United Therapeutics Corporation (UTHR) Earnings Call Transcript & Summary

March 3, 2020

NASDAQ US Health Care Biotechnology conference_presentation 32 min

Earnings Call Speaker Segments

Hiroshi Shibutani

analyst
#1

My name is Chris Shibutani, and welcome to this presentation of United Therapeutics at the Cowen Healthcare Conference. I'm a member of the biotech research team and really appreciate you joining us today. We have a special treat with a fireside chat discussion with the United Therapeutics management. We recently upgraded the stock, which has been around for a long time. And I think it's high time for people to pay attention. We look at the story, many under [ tensions, ] presumptions that people have had about some of the trends within the business have changed. And it's worth taking a look -- a closer look in the debate. I'm joined on stage here by Michael Benkowitz, who is, get your title correct, President and Chief Operating Officer.

Michael Benkowitz

executive
#2

Got it.

Hiroshi Shibutani

analyst
#3

Correct? Terrific. So I think many of you who have known the story for a long time have known Martine and the brilliance that has really been the integral to her coming up with this company and really establishing United as a franchise in this orphan indication. We also have, in the audience, James Edgemond. So James thinks he's safe sitting there, but we may call him out episodically if we need to. But I think this is a really special opportunity to get to talk to you, to see who you are, et cetera. And it speaks to also the larger, broader voice that is very integral to and maybe just a little bit inside baseball inside Wall Street, but just the level of communication on this story. A quick shout-out to Dewey Steadman, who is in the Investor Relations function, who, again, I feel is very emphatic that this is a story that has had such opaque visibility candidly. It's a tough market. It's a tough story, but I think being able to grasp on where the hooks as we're climbing this wall to figure out the investment thesis on the stock is very essential. So Michael, thank you for joining us.

Hiroshi Shibutani

analyst
#4

And I'll start by asking you a little bit. Tell us about your background, what brought you to the company, kind of what's on your plate in terms of the mission-critical things that you see as your objectives to keeping United still going?

Michael Benkowitz

executive
#5

Sure. Thanks, and thanks for having us here. We're really, really thrilled to be here and have a chance to talk about our story. So I joined the company as an employee about almost 10 years ago. Prior to that, I was in -- doing some business consulting, and United Therapeutics was a client of mine, and I was providing some consulting advice to the Board of Directors. So I got to know the Board. I got to know Martine, the rest of the then management team at the time. And she, along the way, as I said, about 10 years ago, asked me to come inside and join the company as effectively a Chief Administrative Officer. And as I'd like to joke with people, I basically had responsible for all the things that nobody else wanted to deal with. And so I took on a lot of responsibility for overseeing a lot of back-office functions and got to know the business and grew with the company in terms of my competence in the biotech space. And then about 4 years ago, our President and Chief Operating Officer -- co-CEO and President and Chief Operating Officer resigned. And I got the call from Martine again and as she said, "I think you're ready. I'd like you to take on the role of President and Chief Operating Officer." And I said, "All right, I'm in." And so it's been coming down. We had another learning curve over the last 4 years, but it's been a great ride. It's a great story. We're very passionate about what we do, not only at the executive level, but really down to every single employee. It's a really unique company and culture and that the -- it's very mission-centric. And I know companies talk about that all the time, and it's really true at United Therapeutics, just because of the roots of the company, why it was founded, trying to find a cure for Martine's daughter, who works with the company, that's walking the halls every day, so we get to kind of see it and live it every single day.

