United Therapeutics Corporation (UTHR) Earnings Call Transcript & Summary

Great. Well, thanks for joining us, everybody. I'm Terence Flynn, the U.S. biopharma analyst here at Morgan Stanley. Very pleased to be hosting United Therapeutics today. We have Michael Benkowitz, the company's President and COO. And then I'd refer you to the research disclosures at www.morganstanley.com/researchdisclosures. But again, Michael, thank you so much for joining us. I really appreciate the time today. I thought maybe we'd start just high level in terms of kind of strategy. Capital allocation priorities, I think there's obviously been a lot of focus on the share repurchase program that you guys announced as well as potentially business development and M&A. So as you think about those two ends of the spectrum in terms of how you guys are thinking about allocating capital? Maybe just give us the latest on the outlook on both of those different buckets here.

Sure. First, Terence, thanks for hosting us. We're very happy to be here today. Our capital allocation priorities have largely remained unchanged over the last few years. I think what we've consistently said is that in order of priority, we're going to invest in the business, whether that be R&D pipeline, expanding manufacturing capabilities. Number 2 is business development. And then number 3 three are share repurchases. Now interestingly, over the last 12 months, we've kind of hit all 3 of those with the announcement that we're building a new DPI manufacturing facility in Research Triangle Park, North Carolina to support our Tyvaso DPI business and then what we expect will be an ever-growing business with a positive readout of our IPF studies. On the business development side, we did 2 small acquisitions last year. We acquired a company called IVIVA and another company called MiroMatrix, which helped us round out our organ manufacturing pipeline. And then, of course, we did the large buyback in March that we're kind of working our way through right now. So I would say that the priorities haven't really changed. We're continuing to kind of look at all 3 of those things and just depending on how we're feeling about our balance sheet and the way those opportunities against each other would decide how we want to allocate that capital.

Yes. Is it fair to think that once the current share repo program winds down, you guys would consider another authorization? Or is that again more tactical, depending on kind of the -- some of these other investment opportunities.

Yes. I think it's more of the latter. I think we're still trying to kind of wind down this current program, which will -- and that should be done by the end of this month. And then that was really intended to be not part of a program per se, just sort of a one-time repurchase. I think in the future, we'll just continue to assess that through the lens that I just described.

Yes. And then obviously touched on some of the smaller deals you did to round out the Oregon business or Oregon pipeline. Is that going to be the focus for additional be the M&A? Or are you guys looking at other therapeutic areas as you continue to kind of diversify outside of PAH here over the longer term?

Yes. We time and we really tend to look at business development opportunities through a fairly broad lens and really look at opportunities that play to our strength. So we think rare disease specialty products is a strength of ours. We talk internally about identifying quarters of indifference and running like hell down them. So we're really looking at, I think, unmet needs. Cardiopulmonary is obviously a strength of ours, but we're not limiting ourselves to those areas where we have and will continue to look outside those areas. And then things that really, I think, just kind of take advantage of our clinical development, our manufacturing and our sales and marketing expertise.

Yes. What -- any broad-level thoughts on what the environment is out right now for kind of BD and M&A? Is it a buyer's market as a seller's market right now? Or again, are you guys looking at more kind of niche areas that are less [indiscernible] by some of these larger companies?

Yes. I think we're looking at more niche areas. I mean we're -- as we're talking about we're in a unique and, I think, great position. We don't feel like we have to do anything. So I think we can be pretty selective and choosy and make sure that it's the right fit for us.

Okay, great. Maybe just moving to the business. As we think about second half of the year here, maybe just help us think through what are kind of the puts and takes going into the back half of the year? And then anything on the inventory side that we need to consider as we think about some of the second half dynamics?

Yes. I mean, I think for the second half of the year, it just continue to execute from a sales and marketing perspective. I think we -- last year was a really strong year for us. And then we came into the first half of this year I've talked about -- talked on prior earnings calls where we actually saw a bit of an inflection, particularly in the Tyvaso business with referrals and starts saw that in the first quarter and have continued to see that as we move -- now moving into the second half of the year. So really, really happy with how that's going. I think the sales force expansion that really went live at the beginning of the year is really taking hold and we're seeing -- starting to see the benefits of having additional people out in the market, meeting with physicians. And so for us, it's really about just continuing to execute and do the things that we've been doing. And I think everything else will really kind of follow from that. On the inventory side, we're in great shape. I mean we had some challenges last year that we were able to work through and bring on some additional manufacturing capacity with our partner at MannKind. That's continued into this year. The last bottleneck that we had was around kitting or packaging. And we're able to bring that in-house earlier this year. We stood up a high-speed kitting line. And so that barrier has been or that obstacle has been removed. And so we're in a really good position from an inventory standpoint, both MannKind and United Therapeutics, we're able to start building inventory, which is great. And then we'll have some additional manufacturing capacity to come online late this year or maybe early next year. So from that standpoint, I think we're in excellent shape.

