Great. Good afternoon, everyone. My name's Jessica Fye. I'm the Large Cap Biotech Analyst at JPMorgan, and we are delighted to be continuing the conference today with United Therapeutics. We are not switching rooms for Q&A. We're gonna stay right here. There's a couple ways you can ask questions. You can raise your hand, and someone will bring you a mic. You can enter it electronically in a portal, and it'll send it to me on an iPad, and I can ask my management team. You can just listen to me ask questions, but hopefully you have some of your own. Well, anyway, with that, let me pass it over to United Therapeutics Chairperson and CEO, Martine Rothblatt, for the presentation.
Thank you, Jess. Thank you, everybody. I'd like to start our presentation by just saying a comment about the company's tagline, Enabling Inspiration. As a CEO, when I think about what my fundamental job is at United Therapeutics, it's to make sure that all of our 1,000 Unitherians are really having the best possible career development experience of their life. To inspire all of them, and by inspiring everybody who works at our company, we find that all of our goals in terms of drug development and physician education and enhancing patient health sort of happen as just a natural consequence of everybody working at the company feeling a great sense of inspiration. That's really the backstory on the tagline here, Enabling Inspiration.
We have the standard safe harbor statement, and I won't be able to read it and have any time left for my presentation, so I'll trust you to read it quickly. United Therapeutics is, I think, today, most characterized by a very robust pipeline. We now have five registration phase studies and seven preclinical product leads. The five registration phase studies are the ones that I'll focus on in today's presentation. Two of the studies, TETON 1 and TETON 2, relate to idiopathic pulmonary fibrosis. Two of the studies, ADVANCE CAPACITY and ADVANCE OUTCOMES, relate to pulmonary hypertension. The fifth one, EVLP/CLES, relate to our transplantation business segment. I'll talk mostly today about our growth in pulmonary hypertension and our pipeline opportunities in pulmonary fibrosis. First, pulmonary hypertension. United Therapeutics began as a pulmonary hypertension company.
It's pretty well known that my daughter was diagnosed with this illness and was given a very short horizon of survival, and it's thanks to the medicines that our company and our industry have developed for pulmonary hypertension that she's alive and well in her thirties, working at United Therapeutics today. I think all of us, whether we're in finance or in biotechnology, can be enormously proud of being in an industry that actually makes a difference in people's lives, actually saves people's lives with things coming from our imagination to actual reality. I'd like to talk now about where we are in pulmonary hypertension and where we'll be going over the next several years. We expect very rapid growth in our company from three pulmonary hypertension drivers.
The first is called Tyvaso DPI, and I'm very happy to recognize the CEO of the manufacturer of our DPI device, Michael Castagna, sitting in the second row there. Thanks for being here, Michael. The second growth driver is Orenitram, specifically transitions from Remodulin to Orenitram. The third growth driver is a product in our pipeline called ralinepag. Well, Tyvaso DPI has proven to be an extraordinarily successful product.
When we first considered launching this product some, 18-24 months ago, we set forth a goal to double our number of Tyvaso patients from 3,000 to 6,000 through a combination of entering into a new indication that we had just received approval for, Group 3 pulmonary hypertension or interstitial lung disease with pulmonary hypertension is its kind of wordier name, and also through the introduction into the market of a new type of Tyvaso DPI. DPI is a short acronym for dry powder inhaler, a vastly simpler and more convenient way to take our Tyvaso medicine.
I'm very pleased to report at this conference, for the very first time, that we achieved the goal that we set out for ourselves some two years ago to double the number of patients we had on Tyvaso from 3,000 people being helped to 6,000 people being helped by the end of 2022. We accomplished it just last week. Again, a very cool and exciting thing to me about being in a biotechnology company is in the span of a pretty short period of time, you can go from helping 3,000 people stay alive and enjoy a better quality of life with a medicine to helping 6,000. I mean, that's a huge number of additional lives really being helped, and we just feel super excited and proud about that. That goal has been achieved.
By achieving that goal, we've really, in essence, set a platform for ourselves to achieve our next goal, which is to grow to 25,000 patients overall with all of our pulmonary hypertension treatments by the year 2025. Now let me walk through a few of the reasons why not only was Tyvaso DPI an important part of growing from 3,000- 6,000 patients in just such a short period of time, but also why we think it'll be a very important part of growing from roughly 12,000 total pulmonary hypertension patients that we treat today to 25,000 pulmonary hypertension patients by the year 2025. Tyvaso DPI is a very differentiated product. It's unique in so many different features. As shown in this slide, it's first of all, super simple to use.
