Q1 2024 United Therapeutics Corp Earnings Call

May 1, 2024

[Analyst]: Kind of like why me?

Operator: Good morning and welcome to the United Therapeutics Corporation Q1 2024 Earnings Webcast. My name is Danielle, and I will be your conference operator today. All participants on the call. Portion of this webcast will be in listen-only mode until the question-and-answer portion of the earnings call. If you would like to ask a question during that time, simply press star, then the number 1 on your telephone keypad. If you would like to withdraw your question, simply press star, then the number 2 on your telephone keypad. Please note this call is being recorded. If you require operator assistance, please press star, then 0. I will now turn the webcast over to Dewey Steadman, head of investor relations at United Therapeutics.

[Analyst]: Yeah, perfect.

Good morning, and welcome to the United Therapeutics Corporation first quarter 2024 earnings webcast. My name is Danielle and I will be your conference operator today, all participants on the call portion of this webcast will be in listen only mode until the question and answer portion of the earnings call.

Danielle: Good morning and welcome to the United Therapeutics Corporation First Quarter 2024 Earnings webcast. My name is Danielle and I will be your conference operator today. All participants on the call portion of this webcast will be in listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during that time, simply press star then the number 1 on your telephone keypad. If you would like to withdraw your question, simply press star then the number 2 on your telephone keypad. Please note this call is being recorded. If you require operator assistance, please press star then 0. I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Good morning and welcome to the United Therapeutics Corporation First Quarter 2024 Earnings webcast. My name is Danielle and I will be your conference operator today. All participants on the call portion of this webcast will be in listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during that time, simply press star then the number 1 on your telephone keypad. If you would like to withdraw your question, simply press star then the number 2 on your telephone keypad. Please note this call is being recorded. If you require operator assistance, please press star then 0.

Operator: Good morning and welcome to the United Therapeutics Corporation First Quarter 2024 Earnings Webcast. My name is Danielle and I will be your conference operator today.

All participants on the call portion of this webcast will be in listen-only mode until the question and answer portion of the earnings call. If you would like to ask a question during that time, simply press star then the number 1 on your telephone keypad. If you would like to withdraw your question, simply press star then the number 2 on your telephone keypad. Please note this call is being recorded. If you require operator assistance, please press star then 0.

If you would like to ask a question during that time.

Star then the number one on your telephone keypad.

It was if you would like to withdraw your question simply press Star then the number two on your telephone keypad.

Please note this call is being recorded.

Speaker Change: If you require operator assistance. Please press Star then zero.

Speaker Change: I will now turn the webcast over to Dewey Steadman head of Investor Relations at United Therapeutics.

I will now turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics.

Dewey Steadman: Thank you, Danielle, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation Q1 2024 earnings webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements will 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 forward-looking statements. Today's remarks 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. Full prescribing information for the products is available on our websites.

Dewey Steadman: Thank you, Danielle, and good morning. It's my pleasure to welcome you to United Therapeutics Corporation's First Quarter 2024 Earnings Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements will involve risks and uncertainties that may cause actual results to differ materially.

Dewey Steadman: Thank you, Danielle, and good morning. It's my pleasure to welcome you to United Therapeutics Corporation's First Quarter 2024 Earnings Webcast.

Dewey Steadman: Thank you Danielle and good morning, It's my pleasure to welcome you to the United Therapeutics Corporation first quarter 2024 earnings webcast remarks. Today will include forward looking statements, representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially our latest SEC.

Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements will 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 forward-looking statements. Today's remarks 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. And full prescribing information for the products is available on our website.

Dewey Steadman: Our latest FCC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties, and we assume no obligation to update forward-looking statements. Today's remarks 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: Billings, including forms 10-K, and 10-Q contain additional information on these risks and uncertainties and we assume no obligation to update forward looking statements. Today's remarks 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 surface.

Today's remarks 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. And full prescribing information for the products is available on our website.

Dewey Steadman: Basic for medical decision, making or to suggest that any products are safe and effective for any unapproved or investigational uses and full prescribing information for the products are available on our website.

Dewey Steadman: And full prescribing information for the products is 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 Pat Poisson, our Executive Vice President of Technical Operations. Note that Pat Poisson and I will present at a fireside chat session and one-on-one meetings at the Goldman Sachs Global Healthcare Conference on June 12th in Miami.

And full prescribing information for the products is 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 Pat Poisson, our Executive Vice President of Technical Operations. Note that Pat Poisson and I will present in a fireside chat session and one-on-one meetings at the Goldman Sachs Global Healthcare Conference on June 12th in Miami.

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 Pat Poisson and I will present in a fireside chat session and one-on-one meetings at the Goldman Sachs Global Healthcare Conference on 12 June in Miami. Also, our scientific, medical, and commercial teams will present at the American Thoracic Society International Conference, 17 through 22 May in San Diego, the 7th World Symposium on Pulmonary Hypertension, 29 June to 1 July in Barcelona, and the Pulmonary Hypertension Association's 2024 International PH Conference and Scientific Sessions, 15 to 18 August in Indianapolis.

Dewey Steadman: Also, our scientific, medical and commercial teams will present at the American Thoracic Society International Conference, May 17th through the 22nd in San Diego; the 7th World Symposium on Pulmonary Hypertension, June 29th to July 1st in Barcelona and the Pulmonary Hypertension Association's 2024 International PH Conference and Scientific Sessions, August 15th to 18th in Indianapolis. Now, I will turn the webcast over to James Edgemond, our CFO and Treasurer, for some brief comments on our recent Accelerated Share Repurchase Plan; followed by Martine and Michael for an overview of our first quarter 2024 financial results and the business activities of United Therapeutics. James?

Also, our scientific, medical and commercial teams will present at the American Thoracic Society International Conference, May 17th through the 22nd in San Diego; the 7th World Symposium on Pulmonary Hypertension, June 29th to July 1st in Barcelona and the Pulmonary Hypertension Association's 2024 International PH Conference and Scientific Sessions, August 15th to 18th in Indianapolis.

Speaker Change: Accompanying me on today's call are Dr. Martine Rothblatt, our chairperson and Chief Executive Officer, Michael <unk>, Our President and Chief operating Officer, James <unk>, Our Chief Financial Officer and Treasurer.

Speaker Change: Dr. Leigh Peterson, our executive Vice President of product development, and so you know transplantation and Pat <unk>, our executive Vice President of technical operations.

Speaker Change: Note that Pat and I will present in a fireside chat session and one on one meetings at the Goldman Sachs Global Healthcare Conference in June on June 12th in Miami.

Speaker Change: Also our scientific medical and.

Speaker Change: And commercial teams will presented at the American Thoracic Society International Conference May 17th through the 20th second in San Diego The seventh World Symposium on pulmonary hypertension June 29th July 1st in Barcelona, and the pulmonary hypertension Association's 2024 International Ph conference in scientific sessions August 15th.

Now, I will turn the webcast over to James Edgemond, our CFO and Treasurer, for some brief comments on our recent Accelerated Share Repurchase Plan; followed by Martine and Michael for an overview of our first quarter 2024 financial results and the business activities of United Therapeutics. James?

