Q2 2024 United Therapeutics Corp Earnings Call

July 31, 2024

Operator: Good morning, everyone, and welcome to the United Therapeutics Corporation Q2 2024 Earnings Webcast. My name is Cole, and I'll be your conference operator today. All participants on the call portion of this webcast will be in a listen-only mode until the question and answer portion of this earnings call. If you would like to ask a question during that time, simply press the star, then number one on your telephone keypad. If you would like to withdraw your question, please simply press the star, then the number two on your telephone keypad. And please note that this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.

If you would like to ask a question during that time, simply press the star, then number one on your telephone keypad. If you would like to withdraw your question, please simply press the star, then the number two on your telephone keypad. And please note that this call is being recorded.

Operator: If you would like to withdraw your question, please simply press the star and the number two on your telephone keypad. And please note that this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.

Dewey Steadman: Yes, thank you, Cole. Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation's second quarter 2024 earnings webcast. Remarks we make 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.

Dewey Steadman: Yes, thank you, Cole. Good morning. It's my pleasure to welcome you to the United Therapeutics Corporation Q2 2024 Earnings Webcast. Remarks we make 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. Remarks today may discuss the progress and results of clinical trials or other developments with respect to our products. And 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.

Dewey Steadman: 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. Remarks today may discuss the progress and results of clinical trials or other developments with respect to our products, and these remarks are intended solely to educate investors and are not intended to serve as a basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or uninvestigational uses, and full prescribing information for our products is available on our website.

Speaker Change: Remarks we make today will include forward-looking statements representing our expectations or beliefs.

These remarks are intended solely to educate investors and are not intended to serve as a basis for medical decision making or to suggest that any products are safe and effective for any unimproved or uninvestigational uses. And full prescribing information for our products are available on our website.

Dewey Steadman: Full prescribing information for our products are available on our website. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Patrick Poisson, our Executive Vice President of Technical Operations. Note that Michael Benkowitz and I will participate in a fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on 4 September. James Edgemond and I will participate in a fireside chat and one-on-one meetings at the 2024 Wells Fargo Healthcare Conference in Boston the next day, 5 September.

Dewey Steadman: Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Technical Operations. Note that Michael Benkowitz and I will participate in a fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4th, and James Edgemond and I will participate in a fireside chat and one-on-one meeting at the 2024 Wells Fargo Healthcare Conference in Boston the next day, September 5th.

Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, Michael Benkowitz, our President and Chief Operating Officer, James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Technical Operations.

Speaker Change: James Edgemond, our Chief Financial Officer and Treasurer, Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation, and Pat Poisson, our Executive Vice President of Technical Operations.

Note that Michael Benkowitz and I will participate in a fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4th, and James Edgemond and I will participate in a fireside chat and one-on-one meeting at the 2024 Wells Fargo Healthcare Conference in Boston the next day, September 5th.

Speaker Change: Note that Michael Benkowitz and I will participate in the fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4th, and James Edgemond and I will participate in the fireside chat and one-on-one meetings

Dewey Steadman: Our scientific, commercial, and medical affairs teams will be present at the Pulmonary Hypertension Association 2024 International PH Conference and Scientific Sessions, August 15th to 18th in Indianapolis, the European Respiratory Society Congress in Vienna, September 7th to 11th, and the American College of Chess Physicians Chess 2024 Annual Meeting in Boston, October 6th-9th. Now I will turn the webcast over to Dr. Rothblatt for an overview of our second quarter 2024 financial results and the business activities of United Therapeutics. Dr. Rothblatt?

Dewey Steadman: Our scientific, commercial, and medical affairs teams will be present at the Pulmonary Hypertension Association 2024 International PH Conference and Scientific Sessions, 15 to 18 August in Indianapolis, the European Respiratory Society Congress in Vienna, 7 to 11 September, and the American College of Chest Physicians, CHEST 2024 annual meeting in Boston, 6 through 9 October. Now, I will turn the webcast over to Dr. Rothblatt for an overview of our Q2 2024 financial results and the business activities of United Therapeutics. Dr. Rothblatt?

Martine A. Rothblatt: and the American College of Chess Physicians Chess 2024 Annual Meeting in Boston, October 6-9. Now, I will turn the webcast over to Dr. Rothblatt for an overview of our second quarter 2024 financial results and the business activities of United Therapeutics. Dr. Rothblatt.

Martine A. Rothblatt: Thank you very much, Dewey. We at UT are very pleased and proud to present the results of another record quarter. As described in the press release, the PowerPoint, and the financials, we are doing very well across the board. Double-digit revenue growth is the norm.

Martine Rothblatt: Thank you very much, Dewey. We at UT are very pleased and proud to present the results of another record quarter. As described in the press release, PowerPoint, and the financials, we are doing very well across the board. Double-digit revenue growth is the norm. In a moment, our president, Michael Benkowitz, will provide some deep insight into these numbers. So let me start with the strategic overview. We see our business as three waves of success. First, approved products that are market leaders for the mid-2020s. Second, next-generation products and new indications that can be market leaders in the late 2020s. Third, an organ manufacturing business that can transform the treatment of end-stage organ disease. Examples of the first wave are Remodulin, Tyvaso, Orenitram, and Unituxin.

Martine A. Rothblatt: We at UT are very pleased and proud to present the results of another record quarter.

Martine A. Rothblatt: As described in the press release, PowerPoint, and the financials, we are doing very well across the board. Double-digit revenue growth is the norm.

Martine A. Rothblatt: In a moment, our president, Mike Benkowitz, will provide some deep insight into these numbers. So, let me start with a strategic overview. We see our business as three waves of success. First, we approve products that are market leaders for the mid-2020s, second, next-generation products and new indications that can be market leaders in the late 2020s, third, an organ manufacturing business that can transform the treatment of end-stage organ disease. Examples of the first wave are REMODULIN, TYVASO, ORENITRAM, and UNITUXIN.

In a moment, our president, Mike Benkowitz, will provide some deep insight into these numbers. So, let me start with a strategic overview. We see our business as three waves of success. First, we approve products that are market leaders for the mid-2020s, second, next-generation products and new indications that can be market leaders in the late 2020s, third, an organ manufacturing business that can transform the treatment of end-stage organ disease.

Examples of the first wave are REMODULIN, TYVASO, ORENITRAM, and UNITUXIN. Examples of the second wave are RALINEPAG as a once-daily pill for pulmonary hypertension, and our Teton trial aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis.

Martine A. Rothblatt: Examples of the second wave are Relenopag as a once-daily pill for pulmonary hypertension, and our Teton trial aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis. Now, I'm sometimes asked, with all of this success, Martine, what keeps you up at night?

Examples of the second wave are Relenopag as a once-daily pill for pulmonary hypertension, and our Teton trial aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis.

Speaker Change: We see our business as three waves of success.

Martine A. Rothblatt: First, approve products that are market leaders for the mid-2020s.

Martine A. Rothblatt: Second, next generation products and new indications that can be market leaders in the late 2020s.

Martine A. Rothblatt: Examples of the first wave are remodulin, tybaso, orenotram, and unituxin.

Martine Rothblatt: Examples of the second wave are ralinepag as a once-daily pill for pulmonary hypertension, and our TETON trial, aiming to show improvement in pulmonary fibrosis. Examples of our third wave of success are our xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis. Now, I'm sometimes asked, "With all of this success, Martine, what keeps you up at night?" Well, let me start with what does not keep me up. What does not keep me up is our foundational business, because I do not see any threats to the vitality of our Remodulin, Tyvaso, or Orenitram products. For Remodulin and Tyvaso, my confidence is born of the uniqueness and clinical efficacy of our drug device combination technology. For Remodulin, there is no other parenteral drug delivery device that is as small, accurate, and easy to use as our Remunity pump.

Now, I'm sometimes asked, with all of this success, Martine, what keeps you up at night? Well, let me start with what does not keep me up at night. What does not keep me up is our foundational business because I do not see any threats to the vitality of a REMODULIN, TYVASO, or ORENITRAM product. For REMODULIN and TYVASO, my confidence is born of the uniqueness and clinical efficacy of our drug-device combination technology. For REMODULIN, there is no other parenteral drug delivery device that is as small, accurate, and easy to use as our Remunity pump. Its patented Acoustic Volume Sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts. For TYVASO, there is no other dry powder inhaler so well-matched to deep lung delivery of our drug as the Mankind DPI.

Martine A. Rothblatt: Well, let me start with what does not keep me up at night. What does not keep me up is our foundational business because I do not see any threats to the vitality of a REMODULIN, TYVASO, or ORENITRAM product. For REMODULIN and TYVASO, my confidence is born of the uniqueness and clinical efficacy of our drug-device combination technology. For REMODULIN, there is no other parenteral drug delivery device that is as small, accurate, and easy to use as our Remunity pump.