Hiroshi Shibutani

analyst
#6

Yes. No. I think there's that understanding of kind of the depth and tenacity of that culture is very much part of what's understood about the story. It's just been a little bit harder to sort of crack in and understand and figure out what makes things tick. I think one of the things, it's the definition of a franchise, right, a dominant presence across the space. And you think about developing medicines to address these patients. And over the last decade, just thinking about sort of the infused versions, the inhaled, the oral development, coming across all the macro history of developing that portfolio of drugs was a journey, which had its bumps and bruises, et cetera, but certainly -- and there's further to go in terms of like addressing the needs of patients without a doubt, but it's still transformational. For investors' minds, however, there's kind of a time limit. And what was always out there was this sense that there was a cliff, so to speak. Generics were coming. And frankly, anyone who read through the Ks and Qs knew that there are also a lot of courtroom battles happening in the background, tends to be a little bit less visible to The Street. A couple of those things have changed. I think one of the central debates now is what's happening with Remodulin and what's happening in terms of the generics are coming, generics are coming. It took a while to get here. They got here, hasn't had much of an impact. And there's kind of 2 ways to talk about it specifically, maybe, there's the subcu portion, which we'll get into a little bit more later. There was a little bit of courtroom drama, which I think sort of flipped your way unexpectedly or maybe not in your mind. But on the IV side, why is it that we're really not seeing any impact from generics, in particular on the IV side, where there's no constraint of having some sort of a cartridge? And also, why is it -- and I know that it's a little bit of sort of the WACC pricing of the generic is just a little bit sort of like manufacturer-suggested sticker price or whatever. So why is it that there doesn't seem to be any evidence, or maybe I'm wrong, of kind of pricing pressure, given now that, actually, we are seeing multiple generics? Talk to this issue of why is it not as that as we have been all hearing.

Michael Benkowitz

executive
#7

Yes. And I think the way this has played out is, not to toot our own horn, but it has played out about as well as we could have expected and how we had predicted and what we have been talking about for the last 5 years. So it's just -- it's not your typical space with where you have a generic entrant. And so I think it starts with the fact that there really is limited peer pressure. There's a couple of reasons for that. I think the pricing certainly works in our favor. I think the fact that it's a small disease space. And so when you take the 30,000 to 40,000 patients that have PAH, and then you whittle that down to the even much smaller number that are on Remodulin and break that out among the various payers, the impact to an individual payer of having a patient on this therapy is just not that great. So when you don't have a huge difference in price, and you don't have a lot of patients that are really driving the cost at an individual payer, you're just not going to see a lot of -- you're not going to see a lot of pressure. I think it also helps that this is a medical benefit drug as opposed to a pharmacy benefit drug. So it's a much more manual process. You don't have this automatic switching of patients that you see on the pharmacy side. So I think those are -- so I think it starts there. And then secondary to that is the -- I think the relationships, the brand equity we've built up with the physicians. So there's really no interest on the part of doctors to switch these patients. Other one is I think they value what we brought to the community. They value the investments we have made. They value the investments we are making and developing new therapies, more convenient technologies and trying to find a cure for the disease. These are also very, very sick patients. And I think when you get a patient that has to go on Remodulin, they're very fragile. And I think that the doctors are really reluctant to mess with that and experiment with a generic, which, while the FDA says it's equivalent, the doctors know it's not necessarily equivalent. And a lot of these physicians have been around for a very long time. And they, hey -- they lived through, through all that experience, and they know that there is some bioequivalent differences that are allowed. And then, in fact, what we've even seen in the limited transitions that we've had from Remodulin to generic is about 10% of those have had to transition back because due to tolerability issues or adverse events or worsening, and so some of these patients have ended up in the hospital. The doctors are switching back to Remodulin, and they've stabilized. And so I think that's a key point of it. And then the third thing, I guess, coming back, there's a payer component, but there's also a patient component, which is there's really no cost difference for the patients. We provide co-pay card assistance for commercial patients. We're also providing pre-mix for the IV patients. So we've got some convenience factors and some services that I think both the patients and the doctors recognize. So it's really, I think, a combination of various factors that have us where we sit today.

Hiroshi Shibutani

analyst
#8

And then just to keep everyone on the same page, the whole flow line experience was very much about the question of switching patients over to another formulation or generics and how brittle and vulnerable these very sick patients can be and the problems that they've ran into, which I think created a little bit of a bad after taste with a long memory in the minds of physicians.

Michael Benkowitz

executive
#9

That's right.

Hiroshi Shibutani

analyst
#10

And I think what my team was modeling is we originally thought about how new patient starts might be the way to go. And yet, based on the commentary that you and Martine shared during the quarter, you talked about it was like these high-dose patients, which kind of makes sense because I think some of the pricing models are based upon the more drug you get, the more you're paying to a certain extent.

Michael Benkowitz

executive
#11

That's right.