Dewey Steadman: 18th in Indianapolis.

Dewey Steadman: Now, I will turn the webcast over to James Edgemond, our CFO and treasurer, for some brief comments on our recent accelerated share repurchase plan, followed by Martine and Michael for an overview of our Q1 2024 financial results and the business activities of United Therapeutics.

Dewey Steadman: Now I will turn the webcast over to James <unk>, our CFO and treasurer for some brief comments on our recent accelerated share repurchase plan, followed by Martina and Michael for an overview of our first quarter 2024 financial results and business activities of United Therapeutics, Jamie. Thank.

Martine Rothblatt: James.

James Edgemond: Thank you, Dewey, and good morning, everyone. In our meetings with shareholders over the last several years, we've noticed a common theme: shareholders are excited about our potential, both the continued growth in our foundational core business and our innovative organ manufacturing opportunities, and they are also impressed by our P&L philosophy that results in outstanding cash flow generation to support our ways of growth. But we recognize that there has been a disconnect between our desire to preserve capital to support our ambitious long-term organ manufacturing goals and some shareholder perspectives around capital allocation.

James Edgemond: Thank you, Dewey, and good morning, everyone. In our meetings with shareholders over the last several years, we've noticed a common theme. Shareholders are excited about our potential, both the continued growth in our foundational core business and our innovative organ manufacturing opportunities. And they are also impressed by our P&L philosophy that results in outstanding cash flow generation to support our waves of growth. But we recognize that there has been a disconnect between our desire to preserve capital to support our ambitious long-term organ manufacturing goals and some shareholder perspectives around capital allocation.

James Edgemond: Thank you, Dewey. And good morning, everyone.

James: Thank you Joey and good morning, everyone.

In our meetings with shareholders over the last several years, we've noticed a common theme. Shareholders are excited about our potential, both the continued growth in our foundational core business and our innovative organ manufacturing opportunities. And they are also impressed by our P&L philosophy that results in outstanding cash flow generation to support our waves of growth. But we recognize that there has been a disconnect between our desire to preserve capital to support our ambitious long-term organ manufacturing goals and some shareholder perspectives around capital allocation.

Speaker Change: In our meetings with shareholders over the last several years, we've noticed a common theme shareholders are excited about our potential.

James: With the continued growth in our foundational core business and our innovative Oregon manufacturing opportunities and they are also impressed by our P&L philosophy their results and outstanding cash flow generation to support our waves of growth.

James: But we recognize that there has been a disconnect between our desire to preserve capital to support our ambitious long term, Oregon manufacturing goals and some shareholder perspectives around capital allocation.

James Edgemond: We continue to follow our three capital allocation priorities, which in order are: first, to invest in our commercial and R&D opportunities through P&L spend, as well as capital outlays like our new North Carolina manufacturing facility. Our second priority, to pursue intelligent business and corporate development opportunities that enhance our rare disease focus and complement our organ manufacturing initiatives like bolt-on M&A and in-license opportunities. And our third priority, to return capital to shareholders like share repurchases. And we consider all three priorities when deploying our financial capital. Over the last year, we've learned a great deal about the size, the staging, and the timing for capital expenditures associated with the construction and commissioning of our designated pathogen-free facilities, or DPFs, to support our xenotransplantation efforts.

James C. Edgemond: We continue to follow our three capital allocation priorities, which in order are: first, to invest in our commercial and R&D opportunities through P&L spend, as well as capital outlays like our new North Carolina manufacturing facility. Our second priority, to pursue intelligent business and corporate development opportunities that enhance our rare disease focus and complement our organ manufacturing initiatives, like bolt-on M&A and in-license opportunities. And our third priority, to return capital to shareholders, like share repurchases. And we consider all three priorities when deploying our financial capital.

James: We continue to follow our three capital allocation priorities, which in order are first to invest in our commercial and R&D opportunities through P&L spend as well as capital outlays like our new North Carolina manufacturing facility.

James: Our second priority to pursue intelligent business and corporate development opportunities that enhance our rare disease focus and complement our Oregon manufacturing initiatives like bolt on M&A and in license opportunities.

James: And our third priority.

James: To return capital to shareholders like share repurchases and we consider all three priorities when deploying our financial capital.

James: Over the last year, we've learned a great deal about the size the staging and the timing for capital expenditures associated with the construction and commissioning of our designated pathogen free facilities or D. P F.

James C. Edgemond: Over the last year, we've learned a great deal about the size, the staging and the timing for capital expenditures associated with the construction and commissioning of our designated pathogen-free facilities, or DPFs, to support our xenotransplantation efforts. With the commissioning of our Christiansburg, Virginia clinical-scale DPF last quarter, we now better understand the phasing of capital spending associated with a commercial-scale DPF construction project for the commercial launch of our xeno organs.

James: To support our Zeno transplantation efforts.

James Edgemond: With the commissioning of our Christiansburg, Virginia clinical scale DPF last quarter, we now better understand the phasing of capital spending associated with a commercial scale DPF construction project for the commercial launch of our xenoorgans. With this improved awareness of our future cash outlays and taking into consideration our near-term cash flow generation potential, we saw an opportunity to return capital to you, our shareholders, to deploy it as you see fit, and announced on 25 March a $1 billion accelerated share repurchase program, or ASR. Through the ASR, we expect Citibank to repurchase $1 billion in UTHR shares through the end of Q3 of this year.

James: With the commissioning of our Christiansburg, Virginia clinical scale D. P. F last quarter, we now better understand the phasing of capital spending associated with the commercial scale DPF construction project for the commercial launch of ours, you know Oregon's.

James: With this improved awareness of our future cash outlays and taking into consideration our near term cash flow generation potential.

James C. Edgemond: With this improved awareness of our future cash outlays and taking into consideration our near-term cash flow generation potential, we saw an opportunity to return capital to you, our shareholders, to deploy the [inaudible] and announced on March 25th a $1 billion Accelerated Share Repurchase program or ASR. Through the ASR, we expect Citibank to repurchase $1 billion in UTHR shares through the end of the 3rd quarter of this year. Under the ASR on March 27th, Citibank delivered to us approximately 3.3 million UTHR shares, representing approximately 80% of the total shares that will be repurchased under the ASR and we have placed these shares into Treasury stock as reflected on our balance sheet. The final number of shares that we will ultimately repurchase, pursuant to our ASR agreement with Citibank, will be based upon the average of the daily volume weighted average price per share of our common stock during the ASR agreement.

With this improved awareness of our future cash outlays and taking into consideration our near-term cash flow generation potential, we saw an opportunity to return capital to you, our shareholders, to deploy the [inaudible] and announced on March 25th a $1 billion Accelerated Share Repurchase program or ASR. Through the ASR, we expect Citibank to repurchase $1 billion in UTHR shares through the end of the 3rd quarter of this year. Under the ASR on March 27th, Citibank delivered to us approximately 3.3 million UTHR shares, representing approximately 80% of the total shares that will be repurchased under the ASR and we have placed these shares into Treasury stock as reflected on our balance sheet.

James: We saw an opportunity to return capital to capital to you our shareholders to.

James: To deploy it as you see fit.

