United Therapeutics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 2, 2023

There are 12 speakers on the call.

Operator

Good morning, and welcome to the United Therapeutics Corporation Second Quarter 2023 Earnings Webcast. My name is Danielle and I will be your conference operator today. All participants on the call portion of this webcast will be in listen only mode until the question and answer portion of this earnings call. Please note this call is being recorded. I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Speaker 1

Thanks, Danielle, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation 2nd quarter 2023 earnings webcast. Accompanying me on today's webcast are Doctor. Martine Rothblatt, our Chairperson and Chief Executive Officer Michael Benkowitz, our President and Chief Operating Officer James Edgemond, our Chief Financial Officer and Treasurer Pat Poisson,

Speaker 2

our

Speaker 1

Executive Vice President of Technical Operations and Doctor. Lee Peterson, our Senior Vice President of Product Development. Please note that 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, and we assume no obligation to update these forward looking statements.

Speaker 1

Today's remarks also 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 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. Remember, full prescribing information for our products are available on our website. Note that Pat Posehn and I will be participating in 1 on 1 meetings at the 2023 Wedbush 21st Annual Global Healthcare Conference on September 11. In addition, we will present data at the European Society of Cardiology in Amsterdam in August, the European Respiratory Society in Milan in September and at the CHEST Annual Meeting in Hawaii in October.

Speaker 1

Now, I will turn the webcast over to Doctor. Rothbodt for an overview of our Q2 2023 financial results and the business activities of United Therapeutics. Martine?

Speaker 2

Thank you, Dewey. I'm thrilled that United Therapeutics continues to report double digit revenue growth and our highest quarterly revenue ever. We expect this growth trajectory to continue with our current business as we expect to reach a $4,000,000,000 annual revenue run rate by mid decade. Beyond that, we expect continued waves of growth with an additional doubling of our revenue from the potential launch Tyvaso in pulmonary fibrosis and of Ralinepag in pulmonary arterial hypertension and then yet another doubling of our revenues with the potential for an unlimited supply of tolerable transplantable organs in the next decade. Let me now drive a little bit deeper into some of these absolutely fantastic results that we are pleased to report this quarter.

Speaker 2

As mentioned, the total revenues We're at $596,000,000 for the 3 months. But it's interesting to compare that with the matching It's a percentage growth rate of 28% and very much in line with the type of growth rate that we have previously indicated We expect to achieve in order to achieve that $4,000,000,000 revenue run rate by mid decade. Another deeper level to look at is the company's net income. For the past quarter, we reported over $250,000,000 in net income. And again, it's instructive to compare that with the quarter matching quarter in 2022 When we reported $116,000,000 in net income, a percentage change of low number of shares outstanding, which helps drive those fantastic results.

Speaker 2

Now let's dive even deeper Into some of the results on the products. Tyvaso, dollars 319,000,000 Up 59% from last year Remodulin, dollars 127,000,000 down about $5,000,000 from the matching quarter last year. Orenitram, dollars 95,000,000 up 20% from the matching quarter last year Unituxin, dollars 44,000,000 essentially flat from the matching quarter last year. We don't really talk that much about Unituxan, but I probably should stop and for people who are perhaps newer to United Therapeutics, remind everyone that this is a treatment for Neuroblastoma, pediatric cancer with a very high rate of mortality. And for the based on the several years that Unituxan has been used by doctors to treat Pet cancer, approximately 50% of the kids treated with Unituxan As well as the other concomitant therapies used, their cancer is wiped out.

Speaker 2

It does not return. Even 5 years later, when they're checked, the cancer has not returned in about half of the patients. I find that truly remarkable and just a miracle of biotechnology and one of the many blessings So in any event, because that drug is so well used by the pediatric Oncologists, we're now looking at on an annualized basis. It's getting close to $200,000,000 a year. Now in addition to those top line revenues and profit figures, Let's dive a little bit into the spending section.

Speaker 2

And here we break out our Spending in large categories in terms of external research and development, internal research and development and then the general administrative and sales and marketing categories with a few miscellaneous rows Put in there according to GAAP standards. So the external research and development is what we spend So we've got quite a few clinical trials going on right now. And most of them are in the Phase 3 stage of development, which is the largest and the most costly phase of development. We have the 2, TETON1 and TETON2 Phase III trials for idiopathic pulmonary fibrosis. And then we have this new TETON3 or also called Type of pulmonary fibrosis, which is another Phase III trial just starting up this year.