Hiroshi Shibutani

analyst
#12

So from that standpoint, if I'm a payer, I'm sitting here looking at the spend on some of these high-dose patients, they might be the more visible targets to switch over. That kind of flies in the face a little bit of this whole notion that you want to be careful about transitioning these patients. Why aren't we maybe seeing a difference, seeing more the new patient starts being moved over? And are we actually seeing a bit of a seasonal phenomenon, so we better gear ourselves a little bit to watch the first half of this year to see if that -- the next tide is going to come in on that phenomenon?

Michael Benkowitz

executive
#13

Yes. I mean I think we're obviously monitoring us on a weekly, if not daily, basis because we get the feeds from -- in terms of referrals and starts from our specialty pharmacy partners. So yes. So I think the question around the high-dose transitions is really a function of one group of patients. And these are those patients that are on the dual eligible Medicare/Medicaid, which is a very small percentage of our patients. And so that was the -- those were the patients that initially transitioned over. And then, as we described, I think, on the call last week, those transitions have slowly declined and really value the trickle. We had one in December, and I'm not sure we had any in January. And so that really has really slowed. And so it's really just that group of patients. And then you have onesies, twosies along the way, but it was just really a specific patient type that we saw a transition over that's decline. The new patient starts has been -- I think it goes back to what I said about the doctors and their belief in the brand and their belief in United Therapeutics. And they're just not ready for the generic drug. In fact, as we've talked about in the last couple of quarters, we've actually seen a record high number of new patient starts for Remodulin, which is interesting. And I think, actually, part of that is Sandoz is out there. They contracted with a company that have a sales force. I actually think that share of voice and increase -- share of voice has worked in our favor. We have our folks out talking about Remodulin, their folks out talking about infused treprostinil. The doctors clearly have shown, at least up until now, they have a strong bias and favor of the brand. And so that's in order to our benefit.

Hiroshi Shibutani

analyst
#14

Interesting. Okay. No. And obviously, Sandoz is they're no dummies. They took a very stealth approach, which is appropriate, thinking about creating a group of folks who understood the patients, et cetera, but that's actually built a share of voice. Just talk a little bit about the RemUnity pump. So one of the things when we had a physician survey last summer, we talked about all these different delivery devices, which obviously had sort of patient advantages, more patient friendly, quality of living, et cetera, which we, hardcore biotech analysts, think of as being kind of largely soft and squishy, things that we're not going to move numbers on. But the doctors felt that, that was very compelling. We were also watching a lot of these devices get to the regulatory gating process. And obviously, the fully implantable is kind of like one of the end game goals, but that's going to struggle to sort of get out onto the market. Congratulations. You do have the subcu RemUnity DEKA pump coming. That was also one of the things which is going to benefit from this successful legal action where you've kind of have the cartridges cornered on that. Tell us how the RemUnity launch is going to be. My sense is that there's kind of a limited number of these cartridges. Are you looking to switch everybody over and defend the fort? Just sort of what's the RemUnity launch point to look like and the impact on that subcu portion of the market?