James C. Edgemond: Citibank delivered to us approximately 3.3 million UTHR shares, representing approximately 80% of the total shares that will be repurchased under the ASR, and we have placed these shares into Treasury stock as reflected on our balance sheet. The final number of shares that we will ultimately repurchase, pursuant to our ASR agreement with Citibank, will be based upon the average of the daily volume weighted average price per share of our common stock during the ASR agreement.

James: And announced on March 25th a $1 billion accelerated share repurchase program.

James: Or a S R.

James: Through the ASR, we expect Citibank to repurchase $1 billion in U T. H our shares through the ended the third quarter of this year.

James Edgemond: Under the ASR, on 27 March, Citibank delivered to us approximately 3.3 million UTHR shares, representing approximately 80% of the total shares that will be repurchased under the ASR, and we have placed these shares into treasury stock as reflected on our balance sheet. The final number of shares that we will ultimately repurchase pursuant to our ASR agreement with Citibank will be based upon the average of the daily volume weighted average price per share of our common stock during the ASR agreement. Following the ASR, we believe that we will have ample financial capital to deploy for the commercial scale DPF facilities in the coming years that I previously mentioned.

James: Under the ASR on March 27th.

James: Citibank delivered to us approximately $3 3 million U T HR shares representing approximately 80% of the total shares that will be repurchased under the ASR.

James: And we have placed these shares into treasury stock is reflected on our balance sheet.

The final number of shares that we will ultimately repurchase, pursuant to our ASR agreement with Citibank, will be based upon the average of the daily volume weighted average price per share of our common stock during the ASR agreement. Following the ASR, we believe that we will have ample financial capital to deploy for the commercial-scale DPF facilities in the coming years that I previously mentioned. We also continue to believe in our core business and our cash flow generation potential, driven by our foundational products, led by TYVASO DPI and Nebulized TYVASO and potentially accelerated by our innovative studies of TYVASO in pulmonary fibrosis and RALINEPAG in pulmonary hypertension. We're excited about our current business and our growth potential and we appreciate the feedback and support of our shareholders. I'll now turn the call over to Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, for insight into our development portfolio. Martine?

James: The final number of shares that we will ultimately repurchase pursuant to our ASR agreement with TD Bank will be based upon the average of the daily volume weighted average price per share of our common stock during the ASR agreement.

James: Following the ASR, we believe that we will have ample financial capital to deploy for the commercial scale of <unk> facilities in the coming years that I previously mentioned.

James C. Edgemond: Following the ASR, we believe that we will have ample financial capital to deploy for the commercial-scale DPF facilities in the coming years that I previously mentioned. We also continue to believe in our core business, and our cash flow generation potential is driven by our foundational products, led by Tyvaso DPI and Nebulize Tyvaso, and potentially accelerated by our innovative studies of tyvaso and pulmonary fibrosis and relinopag and We're excited about our current business and our growth potential, and we appreciate the feedback and support of our shareholders. I'll now turn the call over to Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, for insight into our development portfolio. Martine?

James Edgemond: We also continue to believe in our core business and our cash flow generation potential driven by our foundational products led by Tyvaso DPI and Nebulized Tyvaso, and potentially accelerated by our innovative studies of Tyvaso in pulmonary fibrosis and ralinepag in pulmonary hypertension. We're excited about our current business and our growth potential, and we appreciate the feedback and support of our shareholders. I'll now turn the call over to Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, for insight into our development portfolio. Martine?

James: We also continue to believe in our core business and our cash flow generation potential driven.

We also continue to believe in our core business and our cash flow generation potential, driven by our foundational products, led by TYVASO DPI and Nebulized TYVASO and potentially accelerated by our innovative studies of TYVASO in pulmonary fibrosis and RALINEPAG in pulmonary hypertension. We're excited about our current business and our growth potential and we appreciate the feedback and support of our shareholders.

James: Driven by our foundational products led by <unk>, ACO, DPI and Nebulize Taipei So.

James: And potentially accelerated by our innovative studies of <unk> in pulmonary fibrosis and relented peg in pulmonary hypertension.

James: We're excited about our current business and our growth potential and we appreciate the feedback and support of our shareholders.

James: I'll now turn the call over to Dr. Martine Rothblatt, our chairperson and Chief Executive officer for insight into our development portfolio Martine.

I'll now turn the call over to Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer, for insight into our development portfolio. Martine?

Martine Rothblatt: Thank you, James. Good morning, everyone. I'm going to let the next few slides speak for themselves and forgo a script in favor of speaking directly from the perspective of being our CEO. We have had a fantastic quarter, coming on the heels of previous great quarters, and we are confident continued good news will flow in the quarters ahead. The main basis for our confidence is that we have multiple best-in-category products for growing indications: Remodulin for parenteral PAH; Orenitram for oral prostacyclin in PAH; Tyvaso for inhaled treatment of both PAH group 1 and PH group 3 in interstitial lung disease; and Unituxin for neuroblastoma. Other categories of good news in the years ahead are clinical trial outcomes. We have three phase III trials in varieties of pulmonary fibrosis known as the TETON trial and another phase III trial of a best-in-class oral prostacyclin agonist called ADVANCE OUTCOMES.

Martine A. Rothblatt: Thank you James good morning, everyone.

Martine A. Rothblatt: Thank you, James. Good morning, everyone.

Martine A. Rothblatt: I'm going to let the next few slides speak for them.

Martine A. Rothblatt: I'm going to let the next few slides speak for themselves and forgo a script in favor of speaking directly from the perspective of being our CEO. We have had a fantastic quarter, coming on the heels of previous great quarters and we are confident continued good news will flow in the quarters ahead. The main basis for our confidence is that we have multiple best-in-category products for growing indications: REMODULIN for parenteral PAH. ORENITRAM for oral prostacyclin in PAH, TYVASO for inhaled treatment of both PAH Group 1 and PAH Group 3 in interstitial lung disease and UNITUXIN for neuroblastoma. Other categories of good news in the years ahead are clinical trial outcomes. We have three Phase III trials in varieties of pulmonary fibrosis, known as the TETON Trial and another Phase III trial of a best-in-class oral prostacyclin agonist called OUTCOMES. Upon approval and market launch, the products from these Phase III trials could help more than twice the number of people that we are helping today.

I'm going to let the next few slides speak for themselves and forgo a script in favor of speaking directly from the perspective of being our CEO. We have had a fantastic quarter, coming on the heels of previous great quarters and we are confident continued good news will flow in the quarters ahead. The main basis for our confidence is that we have multiple best-in-category products for growing indications: REMODULIN for parenteral PAH. ORENITRAM for oral prostacyclin in PAH, TYVASO for inhaled treatment of both PAH Group 1 and PAH Group 3 in interstitial lung disease and UNITUXIN for neuroblastoma.

Martine A. Rothblatt: <unk> and forego a script in favor of speaking directly from the perspective of being our C E O.

Speaker Change: We have had a fantastic quarter.

Martine A. Rothblatt: On the heels of previous great corridors, and we are confident continued good news will flow in the quarters ahead.