Speaker 2

We have the ongoing worldwide rolenopag clinical trials covering countries in almost every continent. And that is a more expensive clinical trial because that clinical trial is aiming for an endpoint to show that we reduce Death and morbidity in patients with pulmonary hypertension. So we have to both enroll more patients and Keep the study going longer until we get statistically significant difference in the death rates. And then we look at that and hope to achieve our statistical significance with respect to the treated or active group. We also still are ongoing with the gene therapy trial.

Speaker 2

And so all of these trials combined, They end up costing us more than $100,000,000 a year just in spending outside of the company, And that's not even talking about the level of spending inside of the company. Now inside of the company, we've got our great team of clinical drug developers, Ultimately led by Doctor. Peterson, who joins me on the call today, and she has just been doing an amazing, amazing job of running all of these Phase III trials simultaneously. And it really It takes a humongous amount of effort to get drug labeled, translated, shipped to these countries all over the world, Constantly be monitoring those centers, sending people there every month to make sure that the protocol is being complied with. I cannot begin to tell you how long the checklist is to conduct these clinical trials.

Speaker 2

So it's not surprising that there is another More than $100,000,000 a year spent on internal research and development. Now under the internal research and development category, We also covered the development activities for the organ manufacturing efforts that I described in at The beginning of the call. And there we've got the lead program, our xenotransplantation efforts. And there, in accordance with the FDA guidance, which we received in our Interact meetings with the FDA, Both for the Zeno Kidney and for the Zeno Heart, we are proceeding with the pivotal preclinical Studies necessary to enable an opening of an IND for Zeno Kidney and Zeno Heart. We are doing our best to hopefully be able to open that IND as soon as possible.

Speaker 2

It's not really possible to predict exactly when the FDA would feel that it was The appropriate time to do that. But I would say that the time frame for that FDA decision, Kind of reasonable case is a 'twenty four, 'twenty five time frame, more pessimistic case Could be a 'twenty five, 'twenty six time frame. But any way you look at it, it is literally around the corner in drug development speak. And that's an additional area of significant spend. We also are continuing to spend heavily on our Laboratory based lung manufacturing activities, both with allogeneic as well as with autologous Cellularization and that too is a really a trailblazing effort where people, many of them are own patients who have been treated with our medicines for pulmonary hypertension.

Speaker 2

But in the event that their disease progresses, which is usually the case with pulmonary hypertension and for that matter pulmonary fibrosis as well And of course, many other lung diseases, you progressed to the point of needing a lung transplant. And we are doing our best But in the meantime, we have a really remarkable program, which we call lung bioengineering. And in this program, We take lungs from organ donors who, for various reasons, The transplant surgeons feel they are not quite ready or certain That they want to use that donor lung for to put into a very, very sick person who needs that lung. So they asked the organ procurement organizations to fly those lungs to 1 of our 2 Lung Bioengineering Centers. 1 is in Silver Spring, Maryland across the street from our headquarters And the other is in Jacksonville, Florida on the campus of the Mayo Clinic.

Speaker 2

And there are highly skilled, We work on a patient and they do everything that they can to render that lung suitable for transplantation. Again, quite to me as a person who's actually never done the procedure, I'm like blown away that half of the time They succeed. And the one that was not going to be used to save a person's life is, in fact, able to be used to save a person's life. And to date, we have saved over 300 people's lives with these lung bioengineering products. I'll also mention just kind of coincidentally that when we are not able to use the lung to save a person's We are oftentimes able to use the cells from the lung to assist in our efforts to manufacture allogeneically cellularized lungs in our laboratories.

Speaker 2

So it's kind of everything all fits together here at United Therapeutics. I know I've talked Don for quite a while here, but There is just so many exciting things going on at United Therapeutics. We have been able to build up A substantial cash balance, and we are targeting that for 3 main Areas of deployment. 1st and foremost is to invest in all of the internal projects That we have going here at United Therapeutics, and I've mentioned several of them in my remarks today. You may recall just last The quarter, we talked about $500,000,000 being allocated to the production of a dedicated Park, North Carolina.