Okay. Great. The other question we get just the impact of Part D at this time. You guys have talked about this as well, but maybe you could just elaborate on that and rebating dynamics as we head into 2025 and how to think about those 2 things for next year?

Sure. So from a part just to kind of calibrate everybody on the part of your redesign because it's been sort of implemented in phases. So for this year, the catastrophic coverage phase for the patients went away and so the patient out-of-pocket dropped for a drug like ours from close to $15,000 out of pocket to about $3,000 or $3,500 out of pocket. As a result of that and then the Part D plans in Medicare are now picking up the catastrophic. And then next year, the out-of-pocket drops to $2,000 for the patients and the manufacturers pick up the split on the catastrophic is 60% on the Part D plans, 20% Medicare, 20% on the manufacturer. So what's happened is as a result of the patient out-of-pocket going down, the utilization of our patient assistance program has also decreased. And so coming into the -- coming out of last year, we had probably round numbers, 20% of our patients were in the patient assistance program. And then that dropped considerably in the first quarter. It has continued to trickle down over the balance of the year. And I think we'll kind of settle out at roughly 10% of our patients, plus or minus a couple of percentage points. It will be a swing quarter-to-quarter will be in patient assistance. So we've been able to see a nice uplift in kind of our commercial patients. As we head into next year, I mentioned that the manufacturers are now on the hook for 20% of the catastrophic. Fortunately, we were granted a small biotech exemption by CMS. And so as a result of that, that 20% for us gets phased in over 7 years. So next year, we pay 1% and then it slowly steps up. And I think it's by 2031, is when we're at the 20% level. So it's kind of a net benefit for us. Now because the Part D plans are having to pick up now so much of the catastrophic, they're knocking on our door and all the manufacturers' doors and saying, hey, we want more in the way of rebates. And so we have -- we've entered into some contracts. We're talking with other payers about doing some rebating, but really pretty modest in the grand scheme of things. I'm actually really happy with where we're landing in terms of the rebate percentages are quite a bit lower than where I thought we were going to end up. And so I would say, at least for the next, I don't know, 4, 5 years until we get to that closer to that 20% having to pay that. I think the reduction of PAP utilization which is going to be offset by the additional rebating. I think it's still going to be -- end up being a net positive for us on the revenue side of things.

Okay. Got it. What do you think led to the rebates being less onerous than you initially thought. Is it the level of competition in? Is it something else? Like, what gave you that leverage, do you think, to minimize the impact there?

Yes. I think it's a couple of things. One is it's certainly the competition -- level of competition coupled with the volume that we already have with these payers. And so it's a little bit goes a long way because we've been able to really build up really good market share with these various payers.

Yes. Okay. Got it. I guess, just moving on to Tyvaso for ILD, obviously, that's been the major growth story for the company here. You guys had a lot of success in terms of kind of building out this market and diagnosing patients. You mentioned the sales force expansion. Maybe just where are we in terms of market build now? And what are some of the next steps that you're taking here to continue that momentum that we've seen through -- since the approval 2 years ago now at this point in time?

Yes, a couple of -- I mean, I think if you kind of think about where we are in terms of the PH-ILD market, I would say we're -- I mean, roughly about 15% penetration. So pretty good over -- after a couple of years, but still a lot of opportunity out there, I think, for us to take advantage of. And that was largely why we expanded the sales force at the beginning of the year. And so I think that -- like I said, that's gone very well. In terms of kind of breadth and depth on the prescribing side. Since we launched into PH-ILD, we've more than doubled the number of Tyvaso prescribers. So that's really kind of our breadth metric. And then on depth, which we define as physicians that have 3 or more patients on Tyvaso, we've consistently been at about 40% of the prescribers. So we've been growing the top and we've been growing the depth as well on a numbers basis. And then the thing that I've really been pleased to see since the beginning of this year alone, just since January, we've grown the prescriber base by about 10% and almost all of that has come from the ILD treaters. So when we initially launched in the PH-ILD, we had, I would say, the vast majority of patients were being screened with the ILD docs and then they suspected that they had pulmonary hypertension, they would then be referred to the PH clinics. And so over time -- we knew that -- and we knew this was going to have to happen over time is that we were going to have to convert these ILD docs into treating physicians, and we're starting to see that, which is great. It really sets us up very nicely if we have a positive readout on our IPF trials.