Speaker Change: Well, let me start with what does not keep me up.

Martine A. Rothblatt: What does not keep me up is our foundational business, because I do not see any threats to the vitality of our remodulin, tyvaso, or oranatram products.

Martine A. Rothblatt: For Remodulin and Tyvaso, my confidence is born of the uniqueness and clinical efficacy of our drug-device combination technology.

Martine A. Rothblatt: Its patented Acoustic Volume Sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts. For TYVASO, there is no other dry powder inhaler so well-matched to deep lung delivery of our drug as the Mankind DPI.

Martine Rothblatt: Its patented acoustic volume sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts. For Tyvaso, there is no other dry powder inhaler so well matched to deep lung delivery of our drug as the MannKind DPI. The proof is really in the pudding. In record times, thousands of patients have begun using our patented device in both old and new pulmonary indications, such as pulmonary arterial hypertension and interstitial lung disease. Competition in our current foundational business doesn't really keep me up either, because they are mostly used in combination with our drugs, or if not, use drug delivery devices that are not as elegant as our Remunity and our DPI devices. Now, let me jump ahead to the organ business.

Speaker Change: Its patented Acoustic Volume Sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts.

Martine A. Rothblatt: For Tyvaso, there is no other dry powder inhaler so well matched to deep lung delivery of our drug as the Mankind DPI.

Martine A. Rothblatt: The proof is really in the pudding. In record time, thousands of patients have begun using our patented device in both old and new pulmonary indications, such as pulmonary arterial hypertension and interstitial lung disease. Competition in our current foundational business doesn't really keep me up either because they are mostly used in combination with our drugs, or if not, they use drug delivery devices that are not as elegant as our remunity and our DPI devices. Now, let me jump ahead to the organ.

Martine A. Rothblatt: Competition in our current foundational business doesn't really keep me up either because they are mostly used in combination with our drugs or if not use drug delivery devices that are not as elegant as our immunity and our DPI devices.

Martine A. Rothblatt: That also doesn't keep me up, because in the last year, we have obtained multiple times scientific proof that our xenokidneys function well in human bodies with no more immunosuppression than an allograft. Folks, that cannot happen by accident. Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production, but I see no showstoppers, and we have achieved proof of concept. It is only in our second wave of success, TYVASO for pulmonary fibrosis and ROLENOPEG for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded.

That also doesn't keep me up, because in the last year, we have obtained multiple times scientific proof that our xenokidneys function well in human bodies with no more immunosuppression than an allograft. Folks, that cannot happen by accident. Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production, but I see no showstoppers, and we have achieved proof of concept.

Martine Rothblatt: That also doesn't keep me up, because in the last year, we have obtained multiple times scientific proof that our xeno kidneys function well in human bodies with no more immunosuppression than an allograft. Folks, that cannot happen by accident. Of course, there's much more work to do to get these xeno kidneys FDA approved, and even more work to do to get them into quantity production. But I see no showstoppers, and we have achieved proof of concept. It is only in our second wave of success, Tyvaso for pulmonary fibrosis and ralinepag for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded, and even a study that is 90% powered for success, by definition, still has a 10% chance of missing.

Martine A. Rothblatt: Now, let me jump ahead to the organ business.

Martine A. Rothblatt: That also doesn't keep me up because in the last year we have obtained multiple times scientific proof that our xenokidneys function well in human bodies with no more immunosuppression than an allograft.

Martine A. Rothblatt: Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production, but I see no showstoppers, and we have achieved proof of concept. It is only in our second wave of success, Tyvaso for pulmonary fibrosis and Rolenopeg for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded.

Martine A. Rothblatt: Folks, that cannot happen by accident.

Martine A. Rothblatt: Of course, there's much more work to do to get these xenokidneys FDA approved, and even more work to do to get them into quantity production. But I see no showstoppers, and we have achieved proof of concept.

It is only in our second wave of success, TYVASO for pulmonary fibrosis and RALINEPAG for PAH, that I find myself kept up at night. The reason is that the results of a clinical trial cannot be known until it is unblinded. And even a study that is 90% powered for success, by definition, still has a 10% chance of missing. Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and RALINEPAG clinical trials. But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high. In conclusion, UT is a rock-solid bet on its current foundational business.

Speaker Change: It is only in our second wave of success, TAIVASO for pulmonary fibrosis and ROLENIPEG for PAH, that I find myself kept up at night.

Martine A. Rothblatt: The reason is that the results of a clinical trial cannot be known until it is unblinded. And even a study that is 90% powered for success, by definition, still has a 10% chance of missing.

Martine A. Rothblatt: And even a study that is 90% powered for success, by definition, still has a 10% chance of missing. Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and RALINEPAG clinical trials. But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high. In conclusion, UT is a rock-solid bet on its current foundational business.

Martine Rothblatt: Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and ralinepag clinical trials. But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high. In conclusion, UT is a rock-solid bet on its current foundational business. UT is a very, very good bet and a highly rewarding one at that, in its next-stage generation products that are now in late-stage clinical trials. UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs. With that strategic overview, I'd like to now turn the call over to our President, Michael Benkowitz. Mike?

Martine A. Rothblatt: Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and Relenopag clinical trials.

Martine A. Rothblatt: But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high.

In conclusion, UT is a rock-solid bet on its current foundational business. UT is a very, very good bet and a highly rewarding one at that in its next-stage generation products that are now in late stage clinical trials. And UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs. With that strategic overview, I'd like to now turn the call over to our president, Michael Benkowitz. Mike?

Martine A. Rothblatt: In conclusion, UT is a rock-solid bet on its current foundational business.

Martine A. Rothblatt: UT is a very, very good bet and a highly rewarding one at that in its next-stage generation products that are now in late stage clinical trials. And UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs. With that strategic overview, I'd like to now turn the call over to our president, Michael Benkowitz. Mike?

Martine A. Rothblatt: and UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs.

Martine A. Rothblatt: With that strategic overview, I'd like to now turn the call over to our President, Michael Benkowitz.

Michael Benkowitz: Thanks, Martine, and good morning everyone. As Martine noted, today we reported yet another quarter of record revenue at $715 million and 20% growth from the second quarter of 2023. We saw meaningful worldwide revenue growth for all of our key products: TYVASO, ORENITRAM, REMODULIN, and UNITUXIN. First, I want to touch on TYVASO, which when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed process cyclin treatment in the U.S. Total TYVASO revenue for the second quarter was $398 million, up 25% over last year, with growth led by continued update of TYVASO's API, increase in pricing and increased commercial utilization following the implementation of the part B resign produced under the Inflation Reduction Act or IRA. For the franchise, we saw record referrals and starts during the quarter, leading us to have confidence in the durability of our growth profile, as Martine mentioned.

Michael Benkowitz: Thanks, Martine, and good morning, everyone. As Martine noted, today, we reported yet another quarter of record revenue at $715 million and 20% growth from Q2 2023. We saw meaningful worldwide revenue growth for all of our key products, Tyvaso, Orenitram, Remodulin, and Unituxin. First, I want to touch on Tyvaso, which, when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed prostacyclin treatment in the US. Total Tyvaso revenue for the second quarter was $398 million, up 25% over last year, with growth led by continued uptake of Tyvaso DPI, an increase in pricing and increased commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act, or IRA.

Michael I. Benkowitz: Thanks, Martine. Good morning, everyone.

Michael I. Benkowitz: As Martine noted, today we reported yet another quarter of record revenue at $715 million and 20% growth from the second quarter of 2023.

Speaker Change: We saw meaningful worldwide revenue growth for all of our key products, Tybaso, Orenatram, Remodulin, and Unituxin.

Michael Benkowitz: First, I want to touch on TYVASO, which when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed process cyclin treatment in the U.S. Total TYVASO revenue for the second quarter was $398 million, up 25% over last year, with growth led by continued update of TYVASO's API, increase in pricing and increased commercial utilization following the implementation of the part B resign produced under the Inflation Reduction Act or IRA. For the franchise, we saw record referrals and starts during the quarter, leading us to have confidence in the durability of our growth profile, as Martine mentioned.

Speaker Change: First, I want to touch on Tybaso, which when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed cross-recycling treatment in the U.S.

Speaker Change: Total TYBASA revenue for the second quarter was $398 million, up 25% over last year, with growth led by continued uptake of TYBASA DPI.

Speaker Change: an increase in pricing, and increased commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act, or IRA.