Speaker 2

So that is in recognition of the very excellent take up That the Tyvaso DPI product has seen among physicians, patients and their families all Supporting the patience in that regard. And then another area of capital deployment would be to Build the GMP equivalent production facilities for the Xeno Kidneys and Xeno Hearts that I mentioned previously. And of course, the FDA wants to see and we would also want to see That those Xeno Kidneys and Xeno Hearts are manufactured in a totally clinically appropriate fashion, which requires the animal equivalent of a GMP facility. The technical name for it is a designated pathogen free Facility, so capital is also targeted for that. In addition, we have a very robust Business Development Group, led by Doctor.

Speaker 2

Betsy Eads of our company. And She is frequently bringing to us often very compelling candidates For potential either investment or outright acquisition and we need to Retain adequate capital for those opportunities, you may recall that I think probably The next biggest impact drug that we could have in pulmonary hypertension, rolenopag, Was acquired through our business development efforts for about $1,000,000,000 So these type of opportunities are regularly being reviewed by Doctor. Eads. And then 3rd is to repurchase Shares to the extent that there is excess capital that can't be deployed for internal business development or external business development, Of course, the next up would be to engage in share repurchases. And we have repurchased Lots of shares over time.

Speaker 2

In fact, I mentioned earlier that our outstanding share count is relatively modest compared to peers and that is because in no small part, our previous share repurchases. So with those introductory remarks, I'd now like to turn the phone over to Michael Benkowitz, our President and Chief Operating Officer. Mike?

Speaker 3

Thanks, Martine. Good morning, everyone. As Martine said, we had a phenomenal second quarter from a revenue standpoint, setting revenue records for Tyvaso, Orenitram and total treprostinil. And I want to begin by publicly thanking and congratulating all of our commercial medical affairs teams at United Therapeutics for their hard work and achievements during the quarter. As usual, I'll provide some color on what we're seeing with respect to Tyvaso or Renitram and Remodulin.

Speaker 3

So I'll start with Tyvaso where I want to highlight several things. I should also mention that for purposes of these comments, Tyvaso refers to the combined nebulizer and DPI, unless I otherwise know. So first, as I just mentioned, we posted the highest quarterly revenues ever for Tyvaso, which reflects increasing physician and patient demand in both the PAH and PAH ILD indications as well as the Tyvaso DPI inventory build of about $30,000,000 in the quarter at the specialty pharmacies. Our underlying demand metrics, that is referrals, which is what we call prescriptions, New patient starts and net patient adds remain very strong and roughly in line with the last few quarters. New patient starts are trending around a seventy-thirty split between DPI and the nebulizer respectively.

Speaker 3

The transitioning of long term existing nebulized Tyvaso patients to Tyvaso DPI has largely played out at this point at least until the Part D redesign provisions of the Inflation Reduction Act begin to go into effect over the next 2 years. And in fact, nebulized Tyvaso referrals and starts have trended upward over the last few months. We do expect that there will be some basal level of transitioning between the nebulizer and DPI going forward as physicians optimize to which delivery device is best suited to each of their patients. We also continue to make Great progress growing the Tyvaso prescriber base and prescribing depth within that base. On the Tyvaso DPI supply side, Our partner, MannKind, completed their production expansion and process improvement efforts during the quarter, which we expect will increase production capacity by about 2 50% going forward.

Speaker 3

We started to benefit from these enhancements at the end of June, when as I mentioned, the specialty pharmacies were able to build about $30,000,000 of DPI inventory. Specialty pharmacy inventory levels on the last day of the quarter actually reached their contractual range based on historical demand. However, this could fluctuate through the remainder of the year as Tyvaso DPI demand grows and until MannKind has a few more months of production with the additional capacity. We anticipate that specialty pharmacies may be able to get into the regular ordering patterns for Tyvaso DPI sometime either later this year or in the first half of twenty twenty four. As a reminder, MannKind is also undertaking work to further expand production capacity even beyond these most recent improvements, which we would expect will come online in 2024.

Speaker 3

I should also note that the nebulizer destocking that we highlighted in the Q4 of last year and Q1 of this year did in fact conclude in the Q1. 2nd quarter nebulizer orders were in line with specialty pharmacy Actual inventory levels and patient demand. So to wrap up the Tyvaso story, we're extremely pleased with the progress we've made and the opportunity that lies ahead of us. Our focus and efforts in the second half of this year and into 'twenty four fall into 4 main areas. First is increasing production and supply of Tyvaso DPI in partnership with MannKind.

