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. You know, capital allocation priorities, I think, you know, there's obviously been a lot of focus on, you know, the share repurchase program that you guys just announced, as well as, you know, potentially business development and M&A. So as you think about, you know, 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. You know, 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 two is business development, and then number three are share repurchases. Now, interestingly, over the last 12 months, we've kind of hit all three 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 two 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, you know, kind of working our way through right now. So, you know, I would say that the priorities haven't really changed. We're continuing to, you know, kind of look at all three of those things, and just depending on, you know, how we're feeling about our balance sheet and, you know, weigh those opportunities against each other, we decide how we wanna allocate that capital.
Yep. 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, dependent on kind of some of these other investment opportunities?
Yeah, I think it's more the latter. You know, I think we're still trying to kind of wind down this current program, which will end. That should be done by the end of this month. And then, you know, 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.
Yep. And then obviously, you touched on some of the smaller deals you did to round out the organ business or organ pipeline. Is that gonna be the focus for additional BD 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?
Yeah, I mean, 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, you know, we think rare disease, specialty products is a strength of ours. You know, we talk internally about, you know, identifying corridors 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. We have and we'll continue to look outside those areas. And then, you know, things that really, I think, just kind of take advantage of our clinical development, our manufacturing, and our sales and marketing expertise.
Yep. 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? Is it a seller's market right now? Or again, are you guys looking in more kind of niche areas that are less affected by some of these larger companies?
Yeah, I think we're looking at more niche areas. I mean, as we talked about, we're in a unique and I think great position, where 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, it's the right fit for us.
Yep. Okay, great. Maybe just moving to the business. As we think about, you know, 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?
Yeah, I mean, I think for the second half of the year, it's just continuing to execute from a sales and marketing perspective. I think we, you know, last year was a really strong year for us, and then we came into the first half of this year, and I've talked on prior earnings calls, where we actually saw, you know, 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've moved, you know, now moving into the second half of the year. So, you know, 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 you know, starting to see the benefits of having additional people out in the market meeting with physicians. So for us, it's really about just continuing to execute and do the things that we've been doing, and I think you know, everything else will really kind of follow from that. On the inventory side, we're in great shape. I mean, we you know, 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, you know, that barrier's 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 actually built, you know, we're able to start building inventory, which is great, and then we'll have some additional manufacturing capacity come online late this year, maybe early next year, so from that standpoint, I think we're in excellent shape. Yep.
Okay, great. You know, the other question we get is just the impact of Part D redesign. 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 two things for next year.
Sure. Just to kind of calibrate everybody on the Part D redesign, 'cause it's being sort of implemented in phases. For this year, the catastrophic coverage phase for the patients went away. The patient out-of-pocket dropped, you know, for a drug like ours, you know, from close to $15,000 out-of-pocket to about $3,000 or $3,500 out-of-pocket. As a result of that, the Part D plans and Medicare are now picking up the catastrophic. 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, you know, 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, you know, coming out of last year, we had probably, you know, round numbers, 20% of our patients were in the patient assistance program. And then that dropped considerably in the first quarter and 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 percentage points. There'll 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, you know, 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. So as a result of that, that 20% for us gets phased in over seven years. 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, a net benefit for us.
Now, because the Part D plans are having to pick up now so much of the catastrophic, you know, 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, you know, 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 gonna end up.
So, you know, I would say, at least for the next, I don't know, four or five years, until we get to that, you know, closer to that 20%, having to, having to pay that, I think, I think it's still gonna end up being a net positive for us on, 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? Is it something else? Like, what gave you that leverage, do you think, to minimize the impact there?
Yeah, I think it's a couple of things. One is, it's certainly the level of competition coupled with the volume that we already have with these payers. And so it's, you know, a little bit goes a long way because we've been able to really build up really good market share with these various payers.
Yeah. Okay, got it. Okay, I guess just moving on to Tyvaso for ILD. Obviously, that's been the major growth story for the company here. You guys have 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, you know, steps that you're taking here to continue that momentum that we've seen through, you know, since the approval, was it two years ago now at this point?
Yeah. 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, beginning of the year. And so I think that, like I said, that's gone very well. You know, we in terms of, you know, kind of breadth and depth on the prescribing side, you know, 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 three or more patients on Tyvaso, we've consistently been at about 40% of the prescribers. So, you know, 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 is 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 in from the ILD treaters.
So, you know, when we initially launched in the PH-ILD, we had, I would say, the vast majority of patients were being screened at, with the ILD docs, and then if they suspected that they had pulmonary hypertension, they would then be referred to the PH clinics. And so, you know, over time, we knew that, and we knew this was going to have to happen over time, is that we were gonna 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.