You can see a picture of it there. If any of you remember ever having maybe like a little tiny, you know, Pez device without the Pez cartridge, it's as small as that. Secondly, it's super portable. It doesn't require an extra battery pack or a plug to plug into anything. In fact, the tiniest pocket and the tiniest skinny jeans could easily accommodate the Tyvaso DPI device. Third, there is very, very high patient satisfaction. I am pleased to report at this JPMorgan conference that the lowest patient discontinuation rate that we have ever seen in any of our product launches is with the Tyvaso DPI device. While we've launched it only pretty recently, something like a half year ago, it's virtually nobody wants to discontinue from this product, which in the drug world, it's pretty astonishing.
Finally, it's got proven efficacy. I'm going to talk through some of the reasons in a moment for that efficacy. Of course, in order to get FDA approval, we had to prove our efficacy, and we had to prove it was just as good as with our previous product. It's ancestor product, if you will, the Tyvaso nebulizer. The next few slides, I think, are gonna walk you through why we have this differentiated capability that's associated with such proven efficacy. When you're trying to deliver a drug to the lungs, what really matters is high throughput. You want to get the drug all the way down into the deep lung. The deep lung is where most of the alveoli uptake of the drug will be.
A high throughput, meaning getting from the source to the destination, is what's absolutely critical. The question is: how do you get high throughput? Drug deposition from a low throughput device is gonna get stuck up in the upper portions of the lung, and that's not gonna be very as helpful as getting it down to the deep lung. Why is it that an efficacious drug is associated with a deep lung penetration and much more drug is required if you're only gonna get a low throughput? That's kind of like if you're sending a message to somebody and it only gets half the way. It's not as good, and maybe you might have to send the message several times until maybe one of the packets of information finally gets all the way through.
What's much better is to have a high throughput channel where you send the message and it gets all the way to its destination. From a high throughput device like DPI, it goes all the way down to the bottom part of the lung. The reason it does so is because the device kind of packetizes, or you could say particularizes the drug into highly agitated particles, which we call high resistance. As a result of having that high resistance, you get a low flow down to the deep part of the lung. With a drug which does not have the same characteristics of high resistance and low flow, you only get a deposition of the drug mostly to the upper reaches of the lung. It's high throughput that lends itself to deep lung deposition.
Now, one of the consequences of having a low throughput device is that you have to take a lot more drug in order to get an equivalent effect. It's like if you have a noisy channel, you have to send your messages a lot more times. You have to scream your messages through for any of them to get to the destination. If you have a high throughput channel like the Tyvaso DPI device, you can send fewer messages, and they will get to their destination. In fact, quantitatively, based on the published literature, Tyvaso is able to get its level of efficacy achieved with just a little bit more than half of what other low throughput devices, also known as low resistance or high flow devices, can do.
Well, I've talked a bit about the unique differentiating features of Tyvaso DPI and why we feel so confident that it could be one of our major drivers to doubling our revenues over the next three years or so. Let me now talk about another of the drivers I mentioned at the beginning, transitions of patients from Remodulin to Orenitram. I wanna share with you one of the most startling facts that have come out in the field of pulmonary hypertension over the past two, three years, pretty much since we last all met in person at a JPMorgan conference. Thank you, Jess, for bringing us all back together in person again.
It's definitely much nicer. There have been 16 recent publications that demonstrate that if you use a parenteral prostacyclin, that means an infused form of prostacyclin, such as Remodulin, and then you use that aggressively enough that you can bring the patient's pulmonary artery pressures down below 40 mm of mercury. That's kind of like, you know, for pulmonary artery pressure, that might be like the equivalent of a systemic atrial pressure of, like, 130 mm of mercury. If you can use an antihypertensive to bring somebody's pressures down under 130, might not be optimal, but it's certainly gonna be associated with a much longer longevity than if the person was stuck at 150, 160 mm of mercury, something like that.
Most of the pulmonary hypertension patients, their pulmonary artery pressures are, unfortunately, they're stuck at 50, 60, 70, 80, even higher levels of millimeters of mercury. Oops. That is associated with a very short survival. These 16 publications have shown that if you could bring those pressures down under 40 mm of mercury through an aggressive parenteral product, that you can ramp up the dose rapidly and then transition those patients to an oral drug. There is survival that is clocked at 10 years, 15 years, 20 years. I've gotta share with you, this, for me, is absolutely revolutionary because when my daughter was first diagnosed with pulmonary hypertension at the beginning of our company, the lifespan was three to five years.