Speaker 3

2nd is increasing physician screening for PH ILD in their ILD patient 3rd is growing the prescribing breadth and driving depth to 3 plus patients, as I mentioned on prior calls. And then 4th is continuing to increase patient retention on Tyvaso. While we've made very good progress on each of these items thus far, there's still more we can do. To this end, we recently realigned product promotional responsibilities within our existing commercial headcount and are in the middle of a headcount expansion, including in sales drive these efforts. Turning to Remodulin, this business continues to be incredibly resilient even though it has faced Faced generic competition for almost 4 years now.

Speaker 3

Continuing a trend that started last quarter, we saw a near record number of referrals in the 2nd quarter and active Remodulin patients remain at pre generic levels. RemUnity continues to gain traction in the market as it is the only subcutaneous pump widely available for new Remodulin patient starts. Finally, Orenitram had another record quarter with the highest revenue in patients on therapy since its launch. Our 90 day titration kit launched during the Q1 has continued to receive positive patient and physician feedback. Study has now been published in 2 medical journals.

Speaker 3

We look forward to disseminating this important information to clinicians in appropriate forums over the balance of this year at Intinix. So to wrap up, we're very pleased with the overall treprostinil business led by the incredible demand for Tyvaso DPI, And we believe we're on our way to hitting our goal of a $4,000,000,000 annual revenue run rate by the middle of the decade. With that, I'll turn the call back over to you, Martine.

Speaker 2

Mike, that was an amazing awesome wrap up. Thank you so much. How do you stay on top of so many details? It blows my mind. Perfect.

Speaker 2

Wow. We have the best in the President. Thank you, Mike. Okay. Operator, please open up the lines for any questions.

Speaker 2

And like I'll Forward them amongst Mike, Pat and Doctor. Peterson.

Operator

Thank you. We will now begin the question and answer session. The first question comes from Ash Verma of UBS. Please go ahead.

Speaker 4

Hi, thanks. Good morning and congrats for a very strong quarter here. I have two questions. 1, just on Tyvaso in IPF. So wanted to ask What's your level of conviction in clinical success here?

Speaker 4

The prior INCLREASE study showed benefit in the PHIPF subset, But in the TETON studies, you're studying IPF all comers? And then second one, can you provide some color on the patient Like how much of the new patient adds is coming from PAH versus PAH ILD? And do you expect the patient adds per quarter to start to ramp up

Speaker 2

We have So many callers in the queue. I'm just going to have to limit it to one question per caller. So we'll take your first question about pulmonary fibrosis. And Doctor. Peterson, could you kindly respond to Ash's question?

Speaker 5

Yes, sure. Thanks for the question. So as you mentioned We had data from increase in pH IPF, a subpopulation of increase that exhibited improvements in FVC, which is It's a marker that indicates potentially an anti fibrotic activity of Tyvaso. Now this in addition to Many, many publications on also a mechanism for Tyvaso, which is anti fibrotic, gives us confidence That will also work in the population of TETON-one and TETON-two, which are IPF, idiopathic pulmonary fibrosis, as well as our new study In which is progressive pulmonary fibrosis.

Speaker 2

That's excellent. Thank you so much, Doctor. Peterson and operator, could you please take the next caller?

Operator

The next question comes from Eun Yang from Jefferies. Please go ahead.

Speaker 6

Thank you. Congrats on the great quarter. That's amazing numbers on Tyvaso. The Question on DPI inventory build about $30,000,000 in second quarter. Would that The inventory levels that you would expect going forward or do you think it would increase or Could there be some drawdown in Q3?

Speaker 6

Thank you.

Speaker 2

Great question and so nice to hear your voice this morning, Ewan. Thank you for the congratulations. The questions with regard to inventory, we normally ask our Chief Financial Officer, James Edgemontu, handle because he's totally on top of the flow of

Speaker 7

Good morning, Eun, and thanks for the congrats on the quarter. Two parts to the response. So Michael talked about the $30,000,000 Addition to DPI inventory during the quarter, which was specific to DPI Inventory build and Michael addressed nebulizer's inventory as well, which is pretty much normalized. With respect To the demand for DPI for the balance of the year, as Michael talked about, this could really fluctuate going forward through the remainder of the year As we think about patient demand as well as the manufacturing at MannKind as we work through some of the improvements that we've highlighted. So going forward, there certainly could be a fluctuation in DPI inventory.

