United Therapeutics Q1 2025 Earnings Report

United Therapeutics EPS Results

• Actual EPS: $6.63
• Consensus EPS: $6.29
• Beat/Miss: Beat by +$0.34
• One Year Ago EPS: $6.17

United Therapeutics Revenue Results

• Actual Revenue: $794.40 million
• Expected Revenue: $726.82 million
• Beat/Miss: Beat by +$67.58 million
• YoY Revenue Growth: +17.20%

United Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 4/30/2025
• Time: Before Market Opens
• Conference Call Date: Wednesday, April 30, 2025
• Conference Call Time: 9:00AM ET

United Therapeutics (NASDAQ:UTHR), a biotechnology company, engages in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases in the United States and internationally. The company offers Tyvaso DPI, an inhaled dry powder via pre-filled and single-use cartridges; Tyvaso, an inhaled solution via ultrasonic nebulizer; Remodulin (treprostinil) injection to treat patients with pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise; Orenitram, a tablet dosage form of treprostinil, to delay disease progression and improve exercise capacity in PAH patients; and Adcirca, an oral PDE-5 inhibitor to enhance the exercise ability in PAH patients. It also markets and sells Unituxin (dinutuximab) injection, a monoclonal antibody for treating high-risk neuroblastoma; and Remunity Pump, which contains a pump and separate controller for Remodulin. In addition, the company engages in developing RemoPro and Ralinepag for the treatment of PAH; Aurora-GT, a gene therapy product to rebuild the blood vessels in the lungs; and Nebulized Tyvaso, for the treatment of idiopathic pulmonary fibrosis, as well as xenografts, which are development-stage organ products. It has licensing and collaboration agreements with DEKA Research & Development Corp. to develop a semi-disposable system for the subcutaneous delivery of treprostinil; MannKind Corporation to develop and license treprostinil inhalation powder and the Dreamboat device; and Arena Pharmaceuticals, Inc. to develop Ralinepag. The company was incorporated in 1996 and is headquartered in Silver Spring, Maryland.

United Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• United Therapeutics reported a record revenue quarter of $794 million in Q1 2025, marking 17% year-over-year growth driven by robust demand for its treprostinil products, including Tyvaso, Orenitram and Remodulin.
• The company has achieved double-digit revenue growth for eleven consecutive quarters, and management expects momentum to continue led by Tyvaso and Tyvaso DPI alongside solid performance from other commercial products.
• Its innovation pipeline is advancing rapidly with five registration-phase studies, a pending FDA marketing application, and multiple preclinical candidates—including three xenotransplant organs—targeted for trials within a year.
• United Therapeutics maintains strict financial discipline, capping cash operating expenses at 50% of prior-year revenue, generating over $1 billion in annual operating cash flow and preserving a cash balance exceeding $5 billion.
• The company is strategically allocating capital across internal R&D and manufacturing investments (new DPI and pathogen-free facilities), acquisitions (IVEVA, MiroMatrix), technology partnerships, and returned $1 billion to shareholders via a share repurchase.

Presentation

[Operator]

Good morning and welcome to the United Therapeutics Corporation First Quarter twenty twenty five Corporate Update. My name is Torben 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 would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

[Operator]

Please go ahead.

[Dewey Steadman, Head, IR at United Therapeutics]

Thank you, Dorwin, and good morning. It is my pleasure to welcome you to the United Therapeutics Corporation first quarter twenty twenty five corporate update webcast. 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 ks and 10 Q, contain additional information on these risks and uncertainties, and we assume no obligation to update these forward looking statements.

[Dewey Steadman, Head, IR at United Therapeutics]

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. Full prescribing information for those products are available on our website. Accompanying me on today's call 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 Doctor.

[Dewey Steadman, Head, IR at United Therapeutics]

Lee Peterson, our Executive Vice President of Product Development and Xenotransplantation and Pat Poisson, our Executive Vice President of Technical Operations. Our Scientific Commercial and Medical Affairs team will present at the American Thoracic Society International Conference in San Francisco from May 16 to the twenty one. And now I will turn the webcast over for Martine for an overview of our development pipeline and business activities. Martine?