Michael Benkowitz

executive
#15

Yes. So we're very excited about RemUnity. This is part of our -- I think our broader strategy. And I think you've heard Martine talk on prior earnings calls about this notion of approved and improved. And I think this fits very nicely within that mantra. And I think we're really trying to do that with all of our products, not just Remodulin, but Tyvaso with a brief study, which we'll have a chance to talk about, and then also with Orenitram. And so it was very -- a lot of excitement around the approval of the RemUnity pump. And so in terms of launching for that, as we said in our press release last week, we're working towards a July 4 launch of that product. We think that the benefits that, that brings to the patients is, I mean, it's a 21st century technology. If you look at the current MS3 pumps which were developed in the '90s, and it's just more advanced technology. And so what that brings is a sleeker profile. It's much more discrete, and that's, believe it or not, very important to patients. The patients get to this stage in their disease, and they're having to go on a pump. There's a lot of resistance because of the stigma associated with being on a pump. So if you can give them something that is more discreet and not as obvious, that certainly is attractive to them. It's -- it will be more convenient because they'll be given prefilled cassettes. They won't have to do the work of having to fill their own drug every 2 to 3 days. They'll just snap the cartridge in and out. So from a quality of life standpoint, it's also water resistant, so they can take a shower with a pump, which they can't currently do with the MS3. So these little things that we don't always think about, but as a patient with the disease, it's the minor inconveniences that really make an impact. And so I think there'll be a lot of attractiveness on the part of patients because of that. It's also got some enhanced safety features with some better alarms and notifications that just make it, I think, a little bit safer than what's currently out there. So in terms of the launch and how we transition, having said all of that, and I do think that patients, by and large, once they see the pump and experienced it and understand its benefits, vast majority will want to convert over, but not everyone. I mean, again, you have really, really sick patients here. And if the patients feel like they're stable, they may not want to mess with anything. And if they want to continue on the MS3, and that's fine. And I think we -- from a supply standpoint, we have enough to affect this transition over a period of time. So it's not like we're going to have to force switch everybody on day 1. So we'll roll it out, and we'll be as aggressive as we can in terms of promoting it. And if anybody that wants to switch over can switch over. And certainly, we'll encourage that with new patient starts. But I think it will play out over a period of time. But I'm very confident in our ability to produce enough supply for patients for those that want it and then know that we've got enough of the MS3 to affect that transition over whatever time period we think we need to.

Hiroshi Shibutani

analyst
#16

Got it. So it sounds like you'll have capacity to move over in a bold case scenario, et cetera? RemUnity comes for all who want this.

Michael Benkowitz

executive
#17

Yes. That's right.

Hiroshi Shibutani

analyst
#18

Perfect. Pricing and margins on the pumps, is there -- any dynamics there? Is it going to be sort of a pressure point in terms of getting people not to switch?

Michael Benkowitz

executive
#19

If anything -- we're still sorting through the pricing issue. If anything, the RemUnity pump will be less expensive than the MS3.

Hiroshi Shibutani

analyst
#20

Got it. Let's move over to the Tyvaso story, the inhaled franchise. And so I always thought that the inhaled as sort of cumbersome, just by nature of the number of times a dose, et cetera. Tyvaso or inhaled therapies, in general, was kind of caught in the middle. The infused were always kind of the cornerstone. And the oral therapies have really sort of come up gangbusters and sort of finding the fit. And then out of nowhere, kind of data starts knocking, then all of a sudden INCREASE study work.

Michael Benkowitz

executive
#21

Yes.

Hiroshi Shibutani

analyst
#22

Talk to us about sort of what you're going to do with this data now and sort of like what are the next steps and the time lines to just sort of getting the label expanded for this indication. And then I want to follow through in terms of like who these patients are and stuff like what are concrete next steps...

Michael Benkowitz

executive
#23

Yes. So we're...

Hiroshi Shibutani

analyst
#24

When are we going to see the details? And what are the next...

Michael Benkowitz

executive
#25

Yes. So top line data, we released last week, as you know. And so we're following through the detailed data, working on the primary manuscript, which we'll submit here probably in the next few weeks. And then we were accepted at a late-breaker for the ATS conference coming up in May so we'll do, I think, a pretty in-depth presentation at that conference. And I expect we'll probably issue a press release around that with more details around the data and then working towards an FDA filing in the summertime.

Hiroshi Shibutani

analyst
#26

Okay. Great. I'm going to be a bully about time lines, and Dewey knows that this is the usual BS that The Street does. But trying to sort of like peg time lines and keep you to it because, I mean, historically, every company has a challenge of identifying the time lines, keeping to it and internally having what you have and then meeting and I give you beating expectations, which I think would be helpful for the stock from that standpoint. But let's talk about these patients. It's a -- the Venn diagrams overlap to some extent. And I think that it was discussed, broadly speaking, in terms of what the epidemiologic population is like. But what are the real patients that you're thinking that the INCREASE study identified for you? And where are you in terms of thinking that you're already interfacing with either those patients or the physicians or the additional incremental work that needs to get done? What is the -- how do you make the actualization of the commercial opportunity?

Michael Benkowitz

executive
#27

Sure. Yes. So we estimate that there's about 230 patients in the U.S. with ILD.