Speaker 7

But I would want to reiterate what Michael said Across the portfolio of products, as we completed the quarter, we were in contractual requirements with all the products, But it is important to highlight the DPI fluctuation going forward based upon demand as well as manufacturing at MannKind. So thanks for the question. And Martine, back to you.

Speaker 2

James, just excellent answer as always. So thank you and Ewan, thanks for asking the question. Operator, can you please Pull up the next person from the queue.

Operator

The next question comes from Hartaj Singh from Oppenheimer. Please go ahead.

Speaker 8

Great. Thank you for the question and the really nice quarter. Really tough comp last year at this quarter, so it's really Well done. Just a question on Ralinepag. Assuming the Phase 3s are successful, Martina and team, How do you see the product sort of where do you see it being used in the treatment paradigm?

Speaker 8

Is it a straight replacement for Orinram? Will you take some of the selexipag patients? There could be some generics there by then. Any thoughts there? Thank you.

Speaker 2

Yes. That's a great question. I'm really happy to have it. I think Hartaj, you've been able to ask a question that kind of transcends 2 different areas. So unusually, I'm going to ask 2 separate team members to respond to your question with regard to their different levels of involvement in the Front line treatment for pulmonary hypertension, clinical situation and market.

Speaker 2

First of all, Mike, if you could answer Hartaj in Where you see placing ralinepag once approved in the basically the presentation of Treatment options that would be presented to physicians by especially by our sales force. And then perhaps Lee, if after Mike talks, you can provide some insight that you're able to share From our clinical trials in terms of how you see what the protocol calls for in our clinical trials And that might also help to shed some light on Hartaj's question in terms of where it's being used in the clinical trial Outcomes in particular. So, Mike, you first.

Speaker 3

Sure. And again, all of this is obviously contingent On how the study reads out the data and kind of what we see through the trial Hartaj. But I think generally speaking, I think we expect that You'll still start with a PD-five and an ERA. And then at that point, as once the disease The patient's disease continues to progress. The doctor has an option as to what to add.

Speaker 3

That's where I think We're expecting that Ralinepag's sweet spot is going to be right after the PD-five and ERA. Now For various reasons depending on where the patient is in their disease journey, it could be maybe they need something stronger so they go to Orenitram or maybe they want the So they start there and then they kind of transition back and forth, but I really kind of look at it as being sort of And that sort of area of after PD-five and ERA and patients' disease has started to progress further.

Speaker 2

Yes, Mike, that makes such perfect sense because it would really be, to my understanding, The only once a day prostacyclin category, it's not exactly a prostacyclin analog, But it works on that pathway. So the only once a day treatment, which will just be huge for the patients because if you miss even Few doses, this disease is insidious and it could just start reclaiming territory in your lungs. So compliance is king and once a day Is the AMPORE type of delivery for compliance. Ali, what kind of insights do you have on Hartaj's question From the conduct of the outcome study?

Speaker 5

Yes. So, really with as Michael just said, with regard to selexipag, I mean, Of course, we're shooting for a better clinical effect, but also that the fact that Michael just said it's ralinepag is once daily dosing versus twice. So, I mean, that's most patients feel that that's an advantage. But scientifically, with about your question Regarding Orenitram, now you might remember that Orenitram or treprostinil Actually, binds and interacts with multiple prostacyclin receptors Versus selexipag and ralinepag who are IP specific activators of the IP only receptor. And so and it's thought at least from several non clinical studies That these different receptors have different activities.

Speaker 5

And so, this could very well translate to the clinic where Certain patients do better when they have binding and activation of multiple And some patients might do better with regard to both tolerability and Efficacy, if they simply have binding and activation of the IP receptor. And So I hope that answers your question as to where we see things. It's not a complete overlap with regard to the mechanisms of action for sure.

Speaker 2

Brilliant answer. Wow. That's why I'm so glad we have a scientist on the call. And Hartaj, I'm so glad you asked your question

Operator

The next question comes from Terence Flynn of Morgan Stanley. Please go ahead.

Speaker 9

Great. Thanks so much for taking the question. Congrats on the quarter. A Two part question for me. Just wondering if you can comment at all on Tyvaso patient start trends in July versus June as well as Breadth of prescriber base.