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Thank you, Dewey, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. However, Mike and I will not speak directly to the slides. How often can a CEO report to their investors and stakeholders that we've had a record revenue quarter. For United Therapeutics, it has been nine quarters out of the past 12.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

That reflects on the strong execution of our long term vision to be a biotech leader with a relentless drive to deliver to patients with rare and underserved diseases, a broad array of solutions to help improve their lives. Our solid foundation built by Tyvaso, Orenitram, Remodulin and Unituxin continues to grow revenue by double digits now for eleven quarters in a row. We expect this momentum to continue led by Tyvaso and Tyvaso DPI with continued solid performance by our other commercial products. Moving to our innovation and revolution waves, we believe our record revenue performance can continue for the foreseeable future as we have entered a sustained period of clinical and regulatory events poised to propel our business forward. We continue to grow our pipeline with five registration phase studies underway, a pending marketing application at the FDA and several new preclinical candidates, including three xeno organs that should be ready for clinical trials within a year.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

We also have other exciting innovations we will share later that we expect will keep our product portfolio innovating for years to come. We're planning for the first transplant in our uKidney clinical study, which we're calling the EXPAND study in the middle of this year. This will be followed by investigational new drug applications for the EXTEND study evaluating the Euthymo kidney and the EXPRESS study evaluating the U Heart. Both of those INDs are expected to be submitted within the next year. We recently received positive feedback from the FDA on our Euthymo Kidney program that gives us confidence to file INDs for both the Euthymo kidney and U Heart without conducting additional baboon clinical studies.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

What makes United Therapeutics unlike any other biotech is that we've been able to accomplish this massive business growth and unparalleled pipeline productivity while maintaining strict financial discipline. We never spend more than 50% of prior year revenue on cash operating expenses and as a result, we have an industry leading productivity per employee and more than $1,000,000,000 in annual operating cash flow and we're deploying our capital thoughtfully and strategically to provide for a sustainable business in the years to come. In the past six quarters, we have touched on all three areas of our capital allocation philosophy across both our commercial and development portfolios. We've invested in CapEx to support our new Tyvaso DPI manufacturing facility and acquired additional real estate to support future commercial manufacturing needs. We also commissioned the world's first clinical scale designated pathogen free facility in Virginia and plan to complete two others in short order.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

On corporate development we acquired IVEVA and MiroMatrix to enhance our organ alternative development expertise and we've licensed in new technologies to support our small molecule business. And with all this, we still returned $1,000,000,000 to you, our shareholders through an accelerated share repurchase program last year that was universally well received. We will continue to evaluate all three core areas of our capital allocation philosophy on an ongoing basis and we plan to pursue multiple avenues of capital allocation in the future. Our commercial business is extremely strong and growing that along with five registration studies underway, several important data reads in the next eighteen months and revolutionary progress on revolutionary organ programs makes United Therapeutics a truly unique and compelling story and I thank you our stakeholders and shareholders for joining us on this journey. We're only just beginning.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

And with that, I'll now turn the call over to our President, Mike Benkowitz, who will give an overview of our spectacular commercial performance for the quarter. Mike?

[Michael Benkowitz, President & COO at United Therapeutics]

Thank you, Martine, and good morning, everyone. Today, we are pleased to report a strong start to the year with another quarter of record revenue at $794,000,000 representing 17% growth from the first quarter of twenty twenty four, driven by robust results for each of our treprostinil products. This quarter's performance is reflective of consistent patient demand, where we continue to see very strong referrals, starts and patient shipments for all of our treprostinil products: Tyvaso, both DPI and nebulizer, Orenitram and Remodulin as well as Unituxin. We continue to see growth in the number of treprostinil prescribers and increases in the depth of prescribing within practices as measured by writers with three or more patients. Overall, we believe these results demonstrate that treprostinil continues to be an important part of the treatment armamentarium for pulmonary hypertension even with new therapies reaching the market.