That is still the normal quoted untreated duration of life available for a person newly treated with, newly diagnosed with pulmonary hypertension. The change 3-5 years into 10, 15, 20 years is extraordinary. We believe there is a new paradigm that has formed here, which is you use Remodulin aggressively to bring the pulmonary artery pressures down under 40 mm of mercury and then transition the patient over to a Orenitram, it's a pill that can be orally titrated to the equivalent dose, and that patient should be able to enjoy a much longer lifespan. That's the second big driver of our growth in the next few years.
In fact, we just reported results of one study related to this called the EXPEDITE study, and we have another study called the ARTISAN study, which is trying to scientifically prove these results further. Now, there are three different types of oral prostacyclins that one might consider transitioning a parenteral to oral patient to, once you get their pressures under 40 mm of mercury. One is our Orenitram. You see it in the left column that I've been talking about. The next is Selexipag, also known as Uptravi. It's not really a prostacyclin drug, but it's a prostacyclin-like drug. That's a product of Johnson & Johnson. The third one is a product which is one of the highlights of our pipeline, Ralinepag. You see here there's some very unique features of Ralinepag.
It only needs to be dosed once a day instead of twice or three times a day. Yet there is no set dose ceiling, unlike Selexipag, which has to be dosed twice a day. It is in a unique sweet spot for a pill. Once a day, no preset dose ceiling, and the patient can be told, "Look, the bad news is you've got pulmonary hypertension. The good news is that we've got a bridge to get you from where you are to a place that you can live a normal expected period of life. It's gonna be a little bit tough getting there.
The bridge is gonna be a little bit rocky because it's a parenteral treatment, but it should not last more than hopefully six to 12 months, and then we'll get you on one pill a day if our Ralinepag results turn out to be successful. We're enrolling this study right now. It's actually over half enrolled, and we should be able to have the results of that study in under a couple years and then hopefully have a morbidity and mortality result, which is the best in class for pulmonary hypertension. I've talked quite a bit, I know, about pulmonary hypertension, and some of you are probably really wondering, you know, where does pulmonary fibrosis come into this?
While there are some patients who have pulmonary hypertension as a consequence of pulmonary fibrosis, there are many, many more patients who have pulmonary fibrosis without pulmonary hypertension. It, like pulmonary hypertension, is a fatal chronic disease that strikes many people in the prime of their life. Now, we believe at United Therapeutics that while our pipeline of products that I just got done describing can grow our pulmonary hypertension business to more than twice its current size, which you see there in the red circles. You see the current level of pulmonary hypertension. Our business book there is about $2 billion a year. We think that the products in our pipeline, just for pulmonary hypertension and continued growth of products like Tyvaso DPI for pulmonary hypertension, can grow that revenue base to well over $4 billion.
Even larger is the market opportunity for our company in idiopathic pulmonary fibrosis. We have two registration trials going on in idiopathic pulmonary fibrosis called the TETON 1 and TETON 2 studies. TETON 1, both of those studies are enrolling right now. They're enrolling quite rapidly. The TETON 1 enrollment, this is the first time, again, at a JP Morgan conference that we have shown the curve of our projected enrollment in this registration study. We are projecting at the current rate of enrollment, it would be fully enrolled at the end of 2024. There is a 12 month last patient, last visit endpoint, we would be able to report these results at the beginning of 2026. Of course, if we increase our rate of enrollment, we could move that forward a little bit.
If the rate of enrollment slows down, it would be shifted to the right a little bit. Nominally, this is what it looks like right now. We have a parallel TETON 2 study, which we believe will be fully enrolled at just about the same time. The reason that this blue circle I showed before for IPF is so large is because pulmonary fibrosis has really a dearth of adequate products compared to how many patients are treated with it, treated for it. Let me give you a quick example. Pulmonary hypertension in the United States alone, there are about 50,000 patients which have been censused in some way or another. These 50,000 patients face an array of 15 different medicines that can be used to treat them.
That's a remarkable accomplishment for our industry in 20 years or so. Also 15 drugs is a healthy number of options for physicians to have to treat their patients with pulmonary hypertension. Pulmonary fibrosis has over 100,000 patients in the United States, twice as many as there are pulmonary hypertension. There are only two drugs approved to treat this condition. The two drugs you see shown on this slide, those two drugs are generating around $3.5 billion in revenue. As I'll show you in the next slide, neither of those drugs are really helping the patients the way we would love to see them helped.
