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United Therapeutics Corp (UTHR 1.75%)
Q3 2020 Earnings Call
Oct 28, 2020, 9:00 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2020 Earnings Call. My name is Kenzie, and I will be your conference operator today. [Operator Instructions]
I will now turn the conference over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics.
Dewey Steadman -- Head of Investor Relations
Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2020 Earnings Call. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairman and Chief Executive Officer; Mr. Michael Benkowitz, our President and Chief Operating Officer; Mr. James Edgemond, our Chief Financial Officer and Treasurer; and Dr. Leigh Peterson, our 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 Form 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update these forward-looking statements.
Today's remarks may also include financial measures that were not prepared in accordance with U.S. generally accepted accounting principles or GAAP. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in our earnings release available on our website at ir.unither.com. 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 not -- 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. Full prescribing information for these products are available on our website.
Now I'll turn the call over to Dr. Rothblatt for an overview of the third quarter 2020 financial results and business activities of United Therapeutics. Martine?
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thank you, Dewey. Good morning, everybody, and welcome to our third quarter earnings call for 2020. I'm going to be joined on the call today by our President, Michael Benkowitz; our Chief Financial Officer, James Edgemond; and our Head of Product Development, Dr. Leigh Peterson. We really have all good news to report today so it's going to be a very fun earnings call. Let me define the good news into two categories: pulmonary hypertension and pulmonary fibrosis. Let's start with pulmonary hypertension. We had, over the past quarter, the highest number of patients on our treprostinil medicines ever. In addition to that, we've seen double-digit growth in the number of our patients on Orenitram and a number of patients on Tyvaso, that's double-digit growth year-to-year, quarter-to-quarter. On top of that, we've also had solid Remodulin performance, and we expect this solid Remodulin performance to be even further enhanced with two planned launches for 2021: first, the Remunity launch for the patients on subcutaneous forms of Remodulin; and secondly, the ISR, or Implantable System for Remodulin, launch for patients on the intravenous form of Remodulin.
These new product launches are important because most pulmonary hypertension patients declined Remodulin due to its great difficulty of delivery. Indeed, most pulmonary hypertension patients die without ever having access to Remodulin therapy. Speaking of our pipeline for pulmonary hypertension, also great significance is our accelerating progress on ralinepag. We expect both the ralinepag outcomes and the ralinepag capacity Phase III trials to be half enrolled in 2021 and fully enrolled by the end of 2022. Let me now turn to some of the good news related to pulmonary fibrosis. We remain on schedule to launch our Tyvaso product for IPF-associated pulmonary hypertension in April '21, subject to FDA approval on its PDUFA date. We expect to further penetrate that 30,000 patient market for patients with pulmonary fibrosis-associated pulmonary hypertension with the launch of our Dreamboat TreT product by the end of 2021 or possibly early 2022. I'd like to remind everyone that systemic drugs for treating this type of pulmonary hypertension, the pulmonary fibrosis-associated pulmonary hypertension, are contraindicated, leaving Tyvaso as probably the only medicine approved by the FDA to treat this 30,000 patient population. We then expect to greatly expand our pulmonary fibrosis footprint with our TETON study in pure pulmonary fibrosis patients starting in the first quarter of '21. Indeed, we will be filing the IND for this TETON study next quarter.
That 700-patient study should be completely enrolled by 22. So there's a lot of things that are happening, both -- not only in our core historical franchise of pulmonary hypertension, but you can also see that the company is making a steady adjacent market expansion into the field of pulmonary fibrosis, first, by having kind of one leg in two camps with the Group three pulmonary hypertension associated with pulmonary fibrosis and then with the other leg completely in the pulmonary fibrosis side of the fence with the TETON study. While I've been talking about our pipeline, let me also talk about things that are going on at the Phase I and what I would call the Phase 0.9 level of our pipeline. So with regard to Phase I in the -- in early 2021, we will begin clinical development of our once-daily form of Orenitram based on an IND that will be going in shortly. This will be much more convenient for patients than the three times daily form of Orenitram and, I think, will be instrumental in continuing the double-digit growth that we're currently seeing year-over-year in Orenitram. Another exciting activity that I would say is at the Phase 0.9 level is RemoPro.