[Michael Benkowitz, President & COO at United Therapeutics]

Building on Martin's comments, we remain confident that Tyvaso DPI is positioned for sustained growth over the long term due to the convenience of the device, its unlimited dosing potential, the thousands of prescribers and many, many thousands of patients' experience with the product since launch as well as the fact that there are no payer incentives to prefer an alternative product. Moreover, if positive, the TETON data in idiopathic pulmonary fibrosis, which is expected soon, could shift Tyvaso use into a much larger market where we will have orphan drug exclusivity and rapidly position Tyvaso for continued long term growth. To wrap up, we couldn't be prouder of the unwavering effort of our dedicated team to deliver this outstanding performance and to provide therapies to our patients in need. And we believe that we are set up well to continue to execute throughout the remainder of the year and beyond. With that, I'll turn things back to Martin to run the Q and A session.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Thank you so much, Mike. That's an amazing report. Operator, can we have the first caller, please?

[Operator]

Sure. We will now begin the question and answer session. The first question comes from Joseph Thome with TD Cowen. Please go ahead.

[Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen]

Hi there. Good morning. Congrats on the quarter and thank you for taking my question. Maybe will the Uthimo kidney program enroll the same target population as the 10 gene kidney program? And we saw the great progress obviously with Ms.

[Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen]

Looney, but then I did see that she did have to be explanted. So maybe if you could talk a little bit about what you learned from that experience and how you might apply that to the upcoming trial? Would be great. Thank you.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Sure. Thank you for your question, Joe, and thank you for the congrats. I'm going to assign that question to Doctor. Lee Peterson. She's in charge of all of our xenotransplantation activities.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Doctor. Peterson?

[Leigh Peterson, Executive Vice President of Product Development & Xenotransplantation at United Therapeutics]

Yes. Hi. Thanks for the call. And yes, we haven't completed our clinical protocol for our euthymal kidney study yet. But yes, we do plan on enrolling a very similar, if not identical patient population into that study as what we're enrolling into the 10 gene xenokidney study.

[Leigh Peterson, Executive Vice President of Product Development & Xenotransplantation at United Therapeutics]

And yes, we learned an incredible amount. We're very, very grateful for Ms. Looney's participation through the EIND conducted by NYU. And we learned a lot. We learned a little bit more about tweaking the immunosuppression, which is a little bit different than what's commonly done in allotransplantation.

[Leigh Peterson, Executive Vice President of Product Development & Xenotransplantation at United Therapeutics]

And we're looking forward to applying all of the learnings with regard to the immunosuppression and follow-up that we learned with her. So, again, we're really, really grateful. We consider it definitely a positive experience and it's unfortunate that she did have the unrelated infection that required us to have to reduce the amount of immunosuppression that she was on which ultimately resulted in rejection. But again, it was an unrelated infection and so learning how to manage that without having to reduce the immunosuppression quite as much is going to be key in the study.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Thank you so much, Doctor. Peterson for all of that great color on the progress that we're making both with the 10 gene kidney and with the final kidney and as we are now referring to the trials as the EXPAND trial for the 10 gene kidney, is now enrolling. Thank you very much. Operator, we're ready for the next question.

[Operator]

Our next question is from Jessica Fye with JPMorgan. Please go ahead.

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

Hey, guys. Good morning. Congrats on the strong quarter. I was wondering if you could elaborate for Tyvaso on kind of the magnitude of your contribution to contribution to sales from the continued implementation of the Part D redesign. I think you guys had previously said that was kind of mostly realized in 2024.

[Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan]

So I'm just curious the extent to which you're seeing that benefit again this year as the out of pocket cap is further reduced?

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Yes. Thank you so much for that question and so nice to hear your voice this morning. If it's okay with you, think the best person to address that question would be Michael Bankowitz. Mike?