... And so that was went coincident with the sales force expansion, the January figure you gave, the 10% prescriber base, is that-
Yeah, since January. Yep.
Yeah. Okay.
Yeah.
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 the large... Yeah, there's. It's a larger base.
Yeah.
Yeah.
Is it twofold bigger?
No, it's probably about, if I think about it, it's I would say maybe about 40%-50%.
40%-50% bigger?
Yeah.
Okay. And so that's part of it, is just getting out there among-
Yep
Those kind of more community-oriented physicians to kind of build. Okay.
Right.
Are there any other efforts in terms of, you know, diagnosis, treatment paradigm steps that need to be implemented as you kind of broaden out to this, you know, second group of physicians here that are things we should think about that could further build momentum into 2025?
I think there's a couple. One is just it's not sexy, but it's just the blocking and tackling of just repetition and getting out in front of the physicians and educating them. And I think we've... You know, we have done a good job of that. We will continue to do a good job of that. We have a couple different initiatives that I think can help us over time. I mean, they won't necessarily be like a binary flip on the switch, and all of a sudden you see a pop, but I think [they] will start to help us build over time. One is we're doing, you know, kind of phase four-ish type studies through our medical affairs group to do some validated screening.
Different screening tools to help identify these patients earlier. You know, based on these algorithms, you know, be able to kind of predict to a reasonably high level whether the patients will be confirmed to have pulmonary hypertension through a right heart cath. So that work's ongoing, so I think that will help. 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 gonna be launching that later this month. So it's gonna be, I think, a much more comprehensive, cohesive, high touch support program for our patients.
And so that'll, I think that'll allow us to, you know, close some of the gaps that we see between what the physician's offices are able to offer, what the specialty pharmacy nurses are able to offer, and really just kind of be that quarterback for the patient, particularly when they initiate therapy. Because that's where it really, the patients tend to struggle. They 'cause it's, you know, it's complicated medicine to take. You have to titrate. You have to do certain things to manage your side effects. And so, you know, 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 three to four months.
'Cause once we know, we know that once we get them to month three or month four, they're typically on for three years.
Okay, got it. So that's the... Is there anything else you can talk about in terms of what that looks like? Is it like a digital approach, or is there any-
It's omni-channel.
Okay.
It's people, it's technology, you know, it's everything.
Yeah. 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?
Yeah, 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-
Okay
I would say. I think it's, you know, overall it's comparable, and then, you know, like I said, it's, it's in both PAH and PHILD. I think that first kind of three to four months is critical. If we can get help the patients get through that period of time, they-
Yep
Tend to stay on for a really long time.
Okay. Okay, great. You know, the other one is, you know, as we think about, I guess, 'Cause right now, you know, Liquidia, obviously, post this decision is delayed until May twenty twenty-five. But maybe just as we think forward to that time when, you know, if Liquidia does reach the market, what are kind of the key differentiation things that you're gonna lean into, relative to that product? And again, it sounds like this patient support program maybe could be one of those.
Mm-hmm.
But how do you think about that from... Again, this is more of a, like, 18-month type question?
Yeah, I mean, I think for, you know. So you're right. I think, you know, 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, I mean, it does matter to physicians.
Yeah.
I mean, I think we saw that when a generic Remodulin launched. So I think we've got actually, again, some data points to suggest that stuff matters. So that that's a big part of it. In terms of product differentiation relative to the Liquidia product, I think, you know, 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. You know, kind of the open load inhale is very simple, doesn't require any cleaning. Ours is one breath per session. Theirs is gonna be two breaths per session.
We don't have a max dose in our label, so the patients can titrate up as high as they want to. The other thing I think that's, you know, gets a little technical and kind of into the weeds, but I think patients will experience this as they use our device. But ours is what's called a low flow 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 you know, compromised lungs. And so, you know, not having to generate that, you know, high inspiratory flow rate is really important.
So it's gonna allow them to, I think, you know, 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. Yeah.
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 of the more specific questions that we should think about in the PAH market here, or is it pretty much steady state?
I think it's pretty much steady state. I mean, obviously, Merck launched their product, so they're out on the market. I think what we're seeing there is, I mean, obviously, we don't have visibility into, like, their actual data, so a lot of this is anecdotal, but it does seem like, by and large, that drug's being used as studied in the clinical trial. So on top of background therapy, including prostacyclin, 70% of the patients in their trial were on background prostacyclin. And so, you know, so far that's how it's looking.
And then, you know, I kinda 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, kinda what's going out the door. And as I look at, you know, the last three months compared to, say, the first four months of the year, it's pretty consistent across the board, so that's, you know, the things are looking solid on that front.