What -- and so that was when coincident with the sales force expansion, the January figure you gave, the 10% prescriber base of that?

Since January, yes.

What's the relative size of the prescriber base, remind us for PAH versus PH-ILD? I think PH-ILD is a larger prescriber base potentially, right?

It's potentially -- yes, it's a larger base.

Is it twofold?

No, it's probably about -- if I think about -- it's -- I would say maybe about 40% to 50%.

40% to 50% bigger. Okay. And so that's part of it is just getting out there amongst those kind of more community-oriented physicians that kind of build. Okay. And are there any other efforts in terms of diagnosis, treatment paradigm steps that need to be implemented as you kind of broaden out to this second group of physicians here that are things we should think about that could further build momentum into '25?

I think there's a couple of -- I mean one is just it's not [indiscernible] but it's just a blocking and tackling of just repetition in getting out in front of the physicians and educating them. And I think we have done a good job of that. We will continue to do a good job of that. We have a couple of different initiatives that I think can help us over time. I mean it won't necessarily be like a binary flip on a switch and all of a sudden, you see a pop, but I think it will start to help us build over time as one as we're doing kind of Phase IV-ish type studies through our medical affairs group to do some validated screening, different screening tools to help identify these patients earlier. And based on these algorithms, be able to kind of predict to a reasonably high level whether the patients will be confirmed to have pulmonary hypertension through right heart cath. And so that work is ongoing. So I think that will help. And then the last thing that we're doing that we haven't really talked too much about, but we're getting ready to -- we've kind of revamped our patient support program. And we're going to be launching that later this month. And so it's going to be, I think, a much more comprehensive cohesive high-touch support program for our patients. And so that will -- I think that will allow us to close some of the gaps that we see between what the physician's office are able to -- physician's offices are able to offer, what the specialty pharmacy nurses are able to offer and really just -- really kind of be that quarter back for the patient, particularly when they initiate therapy. Because that's where really the patients tend to struggle way because it's a complicated medicine to take. You have to titrate. You have to do certain things to manage your side effects. And so I think what we're seeing is the patients require a lot of support. And I think with this program, what we're hoping to do is the main thing is just increase that patient retention in the first 3 to 4 months. Because once we know -- we know that once we get into month 3 or month 4, they're typically on for 3 years.

Okay. Got it. Is there anything else you can talk about in terms of what that looks like? Is it like a digital approach? Or is there anything...

It's omnichannel. So it's people, it's technology, it's everything.

Okay. Okay. Got it. That led into my next one, which is the duration of treatment on the ILD side and like how does that compare with what you see on PAH?

Yes. It's -- I think we're starting to get enough data now, enough experience to start to see some trends, and it's pretty comparable. I would say. I think it's -- overall, it's comparable. And then like I said, it's in both PAH and PH-ILD. I think that first kind of 3 to 4 months is critical if we can help the patients get through that period of time, they tend to stay on for a really long time.

Okay. Okay. Great. The other one is as we think about, I guess, the -- because right now, Liquidia, obviously, post this decision is delayed until May 2025. But maybe just as we think forward to that time when if Liquidia does reach the market, what are kind of the key differentiation things that you're going to lean into relative to that product. And again, it sounds like this patient support program maybe could be one of those. But how do you think about that from -- like -- and this is more of a like 18-month type question.