Michael Benkowitz: For the franchise, we saw record referrals and starts during the quarter, leading us to have confidence in the durability of our growth profile, as Martine mentioned. The percentage of Tyvaso DPI patients using our patient access programs continues to tick down following the implementation of the first provisions of the IRA earlier this year, albeit not at the same rate we saw between Q4 2023 and Q1 2024. We could continue to see a modest decline in patient access program utilizations through the remainder of the year, as new patients on therapy are less likely to need patient assistance, having met their copay obligations on another product before starting Tyvaso DPI. The benefit from this could be offset by modest rebates from our initial contracting efforts to ensure period access in the future for Tyvaso DPI.

Michael I. Benkowitz: For the franchise, we saw record referrals and starts during the quarter, leading us to have confidence in the durability of our growth profile, as Martine mentioned.

Michael I. Benkowitz: The percentage of TYVASO DPI patients using our patient access programs continues to tick down following the implementation of the first provisions of the IRA earlier this year, albeit not at the same rate we saw between the fourth quarter of 2023 and the first quarter of 2024. We could continue to see a modest decline in patient access program utilization through the remainder of the year as new patients on therapy are less likely to need patient assistance having met their copay obligations on another product before starting TYVASO DPI. The benefit from this could be offset by modest rebates from our initial contracting efforts to ensure parity of access in the future for TYVASO DPI.

Martine: The percentage of Tybaso DPI patients using our patient access programs continues to tick down following the implementation of the first provisions of the IRA earlier this year.

Martine: albeit not at the same rate we saw between the fourth quarter of 2023 and the first quarter of 2024.

Martine: We could continue to see a modest decline in patient access program utilization through the remainder of the year as new patients on therapy are less likely to need patient assistance having met their co-pay obligations on another product before starting Tybaso DPI.

Michael I. Benkowitz: The benefit from this could be offset by modest rebates from our initial contracting efforts to ensure parity of access in the future for TEDASO DPI.

Michael I. Benkowitz: As an aside, we understand that CMS will soon publish the negotiated prices for the first 10 drugs selected under the IRA's drug price negotiation provision. I want to remind investors that our drugs are not on this list. In addition, based on our current understanding of the IRA statute and guidance issued by CMS thus far, we expect our troprostyl products will not be subject to price negotiation under the IRA because there is at least one marketed generic version of troprostyl.

Michael Benkowitz: As an aside, we understand that CMS will soon publish the negotiated prices for the first 10 drugs selected under the IRA's drug price negotiation provision. I want to remind investors that our drugs are not on this list. In addition, based on our current understanding of the IRA statute and guidance issued by CMS thus far, we expect our treprostinil products will not be subject to price negotiation under the IRA because there is at least one marketed generic version of treprostinil. Moving to Orenitram, we reported yet another quarter of record revenue at $107 million, representing 13% growth from the second quarter of 2023. Like the first quarter, this was driven by a combination of increased commercial utilization, pricing, and a modest increase in average dose from prior quarter levels. Recall that Orenitram and Remodulin are priced on a per milligram basis.

Michael I. Benkowitz: As an aside, we understand that CMS will soon publish the negotiated prices for the first 10 drugs selected under the IRAs.

Michael I. Benkowitz: Drug Price Negotiation Provision.

Speaker Change: I want to remind investors that our drugs are not on this list.

Speaker Change: In addition, based on our current understanding of the IRA statute and guidance issued by CMS thus far, we expect our troprostanol products will not be subject to price negotiation under the IRA because there is at least one marketed generic version of troprostanol.

Michael I. Benkowitz: Moving to ORENITRAM, we reported yet another quarter of record revenue at $107 million, representing 13% growth from the second quarter of 2023. Like the first quarter, this was driven by a combination of increased commercial utilization, pricing, and a modest increase in average dose from prior quarter levels. Recall that ORENITRAM and REMODULIN are priced on a per milligram basis. Like with TYVASO DPI, we saw a modest decrease in patient access program use for ORENITRAM in the second quarter, driven by the same dynamics. Likewise, we expect a modest decline in patient access program use through the remainder of the year.

Speaker Change: Moving to a rent-a-tramp, we reported yet another quarter of record revenue at $107 million, representing 13% growth from the second quarter of 2023.

Speaker Change: Like the first quarter, this was driven by a combination of increased commercial utilization, pricing, and a modest increase in average dose from prior quarter levels. Recall that a Renisham and Remodulin are priced on a per milligram basis.

Michael Benkowitz: Like with Tyvaso DPI, we saw a modest decrease in patient access program use for Orenitram in Q2, driven by the same dynamics. Likewise, we expected - we expect a modest decline in patient access program use through the remainder of the year. Our medical teams continue to have scientific discussions based on recent scientific publications with healthcare providers on the expedite induction protocol, where PAH patients initiate on Remodulin and then transition to Orenitram as an option for appropriate patients who may not want or need to go on long-term parenteral therapy. Moving to Remodulin. Worldwide revenue of $147 million was up 16% from last year, with very strong performance across all of our underlying demand metrics. This comes 5 years after the first launch of generics for Remodulin, reflecting our continued commitment to our patients and Remodulin.

Speaker Change: Like with high-based ODPI, we saw a modest decrease in patient access program use for a renter in the second quarter, driven by the same dynamics.

Michael I. Benkowitz: Likewise, we expect a modest decline in patient access program use through the remainder of the year. Our medical teams continue to have scientific discussions based on recent scientific publications with healthcare providers on the Expedite Induction Protocol, where PAH patients initiate on REMODULIN and then transition to ORENITRAM as an option for appropriate patients who may not want or need to go on long-term coronary therapy. Moving to REMODULIN, worldwide revenue of $147 million was up 16% from last year, with very strong performance across all of our underlying demand metrics.

Likewise, we expect a modest decline in patient access program use through the remainder of the year. Our medical teams continue to have scientific discussions based on recent scientific publications with healthcare providers on the Expedite Induction Protocol, where PAH patients initiate on REMODULIN and then transition to ORENITRAM as an option for appropriate patients who may not want or need to go on long-term coronary therapy.

Likewise, we expect a modest decline in patient access program use through the remainder of the year.

Speaker Change: Likewise, we expect a modest decline in patient access program use for the remainder of the year.

Our medical teams continue to have scientific discussions based on recent scientific publications with healthcare providers on the Expedite Induction Protocol, where PAH patients initiate on REMODULIN and then transition to ORENITRAM as an option for appropriate patients who may not want or need to go on long-term coronary therapy.

Speaker Change: Our medical teams continue to have scientific discussions based on recent scientific publications.

Speaker Change: with healthcare providers on the Expedite Induction Protocol, where PAH patients initiate on remodulin and then transition to a renitrin as an option for appropriate patients who may not want or need to go on long-term perinatal therapy.

Moving to REMODULIN, worldwide revenue of $147 million was up 16% from last year, with very strong performance across all of our underlying demand metrics. And this comes five years after the first launch of generics for REMODULIN, reflecting our continued commitment to our patients on REMODULIN. REMODULIN both intravenous and subcutaneous, remains the most prescribed granuloplasty cyclin in the U.S. Our Remunity Pump remains the only option for new subcutaneous patient starts. Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all sub-Qs for professional use to REMODULIN and our immunity pump, given the discontinuation of support for the CAD MS3 system by its manufacturer.

Speaker Change: Moving to Remodulin, worldwide revenue of $147 million was up 16% from last year, with very strong performance across all of our underlying demand metrics. And this comes five years after the first launch of generics for Remodulin, reflecting our continued commitment to our patients and Remodulin.

Michael I. Benkowitz: And this comes five years after the first launch of generics for REMODULIN, reflecting our continued commitment to our patients on REMODULIN. REMODULIN both intravenous and subcutaneous, remains the most prescribed granuloplasty cyclin in the U.S. Our Remunity Pump remains the only option for new subcutaneous patient starts. Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all sub-Qs for professional use to REMODULIN and our immunity pump, given the discontinuation of support for the CAD MS3 system by its manufacturer.

Michael Benkowitz: Remodulin, both intravenous and subcutaneous, remains the most prescribed parenteral prostacyclin in the US. Our Remunity pump remains the only option for new subcutaneous patient starts. Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all subcu treprostinil use to Remodulin and our Remunity pump, given the discontinuation of support for the CADD-MS 3 system by its manufacturer. We've seen this trend continue through Q2. Finally, Unituxin. Worldwide revenue of $52 million was up 17% from the prior year quarter, and US Unituxin revenue of $47 million was up 18%. US growth was driven by price and volume. To wrap up, with our 5th quarter in a row of record revenue, our commercial products clearly have the innovation, interest, momentum, and muscle to continue to grow and serve our patients.