Here you see a slide that came from our INCREASE study, published in The New England Journal of Medicine, actually, and was the basis for our approval in interstitial lung disease and Group 3 pulmonary hypertension. The blue shaded area shows the impact on forced vital capacity of our drug, Tyvaso. You can see that we actually improved the forced vital capacity of the patients. The I guess I would call that amber-ish colors show the effects of the baseline drugs that those patients were on. The two drugs I showed just a minute ago, pirfenidone and nintedanib, sorry. Those two drugs slowed the rate of decline in forced vital capacity but did not improve it. Treprostinil via Tyvaso improved it.
We believe that we can have a disease-reversing effect in idiopathic pulmonary fibrosis, which would give rise to be able to reach, at minimum, the level of the revenues of these other two drugs shown, and probably many more. In fact, because these two drugs aren't that effective, only a small fraction of the 100,000 patients in the U.S. with IPF are actually treated with them because they're not effective for most of them. Our drugs would be able to achieve a much higher penetration of those 100,000 patients and thereby achieve a level of revenues which was larger, would be larger even than the revenues we achieve with pulmonary hypertension. In conclusion, I'd like to share with you some bullets that kind of sum up United Therapeutics. We are really...
It's a To me, it's like a match made in heaven because it's a beautiful growth story married to a value balance sheet. We have substantial growth expected through both pulmonary hypertension and pulmonary fibrosis. Our cash flow is dedicated to growth and further product development, not only growth of this near-term pipeline in pulmonary hypertension and growth of the mid-term pipeline focused on pulmonary fibrosis, but also focused on the long-term pipeline of all those organ manufacturing opportunities I showed you on the first slide. The balance sheet is extremely strong with more than $4 billion in cash and short and long-term investments. Finally, we have really demonstrated a proven strong supply chain. One of our key performance measures is to always maintain more than a two year supply of drug for our products at all times.
When something so tragic as COVID hit and many companies were caught with inadequate supply and no real quick way to rectify that with the supply chain problems, United Therapeutics was in very good shape. Not only did our sales of all of our products grow during COVID, but we ended COVID again with more than the two-year inventory of all of our drugs. With those overview remarks and giving you a kind of a whirlwind snapshot of United Therapeutics, I'd like to ask our Chief Financial Officer, James Edgemont, and our President, Michael Benkowitz, to join me on stage for any Q&A , if that's okay with you, Jess. Okay, good. You guys sit there and I'll stand.
Great. As a reminder, if you wanna ask a question, you can submit one electronically, or you can raise your hand. I know it's a really full room, but we'll get someone to run over with a mic. I will start. You talked about some of the advantages of Tyvaso DPI. Can you talk a little bit just more qualitatively about how the launch is going? You know, is it driven by switches from nebulized Tyvaso? Is it driven by patients who are new to therapy who maybe didn't want the nebulizer before? Kinda give us a little more flavor about what that launch looks like.
Sure, Jess, Mike, would you like to take that question?
Sure, happy to. I think I talked a little bit about this, I think it was on the Q3 call. One of the things that we often scratch our heads about in this, in this space is how slow things seem to move, particularly in the face of really awesome data. Happily, that has not been our experience with Tyvaso DPI. It has really, I think, come out of the gates incredibly strong. Physicians are very happy. Patients are very happy. Martine referenced the low discontinuation rate relative to other, our other products, which is obviously very good for patients, very good for us as a company. I think overall the DPI launch is going exceptionally well. In terms of the mix of patients, it's both.
Actually it's probably a little bit heavier on new patients right now as opposed to transitions. I think the transitions will get there. You know, at some point we thought there might be a, I guess a bolus of transitions early on after the launch. In fact, what's actually happening is physicians are just bringing their patients in for their normal, regular checkups and at that time starting to transition over. I think over the course of the next, you know, six to nine months, all of the current patients on the TD-300 that want to transition over to DPI will. As we get into Q3, Q4, that will have played itself out.
Thanks, Mike.
What about... I know at least in the short term, given the different Part D versus Part B coverage for DPI versus nebulizer, there's some different out-of-pocket costs for patients. I guess if we think ahead, to once out-of-pocket costs are maybe lower in Part D, does that maybe ungate even more potential for DPI if it becomes more affordable?