Yes. I mean, I think -- so you're right. I think part of what we bring to the table, I think, is the track record of being in the space, the commitment to the space, the relationships we have, the patient support program and that might sound like mom and apple pie stuff to a lot of people, but it does matter to physicians. I mean, I think we saw that when we -- when a generic Remodulin launch. So I think we've got actually some data points to suggest that, that stuff matters. So that's a big part of it. In terms of product differentiation relative to Liquidia product, I think we feel like we have a differentiated product that is going to be preferred by patients and by physicians. I mean, first is just the ease of the product, kind of the open load inhale is very simple. It doesn't require any cleaning. Ours is one breath precession. There's just going to be 2 breath precession, we don't have a MAX dose in our label so that patients can titrate up as high as they want to. The other thing, I think that gets a little technical and kind of into the weeds, but I think patients will experience this as the -- as they use our device, but ours is what's called a low-flow device, which means the patient doesn't have to have a really strong breath to inhale the drug. And that's really important, particularly for some of the PH-ILD patients that can have really compromised lungs and so you're not having to generate that high inspiratory flow rate is really important. So it's going to allow them to, I think, use DPI much more effectively. And then the other thing it does is because it's low flow, you're getting a much more efficient, consistent and deeper delivery of the drug into the distal airways.

Okay. Great. Maybe let's move over to the PAH side of the business now. Again, I mean, you guys have been one of the innovators here for a very long time. Just anything in terms of high-level market dynamics that we should think about here from either patient diagnosis, patient retention, treatment paradigm, just like top down before we get into some more specific questions that we should think about in the PAH market here? Is it pretty much steady state?

I think it's pretty much steady state. I mean, obviously, Merck launched their products, so they're out on the market. I think what we're seeing there is -- I mean obviously, we don't have visibility into what their actual data. So a lot of this is anecdotal, but it does seem like that by and large, that drug is being used as a study in the clinical trial. So on top of background therapy, including prostacyclins. 70% of the patients in their trial were on background prostacyclin. And so far, that's how it's looking. And then I kind of back that up by looking at our numbers, which obviously, I do see, and I look at referral patterns, I look at start patterns. I look at patient shipments, kind of what's going out the door. And as I look at the last 3 months compared to, say, the first 4 months of the year, it's pretty consistent across the board. So that's -- things are looking solid on that front.

Is it going to do anything in terms of like activating more patients who maybe were on the sidelines or something or not really at this point, it's hard to tell.

It could. I mean in the sense that you've got -- there's sort of an increased share of voice in the PAH space, just talking about the disease state and the treatment options. We were talking joking earlier that we saw this when generic Remodulin launched back in 2017, 2018. Our prescriptions actually grew because we had more people out there talking about infused therapy, and then the doctors were thinking about it and then gravitated it to our product. So I think there is an opportunity or a potential that there is sort of a rising tide just because you've got more people out there talking about pulmonary hypertension.

Yes. What -- and they're doing some earlier-stage studies that we don't have data on yet, but if it were to move earlier stage, I mean would that have any implications for your franchise as you think about like the kind of downstream implications if that were to move from an earlier stage setting?

I don't think so over the medium and long term because at the end of the -- I mean, the drug is not a cure, right? There is no cure, right? None of these drugs will cure. It's still a progressive disease. And so even if they had a trial that suggested that their products should be moved in front of ours, I think eventually the patients are going to get to a prostacyclin. So I don't -- so it could be like a short-term ripple, but I think over the long term, really, there won't be an impact.

Okay. The other thing that I think you guys talked about on the earnings call was the discontinuation of this CADD-7 pump for Remodulin. So maybe just walk us through kind of the dynamics there and what's going on? Because I guess that business has been more stable than I've expected over the last couple of years. But what are the implications of this -- this pump discontinuation for your Remodulin business?

Yes. So it's -- that should be a net positive for our subcu business. So the CADD-MS3 pump is sort of a generic pump that's on the market used for -- was used for administering Remodulin and used for administrating the generic form of Remodulin. And so Smiths Medical discontinued that pump many years ago. They recently, I think, said they're not going to be able to service or repair the pumps that are out in the field. And so the specialty pharmacies have decided that they're going to start proactively switching patients from the MS3 pump over to Remunity. And so we think we've got a few hundred patients left on the MS3. So those will probably be transitioned over the next 2 to 3 quarters. And then it's our understanding they're doing that with all the patients that are on the MS3. And so as it stands right now, the generic companies don't have another pump option. So there could be a little bit of a tailwind for us on the Remodulin side as a result of that.

Yes. Okay. And then remind us, there's no -- that generics you can't refill Remunity with a generic.

Correct. It's exclusive to Remodulin.

Okay, got it. And remind us the subcu IV split, I think previously it was like 50-50. Is that still...

Yes, I mean roughly, sometimes it moves 55-45 and favors subcu, but it bounces around there, 50-50 is a pretty good working assumption.