Martine A. Rothblatt: Tybaso for inhaled treatment of both PAH Group 1 and PAH Group 3 in interstitial lung disease, and Unituxin for neuroblastoma. Other categories of good news in the years ahead are clinical trial outcomes. We have three phase three trials in varieties of pulmonary fibrosis, known as the Teton Trial, and another Phase III trial of a best-in-class oral prostacyclin agonist called Outcome. Upon approval and market launch, products from these phase three trials could help more than twice the number of people that we are helping today.

Speaker Change: The main basis for our confidence is that we have multiple best in category products for growing indications, where modulus <unk> for peripheral P. A H.

Martine A. Rothblatt: I run the tram for oral prostacyclin and P. A H <unk>.

Martine A. Rothblatt: <unk> based so for inhaled treatment of both P. H group, one and ph group three in interstitial lung disease and unit toxin for neuroblastoma.

Other categories of good news in the years ahead are clinical trial outcomes. We have three Phase III trials in varieties of pulmonary fibrosis, known as the TETON Trial and another Phase III trial of a best-in-class oral prostacyclin agonist called OUTCOMES. Upon approval and market launch, the products from these Phase III trials could help more than twice the number of people that we are helping today.

Martine A. Rothblatt: Other categories of good news in the years ahead, our clinical trial outcomes.

Martine A. Rothblatt: We have three phase III trials in fair varieties of pulmonary fibrosis.

Martine A. Rothblatt: And as the <unk> trial.

Martine A. Rothblatt: Another phase III trial of a best in class oral prostacyclin agonist called outcome.

Martine Rothblatt: Upon approval and market launch, the products from these phase III trials could help more than twice the number of people that we are helping today. There is even more good news in the area of organ manufacturing. We have now successfully enabled hundreds of additional lungs to be transplanted. We have now built a xenotransplantation facility with the potential for over 100 xenohearts and 200 xenokidneys a year to be transplanted. We have now commenced a clinical trial of a xenoliver assistance product, and we have now helped to save the life of a woman in New York with our manufactured UThymoKidney. Now let me comment on a few topics that I've heard some questions about. First, the big buyback. James did a superb overview of every aspect of that. We did the recent billion-dollar stock buyback because the stock is too cheap. Full stop.

Martine A. Rothblatt: Upon approval and market launch the products from these phase three trials could help more than twice the number of people that we are helping today.

Martine A. Rothblatt: And there's even more good news in the area of Oregon manufacturing.

Martine A. Rothblatt: And there's even more good news in the area of organ manufacturing. We have now successfully enabled hundreds of additional lungs to be transplanted. We have now built a xenotransplantation facility with the potential for over 100 xenohearts and 200 xenokidneys a year to be transplanted. We have now commenced the clinical trial of a xenoliver assistance product and we have now helped to save the life of a woman in New York with our manufactured ThymoKidney. Now, let me comment on a few topics that I've heard some questions about.

And there's even more good news in the area of organ manufacturing. We have now successfully enabled hundreds of additional lungs to be transplanted. We have now built a xenotransplantation facility with the potential for over 100 xenohearts and 200 xenokidneys a year to be transplanted. We have now commenced the clinical trial of a xenoliver assistance product and we have now helped to save the life of a woman in New York with our manufactured ThymoKidney.

Martine A. Rothblatt: We have now successfully enabled hundreds of additional lungs to be transplanted.

Martine A. Rothblatt: We have now built a zeno transplantation facility with the potential for over 100, Zeno Hearts and 200 casino kidneys, a year to be transplanted.

Martine A. Rothblatt: We have now commenced a clinical trial of a zeno liver assistance product.

Martine A. Rothblatt: And we have now helped to save the life of a woman in New York with our manufactured by MAU kidney.

Now, let me comment on a few topics that I've heard some questions about. First, the big buyback. James did a superb overview of every aspect of that. We did the recent billion-dollar stock buyback because the stock is too cheap, full stop. Because our future is so bright, we believe this could be one of the best ROI investments for our shareholder partners. As James has long said, other great ROI opportunities are, first and foremost, in our own pipeline and secondly, in our strategic business development decisions. Next, I'd like to say a word about insider selling. I personally hold options for 10 full years and I only sell just before expiry.

Speaker Change: Now, let me comment on a few topics that I have heard some questions about.

Martine A. Rothblatt: First, the big buyback. James did a superb overview of every aspect of it. We did the recent billion-dollar stock buyback because the stock is too cheap, full stock. Because our future is so bright, we believe this could be one of the best ROI investments for our shareholder partners. As James has long said, other great ROI opportunities are, first and foremost, in our own pipeline, and secondly, in our strategic business development decisions. Next, I'd like to say a word about insider selling. I personally hold options for 10 full years, and I only sell them just before expiration.

Speaker Change: First the big buyback James did a superb overview of every aspect of that.

Speaker Change: We did the recent $1 billion stock buyback because the stock is too cheap.

Speaker Change: I'll stop.

Martine Rothblatt: Because our future is so bright, we believe this could be one of the best ROI investments for our shareholder partners. As James has long said, other great ROI opportunities are first and foremost in our own pipeline and secondly in our strategic business development decisions. Next, I'd like to say a word about insider selling. I personally hold options for 10 full years, and I only sell just before expiry. This is a passive, longstanding program. There is nothing more than that to read into these sales. They are use-it-or-lose-it sales. Third, our Group 1 business. Our expectation remains that the Group 1 PAH business will continue to grow and will do so even more rapidly if we can gain FDA approval of ralinepag after the completion of our clinical trial.

Speaker Change: Because of our future is so bright we believe this could be one of the best ROI investments for our shareholder partners.

Speaker Change: As James has long said other great ROI opportunities are first and foremost in our own pipeline and secondly in our strategic business development decisions.

Next, I'd like to say a word about insider selling. I personally hold options for 10 full years and I only sell just before expiry. This is a passive, long-standing program. There is nothing more than that to read into these sales. They are use it or lose it sales. Third, our Group 1 business. Our expectation remains that the Group 1 PAH business will continue to grow and will do so even more rapidly, if we can gain FDA approval of RALINEPAG after the completion of our clinical trial. As a reminder, this is a best-in-class, once-a-day oral treatment for PAH and its Phase III trial endeavors to show long-term morbidity and mortality benefit on top of multiple conventional therapies. It is a worldwide study and we intend to commercialize that product globally. Let's talk about TYVASO trends next.

Speaker Change: Next I'd like to say a word about insider selling.

Speaker Change: I personally hold options for 10 full years and I only sell just before expiry.

Martine A. Rothblatt: This is a passive, long-standing program. There is nothing more than that to read into these sales. They are use it or lose it sales. Third, our Group 1 business. Our expectation remains that the Group 1 PH business will continue to grow, and will do so even more rapidly if we can gain FDA approval for LENIPEG after the completion of our clinical trial. As a reminder, this is a best-in-class, once-a-day oral treatment for PAH, and its Phase III trial endeavors to show long-term morbidity and mortality benefits on top of multiple conventional therapies. It is a worldwide study, and we intend to commercialize that product globally. Let's talk about Taiwezo trends next.

Speaker Change: This is a passive long standing program.

Speaker Change: There is nothing more than that to read into these cells. They are use it or lose itself.

Speaker Change: Third our group one business.