This is the painless form of subcutaneous Remodulin designed ultimately to go into the Remunity pump. We plan to file our IND in the fourth quarter of '21 and then move into Phase I right after that in '22. Speaking of filing INDs in '21, another IND we plan to file in '21 is for our xeno-kidney project. This is a 10 gene-modified porcine kidney designed specifically to avoid the types of rejection that are common in xenografting and instead to appear to the recipient as no different than another allograft. We expect to file the IND for the xeno-kidney program in '21 and then, due to the unique nature of that type of a product, move directly into a Phase II/III study in '22.
Well, with that overview of our clinical development and pipeline activities, I'd like to next turn the microphone to our President, Michael Benkowitz, to give a review of other aspects of our operations, including commercialization. Michael?
Michael Benkowitz -- President and Chief Operating Officer
Thanks, Martine. Good morning, everyone. As Martine said, overall, we're extremely pleased with our reported revenue performance in the third quarter, highlighted by strong double-digit year-over-year growth in Orenitram, Tyvaso and Unituxin. And when you adjust our revenue growth to account for the excess order that occurred by one of our distributors in the third quarter of 2019, that growth is even stronger. On this adjusted basis, U.S. Remodulin revenues grew year-over-year and 5% sequentially, and Tyvaso and Orenitram revenues grew by approximately 30% each year-over-year. We periodically caution that our revenues represent sales to our distributors and may not reflect underlying demand for our products. Happily, we can report that revenue growth we saw in Q3 is supported by growing demand in the U.S. as reflected by the following highlights during the quarter. First, after experiencing some COVID-related softness and new patient starts earlier during the pandemic, total treprostinil starts returned to prepandemic levels during the quarter. Second, as Martine noted, the number of patients utilizing one of our treprostinil products reached another all-time high. This is the fourth quarter in a row that we've achieved an active patient since its record for our treprostinil products.
We have a record number of patients benefiting from Orenitram, reflecting continuing and increasing adoption of this therapy by physicians following the FREEDOM-EV label expansion last year. We have more patients benefiting from Tyvaso than we have had in approximately five years prior to the commercial availability of oral prostacyclin class medicines. And finally, we are just shy of a record number of patients utilizing Remodulin. In addition to those highlights, we're seeing increases in average dose levels and the length of time our patients stay on our medicines, both of which positively impact our revenues. So we're very pleased all the way around with the momentum and trending of our commercial products. Meanwhile, we are making very good progress toward our nearer-term new product launches. We are building out our field-based medical sales and nursing teams to support the expected Tyvaso label expansion in April 2021 to include patients with pulmonary hypertension associated with interstitial lung disease following our INCREASE trial. We have started engaging with physicians that treat these patients, which, by and large, is a new prescriber base compared to those currently prescribing our products for PAH, in appropriate forums, such as investigator meetings, scientific presentations at healthcare conferences, advisory boards, market research and one-on-one interactions.
The INCREASE data is roundly considered overwhelmingly positive, and the ILD treating community is looking forward to having Tyvaso in their treatment armamenterium for these very sick patients upon FDA approval. Between the momentum we're seeing with Tyvaso and its approved WHO Group one indication and the excitement around the upcoming launch into WHO Group 3, we're well on our way to solidifying Tyvaso as our largest product in the very near term. Our two upcoming Remodulin pump launches are also progressing. In the case of Remunity, our new subcu pump that was approved by the FDA earlier this year, we believe we have overcome the COVID-related delays that impacted the July launch timing. Our partner, DEKA Research, is building commercial inventory. And once we have sufficient safety stock, which we expect soon, we'll be -- begin making the Remunity pumps commercially available. And finally, our partner, Medtronic, continues their discussions with the FDA to clear the outstanding conditions of approval for the ISR, which is our new IV pump. We believe we remain on track for a launch next year, and we are already working with key PAH centers to get them ready for this launch.
So with that, I'll turn the call back over to Martine.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thanks so much, Mike. Operator, I'm now happy to field the calls, and I'll direct them among Dr. Peterson, James Edgemond and Mike Benkowitz as appropriate.
Questions and Answers:
Operator
[Operator Instructions] Our first question comes from the line of Hartaj Singh from Oppenheimer. Please go ahead. Your line is open.
