Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2022 Earnings Webcast. My name is Chantel and I will be your conference operator today. All participants on the call portion of the webcast will be in a listen-only mode until the question-and-answer portion of this earnings call. [Operator Instructions] I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Good morning. It’s my pleasure to welcome you to the United Therapeutics Corporation third quarter 2022 earnings webcast. Accompanying me on today’s call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; and Pat Poisson, our Executive Vice President of Technical Operations; and Dr. Leigh Peterson, our Senior Vice President of Product Development. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. After today’s remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. A full prescribing information for these products are available on our website. Now, I’ll turn the webcast over to Dr. Rothblatt for an overview of the third quarter 2022 financial results and business activities of United Therapeutics. Martine?

Thanks, Dewey. Good morning, everyone. Currently, we are helping about 12,000 patients, including over 10,000 treprostinil patients, a high mark for our company. And we are making great progress on our goal of 25/25, meaning helping 25,000 patients by the year 2025. Now, achieving that goal will require annual growth in patient adds per quarter. Over the past year, we have increased our patient adds per quarter by about 66% from our historic rate of around 300 per quarter in 2021 to around 500 per quarter in 2022. Of course, there are monthly ups and downs and quarterly variability, but maintaining even half our current growth rate for the next three years seems eminently doable and will allow us to nail 25,000 patients by 2025. Further supporting the achievability of continued growth in quarterly patient add rate is that we have really just begun with multiple new products and new product information. For example, we have just started our Remunity relaunch. We have just released our EXPEDITE top line results for Orenitram, and we have just commenced our WHO Group 3 penetration of ILD with Tyvaso. Then on top of all of this, we are at the very beginning stages of a truly warm embrace by physicians, patients, and payers of Tyvaso DPI. Hence, with three years to go to 2025 and a 30,000 patient Group 3 market waiting to be penetrated with Tyvaso. We feel confident that year-after-year we can increase our quarterly patient adds at the rate needed to meet our announced goals. Now, upon getting even close to 25/25, we expect our revenues will be about double what they are now, since right now we have about half that number of patients. I believe that level of double PAH revenues will be sustainable well into the 2030s…

Thanks, Martine, and good morning, everyone. Overall, we’re extremely pleased with our third quarter commercial performance. We set a number of records on an overall and product-by-product basis during the quarter. But I want to highlight three of these milestones that we’re particularly excited about. First, for the last couple of quarters, we have been saying that we’re effectively at a $2 billion revenue run rate. In the third quarter, our total revenues crossed $500 million for the first time in our history, which puts us in fact on a $2 billion run rate. Second, as Martine mentioned, we exceeded 10,000 U.S. patients and approached 12,000 patients worldwide on one of our treprostinil therapies, Tyvaso, Tyvaso DPI, Remodulin, and Orenitram. Finally, Tyvaso revenues exceeded $250 million for the quarter, which puts that product on a $1 billion annual revenue run rate. As many of you know, a drug that generates $1 billion in annual sales is widely considered to be a “blockbuster product.” So the first – for the first time in the United Therapeutics history, we have a product that has reached blockbuster status, at least on a run rate basis. These results are due to the efforts of our commercial and medical affairs teams who have been working hard all year, but have been particularly effective the last two quarters to help get us to this point. Now, I’ll provide a little bit of color at the product level, starting with Tyvaso. As I said, we reported a really strong quarter for Tyvaso, which was driven by a number of factors. First, the third quarter was our first full quarter with CMS or Medicare coverage for patients with PH-ILD, so that prescribing obstacle has been removed. Second, our continuing efforts to educate prescribers, particularly those ILD specialists, to…

Mike, that was a raft of really great news. So I was totally accurate than that to tee up, I'll say. [ph] Operator, would you please open up the phone lines for any questions?

[Operator Instructions] Our first question comes from Eun Yang with Jefferies. Your line is open.

Thank you. Great quarter. So if I hold you correctly, you added additional 500 patients to Tyvaso this quarter. That’s the same number as in the second quarter, but sales are a lot higher, because I guess it’s according to your comment DPI patients got on pretty early on. But at the same time, given, the tremendous sales growth in quarter-over-quarter, is it fair to assume that patients get on Tyvaso, so that DPI, would that be more from the new patients instead of a switcher from nebulizer? Thank you.

Oh, thank you, Eun. We appreciate your question and Mike, I think you got the most context to answer.