Speaker Change: Our expectation remains that the group one ph business will continue to grow and we will do so even more rapidly if we can gain FDA approval for Atlanta pegged after the completion of our clinical trial.

Martine Rothblatt: As a reminder, this is a best-in-class once-a-day oral treatment for PAH, and its phase III trial endeavors to show long-term morbidity and mortality benefit on top of multiple conventional therapies. It is a worldwide study, and we intend to commercialize that product globally. Let's talk about Tyvaso trends next. Tyvaso has been a dramatic grower since interstitial lung disease approval, and it is a roughly $1 billion indication today. We have only gotten started serving the large unmet need for this product with its unique delivery methods. In addition to our continued growth in PH group 3, supercharged by our two proprietary modes of inhaled drug delivery, we are also very excited about the enrollment of our phase III trials in IPF and PPF known as TETON 1, TETON 2, and TETON PPF.

Speaker Change: As a reminder, this is a best in class once a day oral treatment for P. H.

Speaker Change: And its phase III trial endeavors to show long term morbidity and mortality benefit on top of multiple conventional therapies.

Speaker Change: It is a worldwide study and we intend to commercialize that product globally.

Speaker Change: Yeah.

Speaker Change: Let's talk about tight based on trends next.

Let's talk about TYVASO trends next. TYVASO has been a dramatic grower since interstitial lung disease approval and it is a roughly $1 billion indication today. We have only gotten started serving the large unmet need for this product with its unique delivery methods. In addition to our continued growth in PAH Group 3, supercharged by our two proprietary modes of inhaled drug delivery, we are also very excited about the enrollment of our Phase III trials in IPF and PPF, known as TETON 1, TETON 2, and TETON PPF. Once the results of these studies are approved, we will be able to help multiples of the number of patients we are helping today in PAH.

Martine A. Rothblatt: Tyvaso has been a dramatic grower since interstitial lung disease was approved, and it is a roughly $1 billion indication today. We have only gotten started serving the large unmet need for this product with its unique delivery methods. In addition to our continued growth in PH group 3, supercharged by our two proprietary modes of inhaled drug delivery, we are also very excited about the enrollment of our phase three trials in IPF and PPF, known as Teton 1, Teton 2, and Teton PPF.

Speaker Change: So it's been a dramatic grower since interstitial lung disease approval and they just say roughly $1 billion indication today.

Speaker Change: We have only gotten started serving the large unmet need for this product with its unique delivery methods.

Speaker Change: In addition to our continued growth in ph group three super charged by our two proprietary modes of inhaled drug delivery.

Speaker Change: We're also very excited about the enrollment of our phase III trials in IPF and P. P F. Knowing as T. Todd one <unk>, two and <unk> P. P F.

Martine Rothblatt: Once the results of these studies are approved, we will be able to help multiples of the number of patients we are helping today in PAH. Finally, let me talk about our transformational strategy. As Mike said a year or so ago, the ramp for DPI toward our Tyvaso goals would not be linear, but it would bend upwards after a period of provider familiarity with both treating group 3 PAH patients and our unique product. We are now seeing the bend upward that Mike had predicted. I doubt any organization interacts with as many PAH providers as do we, given our multiple PAH products and multiple pipeline activities, including in addition our exciting ARTISAN trial showing that you can transition patients from a parenteral form of prostacyclin onto oral Orenitram.

Speaker Change: Once the results of these studies are approved we will be able to help multiples of the number of patients. We are helping today in P. A H.

Martine A. Rothblatt: Once the results of these studies are approved, we will be able to help multiples of the number of patients we are helping today in PAH. Finally, let me talk about our transformational strategy. As Mike said a year or so ago, the ramp for DPI toward our Type ASO goals would not be linear, but it would bend upwards after a period of provider familiarity with both treating Group 3PH patients and our unique products. We are now seeing the bend upward that Mike had predicted.

Once the results of these studies are approved, we will be able to help multiples of the number of patients we are helping today in PAH.

Speaker Change: Finally, let me talk about our transformational strategy strategy as.

Finally, let me talk about our transformational strategy. As Mike said a year or so ago, the ramp for DPI toward our TYVASO goals would not be linear but it would bend upwards after a period of provider familiarity with both treating Group 3 PAH patients and our unique products. We are now seeing the bend upward that Mike had predicted. I doubt any organization interacts with as many PAH providers as do we, given our multiple PAH products and multiple pipeline activities, including in addition, our exciting artisan trial showing that you can transition patients from a parenteral form of prostacyclin onto oral ORENITRAM. It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our TYVASO pipeline.

Speaker Change: As Mike said, a year or so ago, the ramp for DPI towards our <unk> goals would not be linear.

Speaker Change: Quick bend upwards after a period of provider familiarity with both treating group III ph patients and our unique product.

Speaker Change: We are now seeing the bend upward that Mike had predicted.

Martine A. Rothblatt: I doubt any organization interacts with as many pH providers as do we, given our multiple pH products and multiple pipeline activities, including, in addition, our exciting artisan trial showing that you can transition patients from a parenteral form of prostacyclin to oral orenitraps. It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our Tyvaso pipeline.

Speaker Change: Doubt any organization interacts with as many ph providers as do we given our multiple products and multiple pipeline activities, including in addition, our exciting artisan trial showing that you can transition patients from a parenteral form of prostacyclin.

I doubt any organization interacts with as many PAH providers as do we, given our multiple PAH products and multiple pipeline activities, including in addition, our exciting artisan trial showing that you can transition patients from a parenteral form of prostacyclin onto oral ORENITRAM. It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our TYVASO pipeline.

Speaker Change: Two oral <unk> it.

It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our TYVASO pipeline. We have organically developed drugs that solve difficult, unmet needs. We have built a magnificent business. We have created a fortress balance sheet and we have pipeline programs that could be worth more than the entire current market cap of our company. The transformation of UT is well underway and we welcome shareholder partners to join us, in not only a great investment opportunity but in supporting a company that is a true biotech innovator. On that note, Mike, can you please take it from here?

It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our TYVASO pipeline.

Martine Rothblatt: It is born of the great confidence in our products that these many, many providers share with us that we undertook the billion-dollar buyback and continue to invest heavily in our Tyvaso pipeline. We have organically developed drugs that solve difficult unmet needs. We have built a magnificent business. We have created a fortress balance sheet, and we have pipeline programs that could be worth more than the entire current market cap of our company. The transformation of UT is well underway, and we welcome shareholder partners to join us in not only a great investment opportunity but in supporting a company that is a true biotech innovator. On that note, Mike, can you please take it from here?

Speaker Change: It is boring is a great confidence in our products that these many many providers share with us that we undertook the $1 billion buyback and continue to invest heavily in archives based so pipeline.

We have organically developed drugs that solve difficult, unmet needs. We have built a magnificent business. We have created a fortress balance sheet and we have pipeline programs that could be worth more than the entire current market cap of our company. The transformation of UT is well underway and we welcome shareholder partners to join us, in not only a great investment opportunity but in supporting a company that is a true biotech innovator.

Speaker Change: We have organically developed drugs that solve difficult unmet needs.