Hartaj Singh -- Oppenheimer -- Analyst
Great. Thank you. And a really, really good quarter, Martine and team. Just a quick question on Tyvaso. You're -- we're seeing a definite uptick in the trend growth over the last few quarters, Martine, as you mentioned, year-on-year, double-digit growth. And then also in our key opinion leader calls, we've noticed that there's a lot of overlap between the physicians treating PAH using Tyvaso there and physicians treating PH-ILD. Do you expect a lot of this enthusiasm to be occurring in those patients and then also Tyvaso uptake in that Group three patients going there? Thank you.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thanks, Hartaj. Excellent question. And good to hear your voice this morning. I think the best person on this call to field the question would be Mike because he is right in the middle of all of the details right now of actually assigning different regional sales managers and their teams among the different types of physicians: those who treat patients with ILD that have never seen really pulmonary hypertension patient treatment options; and those who are normal PAH treatment physicians that, in addition to that, also treat patients with PH associated with their ILD. So Mike would really have the best answers for that. And Mike, if you could provide some color on Hartaj's question?
Michael Benkowitz -- President and Chief Operating Officer
Sure. Thanks, Hartaj, for the question. I think the short answer to the question is it's hard to tell when physicians are writing or submitting referrals or prescriptions for Tyvaso, they're not indicating whether it's a PH-ILD patient or a PAH patient. So it's a little hard to tell if there's some off-label use in that group. What I can tell you, though, about the treating community is -- and as I said in my opening remarks, we do see some differences in that group. I -- by our count, in terms of those physicians that are treating PAH and those that are treating ILD, there's maybe only about a 20% to 25% overlap. And there's sort of an inverse relationship between the number of PAH patients that the doctors see and the number of ILD patients those doctors see.
Or in other words, if you've got a doctor that sees a lot of PAH patients, they're seeing very few ILD patients and vice versa. So what we can see on the referral form are the doctors that are writing the prescriptions. And so what we haven't seen is a lot of new prescribers, which tells us, obviously, that all of the -- the vast, vast majority of these Tyvaso prescriptions are coming in -- are being submitted by your typical PAH doctors. And given the -- just sort of the -- I think the underlying data that we see would lead me to believe that the vast, vast majority are for PAH patients. But again, we don't have the visibility to know exactly whether they're PAH or PH-ILD.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thanks so much, Mike. That's a great response. Hartaj, one little footnote I'd add to Mike's response is it's very interesting to me, just having studied this field for quite a bit, that there are this very substantial quantity of patients in the Group three -- WHO Group three type of pulmonary hypertension, over 30,000 patients that -- for those patients, the systemic drugs are contraindicated. So here, in the field of Group one WHO, we have upwards of 12 different medicines available to treat pulmonary hypertension, and there are just about as many Group three patients as Group one patients, but there are 0, no approved medicines to treat those Group three patients. So it's a screaming unmet medical need, and we are just crossing every finger we could cross that on -- in April, on the PDUFA date that the FDA will give us clearance to translate the INCREASE clinical trial results into an approved treatment for those 30,000 patients, it would be the only approved treatment for those patients. It was a great trial, the INCREASE trial. As you are well aware, Hartaj, we met all of our primary and secondary end points. So I think there is going to be a tremendous amount of excitement among the physicians that finally, they have something to treat those 30,000 patients with. Thanks so much again. Operator, next question please.
Operator
Our next question comes from the line of Eun Yang with Jefferies. Please go ahead. Your line is open.
Eun Yang -- Jefferies -- Analyst
Thank you. For Tyvaso in new indication, PH-ILD, can you comment on your regulatory filing ex the U.S.? And then for TreT, if you use in PH-ILD, do you expect you would need it to run another switching study similar to Phase III BREEZE? Thank you.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Yes. Thank you, Eun, for those very interesting questions and exploring some kind of areas that a lot of people overlook. So I'm glad you've asked those questions. At this point in time, we haven't made a firm decision with regard to the European filing schedule, mostly because we're just like laser-focused on gaining FDA approval to deal with this huge unmet medical need that I just talked about, the 30,000 patients here. So we're kind of like a step-by-step strategy here. And first, we want to be able to successfully get approval into the U.S., and then we'll consider what is the best approach to go as to Europe. The second part of your question is also quite insightful because the Dreamboat TreT device is a much easier to use device than the Optineb nebulizer that we used in the INCREASE study and that we submitted for FDA approval on. And I think most people feel that whatever the captured market would be for this nebulizer, that dry powder Dreamboat device could give you 2, maybe three times larger a market because of its greater convenience. So as you mentioned, Eun, we did -- we do plan to file for approval of the Dreamboat device based on the current BREEZE study in the April -- in April, of 2021, and then that would take its normal FDA approval period. So as I mentioned in my opening remarks, hopefully, we can get that approved, if not by the end of '21, then at the very beginning of '22.