Sure. Yes. I think on the revenue, I think the other thing to keep in mind in terms of comparing the number of patient adds versus the revenue growth is that in the third quarter the vast majority of those patients were commercial patients, whereas in Q1 and Q2, we did not have the CMS coverage. So you still had a number of patients that were going through our patient assistance program are receiving free drugs. So, again, those patients will stay in there through the end of the year and start to transition to commercial drug after the first of the year. But that I think, explains some of the difference in the revenue between Q2, Q3, even though the patient adds were about the same. In terms of the DPI – in terms of the patients coming on, I will say that the DPI uptake, the uptakes have been faster on de novo than transitions, and I think that’s just a function of as we’re out talking with physicians they’re not proactively calling their existing Tyvaso patients and to transition them to DPI. They’re just waiting for the next regular scheduled appointment. And so, as I said in my opening remarks, those transitions are occurring. They’re just going to – they’re going to occur over a little bit of time as physicians are waiting for the patients to come in for their next appointment.

Perfect, Mike. Perfect. Thank you. Operator, we are ready for the next question.

Your next question comes from Hartaj Singh with Oppenheimer & Company. Your line is open.

Great. Thank you. Really nice update all. Thanks, Martine. Just one question. I was lucky enough to be at European Respiratory Society in Barcelona a few weeks ago, and it was interesting to hear some of the excitement around the DPI pump. I mean, you have essentially a third generation pump, there second or I guess, versus potential competitors that could launch on the market whenever, whether it’s this year or next year or the year after that. But can you just speak to that a little bit about how advanced the DPI pump is and why that should be a competitive advantage regardless of competition in the future? Thank you.

Thank you so much Hartaj. It’s so great to hear your voice right at the top of the call. And I am not surprised that you would be at the ERS, you are the person in the industry who’s got I think, nobody above them in terms of your going into the deep scientific research at all of the different medical conferences. But in terms of the details of answering your question, I think maybe again, Mike I might ask you to hit on that since you’ve really shepherded that DPI along the way.

Sure. Happy to. So I think, we agree with you Hartaj. We do think that the DPI does position us well against any current or future competitors. Certainly, I think the convenience the size the fact that it’s one breath four times a day instead of nine to 12 provides, again, a convenience advantage over the nebulizer. So, that certainly helps in that regard. And then I think as we get into looking at potentially other competitors for DPI that come on the market, I think there’s a couple things that work in our favor. One is, one, just I think the – just the United Therapeutics support services, the fact that we’ve been in the market for 25 years, Physicians know us, they know that we’re committed to the patients. I mean, that stuff, that actually matters to physicians. And then as it relates to the pump, I mean, one of the things that we’re particularly proud of and think is really a good thing for patients is that the DPI is what we call a low flow high resistance device. And so that may sound a little counter intuitive, but that’s actually an advantage because with a low flow, high resistance device, you’re relying more on the pump to do the work and less on the patient. So what that does it means that a strong breath is not required to deliver a consistent dose to the distal airways. It’s only one breath per cartridge in under three seconds. And it allows the device to deliver the drug more efficiently. So target dose of Tyvaso nine to 12 breaths. That’s equal to about 54 micrograms to 72 micrograms via the nebulizer. Tyvaso DPI delivers that same equivalent dose with 48 micrograms to 64 micrograms. So it’s actually takes less drug to deliver the same amount of drug. And it also ensures that the delivery that the medications delivered evenly in the airways, as I said and deep into the lung. So, we do think that combined with just kind of the easy kind of open load inhaled administration positions us very well in the marketplace.

Totally. Perfect response, very insightful question. Operator, next up?

Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Hi, good morning. Thanks for taking the questions. Maybe a two part for me on Tyvaso. So I was wondering if you can tell us anything about the current Medicare mix. I think in some real world studies in ILD, it’s about 50% of patients overall would be eligible. So just wondering if you’re seeing something similar there. And then, if that will as we think about kind of the step up and coverage in 2023, maybe you could speak through that Mike. And then just wondering any early read on the duration of therapy with Tyvaso for PH-ILD and how that compares or how that you expect that to compare to the PAH setting? Thank you so much.

Yes, sure. So the first question on the Medicare, on the mix of Medicare and commercial, that’s essentially what we see is it’s roughly a 50/50 mix and it varies month to month, but I think 50/50 is a good to kind of model off of. In terms of what to expect next year with respect to the Medicare patients that are in our patient assistance program transitioning to commercial. So as of right now, I think we have around 700 patients to 800 patients in our PAT [ph] program that are PH-ILD patients with Medicare insurance. So we think a majority, probably not all, but a majority of those will transition over beginning in Q1. So that’ll obviously, I think help from a revenue standpoint as we head into next year. What was the second part of the question?

Duration of therapy for ILD?

Yes, I think, yes, sorry. So on duration of therapy, it’s I think it’s still a little early to tell. I would say early on what we were seeing is I think that physicians were taking their I would say their more advanced stage patients transitioning over to – putting them on Tyvaso. They weren’t staying on as long. I think as the physicians are starting to understand the increased data better, understand how to use Tyvaso, understand how to dose, particularly in the newer treaters that’s starting to improve. So it’s still really, I think, too early to tell whether there’s a distinct difference between PAH patients and ILD patients, because I think, again, we’re still sort of I think, kind of ramping up these ILD treaters on when’s the right time to put these patients on Tyvaso. So I think that’ll play out over time. We would – we’re sort of expecting that once the dust settles, it’s going to be roughly the same.