Speaker 9

Mike, I know you touched on that, but any more color there would be helpful. Thank you.

Speaker 2

Okay. Thank you, Terrence. Mike, you got it.

Speaker 3

Yes, I think on the referral start trends in July versus June, I mean, we're continuing it's been pretty consistent, I think, over the first half That's continuing into July. So I think the rate of referrals and starts is just what we've seen in the first half of the year. And I would say on the prescriber growth, I think the rate of growth has been I think what I've said is The last call is that we've roughly doubled the number of prescribers since we launched. Month to month, quarter to quarter, that doesn't necessarily Change linearly, it's just it's a little choppy. So, that's it's increased marginally above the kind of the doubling in the last We have seen, however, continue maybe stronger growth or higher growth in the last quarter in terms of the depth of 3 plus Prescriber, so which is good.

Speaker 3

I mean, as I said on prior calls, we're using analogy that if we get the prescribers To 3 plus patients, you sort of kind of get the flywheel spending and then the 3 goes to 10 pretty quickly thereafter. So we are making really good progress Yes, on that aspect of prescribing depth and as I said, continuing to add top line prescribers as well.

Speaker 2

Thanks so much, Mike. Yes, that's a great metaphor with the flywheel. You could just see how our success compounds once doctors start using our medicine. Operator, we have time for just 2 last calls.

Operator

The next question comes from Joseph Thelma of TD Cowen. Please go ahead.

Speaker 10

Hi there. Good morning. Congrats on the quarter and thank you for taking my question. Maybe just as we think about penetration into the PHLD market, where do you think you stand now? And Now that the therapy has been on the market for a couple of years in the indication, have your expectations for the size of this market changed at all?

Speaker 10

Thank you.

Speaker 2

Okay. Thank you very much, Joe. Mike, I think you're the best person to answer that.

Speaker 3

Sure. I think on penetration of the market, I think we're in the low single digits. And I say thank because I still and this is I think a question that was asked earlier that we just didn't have time to ask, but around the kind of the mix of the PAH and the PHILB. I mean, the data coming in on the referrals is still not it's still a little dirty. So it's not Still 100% clean in terms of what's Group 1 or what's Group 3.

Speaker 3

But I think based on kind of what we're seeing, it's I think it's fair to say that we're kind of in that Low single digits of the PHILD market. And in terms of the size of the market, nothing's really changed in terms of our understanding of what that is. We kind of started out It's at least $30,000 We still think that that's accurate. You can talk to some KOLs who think it's significantly Higher than that and that may be, but like we've said all along with the 30,000, I mean that's still a really good sized market for us. And so we're really Continued to penetrate in that market and get as I said in my opening remarks really Kind of ramp up the screening of ILD patients to look for pulmonary hypertension.

Speaker 2

Super. Thank you, Mike, so much. Operator, the last question, we just have time for one more, I'm sorry.

Operator

The last question comes from Andreas Argeraj from Wedbush. Please go ahead.

Speaker 11

Yes. Thanks. Good morning and thanks for taking my questions. I'm honored to be the last one here and great quarter and another congrats there as well. So lots of good questions from my colleagues on Tyvaso and the market evolving in PAH.

Speaker 11

Going back to the prepared remarks and the potential use of cash, how are you thinking about outside investment opportunities? Is it just going to be in PH or maybe perhaps broadening the company's core

Speaker 2

Yes, Andreas, deep and interesting question. And I think that We are most interested right now in the pulmonary fibrosis segment in terms of outside investment. It's not to say that we don't have continued interest in the pH segment, But the pH segment is by, I think, almost anybody's estimation, a pretty crowded marketplace At this point in time. And by reflection, when we started the company, There was no oral treatment approved for PH as well. There was no inhaled treatment approved for PH.

Speaker 2

In fact, all that was really available was our parenteral FLOWLEN. And if you compare that With the situation today, I honestly have lost track of how many different drugs and versions of drugs and Generic versions of drugs there are, but it's certainly over a dozen. So pH is a very crowded marketplace. Despite that crowding, there seems to be continued synergy amongst Certain drugs in that crowded field. For example, the PD-five inhibitor Less often, but still frequently an ETRA such as ampersentan can be used in combination with the other drugs.