Speaker Change: Remodulin, both intravenous and subcutaneous, remains the most prescribed coronal process cyclin in the U.S. Our Remunity Pump remains the only option for new subcutaneous patient starts.

Our Remunity Pump remains the only option for new subcutaneous patient starts. Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all sub-Qs for professional use to REMODULIN and our immunity pump, given the discontinuation of support for the CAD MS3 system by its manufacturer. We've seen this trend continue through the second quarter.

Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all sub-Q-troposyl use to remodulin and our immunity pump, given the discontinuation of support for the CAD MS3 system by its manufacturer. We've seen this trend continue through the second quarter.

Michael I. Benkowitz: We've seen this trend continue through the second quarter. Finally, UNITUXIN. Worldwide revenue of $52 million was up 17% from the prior year quarter, and U.S. UNITUXIN revenue of $47 million was up 18%. U.S. growth was driven by price and volume. To wrap up, with our fifth quarter in a row of record revenue, our commercial products clearly have the innovation, interest, momentum, and muscle to continue to grow and serve our patients. With that, I'll turn the call back over to Martine to run the Q&A.

We've seen this trend continue through the second quarter.

Finally, UNITUXIN. Worldwide revenue of $52 million was up 17% from the prior year quarter, and U.S. UNITUXIN revenue of $47 million was up 18%. U.S. growth was driven by price and volume. To wrap up, with our fifth quarter in a row of record revenue, our commercial products clearly have the innovation, interest, momentum, and muscle to continue to grow and serve our patients. With that, I'll turn the call back over to Martine to run the Q&A.

Speaker Change: Finally, Unitexan. Worldwide revenue of $52 million was up 17% from the prior year quarter, and U.S. Unitexan revenue of $47 million was up 18%. U.S. growth was driven by price and volume.

Speaker Change: To wrap up with our fifth quarter in a row of record revenue, our commercial products clearly have the innovation, interest, momentum, and muscle to continue to grow and serve our patients.

Michael Benkowitz: With that, I'll turn the call back over to Martine to run the Q&A.

Martine A. Rothblatt: Michael, that was just such a perfect overview of everything. Thanks so much, and thanks for all of your leadership in all of those areas. Operator, you may now bring forward the first call.

Martine Rothblatt: Michael, that was just such a perfect overview of everything. Thanks so much, and thanks for all of your leadership in all of those areas. Operator, you may now bring forward the first call.

Speaker Change: With that, I'll turn the call back over to Martine to run the Q&A.

Martine: Michael, that was just such a perfect overview of everything. Thanks so much and thanks for all of your leadership in all of those areas.

Operator: Operator, you may now bring forward the first call.

Operator: Thank you, and we will now begin the question and answer session. If you would like to ask a question, please press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the key. And to withdraw your question, please press star then two. And at this time, we will pause momentarily for the first question. Today it will come from Roanna Ruiz with Leerink Partners. Please go ahead.

Operator: ... Thank you, and we will now begin the question and answer session. If you would like to ask a question, please press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the key. And to withdraw your question, please press star then two. And at this time, we will pause momentarily for the first question. Today will come from Roanna Ruiz with Leerink Partners. Please go ahead.

Speaker Change: Thank you, and we will now begin the question and answer session.

Speaker Change: If you would like to ask a question, please press star then 1 on your Touchstone phone.

Speaker Change: If you are using a speakerphone, please pick up your handset before pressing the keys. And to withdraw your question, please press star then 2.

Speaker Change: And at this time, we will pause momentarily for the first question.

Roanna Ruiz: Hey, morning everyone. So I was curious, could you elaborate a bit on the different drivers you saw in the quarter for TYVASO DPI versus nebulized TYVASO? And were there any changes or reasons for greater confidence coming through? Like I think you mentioned, increased number of referrals and possibly ramping the new field force that we should keep in mind going into 3Q this year?

Roanna Ruiz ;: Hey, morning, everyone. So I was curious, could you elaborate a bit on the different drivers you saw in the quarter for Tyvaso DPI versus nebulized Tyvaso? And were there any changes or reasons for greater confidence coming through? Like, I think you mentioned increased number of referrals and possibly ramping the new field force that we should keep in mind going into Q3 this year.

Roanna Ruiz: Hey, morning, everyone. So I was curious, could you elaborate a bit on the different drivers you saw in the quarter for Tyvaso DPI versus nebulized Tyvaso? And were there any changes or reasons for greater confidence coming through? Like, I think you mentioned increased number of referrals and possibly ramping the new field force that we should keep in mind going into Q3 this year.

Speaker Change: So, I was curious, could you elaborate a bit on the different drivers you saw in the quarter for TiVaso DPI versus nebulized TiVaso, and were there any changes or reasons for greater confidence coming through, like I think you mentioned, increased number of referrals and possibly ramping the new field force that we should keep in mind going into 3Q this year?

Martine A. Rothblatt: Thank you for that question, Roanna. That type of commercialization question would be best handled by Michael.

Martine Rothblatt: Thank you for that question, Roanna. That's that type of commercialization question would be best handled by Michael.

Michael Benkowitz: Sure, thanks for the question. So, I think the underlying demand metrics just kind of, we continue to just plug along or chug along like we have the past few quarters with the referrals and with the starts, and it continues to come from both Group 1 PAH as well as Group 3 PHILD. The second part of your question about the salesforce, we started to see some of the impact of that salesforce expansion in the second quarter. As you recall, we started that ramp up in the last fall, really fully deploying that team on January 1.

Michael Benkowitz: Sure. Thanks for the question. So, I think the underlying demand metrics just kinda, you know, we continue to just, I think, plug along or chug along, like we have the past few quarters with the referrals and with the starts, and it continues to come from both Group One PAH as well as Group Three PH-ILD. You know, the second part of your question about the sales force, I think we, you know, are starting to see some of the impact of that sales force expansion in Q2. As you recall, we started that ramp up in the last fall, really fully deployed that team January 1.

Michael Benkowitz: The second part of your question about the salesforce, we started to see some of the impact of that salesforce expansion in the second quarter. As you recall, we started that ramp up in the last fall, really fully deploying that team on January 1. And of course, it takes a little bit of time for the reps to get out in the field and get in front of the physicians and have the opportunity to educate them on the benefits of our products.

Speaker Change: Group 1 PAH as well as Group 3 PHILD. The second part of your question about the sales force, I think we are starting to see some of the impact of that sales force.

Michael I. Benkowitz: And of course, it takes a little bit of time for the reps to get out in the field and get in front of the physicians and have the opportunity to educate them on the benefits of our products. But what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers, actually writing TYVASO. And so when we first launched in the PHILD a couple years ago, our efforts were really focused on educating around the need to screen for pulmonary hypertension and then once they started to do that, [inaudible] the patients had pulmonary hypertension associated with ILD, they get to make the decision whether to put that patient in the PH clinic or try and treat them themselves. So the vast majority of doctors at that time started referring them to the PH clinic. But we knew it would really work for us to, I think, realize the full opportunity that we have at PHILD these physicians were gonna have to start treating just because of the number of patients that are out there and the bandwidth constraints on the physicians in the PAH clinic.

And of course, it takes a little bit of time for the reps to get out in the field and get in front of the physicians and have the opportunity to educate them on the benefits of our products.

Michael Benkowitz: And of course, it takes a little bit of time for the reps to get out in the field and get in front of those physicians and, you know, have the opportunity to educate them on the benefits of our products. But what, you know, what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers actually writing Tyvaso. So when we first launched in the PH-ILD a couple years ago, you know, our efforts were really focused on educating around the need to screen for pulmonary hypertension.

Speaker Change: and the rest of the team. Really fully deployed that team January 1 and of course it takes a little bit of time for the reps to get out in the field.

But what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers, actually writing TYVASO. And so when we first launched in the PHILD a couple years ago, our efforts were really focused on educating around the need to screen for pulmonary hypertension and then once they started to do that, [inaudible] the patients had pulmonary hypertension associated with ILD, they get to make the decision whether to put that patient in the PH clinic or try and treat them themselves. So the vast majority of doctors at that time started referring them to the PH clinic. But we knew it would really work for us to, I think, realize the full opportunity that we have at PHILD these physicians were gonna have to start treating just because of the number of patients that are out there and the bandwidth constraints on the physicians in the PAH clinic.

Speaker Change: Get in front of the physicians and have the opportunity to educate them on the benefits of our products.

Speaker Change: But what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers actually riding Tyvaso.