Great. Mike, thank you very much. Terence, great to hear your new platform there at Morgan Stanley. Operator, next call?

Our next question comes from Joseph Thome with Cowen and Company. Your line is open.

Hi, there. Good morning. Congrats on the progress, and thank you for taking my question. In terms of penetration into that PH-ILD market, now that Medicare is behind us, is it really just patient identification that is key here? Or if there are any physicians that do have identified PH-ILD patients, maybe what are they waiting for before placing their patients on Tyvaso? Thank you.

Yes, very interesting question Joe, and Mike will be able to address it. But just as a tee up as, Mike’s gathering his thoughts here, just to mention that we are talking about 30,000 patients in this ILD market. It is almost like PAH was reborn as ILD. But from the standpoint of United Therapeutics, it’s actually a lot better, because while there are, I’ve actually lost track of how many drugs are approved for PAH 12, as a reasonable guess, 14, almost none of them can be used in ILD because of the very real problem of V/Q mismatch, which I was talking with a physician the other day and they were telling me directly that one time for a patient who they were trying to transplant and gave them a little bit of [indiscernible] to try to help bring down their pressures before transplant saw horrible V/Q mismatch right away, when to inhaled prostacyclin and were able to successfully bridge the patient over to transplant. So V/Q mismatch is a horrible problem. So that basically eliminates all these systemic drugs, either oral or parenteral from the story of penetrating these 30,000 patients. Now due to the amazing work of Dr. Peterson and her team who are on the call and produce the stellar increase results demonstrating the strong safety and efficacy of Tyvaso for ILD. And then you couple that with the wisdom of the FDA in enabling, whether it’s nebulized Tyvaso or DPI to be used in ILD. You have like just a very sweet situation from a pharmaceutical company standpoint of being able to rapidly help upwards of 30,000 patients who were had no previous treatment whatsoever. And this is why you heard the astounding numbers Mike was giving in terms of quarterly and monthly adds, and the big step up that we’ve had from 21 to 22, why very conservatively, we think that that kind of step up averaged across 23 and then average across 24 and average across 25 will sync up with what we need to achieve 25/25. So basically everything is in the right place and it’s up to us to execute expertly. And Mike, maybe if you can just give a few insights on our execution there.

Yes, sure. So I don’t think it’s the case that you’ve got physicians that have diagnosed their patients with their ILD patients with pulmonary hypertension and are just sitting back and not prescribing Tyvaso. I think the name of the game here is actually screening for pulmonary hypertension. And in my opening remarks, I made a comment about the fact that typically when you have a new product or a new indication, there’s a lot of enthusiasm, but then it just kind of takes time for kind of traction to build. And we haven’t seen that with DPI, but I think PH-ILD is probably an example of the norm where there’s a lot of enthusiasm, but then actual call to action and getting people to move and change behaviors has been, I mean, it’s been good. It’s probably been a little bit slower than what we would have expected. But it’s starting to happen. And I think part of that in the case of PH-ILD is the fact that you’ve got, particularly with these ILD treaters there’s this term that I continue to hear called like therapeutic nihilism. So these are like typically really, really sick patient, and I think the doctors are really just unless the patients are going to get a transplant there, their long-term outcome is not good. So there’s this behavior modification, behavior shift that we have to undertake and execute with these doctors to educate them on the fact that the prognosis for these patients, if they have pulmonary hypertension, is like twice as worse than if they just have ILD. That’s sort of the first thing. And then the second thing is that we have an indication to treat the symptoms of pulmonary hypertension and so we’re starting to – we’re starting, we have been making inroads there. I think we’re – there’s still a lot of opportunity ahead of us. I do think at some point, and I’m not sure what the quarterly patient number is, but there’s got to be a tipping point here where I think the floodgates are going to open, as these ILD treaters become more accustom to screening their patients. And then once the patients are started on Tyvaso, they see the benefits. And I think once that happens, like I said, I think we’re going to see just a – I think another kind of step function in our growth.

Perfect, Mike. Thank you so much. Operator, next question, please?

Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Hey guys. Good morning. Great results today. Martine, at the beginning of the call, you were talking about your expectation for quarterly patient adds, even if they were sort of half of what they’ve been in 2022 to put you on track for your long-term targets. I guess in the near to medium term, do you see those adds as largely Tyvaso driven? And maybe just kind of a housekeeping question, beyond the 4Q factors you mentioned like the holidays, were there any favorable ordering patterns in the third quarter that helped the Tyvaso number that we should keep in mind when trying to project 4Q revenue? Thank you.