Okay. And then on oral Remodulin, just to round that out before we go to some of the pipeline questions. Just anything from a trend perspective or switching perspective that you're seeing the pace of change as we think about 2025 for oral that could change growth one way or another? Or is that product pretty much at a steady state basis now?

Well, I mean it has been growing in the last few quarters. And so I think we're still expecting that, that product will continue to grow. I think -- where it gets positioned in the treatment paradigm has changed a little bit. I think with the advent of DPI, I mean that really is, I think, the easiest way to start a patient on a prostacyclin therapy, just from a side effect perspective, ease-of-use perspective. But we are still -- we have some prostacyclin-naive patients that are starting on Orenitram. I think what's going to end up happening over time where Orenitram is going to be used predominantly and we're kind of -- we're heading in that direction is for Remodulin patients that have been on Remodulin for a while, their hemodynamics have stabilized and the doctor feels comfortable transitioning them over to Orenitram and using that as our maintenance drug. Or it's -- patients that would otherwise be good Orenitram candidates. But the doctor wants to get the patient up to a higher -- get up to an efficacious dose more quickly and with fewer side effects. And so what they'll do there is what we call our expedite protocol, which is a short course treatment of Remodulin for anywhere from 2 to 10 weeks. So they'll get them up to a high dose of Remodulin and then transition them over. So we're able to get them to the therapeutic dose of about half the time. And like I said, usually with far fewer side effects. And so we're seeing the adoption of that approach pick up.

Okay. Before I go to IPF, just one last one is ralinepag obviously, is in a Phase III program. It's again another oral prostacyclin option. Where do you guys see that fitting into the ultimate paradigm given what you just discussed for oral Remodulin?

Yes. So we really look at that as really a next-generation IP receptor agonist. And so the selexipag is the product that's on the market that address that -- that works on that receptor right now. There's clearly a market for that. I think there continues to be a market for Orenitram and Tyvaso, which work on multiple receptors in PAH. But I think with ralinepag, that's really, I think, going to be the focus, is that IP receptor market. And like I said, it's a next generation. It's going to be once daily instead of twice daily. It's a more potent drug. We believe there is a titration effect, which you don't see with selexipag. So as you titrate you actually see a benefit through higher doses. And then we're expecting to have a really strong data pack to go with that. If you look at the Phase II study, we saw about a 20% reduction in PVR, pulmonary vascular resistance and a nice increase of 6-minute walk. And so we think the combination of a really strong data package plus once daily will be really attractive to patients and physicians.

Is that enough to differentiate from when there's a generic selexipag on the market? Is that enough to...

Yes, I think it is, particularly if we have the strong data. I think we saw this with Adcirca back in the mid-teens when as a once-daily drug, very strong data, Revatio went generic kind of in the middle of our -- around the time, I guess, soon after we launched, generally, you were able to really see really strong growth of Adcirca.

Okay. Great. Maybe just moving on to IPF. We're starting to get some more questions here as you're going to have the first Phase III data 2025. So maybe just remind us why you guys embarked on this Phase III program? What gives you the confidence here in a positive outcome when we see that data next year?

Sure. So the main driver for this was the data we saw in our INCREASE trial, which is our pivotal study for PH-ILD. We had a secondary endpoint of forced vital capacity -- looking at forced vital capacity and benefit. And we saw in the IPF patients and the progressive pulmonary fibrosis patients, PPF, which you saw an increase or an improvement in FVC. So that was really, I think, the [indiscernible], which surprised us. pleasantly. And so that was really -- that plus we know that there are some antifibrotic properties associated with treprostinil. I mean we've kind of seen that in various preclinical studies. And so we thought -- that data plus the antifibrotic properties was enough to convince us that it was worth doing the trials. And so we already made that decision. And then we had the open-label extension data come a little bit later. We're taking it out to 52 weeks. And what we saw in the main trial, continued through the open-label extension. So that just gave us confidence that it was the right thing to do the trial, and that's really the basis behind doing that.

And any -- in terms of TETON 1 versus 2, any design differences that we need to be aware of or it's just geography?

It's just geography.

Yes. Okay. And do you need both of those trials for an approval? Or is one trial sufficient? I think if we look back, I forget the InterMune days, like forget what the standard was, but there was some back and forth on what was...