Hiroshi Shibutani

analyst
#28

Yes, big number.

Michael Benkowitz

executive
#29

And based on market research and the literature, the estimate puts the PAH-ILD population at about 15% of that conservatively, so that's 30,000. And it could be bigger. The challenge you have, right, is in order to diagnose PAH is you have to do a right heart catheterization and assess the hemodynamic data to see if you meet the definition of PAH. Well, in this population of ILD patients, there is no currently approved treatment for the PAH portion of their disease. The right heart cath is a pretty invasive procedure. So doctors aren't going to do a right heart cath for no reason, right? And so I think what we'll see -- yes, so that's sort of the first piece of it is that we're going to have to educate the doctors that aren't currently seeing these patients that they're going to need to do a right heart cath to really assess whether they have pulmonary hypertension. And so that's why I say it could be -- the 15% could be conservative. It could be higher, but our working numbers are the 30,000 patients. We think that's a plenty big patient population for us, and we can make a lot of inroads with Tyvaso in those patients. The overlap, as it were, is not as much as you think. These ILD patients are typically seen by probably 90% by pulmonologists, 10% by cardiologists. If you think about the PAH patients, it's more of a 50-50 split. We started preliminary launch planning. Our estimate is that there's probably that 20% to 25% overlap in doctors better seeing patients. And so there's a number of doctors that we don't have, and we'll comment on the institutions, not comment on the specific doctors right now. And so that certainly augurs for us expanding our sales force to make sure that we're able to continue to do everything we need to do on the PAH side to grow to proximal revenues in PAH and achieve our goals there while maximizing the opportunity in the PAH-ILD population.

Hiroshi Shibutani

analyst
#30

Is James going to give you a budget to expand that sales force? Is that level of confidence there? Or is that still a discussion to be had?

Michael Benkowitz

executive
#31

The level of confidence is there.

Hiroshi Shibutani

analyst
#32

I think there have been efforts historically to trying these prostacyclins for this patient population and hasn't been that successful, broadly speaking, and therefore, the base case going into some skepticism. Remind us what the reasons why it hasn't and why they had base, in particular, in health delivery?

Michael Benkowitz

executive
#33

Yes, yes. And I think it's not just prostacyclins. It's at the PAH -- more broadly, at a PAH therapy. So I think there's been about a half dozen studies in this particular population with systemic vasodilators. And so the problem with the systemic vasodilators is you end up with what they call the acute mismatch, where you've got the drug going through and that -- veins are dilating, arteries next to damage, alveoli. And you want those arteries actually to remain constricted because you result in -- you get hypoxia. And so the nice thing about the inhaled therapy is there's something about Tyvaso. They know which arteries to go to. So they're going after the healthy arteries next to the healthy alveoli. And so you're getting the drug to the right part of the lung to help the patient.

Hiroshi Shibutani

analyst
#34

Right. Okay. So it's literally just comes down to sort of anatomy physiology that the drug is getting down to the airways, which we're interfacing with a vasculature, and that's the correct matching essentially. These are matching that you need to sort of get the therapeutic benefit. Okay. And then just to clarify one thing. There's a couple of device folks, there's a little company that has an alternative. And you guys have also interfaced with folks who are looking at different ways to make less cumbersome the whole idea of taking inhaled drug. But for this opportunity, in particular, I think people have looked at some of the data, whether it's forced expiratory volume, FEV, or sort of how the inhaled drug substance is actually delivered, whether it's a DPI or not. There's a distinction in terms of nebulizer versus DPI for this ILD indication. I made the question too complicated, but we need to recognize that there's a -- that the delivery mode of the inhaled therapy also matters, right.

Michael Benkowitz

executive
#35

That's right. We think -- well, we believe that, that could certainly be the case. And that's something that is we're looking to -- we're certainly going to take a look with our DPI at looking at using that in this population, but it needs to be studied because that is a very fair hypothesis and one that we're looking at ourselves.

Hiroshi Shibutani

analyst
#36

Great. Let's move to the orals, Orenitram.

Michael Benkowitz

executive
#37

Yes.