Michael Benkowitz: And then once, you know, once they started to do that, suspect that the patients had pulmonary hypertension associated with ILD, you know, then they could make the decision whether to refer that patient into the PH clinic or trying to treat them themselves. I would say the vast majority of doctors at that time started referring to the PH clinic. So, but we knew, you know, really in order for us to, I think, realize the full opportunity we have in PH-ILD, these physicians were gonna have to start treating just because of the number of patients that are out there and the bandwidth constraints on the physicians in the PH clinic.

Speaker Change: started referring to the PH clinic. So, but we knew, you know, really it would work for us to, I think, realize the full opportunity that we have at PHILD. These physicians were gonna have to start treating just.

Michael I. Benkowitz: So it's been really nice to see that over the last six months, we really started to increase both the breadth of ILD prescribers as well as the depth. And recall, the depth metric we always look at is physicians with three or more patients. So we're seeing really positive momentum and growth on both of those key metrics.

Michael Benkowitz: So it's been really nice to see that, you know, over the last six months, we really started to increase both the breadth of ILD prescribers as well as the depth. And recall, the depth metric we always look at is physicians with three-plus patients. And so we're seeing really positive momentum and growth on both of those key metrics.

Martine A. Rothblatt: Thank you so much, Mike, and thank you, Roanna, for your question. Operator, you can bring forward the next question.

Martine Rothblatt: Thank you so much, Mike, and thank you, Roanna, for your question. Operator, you could bring forward the next question.

Speaker Change: Thank you so much, Mike, and thank you, Roanna, for your question. Operator, you could bring forward the next question.

Operator: And our next question will come from Jessica Fye, with J.P. Morgan. Please go ahead.

Operator: Our next question will come from Jessica Fye with J.P. Morgan. Please go ahead.

Speaker Change: And our next question will come from Jessica Fye with JPMorgan. Please go ahead.

Jessica Fye: Great, good morning. Thanks for taking my question. I'm curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial WINREVAIR launch. Do your observations line up with Merck's commentary yesterday? Have you noticed any changes in referrals or starts in PAH?

Jessica Fye [Managing Director, Equity Research Analyst: Great. Good morning. Thanks for taking my question. Curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial Winrevair launch. Do your observations line up with Merck's commentary yesterday? Have you noticed any changes in referrals or starts in PAH?

Jessica Fye: Great. Good morning. Thanks for taking my question. Curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial Winrevair launch. Do your observations line up with Merck's commentary yesterday? Have you noticed any changes in referrals or starts in PAH?

Martine A. Rothblatt: I'm curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial WinRiver launch. Do your observations line up with Merck's commentary yesterday? Have you noticed any changes in referrals or starts in PAH?

Martine A. Rothblatt: Thanks Jess. It's nice to hear your voice this morning. Again, I think it's a market dynamics question that Michael is the best person to answer.

Martine Rothblatt: Thanks, Jess. Nice to hear your voice this morning. Again, I think it's a market dynamics question that Michael is the best person to answer.

Michael Benkowitz: Yeah, sure. Thanks for the question, Jess. Yeah, I mean, I'm not going to really comment too much on Merck's product. I mean, they're plenty capable of speaking for themselves. With respect to our business and specifically in the PAH, I think the business remains very solid, very strong, really strong referral growth, really strong start growth, patient shipments, all of the underlying demand metrics continue to be in line with what we expect, where we think we need to be. And that's obviously being reflected in the revenue line on our financial statement. So at this point, in the first quarter, no surprises there.

Michael Benkowitz: Yeah, sure. Thanks, thanks for the question, Jess. Yeah, I mean, I'm not, I'm not gonna really comment too much on, on, Merck's product. I mean, they're, they're plenty capable of, of speaking for themselves. But with, with respect to our business, and specifically in the PAH, I think the, the business remains fairly, very solid, very strong. Really strong referral growth, really, really strong, start growth, patient shipments, all of the underlying demand metrics, continue to be, in line with what we expect, and what we, what we think we need to be. And, you know, that's obviously being reflected in the, in the revenue line, on our financial statement. So, you know, so, so at this point, you know, through, you know, in Q1, no, no surprises there.

Speaker Change: Thanks for the question, Jess. I'm not going to comment too much on Merck's product. They're plenty capable of speaking for themselves. With respect to our business,

Michael I. Benkowitz: With respect to our business and specifically in the PAH, I think the business remains very solid, very strong, really strong referral growth, really strong start growth, patient shipments, all of the underlying demand metrics continue to be in line with what we expect, where we think we need to be. And that's obviously being reflected in the revenue line on our financial statement. So at this point, in the first quarter, no surprises there.

Speaker Change: And specifically in the PAH, I think the business remains very solid, very strong, really strong referral growth, really strong start growth, patient shipments, all of the underlying demand metrics continue to be in line with what we expect.

Speaker Change: at where we think we need to be.

Michael Benkowitz: So at this point, in the first quarter, no surprises there. I think as Martine said in his opening remarks, if you look at the Merck clinical trial, most of those patients were using Cetatorcept in combination with prostacyclines, and that certainly at least seems to be how that's playing out so far.

Speaker Change: and the revenue line on our financial statement. So, you know, so at this point, you know, in the first quarter, no, no surprises there to be, you know, as Martine said in her opening remarks, if you look at.

Michael I. Benkowitz: I think as Martine said in his opening remarks, if you look at the Merck clinical trial, most of those patients were using Cetatorcept in combination with prostacyclines, and that certainly at least seems to be how that's playing out so far.

Michael Benkowitz: I think, you know, as Martine said in her opening remarks, if you look at the Merck's clinical trial, most of those patients were using sotatercept in combination with prostacyclins, and that certainly at least seems to be how that's playing out so far.

Martine A. Rothblatt: Perfect. Thanks so much, Mike. Thank you, Jess. Operator, could you bring forward the next question please?

Martine Rothblatt: Perfect. Thanks so much, Mike. Thank you, Jess. Operator, could you bring forward the next question, please?

Speaker Change: Perfect. Thanks so much, Mike. Thank you, Jeff. Operator, could you bring forward the next question, please?

Operator: And our next question will come from Ash Verma with UBS. Please go ahead.

Operator: Our next question will come from Ash Verma with UBS. Please go ahead.

Roanna Ruiz ;: Great. Thanks, thanks for that. So my question, just wanted to understand. So, look, I mean, I think the stock has reacted pretty favorably to the ASR, and I know from a cash outflow, you mentioned last quarter that you have now a more specific understanding of what's required for xeno. So given where we are right now, like, what's your appetite for another significant share buyback or another ASR?

Ash Verma: Great, thanks for that. So my question, just wanted to understand, look, I mean, I think the stock has reacted pretty favorably to the ASR, and I know from a cash outflow you mentioned last quarter that you have now a more specific understanding of what's required for Zeno. So given where we are right now, what's your appetite for another significant share buyback or another ASR?

Ash Verma: Great. Thanks, thanks for that. So my question, just wanted to understand. So, look, I mean, I think the stock has reacted pretty favorably to the ASR, and I know from a cash outflow, you mentioned last quarter that you have now a more specific understanding of what's required for xeno. So given where we are right now, like, what's your appetite for another significant share buyback or another ASR?

Great, thanks for that. So my question, just wanted to understand, so look I mean I think the stock has reacted pretty favorably to the ASR and I know from a

Martine A. Rothblatt: Thank you for your question, Ash. That being basically a kind of capital allocation question, I think the best person on the call to answer that would be our Chief Financial Officer, James Edgemond. James?

Martine Rothblatt: Thank you for your question, Ash. That being basically a kind of a capital allocation question, I think the best person on the call to answer that would be our Chief Financial Officer, James Edgemond. James?

James Christopher Edgemond: Great. Thanks, Martine. Ash, it's good to hear your voice. Thank you for the question. There are two kinds of responses to your question. One is, our current ASR is still in process, right? The existing or the second tranche, as we've described in our disclosure, the $700 million is still in process through the end of September of this year. So we're going to first focus on executing the existing ASR and share repurchase program. A second kind of consideration is that we are still committed to allocating capital wisely.

James Edgemond: ... Great, thanks, Martine. Ash, good to hear your voice. Thank you for the question. Two kind of responses to your question. One is, our current ASR is still in process, right? The existing or the second tranche, as we've described in our disclosure, the $700 million still is in process through the end of September of this year. So we're gonna first focus on executing the existing ASR and share repurchase program. A second kind of consideration is we are still committed to allocating capital wisely and in the best interest of stakeholders by first deploying it, as we've said historically, Ash, internally for our R&D initiatives, including manufacturing facilities. And included in those manufacturing facilities, certainly is our consideration of future commercial DPF capital requirements.