Now whether or not that Dreamboat TreT device is approved for just WHO Group one pulmonary hypertension, which is the population in which we did our BREEZE study, or is also going to be approved for the WHO Group three population, that would be a decision, which is, of course, up to the FDA. What we will do to support that decision and provide guidance is as soon as we wrap up the filing based on the BREEZE one study in the WHO Group one population, we will immediately begin a BREEZE two study in the ILD population or the WHO Group three population. And that way, we will at least have that data available for the FDA if they feel that they are not comfortable to approve Dreamboat in Group three without some data. We should have that data by the time they would reach their PDUFA date for approving the BREEZE device in the Group one population. If for any reason things take a little longer, we'll have that data immediately available. I don't think it's really going to be of much consequence because, in fact, the desperation in the WHO Group three population for any treatment is so large that the Optineb base -- the nebulizer-base form of Tyvaso, I think, will be very rapidly taken up. But you always want to keep building on your momentum and making it easier for larger and larger patient populations to avail themselves of Tyvaso. So we will be right on with BREEZE two data for the ILD population. We'll be right on that immediately after completing the BREEZE one filing. Thanks for your question, Eun. Next question operator?
Operator
Our next question comes from the line of Marty Auster with Credit Suisse. Please go ahead. Your line is open.
Marty Auster -- Credit Suisse -- Analyst
Hey, everybody, thanks for taking the question. Martine, will you indulge my 2-decade tenure to let me ask two questions again?
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Yes, Dr. Auster. One for being Marty, and one for being doctor.
Marty Auster -- Credit Suisse -- Analyst
Thank you kindly. So a couple of things I want to follow up on. First on TreT, you reported that the healthy volunteer kind of part of that study was done. Can you comment at all on the -- what that data look like and the equivalence to what you've seen with Tyvaso? And then can you also talk on TreT about what the supply needs that you're anticipating would be? And then if you think you'll be able to kind of meet where the demand for that new device and that new system might be if you were approved on a first pass approval. The second question was on the xeno-organ side. I think there's something like 20,000, 25,000 kidneys transplanted in the U.S. each year. You probably know the number more specifically. But if you could comment maybe on what the overall big picture opportunity -- I know there's a very long wait list, and I know that you're seeing a lot of people that don't get served. But what is the kind of addressable big picture market opportunity there? And when do you need to think about pulling the trigger to make decisions on expanding and building out your DPF capabilities to kind of start thinking about how to meet some of that long-term demand? Thank you.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Okay. Thanks, Marty. Fascinating questions, kind of things we could like talk in a coffee house for hours over, if we could talk in a coffee house. But with regard to the first question on BREEZE, the PK data, the buildup of TreT devices, Dr. Peterson, if you could at least talk about the PK side. And if you feel comfortable talking about the inventory side, roll into that and if not, I'll talk about that at the front-end of the xeno stuff.