Hiroshi Shibutani

analyst
#38

If people don't know, it's Martine Ro spelled backwards. So Orenitram oral, a couple of hundred million dollars drug has been talked forever about $1 billion. Martine sort of always very sized the pipeline, the sort of ambition, et cetera. How do we get to that number on Orenitram? There was a little talk about the comment that was made during the call about the FREEDOM-EV study that's going to continue to drive an inflection. FREEDOM-EV was a very long narrative, et cetera. It's out there. Yes, morbidity and mortality makes a difference. How do we get anywhere close on Orenitram to that $1 billion number? What's the path?

Michael Benkowitz

executive
#39

Yes. I think it's several points. So certainly, it's leveraging and capitalizing on the FREEDOM-EV data, which if you think about it, the data has been out there for a while, our ability to really promote to it, the way we would like to. We've only been able to do that for -- well, since the middle of October. So it's a little bit early days in terms of sales and marketing and commercial effort. But in that period of time, we certainly saw an uptick. And I think that was really, I think, what the genesis of some of Martine's comments around the inflection point. We saw about a 20% in the fourth quarter increase and starts compared to what our historical trending was. We saw an uptick there and we feel that as we head into 2020 and beyond, we're going to going to continue to be able to capitalize on that data. It's contemporary data. It's compelling. And frankly, every time I look at it, I'm just continued to be blown away by how impressive it is. And if you think about it, it's the only oral prostacyclin that's shown a delay in time to clinical worsening. It's shown improvement across key clinical measures, which is becoming an increasing focal point on the part of doctors, and then it has this indication of a mortality benefit. And I think as you compare and contrast that to the competitor drug, I mean, their own data shows that patients aren't getting -- and the registry are not getting better on the drugs. They have a clinical worsening. And then I think we're all aware of what the survival issue was with their drug. So it's just -- as you know, PAH and the doctors, it's hard to change their mindset. It takes a little bit of time. And -- but we're doing it. We've had physicians that, in the past -- historically, based on the FREEDOM-C and the FREEDOM-M studies, that's refused to use Orenitram, and now are taking another look and putting in prescriptions. And so it's just -- we're going to have to continue to regain and build that level of trust with the drug, and we'll get there. It will take a little bit of time. So I think that's really why we believe that over the medium and long term, we have the opportunity to really start to see significant growth in Orenitram. I think the other thing that's sitting out there and is not too far away is a new formulation of Orenitram, which we call OreniPro, and that's a once-daily formulation of Orenitram. So currently, right now, patients are taking drug -- taking Orenitram 3 times a day. And so that's not the best. But if you're sick, you'll do what you have to do. If we can get to a once-daily formulation, that will be much more attractive, I think, to both physicians and the patients. We also suspect that, that will help address some of the tolerability issues that are inherent to prostacyclin therapy.

Hiroshi Shibutani

analyst
#40

Right. Especially getting started with that. When are we going to start to hear about the data on this once a day, whether it does the same thing?

Michael Benkowitz

executive
#41

I think we're still -- we're sourcing -- I know. I know. I know. I'm going to say in the next couple of years. So we're still working on the formulation. The formulation work is ongoing this year. And maybe I'll just leave it at that. And so I think we've got to get the formulation right before we can talk about time frame to launch.

Hiroshi Shibutani

analyst
#42

Okay. I'll be nice this time around. I'm going to let you pass on that. Oral drugs, obviously, ralinepag hit a nice price to be able to get a hold of that compound, which makes a lot of sense. Give us an update in terms of where we are in terms of being able to see data there because we're in Phase III when you picked that up from RemUnity.