Martine A. Rothblatt: We have organically developed drugs that solve difficult, unmet needs. We have built a magnificent business. We have created a fortress balance sheet, and we have pipeline programs that could be worth more than the entire current market cap of our company. The transformation of UT is well underway, and we welcome shareholder partners to join us in not only a great investment opportunity but in supporting a company that is a true biotech innovator. On that note, Mike, can you please take it from here?

Speaker Change: We have built a magnificent business.

Speaker Change: We have created a fortress balance sheet.

Speaker Change: And we have pipeline programs that could be worth more than the entire current market cap of our company.

Speaker Change: The transformation of U T is well underway and.

Speaker Change: And we welcome shareholder partners to join Us and not only a great investment opportunity, but in supporting a company that is a true biotech innovator.

On that note, Mike, can you please take it from here?

Speaker Change: On that note Mike can you please take it from here.

Michael Benkowitz: Thanks, Martine. I will. Good morning, everybody. As Martine noted, today we report yet another quarter of record revenue at $678 million and 34% growth from the first quarter of 2023. We saw meaningful growth for all of our key products: Tyvaso, Orenitram, Remodulin, and Unituxin. Before I get into the details on each of the products, I just want to take a moment to thank all of our fellow Unitarians for an amazing quarter. First, I want to talk about Tyvaso, which, when viewing the nebulizer and dry powder inhaler delivery systems together, represents our largest product and remains the number one prescribed prostacyclin treatment in the US.

Mike: Thanks to our team and I will good morning, everybody as Marty noted today, we report yet another quarter of record revenue at $678 million.

Michael Benkowitz: Thanks, Martine, I will. Good morning, everybody.

Mike: And 34% growth from the first quarter of 2023.

Mike: We saw meaningful growth for all of our key products. They sell a red oak around where module and then you go talk to them before I get into the details on each of the products I just want to take them all that.

Michael I. Benkowitz: Good morning, everybody. As Martine noted, today we report yet another quarter of record revenue at $678 million, and 34% growth from the first quarter of 2023. We saw meaningful growth for all of our key products, Tybaso, Oretatram, Remodulin, and Minotoxin. Before I get into the details on each of the products, I just want to take a moment to thank all of our fellow Unitherians for an amazing quarter

Good morning, everybody.

As Martine noted, today we report yet another quarter of record revenue at $678 million and 34% growth from the 1st quarter of 2023. We saw meaningful growth for all of our key products, TYVASO, ORENITRAM, REMODULIN and UNITUXIN. Before I get into the details on each of the products, I just want to take a moment to thank all of our fellow Unitherians for an amazing quarter

Speaker Change: Thank all of our fellow Unitarians score an amazing quarter.

Speaker Change: First I want to talk about today, so with when viewing the nebulizer and dry powder inhaler delivery systems together represents our largest product and remains the number one prescribed prostacyclin treatment in the U S.

Michael I. Benkowitz: First, I want to talk about TYVASO, which when viewing the Nebulizer and Dry Powder Inhaler delivery systems together, represents our largest product and remains the number one prescribed prostacyclin treatment in the U.S. Total TYVASO revenue for the 1st quarter was $373 million, up 56% over last year; with growth led by continued uptake of TYVASO DPI, a regular annual price increase and increased commercial utilization following the implementation of the Part D redesigned provisions under the Inflation Reduction Act or IRA. Again, this quarter, there were no material changes in inventories of TYVASO DPI at our specialty pharmacy distributors during the 1st quarter and both distributors remain within their contracted inventory levels.

Michael Benkowitz: Total Tyvaso revenue for the first quarter was $373 million, up 56% over last year, with growth led by continued uptake of Tyvaso DPI, our regular annual price increase, and the increased commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act, or IRA. Again, this quarter, there were no material changes in inventories of Tyvaso DPI at our specialty pharmacy distributors during the first quarter, and both distributors remain within their contracted inventory levels. After a relatively consistent monthly referral rate over the course of 2023 - referrals are what we call prescriptions - we saw a nice positive trend break in referral levels for both DPI and nebulizer in the first quarter, with about a 10% to 15% total increase in monthly referrals. This is continuing, at least so far, into the second quarter.

Speaker Change: <unk> revenue for the first quarter was $373 million up 56% over last year with growth led by continued uptake of Televisa D. P. I R.

Speaker Change: Our regular annual price increase and the increased commercial utilization and increased commercial utilization. Following the implementation of the part D redesign provisions under the inflation reduction act or IRR.

Speaker Change: Again this quarter there were no material changes in inventories of today's a DPI and our specialty pharmacy distributors during the first quarter and both distributors remain within their contracted inventory levels.

Michael I. Benkowitz: After a relatively consistent monthly referral rate over the course of 2023, referrals are what we call prescriptions -- we saw a nice positive trend break in referral levels for both DPI and Nebulizer in the 1st quarter, with about a 10% to 15% total increase in monthly referrals. This is continuing, at least so far, into the 2nd quarter. Patient starts also increased but at a lesser rate during the 1st quarter -- but this is not surprising, as there is often a many week lag between referrals and starts. But it does appear that starts per month are increasing, in-line with the 1st quarter referral level into the 2nd quarter. During the 1st quarter, we were pleasantly surprised to see an increase in commercial utilization of TYVASO due to the implementation of the IRA.

After a relatively consistent monthly referral rate over the course of 2023, referrals are what we call prescriptions -- we saw a nice positive trend break in referral levels for both DPI and Nebulizer in the 1st quarter, with about a 10% to 15% total increase in monthly referrals. This is continuing, at least so far, into the 2nd quarter. Patient starts also increased but at a lesser rate during the 1st quarter -- but this is not surprising, as there is often a many week lag between referrals and starts. But it does appear that starts per month are increasing, in-line with the 1st quarter referral level into the 2nd quarter.

Speaker Change: After a relatively consistent monthly referral rate over the course of 2023 referrals.

Mike: Our what we call prescriptions, we saw a nice positive trend break in referral levels for both DPI and annualize or in the first quarter with about a 10% to 15%.

Mike: Total increase in monthly referrals. This is.

Mike: Continuing at least so far into the second quarter.

Michael Benkowitz: Patient starts also increase but at a lesser rate during Q1, but this is not surprising as there is often a many-week lag between referrals and starts. But it does appear that starts per month are increasing in line with the Q1 referral level into Q2. During Q1, we were pleasantly surprised to see an increase in commercial utilization of Tyvaso due to the implementation of the IRA. We were expecting to see this increase begin in Q2 as patients reach their out-of-pocket maximums. We expect commercial utilization will continue to increase over the balance of the year. Lastly, on Tyvaso, we're well positioned for competition should it come to market this year. The sales force expansion that we began last year is now complete and fully deployed as of January 1.

Michael I. Benkowitz: Patient starts also increased, but at a lesser rate during the first quarter. But this is not surprising, as there is often a many weeks lag between referrals and starts. But it does appear that starts per month are increasing in line with the first quarter referral level into the second quarter. During the first quarter, we were pleasantly surprised to see an increase in commercial utilization of Tidaso due to the implementation of the IRA.