[Michael Benkowitz, President & COO at United Therapeutics]

Yes. Thanks, Martine. Thanks, Jess, for the question. Yes. So I think if you're looking year over year, so Q1 of this year to Q1 last year, I mean, there's obviously a benefit, right?

[Michael Benkowitz, President & COO at United Therapeutics]

And I think we talked about it in the last quarter. So we saw a step down in Q1 last year, continue to kind of step down into Q2 and Q3 and then kind of flatten out over the balance of the year. If I look at Q1 versus Q4, I would say like a modest benefit. But then I think you also have to kind of counter or on the flip side of that is with the manufacturers having to start to pick up part of the catastrophic on the back end of the Part D redesign, we had some obligations there. Obviously, it was less because we have the phase in.

[Michael Benkowitz, President & COO at United Therapeutics]

So I think I I haven't looked at the math to see if those exactly cancel each other out, but I think by and large, they probably do. So I think any benefit is really I think very, very modest when looking at the results this quarter.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Great answer, Mike. Totally nailed it. And that queues us up for our next questioner. Operator, you can open up the line.

[Operator]

Yes. We have Roana Ruiz with Leerink Partners with the next question. Please go ahead.

[Roanna Ruiz, Senior Managing Director, Biotechnology Analyst at Leerink Partners]

Great. Good morning, everyone. So I was going to ask about Tyvaso DPI revenue growth specifically in 1Q. Could you help us understand just the general split of prescriber and patient demand driving growth versus a little bit of price increase? And are there any gross to net impacts that we should think about for the product in 1Q or going forward?

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Yes. Thanks, Rona. Michael, again, would be totally on top of all of those numbers. So Mike, can you take that call?

[Michael Benkowitz, President & COO at United Therapeutics]

Sure. Yes. So I think in terms of split between DPI and nebulizer, I think it's settled in at about two thirds, one thirds in terms of new patient starts. We haven't really seen much variability from that really for several quarters now. So I think that mix persists.

[Michael Benkowitz, President & COO at United Therapeutics]

And

[Michael Benkowitz, President & COO at United Therapeutics]

that's great that we have both options, right, because they're just happy to eat patients that tolerate a nebulizer better than they do a powder. And so we have an option for both patients. So that's I think really great that we're able to provide those options to the patients. We did do a price increase at the beginning of the year on both products. I think it was the same amount for both in line with what we typically have done in the past.

[Michael Benkowitz, President & COO at United Therapeutics]

And then on the gross to net question, as we said on the call a couple of months ago, that largely played out in

[Michael Benkowitz, President & COO at United Therapeutics]

the fourth

[Michael Benkowitz, President & COO at United Therapeutics]

quarter. But for the additional, I think it's 1% obligation we have under the Part D redesign of the IRA that I mentioned in the answer to Jess' question, no additional impact there that we observed in Q1.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Perfect. Thank you so much, Michael. Operator, next question.

[Operator]

Certainly. We have Andreas Sargeras with Oppenheimer with the next question. Please go ahead.

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Good morning and thanks for taking our question. Let me also extend my congrats on a fantastic quarter. Martin, you alluded to capital allocation consideration in your opening remarks. And I think last time we left James out of the earnings call. So I wanted to make sure he gets the question here.

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

But a successful share repurchase that was taking place last year, you have $5,000,000,000 in cash. There are a lot of things that are going on in the PAH space from a competitive landscape perspective. How do you consider deploying capital? David, you can elaborate deploying capital either for in terms of acquisitions to grow the business that way? Or and what are some of your thoughts around a repurchase going into a pretty significant catalyst from IPF in Teton?

[Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.]