James C. Edgemond: Thank you for the question. There are two kinds of responses to your question. One is our current ASR is still in process, right? The existing or the second tranche, as we've described in our disclosure, the $700 million is still in process through the end of September of this year. So we're going to first focus on executing the existing ASR and share repurchase program. A second kind of consideration is that we are still committed to allocating capital wisely.

Two kind of responses to your question, one is

Our current ASR is still in process, right? The existing or the second tranche, as we've described in our disclosure, the $700 million still is in process through the end of.

September of this year. So we're going to first focus on executing the existing ASR and share repurchase program. A second kind of consideration is is we are still committed to allocating capital wisely.

James C. Edgemond: And in the best interest of stakeholders, by first deploying it, as we've said historically, Ash, internally for our R&D initiatives, including manufacturing facilities, and included in those manufacturing facilities certainly is our consideration of future commercial DPF capital requirements. Second is, we're going to still focus on corporate development to find those opportunities where we think we can bring value to shareholders and benefits to patients. And third, kind of what we said at the beginning, our Earned Share Repurchase Program.

Speaker Change: and in the best interest of stakeholders by first deploying it as we've set historically, Ash, internally for our R&D initiatives, including.

James Edgemond: Second is we're gonna still focus on corporate development to find those opportunities where we think can bring value to shareholders and values to patients. And third, kind of what we've said at the beginning, I said at the beginning, our current share repurchase program. So our capital allocation program will continue to be the same. We'll continue to evaluate and get more knowledgeable about the construction of the DPF facilities. But right now, we're just gonna continue to focus on the ASR that's in place, and then continue to use that capital allocation waterfall to evaluate any future opportunities, whether it's share repurchase or otherwise. But thank you for the question. Martine, back to you.

Second is we're gonna still focus on corporate development to find those opportunities where we think can bring value to shareholders and values to patients.

And third, kind of what we've said at the beginning, our Earned Share Repurchase Program. So our capital allocation program will continue to be the same, will continue to evaluate.

James C. Edgemond: So our capital allocation program will continue to be the same, will continue to evaluate and get more knowledgeable about the construction of the DPF facilities. But right now, we're just going to continue to focus on the ASR that's in place, and then continue to use that capital allocation waterfall to evaluate any future opportunities, whether it's share repurchase or otherwise but thank you for the question. Martine, back to you.

Martine A. Rothblatt: James, that was a 360-degree comprehensive answer to Ash, so greatly appreciated. Operator, next question please.

Martine Rothblatt: James, that was a 360-degree comprehensive answer to Ash, so, so greatly appreciated. Operator, next question, please.

Operator: And our next question will come from Joseph Thome, with T.D. Cowan. Please go ahead.

[Analyst] (TD Cowen and Oppenheimer): Our next question will come from Joseph Stringer with TD Cowen. Please go ahead.

Operator: Our next question will come from Joseph Stringer with TD Cowen. Please go ahead.

And our next question will come from Joseph Thome with TD Cowan. Please go ahead.

Joseph Thome: Hi there. Good morning, and thank you for taking my question. Maybe just one on the filing strategy for IPF, assuming success. I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing? Or do you think there is a p-value level or level of benefit that you could see in one where you maybe would only need one of these studies to work? And any feedback from the FDA on that point would be helpful if you have it. Thank you.

Joseph Stringer: Hi there. Good morning, and thank you for taking my question. Maybe just one on the filing strategy for IPF, assuming success. I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing? Or do you think there is a p-value level or level of, you know, benefit that you could see in one where, you know, you maybe would only need one of these studies to work? And any feedback from the FDA on that point will be helpful if you have it. Thank you.

Joseph Thome: Hi there. Good morning, and thank you for taking my question. Maybe just one on the filing strategy for IPF, assuming success. I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing? Or do you think there is a p-value level or level of, you know, benefit that you could see in one where, you know, you maybe would only need one of these studies to work? And any feedback from the FDA on that point will be helpful if you have it. Thank you.

Martine A. Rothblatt: Maybe just one on the filing strategy for IPF, assuming success. I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing? Or do you think there is a p-value level or level of benefit that you could see in one where you maybe would only need one of these studies to work? And any feedback from the FDA on that point would be helpful if you have it. Thank you.

I guess, do both of the ongoing IPF studies need to be successful in order to pursue a filing, or do you think there is a...

P-value level or level of benefit that you could see in one where you maybe would only need one of these studies to work and any feedback from the FDA on that point will be helpful if you have it.

Martine A. Rothblatt: Thank you, Joe, for that question. Fortunately, we have on our call the person who's in charge of that entire program, Dr. Leigh Peterson. So, Dr. Peterson, could you kindly respond to Joe?

Martine Rothblatt: Thank you, Joe, for that question. Fortunately, we have on our call the person who's in charge of that entire program, Dr. Leigh Peterson. So, Dr. Leigh Peterson, could you kindly respond to Joe?

Thank you, Joe, for that question. Fortunately, we have on our call the person who's in charge of that entire program, Dr. Leigh Peterson. So, Dr. Peterson, could you kindly respond to Joe?

Leigh Peterson: Yeah, sure. We haven't recently discussed this with FDA. I mean, this was really early, early discussion with the IND. They really just gave us the boilerplate language that they always do, which is typically, we require two studies for, two positive studies for registration. But, of course, I mean, if we see, we'll likely see the Teton 2 results coming out before Teton 1, at least the top-line results, because, as you know, we completed the Teton 2 enrollment period early. And so we'll see those, and we will certainly continue discussions with FDA, I mean, assuming a really significant, highly positive, clinically significant result, then we will certainly have a discussion with them about that.

Leigh Peterson: Yeah, sure. We haven't recently discussed this with FDA. I mean, this was really early, early discussions with the IND. They really just gave us the boilerplate, you know, language that they always do, which is typically we require two studies for, you know, re- two positive studies for registration. But of course, I mean, if we, if we, you know, see... We'll likely see the TETON 2 results coming out before TETON 1, at least the top-line results, because as you know, we completed the TETON 2 enrollment period early. And so we'll see those, and we will certainly continue discussions with FDA. I mean, assuming a really, you know, significant, highly positive, clinically significant results, then we will certainly have a discussion with them about that.

Yeah, sure. We haven't recently discussed this with FDA. I mean, this was really early, early discussion with the IND.

They really just gave us the boilerplate, you know, language that they always do, which is typically we require two studies for, you know, two positive studies for registration. But, of course, I mean, if we, if we,

We'll likely see the Teton 2 results coming out before Teton 1, at least the top-line results, because, as you know, we completed the Teton 2 enrollment period early.

And so, we'll see those, and we will certainly continue discussions with FDA, I mean, assuming a really, you know, significant, highly positive, clinically significant result, then we will certainly have a...

Martine A. Rothblatt: Thank you so much, Dr. Peterson. And just to, you know, because she's too modest to really toot her own horn, but I just want to remind everybody that Dr. Peterson and Dr. Smith, her right-hand clinical trial leader, they're the same team that executed so successfully our interstitial lung disease trial that resulted in really much of what we are celebrating today, the explosive growth in group 3 PAH and the entry into that space of the DPI. So this team, I know for sure, because I see them often, they too, they swept this trial day and night, and this is our, if somebody said like, what is your number one priority, it is the success of the Teton trial and the indication to achieve an indication in pulmonary fibrosis, a market that is probably three times the size of the pulmonary hypertension market.

Martine Rothblatt: Thank you so much, Dr. Pedersen. And just to, you know, because she's too modest to really toot her own horn, but I just want to remind everybody that Dr. Pedersen and Dr. Smith, her right hand clinical trial leader, they're the same team that executed so successfully our interstitial lung disease trial that resulted in really much of what we are celebrating today, the explosive growth in Group Three PAH and the entry into that space of the DPI. So this team, I know for sure, because I see them often, they too sweat this trial day and night and we are, this is our...

have a discussion with them about that.

Thank you so much, Dr. Peterson.

Just to, you know, because she's too modest to really toot her own horn, but I just want to remind everybody that Dr. Peterson and Dr. Smith, her right hand

Clinical Trial Leader. They're the same team that executed so successfully our interstitial lung disease trial that resulted in the in really much of what we are celebrating today.

the explosive growth in Group 3 PAH.

and the entry into that space of the DPI.

So, this team, I know for sure because I see them often, they too, they swept this trial day and night.

Martine Rothblatt: If somebody said, like, "What is your number one priority?" It is the, you know, success of the TETON trial and the indication, to achieve an indication in pulmonary fibrosis, a market that is, probably, you know, three times the size of the pulmonary hypertension market. And again, our trial design is in combination with already approved background therapies, so there's no real kind of having to like, you know, take a patient off a drug to start them on an inhaled treprostinil. And similarly, there's no need to put a patient on another drug to start them because we have both types of patients in the trial. So we would hope for all of that to be in the label. Anyway, sorry to ramble on there a bit, Dr.

and we are, this is our.