Yes. Well, so in the U.S., we think we can potentially file with 1 trial, but we'll have both because TETON, would be the TETON 1 U.S. study. We'll have both because TETON 2, the rest of the world study will read out first. And then for European approval, we'll definitely need both trials.

And what does that commercial opportunity look like these days? I know that InterMune and BI drugs were kind of the first 2 drugs approved. But what's the latest on kind of what that commercial opportunity looks like?

Sure. So in the U.S., there are around 100,000 patients with IPF. It's understanding the patient population and kind of Europe is roughly the same. So that's sort of the size of the market. I think if we see an improvement in FVC like we saw in the INCREASE trial, I think that's going to bode extremely well for us. I mean the 2 drugs you mentioned, the companies mentioned their drugs only slow the rate of decline. So if we're actually able to show an improvement, I think that's going to be a game changer for patients and really -- create a really strong market for us.

Yes. And then would you be able to leverage your existing sales force? I mean, are those pretty much in the similar doctors? Or would you need incremental investment...

We would need to expand. I think we would need to expand. I mean, we certainly -- we can -- so the answer is both. We'll leverage those relationships because it is -- there are similar call points. But I think given the opportunity, we would want to expand that out a little bit. But I think the investment in that is going to be material relative to the opportunity we have in front of us.

Okay. Got it. Okay. Great. Maybe just in the last few minutes on the Oregon manufacturing front. Maybe just remind us like next milestones that we should be focused on as we think about gauging the company's progress on this program.

Sure. Yes. So I think the nearest term 1 is our 10-gene xenokidney program. So you may recall that I think what we've talked about is that the FDA gave -- required us for both -- actually both the heart -- xenoheart and the xenokidney as they wanted us to do some preclinical work in the baboon model. So roughly a dozen transplants of the xenokidney and the xenoheart to baboon. We've completed the xenokidney work and are now scheduled to go back and have a pre-IND meeting with the FDA in the fourth quarter of this year. And so our goal is to hopefully come out of that with the green light to move into a clinical trial next year.

What would you guys give us that update on a one-off basis? Or is that something that's more like a regular course of business update, like a quarterly update kind of thing? Or how do you think about disclosure around that event?

Yes. So it probably won't -- we'd wait until we get the meeting minutes back from the FDA. And then I don't know that we -- I guess it kind of depends on the timing of that. I mean that should be -- yes, it could be a press release or it could be at a quarterly update or conferences depending on when that falls.

Okay. And then what would that program, initial scope of that, I guess, would be a Phase I program technically? Like what does that look like? Is this like you're talking about a handful of patients or...

So that's still to be determined. I think that will be part of the conversations we have with the FDA. I think, we've thought about it in sort of this -- I mean, what we kind of think is going to happen is they're going to -- it won't necessarily be a phase -- typical Phase I/II/III study, but more like a phase study, where they say, do a handful -- do a couple of patients. Let's see how that goes, that's going well, then you kind of incrementally add patients and centers over time. But again, that's still a little bit up in the air until we meet with the FDA.

Okay. Any other like gating -- I mean, is it like length of follow-up, like those are the typical questions that you're working on right now? Or is there anything else that's like a gating item for?

No. I mean, really, they asked us to do the baboon work, collect the data and then -- and there wasn't really an end point per se and that they just wanted us to generate data and then come back and meet with them. So that's where we're at.

And then on the manufacturing side, I know you guys have been building out the facility here. Is that facility ready for the clinical trials, and it would be the same facility that would be used for the commercialization? Or is it like a smaller scale facility that's used for the trials and then you're still working on building out the commercial facility?

So the clinical facility is complete. We completed that earlier this year, and that can support the generation of about 100 to 125 organs per year. So that will just be a clinical facility. And then the commercial facility, we're working on the plans for that. We've not started construction on that. We're going to wait until we get the green light from the FDA to start the clinical trial. Because we're really trying to -- that's going to be expensive. And really, what we're trying to do is we want the pace of the CapEx spend to kind of track with the science. So we'll wait for that. And then, like I said, that's going to be expensive, but that's not a right of check and you're done. I mean, the cost of that will be spread out over several years as we're doing the trial. And most of that's back-end loaded. If the things aren't going well or don't go well, the opportunity to slow down or stop it.

Okay. Well, I think we're up against time. But Michael, thank you very much. Really appreciate your time today. Thanks for joining me.

Yes. Appreciate it. Thank you.