Leigh Peterson -- Vice President of Product Development
Yes, sure. Hi, everyone. Thank you all for calling in. Great to speak with you. So you all know that the TreT study in healthy volunteers, that was -- the primary objective of that was to show comparable PK between Tyvaso and TreT. And that has been completed, and we're actually undergoing the data analysis right now. So I don't have the final, final output package to discuss with you. But I will tell you that, I mean, this was an open-label study. And we're seeing consistent results between the two medications. We're actually seeing -- it appeared at least early on that the TreT device actually seems to penetrate the lung a little bit better than Tyvaso with Optineb. But that also might be because, as you all might know, TreT, you get your entire dose from, like, one to two breaths. And so you just need a tiny little cartridge and you breathe it in, and then you get the full dose whereas with Tyvaso, if you can take like nine or 10 or -- it takes several different breaths to -- multiple breaths to get the full dose. And so that can explain the lung penetration. But again, the final data are being analyzed literally as I'm speaking, and we will be able to get that up to you very shortly. But we definitely do not expect any surprises there.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thanks, Dr. Peterson. Thank you very much. So with regard to the inventory, Marty, I think we're going to be in good shape. In fact, just this week, at the request of our Head of Manufacturing, Pat Poisson, we allocated $5 million for inventory buildup for the TreT launch during 2021. So he regularly visits the MannKind plant in Connecticut where we do the manufacturing of everything. And I feel confident that we'll have adequate supply to meet our needs. As you probably recall from reviewing our proxy, one of our company's four companywide objectives, upon which everybody's bonus is based in the entire company, is that we have to have a 2-year inventory of all commercially launched products at the rate of the product take-up. So Mike Benkowitz and his commercial team, they would provide a forecast to manufacturing in terms of how many Dreamboat TreT patients we expect to garner in the first 12 months after launch, which would be mostly a 2022 thing. And then -- so already in 2021, Pat Poisson and our manufacturing team are making sure that we have two times that amount of inventory built up for at the time of launch so that we can crush that manufacturing and inventory milestone as we actually always have every year for as far back as I can remember. With regard to the xeno question, I think your numbers are quite accurate, Marty.
There are 20,000-plus kidney transplants done. There -- if you get into what are called living-related kidney transplants where people designate a kidney to a relative or something like that, you get up into the 35,000 type of category. Then the next number that comes up a lot is 100,000 people are waiting for kidney transplants and are currently on dialysis. And then the next number that comes up is that there's something like 300,000 people in need of kidney transplant but for various and sundry reasons, they are not even able to access dialysis. So it is -- it's probably one of the largest unmet medical needs in the United States. It's not unrelated to the very high levels of diabetes in the United States, but that's not the only reason for end-stage renal disease. So kidney transplantation is a cure for end-stage renal disease. And people such as ourselves have been working many years in order to have an unlimited supply of transplantable kidneys that would be well tolerated by the recipients. And I think that's what we are on the cusp of here. We've spent several years knocking out or knocking in gene after gene and then testing the results to make sure that we had really the ideal level and the ideal combination of genes that have been knocked in or knocked out. And then we've also constructed a pathogen-free facility, which is the xeno-equivalent of a good manufacturing product in Alabama. And it -- or it is those kidneys coming out of that DPF facility which will be the first ones going into the clinic, which is why I mentioned that we expect to file an IND in 2021 based on kidneys coming out of that DPF. In terms of when we would pull the trigger on building a commercial scale DPF, the one I just referred to in Alabama is a clinical trial scale DPF.
The commercial scale DPF will take a couple of years to build and bring into operation. So I think the right time to pull the trigger on that would be once we have a successful result in the first clinical xeno-kidney transplants. And with the -- as mentioned in the beginning of my -- of the call, with the IND going in, in '21, so we will know in '22 whether we have a successful xeno-kidney product. And so that would be the time to pull the trigger. We have already completely designed the facility using our design architects at EwingCole Company in Philadelphia. They specialize in bio/agro type of manufacturing designs. So we have a well-vetted design that's been reviewed by all of the experts in controlling viruses and microbes and whatnot in animal populations. So I think we're ready to like sign a contract pretty rapidly and proceed with the construction. And then that whole facility could be brought into operation sometime during 2024. Thanks for the question. Marty and operator, we have time for one last question.
Operator
Our last question comes from the line of Joseph Thome with Cowen and Co. Please go ahead. Your line is open.
Joseph Thome -- Cowen and Co -- Analyst
Hi there. Thank you for taking my question. And congrats on a great quarter. Just a little bit on Tyvaso in ILD. Can you comment a little bit on how well these patients are identified currently given that, as you mentioned, there really aren't great treatment options for patients. Do you anticipate that the potential approval of Tyvaso in the indication will change this paradigm? And is it your expectation that there are some PH-ILD patients sort of built up and waiting for launch?