Is it gonna do anything in terms of, like, activating more patients who maybe were on the sidelines or something, or, or not really at this point? It's hard, too 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, and the treatment options. You know, we were talking, joking earlier that, we saw this when, generic Remodulin launched back in, I guess, it was twenty seventeen, twenty eighteen. 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, you know, gravitated to our product. So I think there is an opportunity or potential, that there is sort of like a rising tide, just because you've got more, more people out there talking about pulmonary hypertension.
Yeah. What, and then, like, 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 kinda downstream implications, if that were to move to an earlier stage setting?
I don't think so over the medium and long term, because at the end of the... I mean, you know, the drug's not a cure, right? It's, and there is no cure, right? None of these drugs are cures. It's still a progressive disease, and so, you know, even if they had a trial that suggested that, their product should be moved in front of ours, I think eventually the patients are gonna get to a prostacyclin. So I don't over the... You know, so it could be like a short-term ripple, but I think over the long term, really, there won't be an impact.
Okay. You know, the other thing that I think you guys talked about on the earnings call was the discontinuation of this CADD-MS 3 pump for Remodulin. So maybe just walk us through kind of the dynamics there and what's going on, 'cause I guess that business has been more stable than I've expected, you know, over the last couple of years. But what are the implications of this pump discontinuation for your Remodulin business?
Yeah. So, it's... That should be a net positive for our subQ business. So the CADD-MS 3 pump is sort of a generic pump that's on the market and was used for administering Remodulin and used for administering the generic form of Remodulin. And so Smiths Medical discontinued that pump many years ago. They recently, I think, said they're not gonna be able to service or repair the pumps that are out in the field. And so the specialty pharmacies have decided that they're gonna start proactively switching patients from the MS3 pump over to Remunity. And so, you know, we think we've got a few hundred patients left on the MS3, so those will probably be transitioned over the next, you know, two to three quarters.
And then, it's our understanding they're doing that with all the patients that are on the MS3. And so, you know, 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.
Yeah. Okay. And then remind us, there's no... The generics, you can't refill Remunity with a generic?
Correct. It's exclusive to Remodulin.
Okay. Okay, got it. And remind us that subQ IV split, I think it previously was, like, fifty/fifty. Is that still-
Yeah, it's there. I mean, it roughly sometimes, you know, moves 55-45 in favor of subQ, but it bounces around there. 50/50 is a pretty good working assumption.
Okay. And then on Orenitram, just to round that up before we go to some of the pipeline questions, just you know anything from you know trend perspective or you know switching perspective that you're seeing you know a pace of change as we think about twenty twenty-five for oral that you know could change growth one way or another, or is that product pretty much at a steady state basis now?
It's been, I mean, it has been growing the last few quarters, and so I think we're still expecting 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, you know, we have some prostacyclin naive patients that are starting on our Orenitram.
I think what's gonna end up happening over time, where our Orenitram is gonna be used predominantly, and we're kinda heading in that direction, is for Remodulin patients that have been on Remodulin for a while, their hemodynamics has stabilized, and the doctor feels comfortable transitioning them over to Orenitram and using that as their maintenance drug. Or it's patients that, you know, 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, you know, anywhere from two to 10 weeks.
So they'll get them up to a, you know, high dose of Remodulin and then transition them over, so we're able to get them to that therapeutic dose in about half the time.
Okay.
And like I said, usually with far fewer side effects. And so we're seeing, you know, the adoption of that approach pick up.
Yeah. Okay. Before I go to IPF, just one last one is, you know, ralinepag obviously is in a phase three program. It's again, another oral prostacyclin-
Mm-hmm
Option. Where do you guys see that fitting into the ultimate paradigm, given what you just discussed for oral Remodulin?
Yeah. So I, we really look at that as really a next generation IP receptor agonist. And so you know, the selexipag is the, you know, the product that's on the market that addresses that, that works on that receptor right now. And so 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, you know, that's really, I think, gonna be the focus, is that IP receptor market. And like I said, it's a next generation. It's gonna be once daily instead of twice daily. It's a more potent drug. It's
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, you know, we're expecting to have a really strong data pack to go with that. If you look at the phase two study, we saw about a 20% reduction in PVR, pulmonary vascular resistance, and a nice increase in six-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,
Yeah, I think it is. I think it is, particularly if we have the strong data. You know, I think we saw this with Adcirca back, you know, in the mid-teens when it was a once daily drug, very strong data. Revatio went generic, kind of in the middle of our, you know, around the time- I guess, a little soon after we launched-
Right
and we were able to really, you know, see really strong growth of Adcirca with that.
Okay, great. Maybe just moving on to IPF.
Mm-hmm.
You know, we're starting to get some more questions here as you're gonna have the first phase 3 data of 2025.
Mm-hmm.