Michael Benkowitz

executive
#43

Just starting Phase III, right? So very -- they have the protocol design, and we're just starting to activate sides. So as I think you know and probably most of the audience knows, there's actually 2 studies we're doing with ralinepag. There's the -- what we call the ADVANCE OUTCOMES study, which is your contemporary clinical worsening study. So it's a driven study and the end points on that study look like what we saw, what we're going to be, what you saw with Griffin and the other outcomes-related studies. So that's a large study. It's about 700 patients. That has started to -- that is enrolling right now. It's hard to put a time line on that because it's event-driven. So you have to wait for a number of events to accrue. And I think the guidance we've given around that is we think that that's going to be -- you'll be able to read out, launch that in the medium term, so mid-2020s. But hopefully, we can accelerate that and move it up a little bit faster. The second component -- the second study is the ADVANCE CAPACITY study. So that's an exercise capacity study. It's looking at changes in oxygen uptake from baseline over a 28-week period. So that's a smaller study. And because it's timed a little bit, that one should enroll or should be completed I would think sooner than the OUTCOMES study. From a label-enabling perspective, either one of those independently could result in a label, right, depending on the results in the p-value. So either of those come out of that could get to p-value of less than 0.01, that would be label-enabling. Combined, we can -- we have a little more flexibility. We can go up to p -- a 0.05 p-value, using 1 as a confirmatory study for the other.

Hiroshi Shibutani

analyst
#44

By the time we get to that point, ralinepag is, let's say, the trial works and it's commercialized, we're going to go up against Uptravi. Essentially, it is kind of like peak sales moment here. And so a question that the commercial interface is going to be, why would I try this? Or why would I switch? So when you think about the data we're going to get and the label you are aspiring to, is there something that you're going to be able to equip your sales force with that's going to be differentiating, that's going to actually be a very straightforward compelling reason why ralinepag instead of Uptravi by the time you get through all of this?

Michael Benkowitz

executive
#45

So we expect 3 things, so 3 different [ trays. ] One is once daily versus twice daily. And that'll make it -- that will make a difference. Second, again, similar to what we talked about with Orenitram, the once daily, we expect that, that will help with the tolerability issues and make it a little bit more tolerable for patients than what they experienced with selexipag. And then third, and we'll see to see how the trials come out is, obviously, we'd love to see some improved efficacy.

Hiroshi Shibutani

analyst
#46

Okay. Great. One last thing, there was -- a little bit messy quarter because one of your distributors, et cetera, sort of like screwed up their ordering. It's like, really, why does this happen? And is it a commonplace thing? Was this a one-off opportunity where the stock could get down and people can follow my recommendation? But like what is it about the ordering flows and the sort of like the whole sort of industry map and the supply chain that this could possibly happen and you get the optics of this weird headline, where, oops, 3Q over 4Q was please even it out a bit? What the heck is with that?

Michael Benkowitz

executive
#47

Yes. So it's -- you don't have to change your recommendation. It is really just a function of -- on the distributor side, I would put it up to -- it's almost like an administrative error. So they had double counted some dispenses that were going out the door. And you actually went back to -- -- started, I think, in the second half of 2018, was not material then and then just kind of slowly built. And they got to, I guess, the fourth quarter of 2019, somebody discovered it. Okay, we're going to fix that in one -- we're going to kind of correct our sins in one fell swoop.

Hiroshi Shibutani

analyst
#48

So it's idiosyncratic but not something that we should think as a baseline data.

Michael Benkowitz

executive
#49

It's not. And as we said on the call last week, if you look at the orders, at least through the first 2 months of this year, they're back to where we would expect to get on the patient demand and starts.

Hiroshi Shibutani

analyst
#50

Then finally, as a thank-you treat to the people who actually came, this slide that's behind you looks kind of a cross between [ Justice ] and Wakanda. United Therapeutics has a history of doing these very unusual annual reports and et cetera. Dewey is this like your Easter egg hint as to what the annual report is going to look like? And where is your office in this map?

Dewey Steadman

executive
#51

So our office in the map is actually on the very far left, you can actually see our units here that we've built. It's where RemoLife is, pretty much. But in terms of giving things away, I don't think it really gets anything in the way. We've talked about a lot of these programs that we're looking forward to a lot of these programs and the research that we have coming up and moving in eventually to this tour for PAH, which is organ replacement with the patients themselves. We're not replacing the disease with another disease, rejection. You're replacing the disease with an impressive network.

Hiroshi Shibutani

analyst
#52

Okay, perfect. A lot of great story lines and issues to debate and chew on here with an opportunity. So Michael, thank you very much for joining us.

Michael Benkowitz

executive
#53

Thank you.

Hiroshi Shibutani

analyst
#54

Really appreciate it. Okay. We'll close this out here with United Therapeutics.

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