Mike: Patient starts also increase but at a lesser rate during the first quarter, but this is not surprising as there is offered in many week lag between referrals and starts but it does appear that starts per month per month are increasing in line with the first quarter referral level into the second quarter.

During the 1st quarter, we were pleasantly surprised to see an increase in commercial utilization of TYVASO due to the implementation of the IRA. We were expecting to see this increase began in the 2nd quarter, as patient [inaudible] are out-of-pocket maximums. We expect commercial utilization will continue to increase over the balance of the year. Lastly, on TYVASO, we're well positioned for competition should it come to market this year. The salesforce expansion that we began last year is now complete and fully deployed as of January 1.

Mike: During the first quarter, we were pleasantly surprised to see an increase in commercial utilization of today, so due to the implementation of the Iraq.

Michael I. Benkowitz: We were expecting to see this increase begin in the second quarter as patient tweets are out of pocket. We expect commercial utilization will continue to increase over the balance of the year. Lastly, on Tyvaso, we're well positioned for competition should it come to market this year. The Salesforce expansion that we began last year is now complete and fully deployed as of January 1.

Mike: We were expecting to see this increase began in the second quarter as patients weeks or out of pocket Maximums. We expect commercial utilization will continue to increase over the balance of the year.

Mike: Lastly on <unk>, So we're well positioned for competition should it come to market this year.

Mike: The sales force expansion that we began last year is now complete and fully deployed as of January one we expect that we'll start to see the impact of this enhanced sales team beginning in the second half of the year.

Michael Benkowitz: We expect that we'll start to see the impact of this enhanced sales team beginning in the second half of the year. We are also now engaging regularly with HCPs, or healthcare providers, on the key characteristics of our DPI device, namely that Tyvaso DPI requires only one breath per cartridge. Our low-flow design requires less patient breath than high-flow devices, which we believe will be beneficial to patients with compromised lungs. The low-flow design also allows for a more efficient delivery of treprostinil relative to the nebulizer and other treprostinil DPI devices. And finally, the BREEZE study demonstrated 98% patient satisfaction with Tyvaso DPI.

Michael I. Benkowitz: We expect that we'll start to see the impact of this enhanced sales team beginning in the second half of the year. We are also now engaging regularly with HCPs, or healthcare providers, on the key characteristics of our DPI device -- namely, that TYVASO DPI requires only one breath per cartridge. Our low-flow design requires less patient breath than high-flow devices, which we believe will be beneficial to patients with compromised lungs. The low-flow design also allows for a more efficient delivery of TREPOSTRINIL relative to the Nebulizer and other TREPOSTRINIL DPI devices.

Mike: We are also now engaging regularly with hcp's or health care providers on the key characteristics of our Dubai, our DPI device, namely that type of ACO DPI requires only one breaths per cartridge, our low flow design requires less patient breadth than high flow today, spices, which we believe will be beneficial to patients with compromised logs.

Mike: The low flow design also allows for a more efficient delivery of coprostanol relative to the <unk> and other cross sell DPI devices and finally, the Breeze study demonstrated 98% patient satisfaction with tiny so D. P I.

Michael I. Benkowitz: And finally, the BREEZE study demonstrated 98% patient satisfaction with TYVASO DPI. As I said on our last call, these factors, coupled with the experience physicians have gained through the rapid uptake of TYVASO DPI since launch, lead us to believe that TYVASO DPI will compete effectively with similar product offerings in the inhaled market, given our presence in the PAH and PH-ILD community, our commitment to patients and platform of both Nebulized and Dry Powder delivery options.

Michael Benkowitz: As I said on our last call, these factors, coupled with the experience physicians have gained through the rapid uptake of Tyvaso DPI since launch, lead us to believe that Tyvaso DPI will compete effectively with similar product offerings in the inhaled market, given our presence in the PAH and PH-ILD community, our commitment to patients, and platform of both nebulized and dry powder delivery options. Moving to Orenitram, we are very excited to report that not only did we achieve record revenue for the quarter, but we eclipsed $100 million in a quarter for the very first time, reaching $106 million during Q1, up 20% from the prior year.

Mike: As I said on our last call. These factors coupled with the experienced physicians have gained through the rapid uptake of Taipei. So DPI since large lead us to believe that tight Asa DPI will compete effectively with similar product offerings I mean held market given our presence in the P. H in ph ILD community, our commitment to patients and platform.

Mike: Both <unk> and dry powder delivery options.

Mike: Moving to our rent ahead of time, we are very excited to report that not only did we achieve record revenue for the quarter, but we eclipsed $100 million in a quarter for the very first time, reaching $106 million during the first quarter up 20% from the prior year.

Michael I. Benkowitz: Moving to a ORENITRAM, we are very excited to report that not only did we achieve record revenues for the quarter but we eclipsed $100 million in a quarter for the very first time -- reaching $106 million during the 1st quarter, up 20% from the prior year. This was driven by a combination of increased commercial utilization, pricing and what we consider to be an extremely modest inventory buy-in during the quarter, counter to the normal seasonality we experience with ORENITRAM ordering patterns in the 1st quarter of the year.

Michael Benkowitz: This was driven by a combination of increased commercial utilization, pricing, and what we consider to be an extremely modest inventory buy-in during the quarter, counter to the normal seasonality we experienced with Orenitram ordering patterns in the first quarter of the year. Because Orenitram is a Medicare Part D, as in dog, drug, like Tyvaso DPI, we saw a meaningful increase in commercial utilization for Orenitram due to the implementation of the IRA. Our medical teams continue to have scientific discussions with healthcare providers on the Expedite Induction Protocol, where PAH patients initiate therapy on Remodulin and then transition to Orenitram based on recent scientific publications as an option for appropriate patients who may not want or need to go on long-term parenteral therapy.

Mike: This was driven by a combination of increased commercial utilization pricing and what we consider to be an extremely modest inventory buy in during the quarter.

Mike: Router to the normal seasonality, we experienced with our radar trap ordering patterns in the first quarter of the year.

Michael I. Benkowitz: Because ORENITRAM is a Medicare Part D -- as in dog -- drug, like TYVASO DPI, we saw a meaningful increase in commercial utilization for ORENITRAM due to the implementation of the IRA. Our medical teams continue to have scientific discussions with healthcare providers on the EXPEDITE induction protocol, where PAH patients initiate therapy on REMODULIN and then, transition to ORENITRAM, based on recent scientific publications as an option for appropriate patients who may not want or need to go on long-term parenteral therapy.

Mike: Because of the rent a car is a Medicare part D as in dog.

Mike: <unk>.

Mike: Like <unk>, we saw a meaningful meaningful increase in commercial utilization for our renter traffic due to the implementation of the Iraq.

Mike: Our medical teams continue to have scientific discussions with health care providers on the expedite induction protocol, where ph patients initiate therapy on a module and then transition to a rent a trap based.

Mike: Based on recent scientific publications as an option for appropriate patients, who may not want or need to go on long term parental therapies.