Thanks.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Sure. Thanks for the questions, Andreas. I'm going to refer the capital allocation, the bulk of the capital allocation question to James and just give him a few seconds here while I respond to one of the questions that you sliced in there about internal R and D and the competitiveness of the PAH space and whatnot. So we do, as mentioned in my introductory remarks, we spend about 50 percent of cash on various forms of internal R and D as well as SG and A, of course. And a big part of that spending is in fact allocated to our core competencies in pulmonary hypertension and interstitial lung disease.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

So in that regard, as you know, we have these registration effort going on in Ralinepag and the outcome study, as well as a lot of effort going toward pulmonary fibrosis with TETON-one, TETON-two plus a lot of efforts that don't necessarily have any visibility because they are still in the lead product lead in effort for the product in the preclinical. But we have alternative types of methods of dosing and variations on dosing. We have a once daily Tyvaso dosing in preclinical development. So all of these type of activities are continuing on our part. And as we've seen since the first competition came in to us with say, something like the Liquidia generic parenteral, I guess it was like seven years ago or something.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

It really had no material effect whatsoever. There was quite a bit of concern about sotatercept. We did try to emphasize the fact that all signs for that it was much more complementary than anything else. And in fact, in the year of rollout, it has proven to be exactly that quite complementary. So we are constantly at UT, we are just relentless in improving our drugs, improving our drug delivery devices like another example I'll just drop there.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Our Remunity device is now virtually used by one hundred percent of the patients. So that's pretty amazing to swap out a parenteral delivery device that has had many, many years in the clinic and in patients' hands and in essentially about twenty four months or so do a virtually 100 swap out of that device. For now, I'm preparing for yet a further upgrade of that one to what we call Remunity D9. You'll see similar types of evolution in our inhalation devices. And as mentioned, some of those developments will also allow us to even though I think that our four times a day dosing now is the easiest, the simplest, super effective as the data shows loved by physicians and patients as the data shows.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

I think even there you'll be able to see in the next few years that we'll be able to come out with new products that go for even once a day dosing. So this is just endemic in the UT culture what we call approve and then improve, approve and then improve. And we're relentless about that. Everybody in the company get something approved, then improve it, get something approved, then improve it. And that's what we're doing on Tyvaso too.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

But with that, I'll lead in James, can you answer some of the more econometric financial aspects of the capital allocation question?

[James Edgemond, CFO & Treasurer at United Therapeutics]

Yes. Thank you, Martin. Andreas, thank you for the question and thank you for remembering the last call. As you know, we are committed to allocating capital wisely and we spent a lot of time internally talking about it. We want to do it in the best interest of our shareholders.

[James Edgemond, CFO & Treasurer at United Therapeutics]

And as you know the first priority is deploying our internal our capital for internal research and development and commercial initiatives. As Martine just explained, there is a lot of and the highest priority around spending for research and development. And if you look at the P and L this quarter, you'll see there was a milestone payment we made in research and development and outsized increased R and D kind of outsized for the quarter relative to prior quarters. Just as we moved along and pushed along these initiatives that Martine talked about. And we also spend in our first pillar a lot of capital on our manufacturing facilities.

[James Edgemond, CFO & Treasurer at United Therapeutics]

And as you know we're building a new DPI manufacturing facility in Research Triangle Park, North Carolina that is well on its way. The second priority and consistent priority that we spend capital on is for external corporate development. So we look for new opportunities for potential acquisitions and license opportunities etcetera. And as Martine outlined in her opening remarks over the last year and a half or so, we've actually touched on all these priorities or touched on these priorities relative to business and corporate development. So it is an area that's very active and we look for products that are complementary to our product, existing products and platforms and tend to focus on rare diseases, things in cardiovascular and things where there are corridors of indifference.

[James Edgemond, CFO & Treasurer at United Therapeutics]

So we want to look for opportunities where we can have a big impact and there's little products or competition at this point. And third, we do look as Martine outlined to return cash to shareholders and as Martine talked about for 2024, we did a $1,000,000,000 share repurchase that was well received. So our capital allocation priorities and kind of waterfall is still the same, but as you can see we've been very active in allocating capital across all three in the recent months and years. Thank you very much for remembering. Thank you for the question and Martine I'll turn it back to you.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Thank you, James. Thanks for such a great three sixty degree coverage of that topic. Operator, next question.