I think it does. you know, I think what we've been saying for about the last year or so, and we've received the question around what do we expect the mix of the, of nebulizer versus DPI to be, we said generally 50/50. That reflects what you just said. Our patient mix is roughly half. Half of the patients are on government insurance, half of the patients are on private insurance. Because DPI is in Part D, the out-of-pocket costs for those patients that are on the government insurance, in a lot of ways are prohibitive unless they're able to get some other kind of financial assistance. That's why we really said we think it was gonna settle out around 50/50.
I think once we get into 2024, and certainly into 2025, when those out-of-pockets go down to, I think it's like $3,500-$4,000 and eventually down to $2,000, I think that definitely tilts things in favor of DPI and makes that a much more attractive option for even those patients that are on government insurance.
Next question. Jess.
I'll keep going. you talked on the Q3 call about, I think, 700-800 PHILD patients with Medicare insurance who are on patient assistance. How should we think about the tailwind that it could represent in 2023 as a majority of those patients transition over to reimbursed drug?
Yeah. The way the patient assistance program works for CMS patients is once they're in the patient assistance program, they have to stay in for the entire calendar year. As you said, we had about 700-800 of those patients. These, like you said, are PHILD patients, with Medicare coverage that were in our patient assistance program. Now that we have coverage under CMS, after the 1st of the year, they're now able to transition over to commercial drugs. That process is playing itself out right now. It's hard to know how many of those 700-800 will actually transition over. We think it will be the majority.
It will be the majority, but, you know, what that percentage is, we're still waiting to see. Some of those patients will still be eligible for patient assistance and will reapply. You know, I think we'll have a better sense of that as we get towards the end to the end of the Q1 as to how many of those patients transition over.
Thanks, Mike. Any other questions from the audience? Jess.
I don't mean to put you on the spot about the quarter that just ended, but this is a webcast, Regulation FD situation. Historically, you tend to have some seasonal pressure in the Q4, I think due to ordering patterns. You clearly added a bunch of patients in the Q4, on Tyvaso, and it seems like it's possible there could be a little inventory dynamic, as a result of those Medicare patient assistance program, patients transitioning to paid product. With all those kinda puts and takes, is it possible for 4Q, say, thinking about Tyvaso specifically, for 4Q Tyvaso revenues to not be down sequentially?
That's not a nice question to ask. Well, let me say this, it is a seasonal business. When we have factors that we typically see in the Q4 that have not changed, namely, you know, we basically lose about two weeks with the holidays in terms of shipping days, clinic days. You know, what I'll say is, I think the inventory buy to support the patients that are converting over is more likely to happen in the Q1 than it is the Q4. You know, we have added patients in the Q4. I think we're, you know, happy with how...
We're certainly happy with how things are going from a, from a patient growth standpoint, and, you know, the revenues will fall in line with that.
Okay.
Okay. Jess does not get to ask the next question. Who in the audience is gonna ask the next question?
Right here, Martine.
Oh, okay. Thank you, sir. From Israel.
Yeah. I was intrigued by the opportunity in IPF. Clearly, the two molecules that are on the market.
Not good.
They're inadequate, and you're a long-term thinker. where do cell-based therapies, to treat what is clearly an untreatable disease today, where do they come into your long-term approach to IPF specifically?
Yeah. Thank you very much for the question. You know, cell-based therapies are amazing, and I think definitely are the frontier of medicine during the 21st century. For us, we're going to start off with this Tyvaso therapy, because we already have in vitro data that shows it worked. That in vitro data powered the hypothesis that it would be disease reversing in pulmonary fibrosis. That's the reason we added forced vital capacity as a secondary endpoint in the INCREASE study, 'cause ordinarily in pulmonary hypertension, you wouldn't be looking for forced vital capacity. That hypothesis was further validated in the INCREASE study, we saw the improvement. Now what we are doing is just testing that hypothesis with the 2 TETON studies.
That process will take all of, as I mentioned, 2023 and 2024 to complete enrollment, and then 2025 to get to a point of data readout, and then 2026 for FDA approval, and then 2027 for kind of market launch. That's the general frame. In the biotech industry, even though there are a lot of longer term thinkers, still, like, 4 years is a while to wait. I would say that within United Therapeutics, we are putting, you know, the big majority of our chips on the Tyvaso platform as a treatment for pulmonary fibrosis, and hopefully one that arrests and even reverses the progression of the disease.