So maybe just remind us why you guys embarked on this phase three program. What gives you the confidence here, in a positive outcome, when we see that data in 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, we actually saw an increase or an improvement in FVC. So that was really, I think, the catalyst, which surprised us, pleasantly. And so that was really that plus we know that there are some anti-fibrotic properties associated with treprostinil, and we've kind of seen that in various preclinical studies. And so we thought, you know, that that data plus the anti-fibrotic properties was enough to convince us that it was worth doing the trials.
And so that's and then, you know, and so we already made that decision, and then, you know, we had the open label extension data come a little bit later, where 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 the confidence that it was the right thing to do, to do the trial, and that's really the basis behind doing that.
Any, in terms of Teton One versus Two, any design differences that we need to be aware of, or it's just geography?
It's just geography.
Yeah.
Yeah.
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-
Well, so in the U.S., we think we could potentially file with one trial.
Okay
... but we'll have both because Teton and that would be the Teton One U.S. study.
Yeah.
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.
Yeah. Okay
- trials.
What does that commercial opportunity look like these days? I know that, you know, InterMune and BI drugs were kind of the first two drugs approved, but what's the latest on kind of what that commercial opportunity looks like?
Sure. So in the U.S., there's around 100,000 patients with IPF. It's our understanding the patient population in, you know, kind of Europe is roughly the same. So that's sort of the size of the market. I think if we see an improvement, if we see an improvement in FVC like we saw in the Increase trial, I think that's gonna bode extremely well for us. I mean, the two drugs you mentioned, the two companies you mentioned, their drugs only slow the rate of decline. So if we're actually able to show an improvement, I think that's gonna be a game changer for patients, and really, you know, create a really strong market for us.
... Yeah. Would you, 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 an incremental investment behind that?
We would need to expand. I think we would need to expand. I mean, we certainly can. So the answer is both. We'll leverage those relationships 'cause 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, you know, the investment in that is gonna be immaterial relative to the opportunity.
Yeah
We have in front of us.
Okay, got it. Okay, great. Maybe just in the last few minutes on the organ manufacturing front.
Mm-hmm.
You know, 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. So I think-
Yes.
Yep. Yeah, so I think the nearest term one is our 10-gene xenokidney program. So, you may recall that, I think what we've talked about is that the FDA required us for both, actually, both the xenoheart and the xenokidney. They wanted us to do some preclinical work in the baboon model. So, you know, 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.
Okay. 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, you know, quarterly update kind of thing? Or, or how do you think about disclosure around that event?
Yeah, so it probably won't... We'd wait until we get the meeting minutes back from the FDA-
Okay
... and then, I don't know that we've. It, I guess, kind of depends on the timing of that.
Yeah.
I mean, that could be, you know, could be a press release, or it could be at a quarterly update or a conference-
Yeah
- depending on when that falls.
Okay. And then what would that program, initial scope of that, you know, I guess, would be a phase I program, technically. Like, what does that, what does that look like? Is this like you're talking about, handful of patients or?
So that's still to be determined.
Okay.
I think that, that'll be part of the conversation-
Okay
we have with the FDA. I think, you know, we've thought about it in sort of this. I mean, what we kind of think is gonna happen is, they're gonna - it won't necessarily be a phase, you know, typical phase I, II, III study-
Okay
... but more of like a phaseless study, where they say-
Okay
... Do a handful, you know, do a couple patients. Let's see how that goes. If that's going well, then, you know, you kind of incrementally add-
Yeah
... add patients-
Okay
... and centers over time. But again, that's still-
Yeah
A little bit up in the air until we meet with the FDA.
Okay. Any other, like, gating item? 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, you know, they asked us to do the baboon work-
Yeah
... collect the data, and then there wasn't really an endpoint per se in that.
Yeah.
They just wanted us to generate data and then come back and meet with them.
Yeah.
So that, that's where we're at.
Okay. And then the manufacturing side, I know you guys have been building out the facility here. Is that facility ready for the clinical trials, and would it 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?
Yep. So the clinical facility is complete.
Okay.
We completed that earlier this year, and that can support the generation of about 100 to 125 organs per year. That'll be just a clinical facility. And then the commercial facility, you know, we're working on the plans for that. We've not started construction on that. We're gonna wait until we get the green light from the FDA to start the clinical trial, because we're really trying to. You know, that's gonna 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.
Okay.
So, we'll wait for that, and then, you know, like I said, that's gonna be expensive, but that's not a write a 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 and loaded. We'll have, you know, if things aren't going well or don't go well, the opportunity to slow down or stop it if we need to.
Okay, well, I think we're up against time.
Yeah.
But Michael, thank you very much. Really appreciate-
Thank you
for your time today. Thanks for joining me.
Yeah. Appreciate it.
Thank you.