If somebody said, like, what is your number one priority, it is the, you know, success of the Teton trial and the indication, to achieve an indication in pulmonary fibrosis.

A market that is probably, you know, three times the size of the pulmonary hypertension market.

Martine A. Rothblatt: And again, our trial design is in combination with already approved background therapies, so there's no real need to take a patient off a drug to start them on inhaled triprostanol, and similarly, there's no need to put a patient on another drug to start them because we have both types of patients in the trial. So we would hope for all of that to be in the label. Anyway, sorry to ramble on there a bit, Dr. Peterson, but a great answer to Joe. And operator, due to time constraints, we have time for just one more question.

And again, our trial design is in combination with already approved background therapies.

So, there's no real kind of having to like, you know.

Take a patient off a drug to start them on an inhaled terprosinol, and similarly, there's no need to put a patient on another drug.

to start them because we have both types of patients in the trial. So we would hope for all of that to be in the label. Anyway, sorry to ramble on there a bit, Dr. Peterson, but great answer to Joe. And, operator, due to the time, we have time for just one more question.

Martine Rothblatt: Pedersen, but great answer to Joe. Operator, due to the time, we have time for just one more question.

Operator: And that question will come from Andreas Argyrides with Oppenheimer. Please go ahead.

[Analyst] (TD Cowen and Oppenheimer): That question will come from Andreas Argiris with Oppenheimer. Please go ahead.

Operator: That question will come from Andreas Argiris with Oppenheimer. Please go ahead.

And that question will come from Andreas Argyrides with Oppenheimer. Please go ahead.

Andreas Argyrides: Good morning and thanks for taking our questions and continuing on the topic of Teton. What kind of bridging study might the FDA require to approve subvasive DPI in addition to nebulized if Teton is successful? And then how are you thinking about presenting the data? I mean, is there a chance for, maybe, like an interim readout or anything like that?

James Edgemond: Good morning, and thanks for taking our questions. Continuing on the topic of TETON.

Andreas Argyrides: Good morning, and thanks for taking our questions. Continuing on the topic of TETON. What kind of bridging study might the FDA require to approve Tyvaso DPI in addition to the nebulized if TETON is successful? And then, how are you thinking about presenting the data? I mean, is there a chance for maybe, like, an interim readout of sorts or anything like that?

Good morning and thanks for taking our questions and continuing on the topic of T-Tons.

Andreas Argyrides: ... What kind of bridging study might the FDA require to approve Tyvaso DPI in addition to the nebulized if TETON is successful? And then, how are you thinking about presenting the data? I mean, is there a chance for maybe, like, an interim readout of sorts or anything like that?

What kind of bridging study might the FDA require to approve subvasive DPI in addition to the nebulized if Teton is successful? And then how are you thinking about

Presenting the data. I mean, is there a chance for maybe like an interim readout of sorts or anything like that?

Martine A. Rothblatt: Okay, yeah, thanks for those two questions. Again, I think Dr. Peterson would be the best person on the call to answer them. Once again, just for your recollection, she and her team did the bridging study from the TYVASO nebulizer into the DPI for PAH so she's very, very familiar with how to do that. She also was the lead author in a publication on those results in the New England Journal of Medicine so very much on top of getting the word out in the most credible and respected way. So with that little toot toot of your horn, Dr. Peterson, could you answer the question?

Martine Rothblatt: Okay, yeah. Thanks for those two questions. Again, I think Dr. Peterson would be the best person on the call to answer. Once again, just for your recollection, she and her team did the bridging study from the Tyvaso nebulizer into the DPI for PAH. So she's, you know, very, very familiar with how to do that. She also was the lead author in a publication on those results in the New England Journal of Medicine, so very much on top of, you know, getting the word out in the most credible and respected way. So with that little toot-toot of your horn, Dr. Peterson, can you answer the questions?

Okay, yeah, thanks for those two questions. Again, I think Dr. Peterson would be the best person on the call to answer. Once again, just for your recollection, she and her team did the bridging study from the tyvasin nebulizer into the DPI.

for PAH. So she's, you know, very, very familiar with how to do that.

Leigh Peterson: She also was the lead author in a publication on those results in the New England Journal of Medicine. So very much on top of, you know, getting the word out about the most. [inaudible] Thank you.

She also was the lead author in a publication on those results in the New England Journal of Medicine. So very much on top of, you know, getting the word out in the most...

credible and respected way. So with that little toot-toot of your horn, Dr. Peterson, can you answer the questions?

Leigh Peterson: Thank you. Sure. So, for the bridging study, again, we will, well, let me answer the second question first, for interim results. We will not do an interim analysis or an interim look. For Teton 2, as I just said, we have completed enrollment, so we're in the final follow-up period, and we will have the actual final results within a year, just shortly after the year follow-up is up. So, we completed in July, so that would be July plus some time to clean those data just for the top line results. So, that will be the first time we see the actual results from one of these studies.

Leigh Peterson: Thank you. Yeah, sure. So for the bridging study, again, we will. Well, let me answer the second question first for the interim results. We will not do an interim analysis or an interim look. We have for TETON 2, as I just said, we have completed enrollment, so we're in the final follow-up period, and we will have the actual, you know, final results within, you know, a year, just shortly after the year follow-up is up. So we completed in July, so that would be July plus some time to clean those data just for the top-line results. So, that will be the next time. That will be the first time we see the actual results from these, one of these studies.

Thank you. Yeah, sure. So for the bridging study, again, we will, well, let me answer the second question first for interim results. We will not do an interim analysis or an interim look.

Leigh Peterson: For Teton 2, as I just said, we have completed enrollment, so we're in the final follow-up period, and we will have the actual final results within a year, just shortly after the year follow-up is up. So, we completed in July, so that would be July plus some time to clean those data just for the top line results. So, that will be the next time we, that will be the first time we see the actual results from one of these studies.

We have, for Teton 2, as I just said, we have completed enrollment, so we're in the final follow-up period, and we will have the actual, you know, final results

and it's in within, you know, a year shortly after the year follow up is up. So we completed in July , so that would be July plus sometime to.

Leigh Peterson: And as far as bridging into DPI, now, as you know, so what we did in our brief study, we looked at PAH patients. We transitioned from nebulized TYVASO to TYVASO DPI, and that was actually sufficient to get approval for both PAH patients and PH ILD patients for TYVASO DPI.

to clean those data just for the top line results. So that will be the next time we, that will be the first time we see the actual results from one of these studies. And as far as bridging into DPI, now, as you know,

Leigh Peterson: As far as bridging into DPI, now, as you know, so what we did for in our brief study, we looked at PAH patients. We transitioned from nebulized Tyvaso to Tyvaso DPI, and that was actually sufficient to get approval for both PAH patients and PH-ILD patients, and for the Tyvaso DPI. Now, for the IPF studies, we still have some ongoing discussions with FDA. We will be discussing as soon as, I mean, really, when we get further into the follow-up period or when we get top-line results; we're going to have a discussion because it's a different group. It's the pulmonary division for IPF versus the cardiorenal division for PAH and PH-ILD.

So what we what we did for in our brief study, we looked at PAH patients. We transitioned from nebulized Tyvaso to Tyvaso DPI, and that was actually sufficient to get approval for both PAH patients and PHILD patients.

Leigh Peterson: Now, for the IPF studies, we still have some ongoing discussions with FDA. We will be discussing as soon as, I mean, really when we get further into the follow-up period or when we get top-line results, we're going to have a discussion because it's a different group. It's the pulmonary division for IPS versus the cardiorenal division for PH and PH ILDs. So different groups, different people, sometimes just slightly different requirements. So we need to just confirm what we need to do for the bridging. It might be a matter of a small sub-study in our Teton OLE program, so we need to sort that out, but again, it shouldn't delay. We'll get the results of the Teton studies. We will pursue approval based on the Teton I, and Teton II studies. And then while that is occurring, we'll do what we need to do for bridging.

and

Now for the IPF studies, we

still have some ongoing discussions with FDA. We will be discussing as soon as I mean really when we get

further into the follow-up period or when we get top-line results we're going to have a discussion because it's a different group, it's the pulmonary division for IPS versus

Leigh Peterson: So different groups, different people, sometimes just slightly different requirements. So we need to just confirm what we need to do for the bridging. It might be a matter of a small sub-study in our Teton OLE program, so we need to sort that out, but again, it shouldn't delay.