Speaker 2

And increasingly now, Our own Orenitram is used in combination with those other 2 kind of, I don't want to say weaker, but I'll say non treprostinil strength drugs. So this kind of combination phenomena means that even though the market is very crowded, there always is still great As Mike Benkowitz mentioned in his discussion of ralinepag, that's our expectation in ralinepag that will be used in combination. Thanks for the congrats. But one thing that maybe didn't get enough highlighting on the call, although Doctor. Peterson did talk a bit about it, was the tremendous upswing in growth in Orenitram.

Speaker 2

And that's no like coincidence or just something coming out of the blue. That's Because increasingly, first of all, Orenitram is being used in combination with the PD-5s and ETRAs. It's a convenient pill. And then secondly, we have another study going on to develop Confirmatory data, it's called the ARTISAN study. And this study shows that building on our previous smaller studies That you could rapidly switch a patient from a parenteral drug, like parenteral prostacyclins or treprostinil to Orenitram Apeel.

Speaker 2

And if you do that, you're able to kind of jump over this valley when you have the side effects You're already kind of a nerd to the side effects or they've been mitigated by the time you spent on the parenteral drug. So again, this is all to say that while PH is a crowded area, I think that there is Strong room for United Therapeutics to continue to grow. There hasn't been much discussion on this call about sotatercept, but just to say, Some of the best data that has been published so far on sotatercept is in combination with the treprostinil Product. So I think combination therapies are the way to go. Now kind of exact opposite situation is in pulmonary fibrosis, where you have a comparable size patient population, Yet instead of there being a dozen plus approved drugs for it, there are really only 2.

Speaker 2

And So it's a very, very different situation. Neither of those 2 are reported to be disease modifying in any way. They simply have been shown to slow the rate of progression of the disease, which is good, but not as good as being disease modifying. So I'm very hopeful that we will have something that indicates disease modifying capability come out of our TETON studies, and I'm very hopeful that we can do as much in pulmonary fibrosis As we as a company have done in pulmonary hypertension. So I mentioned, Dom, when I started to answer your question, Andreas, At the beginning of the company, there were very few prescribers because all the patients died.

Speaker 2

There was very little hope. And United Therapeutics has enabled a kind of a reinvention of the pulmonary hypertension space But now there's over a dozen drugs and patients instead of dying from pulmonary hypertension, they live with pulmonary hypertension. And there are patients living literally decades, which is amazing and wonderful. But we would like to be able to do the same thing in pulmonary fibrosis that we've done and are doing in pulmonary hypertension. Some of that will be done with internal R and D, such as the great efforts being led by Doctor.

Speaker 2

Peterson at Teton 1, Teton 2, Teton 3. And then we are also keenly interested In deploying our capital for business development activities that could build out and expand our portfolio in pulmonary fibrosis. So that's just one example of a disease area outside of pulmonary hypertension that we plan to tackle. Andreas, thank you for your question. Operator, feel free to roll into the wrap up script.

Operator

This concludes our question and answer session. I would like to turn it back over to Martine for closing remarks. Thank you for participating in today's United Therapeutics Corporation Earnings Webcast. A rebroadcast of this webcast will be available for replay for 1 week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.uniter.com.

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Key Takeaways

  • United Therapeutics reported 28% year-over-year revenue growth to $596 million and net income more than doubled to $250 million in Q2 2023, on track for a $4 billion annual run rate by mid-decade.
  • Tyvaso sales reached $319 million (+59%), driven by strong demand in PAH and PH-ILD, while the Tyvaso DPI supply ramped up with MannKind’s 250% capacity increase and a $30 million inventory build.
  • The company is investing over $100 million each in external and internal R&D across multiple Phase III trials (TETON 1–3 for pulmonary fibrosis, global Ralinepag mortality/morbidity study, gene therapy) and innovative organ manufacturing programs.
  • In its xenotransplantation efforts, United Therapeutics is advancing Zeno Kidney and Zeno Heart toward IND filings (targeted 2024–25), and its lung bioengineering centers have successfully reconditioned donor lungs to save over 300 lives.
  • Available cash will be deployed to build internal manufacturing facilities (e.g., Park, NC site, GMP-equivalent xeno facilities), pursue business development—especially in pulmonary fibrosis—and repurchase shares if excess remains.
AI Generated. May Contain Errors.
Earnings Conference Call
United Therapeutics Q2 2023
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