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Sure. Let me suggest, like, we give you a 2-part answer to that question, with the first part being given by Dr. Peterson because she was ultimately in charge of the INCREASE study that produced the clinical result in the ILD patients. So she could speak most expertly about those results and -- which were reported at the abstract level at the ATS conference and, I believe, are imminently going to be appearing in a peer-reviewed publication. So she could talk about kind of the medical thing of how well it worked in those patients. And then Mike Benkowitz, our President, who has spent a lot of time thinking about the market segmentation and the approach to the market, can speak more about the second part of your question. Dr. Peterson?
Leigh Peterson -- Vice President of Product Development
Yes, sure. So as you know, Tyvaso worked quite well in the patient population -- WHO three population. And this is -- this was ILD plus pulmonary hypertension. And in this population, the -- for the INCREASE study, the patients actually did have data from a right heart cath, OK? So they had documented pulmonary hypertension. And up until now, since there was no medication for this group, the doctors didn't really -- if they suspected IPF, they -- or even suspected pulmonary hypertension in this population, they didn't give the patients necessarily a right heart cath because even if they did discover PH, there was nothing to treat them so why go through all of that invasive procedure in order to find that out. So we've heard several times that now that there is a treatment, they will be performing those right heart caths to see the degree of pulmonary hypertension because they do have -- they presumably will have an approved treatment relatively soon.
So yes, the identification of this population will definitely be more robust since they have something to give them. And again, also with what Martine said about the publication, so we do expect to publish these results in a major medical journal very shortly prior to the PDUFA date of April. So that definitely will -- what we've also heard from the docs is that once we have that published, that gives them even additional confidence in looking for this -- for pulmonary hypertension in this patient population. And yes, we'll likely -- they have said they will either prescribe or certainly be waiting for the approval if they feel comfortable. So I hope that answers the question. So I give back...
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thank you, Dr. Peterson. That was great answer. And Mike, would you like to add some color on that, that we're getting from all of our medical sales teams?
Michael Benkowitz -- President and Chief Operating Officer
Sure. I agree with everything Leigh said. I think the -- there is a lot of pent-up demand. There's also, I think, an -- there has been, I think, an underdiagnosis of PH-ILD for the reason that Dr. Peterson stated, which is you have these physicians that may suspect pulmonary hypertension. That suspicion typically happens as the -- obviously, as the symptoms become more severe and present themselves. But because there's no treatment out there, the doctors are putting the patients through the very invasive procedure of the right heart cath. All of our interactions with physicians, be it advisory boards, healthcare -- scientific presentations at healthcare conferences, interactions with our medical team suggest that now that there's a treatment available, these physicians suspect that significant percentages of their patient population have pulmonary hypertension and will start to really screen and diagnose those patients appropriately.
So -- and that's really a large part of what we're doing right now to prepare for the launch in April as we've got our medical teams out -- certainly, the key opinion leaders in the field understand the disease and understand the pulmonary hypertension piece related to interstitial lung disease. But as you get into some of the community physicians, we're spending a lot of time educating them on PH-ILD. How do you screen for these patients? How -- what are the things that may lead you to suspect that, OK, this patient has pulmonary hypertension? And then how do you go about arranging for right heart cath to confirm the diagnosis?
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Great. Thanks, Mike. Operator, there's time for one bonus question here. Do you have another person lined up?
Operator
I do. Our next question comes from the line of Liana Moussatos with Wedbush Securities.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
That's excellent. Okay. Hi, Leanna. Good morning.
Liana Moussatos -- Wedbush Securities -- Analyst
Good morning. Thank you. Since COVID continues to be a problem and infection rates are going up and it's affecting our industry, clinical trials and commercialization, can you just give us a brief overview of what has to happen and when you think the timing of this could be resolved between now and maybe end of '21?
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Yes. It's a -- it's like one of these kind of 30,000-foot questions that cover everything. In our company, Liana, we have a risk management group that reports into our Chief Financial Officer, James Edgemond. And this risk management group ultimately has group meetings that involve as many as like 50, 60, 70 people at United Therapeutics. And every week, they issue a report regarding COVID-19 and how it affects all the different parts of the company. So James, maybe if you could provide some color for Liana's question in terms of the overall impact of COVID-19 on United Therapeutics and when we see -- based on inputs we're getting from our risk management group, when we see some of those effects perhaps ameliorating?