Leigh Peterson: So different group, different people, sometimes, you know, just slightly different requirements, so we need to just confirm what we need to do for the bridging. It might be a matter of a small sub-study in our TETON OLE program. So we need to sort that out. But again, it shouldn't delay. We'll get the results of the TETON studies. We will pursue the approval based on the TETON 1, TETON 2, and then while that is occurring, we'll do what we need to do for bridging.

Cardiorenal Division for PH and PHI-LD. So different group, different people, sometimes, you know, just slightly different requirements. So we need to just confirm what we need to do for the bridging. It might be a matter of a small sub-study.

in our Teton OLEs.

Program. It's so we need to sort that out. But again, it shouldn't delay.

Martine A. Rothblatt: We'll get the results of the Teton studies. We will pursue approval based on the Teton I, and Teton II studies. And then while that is occurring, we'll do what we need to do for bridging. Excellent. Excellent answer. Thank you so much, Dr. Peterson. Thank you, everybody for being on the call today. I'd like to just wrap up by drawing everybody's attention to the terrific PowerPoint that Dewey Steadman and his team released. I think it's not only aesthetically beautiful, which it is, but it's just rich in content, graphs, charts, numbers, kind of strategic overview kind of thing.

We'll get the results of the Teton studies. We will pursue approval based on the Teton I, and Teton II studies. And then while that is occurring, we'll do what we need to do for bridging.

We'll get the results of the Teton studies, we will pursue the approval based on the Teton 1, Teton 2, and then while that is occurring, we'll do what we need to do for bridging.

Martine A. Rothblatt: Excellent. Excellent answer. Thank you so much, Dr. Peterson. Thank you, everybody for being on the call today. I'd like to just wrap up by drawing everybody's attention to the terrific PowerPoint that Dewey Steadman and his team released. I think it's not only aesthetically beautiful, which it is, but it's just rich in content, graphs, charts, numbers, kind of strategic overview kind of thing. So please study that PowerPoint in depth if you really wanna understand the beauty of the United Therapeutics story.

Martine A. Rothblatt: So please study that PowerPoint in depth if you really wanna understand the beauty of the United Therapeutics story. And then, finally, I'd like to just do a shout out to everybody that is part of our United Therapeutics family, what we call Unitherians. We're now bumping up on 1,500 people, and it's in line with a metric that Michael, James, and I have long adopted at UT to grow our headcount in accordance with a revenue per head metric of approximately $2 million per head.

So please study that PowerPoint in depth if you really wanna understand the beauty of the United Therapeutics story.

Martine Rothblatt: Excellent. Excellent answer. Thank you so much, Dr. Peterson. Thank you, everybody, for being on the call today. I'd like to just wrap up with drawing everybody's attention to the terrific PowerPoint that Dewey Steadman and his team released. I think it's not only aesthetically beautiful, which it is, it's just rich in content, graphs, charts, numbers, you know, kind of strategic overview kind of thing. So please study that PowerPoint at depth if you really wanna understand the beauty of the United Therapeutics story. And then finally, I'd like to just, you know, do a shout-out to everybody that is part of our United Therapeutics family, what we call Unitherians.

Excellent, excellent answer. Thank you so much Dr. Peterson. Thank you everybody for being on the call today. I'd like to just wrap up with drawing everybody's attention to the terrific PowerPoint that

And then, finally, I'd like to just do a shout out to everybody that is part of our United Therapeutics family, what we call Unitherians. We're now bumping up on 1,500 people, and it's in line with a metric that Michael, James, and I have long adopted at UT to grow our headcount in accordance with a revenue per head metric of approximately $2 million per head. And that's on par with the absolute best, not only of biotech but of really American corporations in general. So now that we're knocking on the door of 3 billion in revenue run rate, that's 2 million per head for our knocking on the door of 1,500 people.

that Dewey Steadman and his team released. I think it's...

It's not only aesthetically beautiful, which it is.

It's just rich in content, graphs, charts, numbers, you know.

kind of strategic overview kind of thing. So please study that PowerPoint at depth if you really want to understand the beauty of the United Therapeutics story.

And then finally, I'd like to just, you know, do a shout-out to everybody.

Martine Rothblatt: We're now bumping up on 1,500 people, and it's in line with the metric that Michael, James, and I have long adopted at UT to grow our headcount in accordance with a revenue-per-head metric of approximately $2 million per head. And that's on par with the absolute best, not only of biotech, but of really, you know, American corporations in general. So now that we're knocking on the door of a $3 billion revenue run rate, that's $2 million per head for our knocking on the door of 1,500 people, and it's just another tremendous testament to the success of United Therapeutics and to the fact that the leaders of this company, Michael, James, myself, Pat Poisson, Dr. Peterson, others.

that is part of our United Therapeutics family, what we call Unitherians, we're now bumping up on 1,500 people.

It's in line with the metric that Michael, James, and I have long adopted at UT to grow our headcount in accordance with a

Martine A. Rothblatt: And that's on par with the absolute best, not only of biotech but of really American corporations in general. So now that we're knocking on the door of 3 billion in revenue run rate, that's 2 million per head for our knocking on the door of 1,500 people. And it's just another tremendous testament to the success of United Therapeutics and to the fact that the leaders of this company, Michael, James, myself, Pat Poisson, Dr. Peterson, others, for all of us, our number one goal is to make sure that everybody working at our company is having the absolute best career development experience of their dreams.

And that's on par with the absolute best, not only of biotech but of really American corporations in general. So now that we're knocking on the door of 3 billion in revenue run rate, that's 2 million per head for our knocking on the door of 1,500 people.

with a revenue per head metric of approximately $2 million per head. And that's on par with the absolute best, not only of biotech, but of really, you know, American corporations in general.

So, now that we're knocking on the door of a 3 billion revenue run rate, that's 2 million per head for our knocking on the door of 1,500 people, and it's just another tremendous

And it's just another tremendous testament to the success of United Therapeutics and to the fact that the leaders of this company, Michael, James, myself, Pat Poisson, Dr. Peterson, others, for all of us, our number one goal is to make sure that everybody working at our company is having the absolute best career development experience of their dreams. And so long as that is happening, then all of our goals pretty much happen automatically.

a testament to the success of United Therapeutics.

and to the fact that the leaders of this company, Michael, James, myself, Pat Poisson, Dr. Peterson, others, for all of us, our number one goal is to make sure that everybody working at our company

Martine Rothblatt: For all of us, our number one goal is to make sure that everybody working at our company is having the absolute best career development experience of their dreams. And so long as that is happening, then all of our goals pretty much happen automatically. And I think another metric I can share with you that I got from our HR department is our percentage of employees who voluntarily terminate, we call voluntary termination rate, is about 5%. That is far lower than, I think, any of our peers, but certainly far lower than the averages in the biotech sector and definitely outside biotech. So the numbers say we're doing things right, the people say we're doing things right, and I hope all of you agree that we're doing the things you want to see us do.

Martine A. Rothblatt: And so long as that is happening, then all of our goals pretty much happen automatically. And I think another great metric I can share with you that I got from our HR department is our percentage of employees who voluntarily terminate, we call it the voluntary termination rate, which is about 5%. That is far lower than I think any of our peers but certainly far lower than the averages in the biotech sector and definitely outside biotech.

And so long as that is happening, then all of our goals pretty much happen automatically.

is having the absolute best career development experience of their dreams. And so long as that is happening, then all of our goals pretty much happen automatically. And I think another metric I can share with you that I got from our HR department is our

And I think another great metric I can share with you that I got from our HR department is our percentage of employees who voluntarily terminate, we call it the voluntary termination rate, which is about 5%. That is far lower than I think any of our peers but certainly far lower than the averages in the biotech sector and definitely outside biotech. So the numbers say we're doing things right. The people say we're doing things right. And I hope all of you agree that we're doing the things you want to see us do. Have a great day. Operator, you can close the call.

Our percentage of employees who voluntarily terminate, what we call voluntary termination rate, is about 5%.

That is far lower than, I think, any of our peers, but certainly far lower than the averages in the biotech sector and definitely outside biotech.

Martine A. Rothblatt: So the numbers say we're doing things right. The people say we're doing things right. And I hope all of you agree that we're doing the things you want to see us do. Have a great day. Operator, you can close the call.

So, the numbers say we're doing things right, the people say we're doing things right, and I hope all of you agree that we're doing the things you want to see us do. Have a great day. Operator, you can close the call.

Martine Rothblatt: Have a great day. Operator, you can close the call.

Operator: 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. Thank you again for your participation. You may now disconnect.

Operator: 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. Thank you again for your participation. You may now disconnect.

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. Thank you again for your participation. You may now disconnect.

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