[Operator]

Roger Song with Jefferies has the next question for us. Please go ahead.

[Roger Song, Analyst at Jefferies Financial Group]

Great. Congrats for the strong quarter and thank you for taking our question. I think Martin, you mentioned a couple of things related to the competitive landscape for PAH. Maybe just can you just qualitatively comment on the potential growth trajectory this year and next, given we have a couple emerging competitor dynamic, if you can kind of understand you don't provide the revenue guidance, but just qualitatively the revenue growth trajectory for the rest of the year and the next will be helpful. Thank you.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Of course, Roger. Thank you for the question. But I'll write with you. I'm going to assign that question to Michael because he oversees so many of the core competencies that we have within UT relevant to the growth trajectory question. For a complex disease like PAH and like ILD, of course, it's very, very important to have a strong commercialization team, sales and marketing personnel, so called specialized sales reps throughout the country.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

But actually it's just the foundation. And on top of that, there is like a superstructure that extends into global medical affairs and many other core competencies. And all of these, we have regional nurse specialists, our drugs are complex and require almost always a drug device combination and there has to be training and how to use these things, working with the nurses, not to mention the entire payer universe. So all of these things are relevant, Roger. And Mike is like a virtuoso conductor.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

He's got all these different sections of the orchestra, all with the goal of providing a growth trajectory for our products that is second to none. And with that lead in, Mike, can you provide some kind of deeper color on all of that?

[Michael Benkowitz, President & COO at United Therapeutics]

Thanks, Martine, and thanks for that introduction. I feel like I just won some kind of award.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Yes. Well, win awards every day at UT.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Yes, absolutely.

[Michael Benkowitz, President & COO at United Therapeutics]

Yes. I think what we've been saying, I think, for the last couple of years and even as recently as the last call and to Martine's comments on this call is we expect to continue to grow revenues of double digit growth with our existing portfolio heading into this year and next year. And then as I said in my opening remarks, if we have Teton, if that's positive, that gets us into an entirely new market, where we have orphan exclusivity. I didn't even touch on Ralinepag, which we're hoping would be commercialized around the same time frame give us a best in class product within PAH. So despite the fact that it has become PAH in particular is becoming an increasingly competitive market, we still feel like we're extremely well positioned to grow in PAH.

[Michael Benkowitz, President & COO at United Therapeutics]

As I said on prior calls, it's still only about forty percent of PAH patients are on any kind of prostacyclin. So I think there's plenty of room for us to grow. There's plenty of room for I mean even the competitive products within that class. So I think it's still prostacyclines I think are still woefully under prescribed within PAH. And with all of our efforts and all the teams that Martine mentioned, we're continuing to make progress there.

[Michael Benkowitz, President & COO at United Therapeutics]

It wasn't too long ago that we were saying it was only about twenty percent of patients in PAH were on process like that. I think through the efforts of our company, other companies bringing new easier products to market such as Tyvaso DPI, we've been able to really expand the utilization of prostacyclines within PAH. And then over in PAH ILD, obviously, it's still I still feel like we're just scratching the surface in terms of what the potential is there. I think with the expansion that we rolled out last year, I think we've the team has done an amazing job in increasing our prescriber base as well as the depth ILD physicians prescribing Tyvaso for pulmonary hypertension associated with ILD. I expect that to continue as we move into the balance of this year and even heading into next year and beyond.

[Michael Benkowitz, President & COO at United Therapeutics]

I think we still have a lot of opportunity there. So we were very confident that we're going to meet these expectations of continuing to grow revenues at a double digit clip with our existing portfolio.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Thank you so much, Mike. Operator, we're actually at the bottom of the hour, but we'll take one last question.

[Operator]

We have our next question from Ash Verma with UBS. Please go ahead.

[Ashwani Verma, Executive Director - SMID Biotech & Biopharma at UBS Group]

Hi. Congrats on the quarter. I have two questions. Just can you give us a sense of how much patient adds there have been in the last few quarters for Tyvaso? Is it more in line with the roughly 500 ish that you have had historically or more or less?