In the longer term, we have another product, which would be called a cell-based product only by a stretch of imagination, and that's our manufactured lungs, that we manufacture these lungs in a laboratory, and we have two different ways that we're going about it. We have an autologous lung manufacturing program and an allogeneic lung manufacturing program. Those lungs should be able to produce the 1 to 2 L per minute of gas exchange that a normal, healthy, non-fibrotic lung provides. Our longer term plan is to be able to have these manufactured lungs entering into clinical trials at the same time that Tyvaso is entering into the commercial market for pulmonary fibrosis, and then the manufactured lungs as an absolute solution to pulmonary fibrosis would be available as a commercial product in the 2030s.
That's some longer term thinking for you, but it's something that we're doing practically every day and making incredible scientific progress. Next question, please.
Oh, hi. I have a question. Do you have any business,
I see you. Yeah.
Thank you for the presentation. Do you have any plan to go to other countries for, yeah, businesses strategies, meanwhile when you prepare your next generation product and you also is preparation for some approval or, yeah, a business plan to expand?
Yes. If I could let Michael Benkowitz, our President, he oversees our global sales development, and we have had some recent approvals elsewhere, so it's pretty exciting.
Yes. We do have plans to look outside the U.S. Remodulin's approved outside the U.S. Tyvaso's approved in certain countries. We recently just received approval for Tyvaso in PAH in Japan. We're currently talking to the EMA about the INCREASE data and the opportunity to submit an application in Europe for PHILD, and we'll hopefully have some news on that later this year. Martine talked about our two TETON studies. One's being conducted outside the U.S. with the expectation that we'd be able to file for approval for IPF outside the U.S. Similarly, Ralinepag is a global study, so we expect that, if that's successful, that we will be able to consider filing for approval outside the U.S. for that product as well.
Yeah. Thanks, Mike. It's a really great question because as you look to the products in our pipeline, the products that are in our pipeline are mostly products that will have global sales markets. As we look to the United Therapeutics five years from now, it would be mostly global sales, including U.S. sales. I think U.S. sales will still be the lion's share of the revenue, but there'll be much more global penetration five years from now. Next question, please.
We have, one on the iPad.
Okay.
Can you talk about areas of interest from a capital deployment perspective, given the healthy cash balance and growing?
Yes. I'm glad for that question. We have James Edgemont, our Chief Financial Officer at the podium. James, can you take that question?
Yep. Thank you, Martine. Thank you for the question. As Martine outlined on the slides, we do have a very healthy balance sheet, with strong cash on the balance sheet and investments, and we expect it to grow. From a capital allocation perspective, we've historically said, and it's still kind of our plan, is we're gonna invest internally in our own research and development, including organ manufacturing. The second area that we are looking to is business development, and I'll spend a minute on that at the end. The third is return of capital to investors through share repurchases, a question that we've gotten today. That's really a distant third. We feel the best and highest use of our cash is to invest in our own programs, and so that's a consistent philosophy.
With respect to business and corporate development, Betsy Eades is here, who is leads up the efforts with Beth Rhodes, who's an SVP at United Therapeutics. When we think about corporate development opportunities, where we tend to look are areas that we actually have strength. In clinical research, in manufacturing, in commercial sales, in regulatory and other areas. The reason is that we feel that we have a lot of strength in these areas that we can put against any corporate development opportunities. It could be cardio, cardiopulmonary, things of that area that we know very well, and that's where we would tend to look. It doesn't mean we won't look for other opportunities that we feel can have a high return to investors.
We do look at these often and regularly on an ongoing basis and a minimum monthly as a group internally. From a capital deployment perspective, our capital allocation is consistent. We feel very comfortable with it, but we continue to look for opportunities to provide a return to investors.
Thank you so much, James. The relentless countdown clock here tells us we have 1 minute left. Is there a chance for a rapid question and answer exchange?
I don't know if this can be a rapid answer, but there's one more question on the iPad. What can you share regarding the kidney xenotransplant program?
Okay, I could do it rapidly. The kidney transplant program notched some major historic milestones in the past year with multiple transplants of our ten-gene kidneys into heart beating, brain dead, full body donors, and demonstrated for the first time in history that a xenograft can go into a human body without causing any hyperacute rejection or even acute rejection within the 24-48 hours of duration of those xeno kidneys. That has paved the way for us proceeding into a pivotal non-human primate study during the period 2023 and 2024, hoping to be able to go into clinical trials in the 2025, 2026 timeframe.
Great. We'll leave it there.
One second. Boom.
Thanks, everybody.