James Edgemond -- Chief Financial Officer and Treasurer
Yes. Thank you, Martine and Liana. Good to hear your voice. So as Martine mentioned, internally, way back to the beginning part of this year, we organized leadership -- a leadership team to make sure that across the organization, we were communicating effectively and coordinating with each other with respect to risk management and the impacts around COVID-19 on all areas of the business, from human capital to manufacturing, the clinical trials, product development through specialty pharmaceutical distributors. And it's been a really effective tool for us to make sure that across the organization, everybody is in tune to what impacts there are to the organization as a whole. And I think broadly speaking, everybody has stepped up. All the Unitarians, as we call ourselves internally, have stepped up to make sure that we have understood the various risks and the impacts, not only internally, but to those of our patients and those, importantly, to the patients and individuals in the clinical trials, both that were enrolled, that continue to be enrolled as well as those that were about to enter clinical trials that we may have shut down, as we talked about, and we've begun to reopen some of those based upon the opportunities and really, the hotspots around the country or around the globe.
So broadly speaking, I think Martine is right. It's been a coordinated effort to really understand and prepare and execute to make sure, as an organization, we can continue, again, for Unitarians or patients at large. From a standpoint of when we think things will get better, we hope for the best, as everybody does in the near term. But we're going to need to stay vigilant around all aspects of the organization to make sure that we can continue to perform as an organization. And so I think as things unfold and we all continue to get better educated and educated on the multiple aspects, we'll certainly continue to communicate in our public filings and on conference calls and various questions. But it's something that we'll continue to take seriously as everybody is doing to make sure the business at whole and at large can continue to move forward. So back to you, Martine.
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Thanks so much, James. To wrap up, everybody on the earnings call, we've had a great quarter. I think this quarter and perhaps more generally, this half of the year will be looked at in retrospect as a key pivot point for United Therapeutics. This will be the time when we pivoted from being solely a pulmonary hypertension company to becoming both a pulmonary hypertension company as well as a pulmonary fibrosis and other forms of interstitial lung disease company. You can see this pivot in us moving into a group of pulmonary hypertension patients, WHO Group 3, as to whom pulmonary hypertension is not their primary problem. Their primary problem is interstitial lung disease. It's, of course, greatly worsened by the pulmonary hypertension, but the source of their pulmonary hypertension is ultimately interstitial lung disease. So for the first time, we're moving into a group of patients for whom pulmonary hypertension is not their number one problem, if you will. And secondly, for the first time, we're moving into a large Phase III study in which patients do not have pulmonary hypertension at all.
They simply have this form of interstitial lung disease, pulmonary fibrosis. If you take a look at a diagram of all the species and subspecies of interstitial lung disease, you'll see it is a very large and diverse population. And we were really pleased to see in the outcome of our INCREASE study that we actually were able to modify the disease. In other words, not only slow the rate of decline in forced vital capacity, but actually improve forced final capacity in the patients with pulmonary fibrosis as well as a couple of other subsets of interstitial lung disease. So it's a very exciting time here at United Therapeutics. You always hope that you could be strong at your home base and then expand from that. And with this adjacency of interstitial lung disease and pulmonary hypertension, we have a very logical and solid basis from which to expand our footprint in providing more and better healthcare to ever larger numbers of people. Thank you so much for your time and attention this morning. Look forward to seeing you at upcoming healthcare conferences. Operator, you can wrap up.
Operator
Thank you for participating in today's United Therapeutics Corporation Conference Call. A rebroadcast will be available for replay for one week by dialing one (800) 585-8367, with the international callers dialing one (416) 621-4642 and using access code 8782637.
Duration: 46 minutes
Call participants:
Dewey Steadman -- Head of Investor Relations
Martine Rothblatt -- Chairman, Chief Executive Officer and Director
Michael Benkowitz -- President and Chief Operating Officer
Leigh Peterson -- Vice President of Product Development
James Edgemond -- Chief Financial Officer and Treasurer
Hartaj Singh -- Oppenheimer -- Analyst
Eun Yang -- Jefferies -- Analyst
Marty Auster -- Credit Suisse -- Analyst
Joseph Thome -- Cowen and Co -- Analyst
Liana Moussatos -- Wedbush Securities -- Analyst