[Ashwani Verma, Executive Director - SMID Biotech & Biopharma at UBS Group]

Just wanted to understand like the volume growth dynamic for PH and PH ILD. And then secondly, for Insmed's upcoming data on TPIP, just what are you expecting this trial can show? And how do you think Tyvaso is competitive position against TPIP? Thanks.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Okay. Mike, do you want to continue your role on that same topic?

[Michael Benkowitz, President & COO at United Therapeutics]

Sure. Yes. I think what I think your first question was around patient adds for Tyvaso. Is that right?

[Ashwani Verma, Executive Director - SMID Biotech & Biopharma at UBS Group]

Yes.

[Michael Benkowitz, President & COO at United Therapeutics]

So going back about one year, one point years, we really kind of moved away from the patient ad metric due to I think just competitive confidentiality reasons. I think what we said about a year and a half ago is, if you look at the revenue, we've gotten to a

[James Edgemond, CFO & Treasurer at United Therapeutics]

point where I think

[Michael Benkowitz, President & COO at United Therapeutics]

the revenues are tracking pretty well with underlying demand. And so I think you can kind of look at how the revenues are trending and really get a good sense of what's happening at the underlying demand level. In terms of the Insmed product, we'll see here in a few weeks when they unwind. So it's hard for me to sort of speculate on what the impact is going to be relative Tyvaso without actually seeing any data. But I think we're all going to find out here pretty quick.

[Michael Benkowitz, President & COO at United Therapeutics]

And then as Martine said in her answer to a prior question, we have some things that we're looking at in the preclinical setting in our pipeline to potentially bring once daily inhaled product to market.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

Yes. Thank you, Mike and thank you, Ash. I'm very skeptical that just copying treprostinil in a kind of a once daily formulation is going to really provide comparably effective control of pulmonary hypertension. However, as Mike and I referred to earlier, we do have a once daily NCE in our early development and the nature of clinical development team and process as such that that can actually move very, very rapidly from our preclinical to registration phase. So not that I think it's necessary, but I think all of you know that another big mantra at United Therapeutics is multiple shots on goal.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

That's why we have so many products for pulmonary hypertension. As you saw from the data today, all of them are growing. I mean, that's super, super cool. Oral, parenteral, inhaled, nebulized, DPI, I mean, it's just like across the board. So we are constantly developing new products.

[Martine Rothblatt, Founder, Chairman & CEO at United Therapeutics]

And finally, I have not seen anything in since the company has begun developing products where some new one comes in and kind of steals the market. It actually has never happened. And the reason why is that when a product when a patient who has a life threatening illness is well managed on the medicine as the patients are well managed on United Therapeutics medicines in overwhelming numbers, It is a very fraught and cautious and slow process to move those patients to some like newbie on the block that has not really been well proven in the clinic. And these are the reasons, the core reasons why Mike and I and the rest of the team can be so confident that United Therapeutics will continue to deliver the type of double digit revenue growth year after year kind of record revenue growth that I reported in my introductory remarks for many years to come. Operator, you can wrap up the call now.

[Operator]

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

Participants

Executives

• Dewey Steadman, Head, IR
• Martine Rothblatt, Founder, Chairman & CEO
• Leigh Peterson, Executive Vice President of Product Development & Xenotransplantation
• James Edgemond, CFO & Treasurer

Analysts

• Michael Benkowitz, President & COO at United Therapeutics
• Joseph Thome, Managing Director, Senior Biotechnology Analyst at TD Cowen
• Jessica Fye, Managing Director & Equity Research Analyst - Biotechnology at JP Morgan
• Roanna Ruiz, Senior Managing Director, Biotechnology Analyst at Leerink Partners
• Andreas Argyrides, Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
• Roger Song, Analyst at Jefferies Financial Group
• Ashwani Verma, Executive Director - SMID Biotech & Biopharma at UBS Group