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