Yes, thanks Jessica, great to hear your voice this morning. And also once again, just want to having the chance to talk with you here on the call. Thank you for JPMorgan inviting us to speak at the major event that you had in New York honoring women entrepreneurs and women in business and focusing on the importance of that and pass on our thanks to Jamie Dimon. It was really exciting to be with him there at that conference. So, going on to the particulars of your question, I do believe that I’ll answer like the first part, and Mike, if you can answer the second part. So I do believe that Tyvaso will be the big driver of this growth that we anticipate in quarterly adds during 2023, 2024 and 2025. However, as I mentioned my opening remarks, we do also believe there will be contributions from our other products. And at one time, it might have seemed like hopeful thinking that Tyvaso could become a blockbuster. I think we’re there and we’ll continue to grow on that. Right now, it might seem a little bit hopeful to think that Orenitram could become a blockbuster. But with the type of results that you’re seeing in EXPEDITE and we have another even stronger study going on called ARTISAN, which will show the same sort of thing that physicians throughout the world. And you’ve seen these posters, no doubt that ERS and other conferences that physicians have shown that if they aggressively dose Remodulin over a short period of time, bring pulmonary artery pressures down below 35 millimeters of mercury, and then fast switch their patients to a high dose of oral equivalent prostacyclin that they are reporting pretty much like Kaplan-Meier survival level close to a 100% at 10…

Sure. So I think just to your second part of your question was just around any anomalies in quarterly patterns in Q3. Short answer is no. That's something that we try to manage pretty tightly because – I mean, yes, I think we've always talked about the fact that there is variability quarter-to-quarter. And that's true. And to a certain extent there is not a whole lot we can do about that. But we do try and track pretty closely with our specialty pharmacy what they are dispensing against what they are ordering. And so one of the metrics that I always kind of look at is what is the value of what we're selling to specialty pharmacy versus the value of what they are dispensing to patients. And so, generally speaking there is about a 5% to 10% difference and that can go either way. So it could be we're 5% higher on sales versus dispenses, or it could be we're 5% lower, than typically what we see as that smooths out over the course of 12 months or four quarters. So, in the third quarter we were kind of within that range. So, nothing unusual there in terms of dispenses and sales. So, anomalies there. And like I said, we continue to monitor that pretty closely because we do want to have – we want to minimize that variability.

Awesome, awesome. Awesome. Are there time – Dewey says there is time for one more question and he is the boss. So next question, operator.

Our next question comes from Andreas Argyrides with Wedbush. Your line is open.

Good morning and congrats on the quarter. And thanks Dewey for taking my question here. So taking a look, at the evolving PAH treatment landscape, how are you thinking about the commercial dynamics over the next several years between your treprostinil products and therapies with novel mechanism of action that could be coming onto the market in the near future? Thanks.

Yes. So thanks for the question. And I referred to this a little bit in the opening remarks in that UT has a long taken what I would call a therapy stacking approach to our pharmacopedia if you will. We have a number of drugs and they help a lot of patients. But in most instances they are stacked on top of other drugs. And they are stacked on top of other drugs, first of all, because that's how we did the clinical trial. Now what we did is we showed our drugs had such an effect on top of background therapy. Why did we do it that way? Well, first of all, it's a lot easier to enroll a clinical trial on top of a background therapy, which is generally used. If you go in there and you say, there is a background therapy that's already approved and already generally used and you say you have got a clinical trial that the patients have to be naive to all therapy. So first of all, you have a little bit of an ethical issue. I'm not saying it's a definite, hard ethical issue, but I don't often get to say that my degree is in medical ethics, so I'm going to say it. So it is a little bit of a medical ethics issue that it's better to be able to show your treatment works on top of background therapy than to take a patient who has a bad disease. There are approved therapies and you kind of condemn them to placebo only. And what is really the beneficence of that for that patient. It's kind of hard to argue. So we've done Orenitram on top of background therapy and other companies, and for example, in our IPF trial we're on top of nintedanib and pirfenidone as background therapy. So other companies see the wisdom of this too. And a lot of the studies of sotatercept are also on top of background therapy. So I think this is the complexion of, of things in the future. Pulmonary hypertension is a multifactorial disease. There are at least six different pathological pathways that have been identified, plus a cyclin pathway, nitric oxide pathway, even serotonin pathways and thromboxane pathways. So all these different pathways. So when you have a multifactorial disease like this, it calls for a therapy stacking approach because different drugs can help address different pathways. I hope that's responsive to your question. And with that, Dewey, feel free to wrap up the call.

Operator, can you go ahead and wrap up the call? Thank you.

Thank you for participating in today's United Therapeutics Corporation’s earning webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the Events and Presentation section of the United Therapeutics Investor Relations website at ir.unither.com.