Michael Benkowitz: Transitioning to Remodulin, worldwide Remodulin revenue of $128 million was up 5% from last year with very strong performance across all of our underlying demand metrics. This is almost five years since the first launch of the generic for Remodulin, reflecting our continued commitment to our patients and the product. Remodulin, both intravenous and subcutaneous, remains the most prescribed parenteral prostacyclin in the US. We expect this momentum to continue given the high level of referrals and starts in Q1. The Remunity pump remains the only option for new subcutaneous patient starts, and we have heard through the channel that specialty pharmacy distributors are beginning to proactively convert remaining sub-Q treprostinil patients to our Remunity pump given the discontinuation of support for the CAD-MS3 system by its manufacturer.

Mike: Transitioning to remodel it worldwide, where module and revenue of 128.

Michael I. Benkowitz: Transitioning to REMODULIN. Worldwide REMODULIN revenue of $128 million was up 5% from last year, with very strong performance across all of our underlying demand metrics. And this is almost five years since the first launch of the generic for REMODULIN, reflecting our continued commitment to our patients and the product. REMODULIN, both intravenous and subcutaneous, remains the most prescribed parenteral prostacyclin in the U.S. We expect this momentum to continue, given the high level of referrals and starts in the 1st quarter.

Mike: It was up 5% from last year with very strong performance across all of our underlying demand metrics and this is almost five years since the first launch of a generic for a module and reflecting our continued commitment to our patients and the product <unk>.

Mike: We're modeling both intravenous and subcutaneous remains the most prescribed parenteral prostacyclin in the U S.

Mike: We expect this momentum to continue given the high level of referrals and starts in the first quarter.

Michael I. Benkowitz: Our REMUNITY pump remains the only option for new subcutaneous patient starts and we have heard through the channel that specialty pharma distributors are beginning to proactively convert remaining sub-Q TREPOSTRINIL patients to our REMUNITY pump, given the discontinuation of support for the CADD-MS3 system by its manufacturer. Regarding the recent approval of the first active inhibitor, based on conversations with physicians both before and after approval, we expect many practices will take a measured stance toward its wide use and most use initially could be consistent with the product's clinical evidence, largely in combination use with a prostacyclin therapy.

Mike: Ah Remunerative pulp remains the only option for new subcutaneous patient starts and we've heard through the channel that specialty pardon me distributors are beginning to proactively convert.

Mike: Beginning to proactively convert remaining sub Q for profitable patients to our immunity path given the discontinuation of support for the Cat M. S. III system biased manufacturer.

Michael Benkowitz: Regarding the recent approval of the first Activin inhibitor, based on conversations with physicians both before and after approval, we expect many practices will take a measured stance toward its wide use, and most use initially could be consistent with the product's clinical evidence, largely in combination use with a prostacyclin therapy. Finally, moving to Unituxin, worldwide revenue of $58 million, a record, was up 19% from the prior year quarter, and US Unituxin revenue of $53 million was up 21%. US growth was driven by both price and volume. To wrap up, following this record quarter, we remain confident that we have the product portfolio, marketing muscle, support structures, clinical data, and commercial expertise to continue to grow in both PAH and PH-ILD. With that, I'll turn the call back over to Martine to run the Q&A.

Mike: Regarding the recent approval of the first accident inhibitor based on conversations with physicians, both before and after approval. We expect many practices will kick in metrics stance toward its white use and most used initially it could be consistent with the product's clinical evidence largely in combination use with a prostacyclin therapy.

Michael I. Benkowitz: Finally, moving to UNITUXIN. Worldwide revenue of $58 million -- a record -- was up 19% from the prior year quarter and U.S. UNITUXIN revenue of $53 million was up 21%. U.S. growth was driven by both price and volume. To wrap up, following this record quarter, we remain confident that we have the product portfolio, marketing muscle, support structures, clinical data and commercial expertise to continue to grow in both PAH and PH-ILD. With that, I'll turn the call back over to Martine to run the Q&A.

Finally, moving to UNITUXIN. Worldwide revenue of $58 million -- a record -- was up 19% from the prior year quarter and U.S. UNITUXIN revenue of $53 million was up 21%. U.S. growth was driven by both price and volume. To wrap up, following this record quarter, we remain confident that we have the product portfolio, marketing muscle, support structures, clinical data and commercial expertise to continue to grow in both PAH and PH-ILD.

Michael I. Benkowitz: Finally, moving the unit toxin.

Mike: <unk> revenue of $58 million, a record was up 19% from the prior year quarter and U S. Unitek. Some revenue of $53 million was up 21% U S growth was driven by both price and volume.

Mike: To wrap up following this record quarter, we remain confident that we have the product portfolio marketing muscle support structures clinical data and commercial expertise to continue to grow in both P. A H N ph ILD.

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

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

Dewey Steadman: Thank you, Mike, for that superb overview and deep dive into so many key and important details of all of our different products. It's literally a historic quarter. It's the best we've ever had. Operator, we're ready for the first question.

Martine Rothblatt: Thank you, Mike, for that superb overview and deep dive into so many key and important details of all of our different products. It's literally a historic quarter. It's the best we've ever had. Operator, we're ready for the first question.

Martine A. Rothblatt: Thank you, Mike, for that superb overview and deep dive into so many key and important details of all of our different products. It's literally a historic quarter, it's the best we've ever had. Operator, we're ready for the first question.

Speaker Change: Thank you Mike for that superb overview and deep dive into so many key end and important details of all of our different products. It's literally a historic quarter. It's the best we've ever had.

Unknown Attendee: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If, at any time, your question has been addressed and you would like to withdraw your question, please press star then 2. The first question comes from Terence Flynn from behalf of Morgan Stanley. Please go ahead.

Operator: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If, at any time, your question has been addressed and you would like to withdraw your question, please press star then 2.

Speaker Change: Operator, we're ready for the first question.

Operator: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. The first question comes from Terrence Flynn from Morgan Stanley. Please go ahead.

Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad. If you are using a speakerphone. Please pick up your handset before pressing the keys.

Speaker Change: If at any time a question has been addressed and you would like to withdraw your question. Please press Star then two.

Speaker Change: Our first question comes from parents Lin from Morgan Stanley. Please go ahead.

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

Leigh Peterson: Great. Good morning. Thanks for taking the question. Maybe a two-part for me. I was just wondering what you're seeing now with respect to breadth of prescribing for Tyvaso and ILD. I know you went to a broader prescriber audience sometime last year, and you have the new sales force, but just wondering if you can comment it all there. And then can you provide the percentage of Remodulin patients that are now on the Remunity pump? Thank you.

Terrence Flynn: Great. Good morning. Thanks for taking the question. Maybe a two-part for me. I was just wondering what you're seeing now with respect to breadth of prescribing for Tyvaso and ILD. I know you went to a broader prescriber audience sometime last year, and you have the new sales force, but just wondering if you can comment it all there. And then can you provide the percentage of Remodulin patients that are now on the Remunity pump? Thank you.

Lin: Great. Good morning, Thanks for taking the question maybe a two part for me was just wondering what you're seeing now with respect to breadth of prescribing for Thai based on ILD. I know you went to a broader prescriber audience sometime last year and you have the new sales force, but just wondering if you can comment at all there and then can you.

Terence Flynn: Great. Good morning, thanks for taking the question. Maybe a two-part for me. I was just wondering what you're seeing now with respect to breadth of prescribing for TYVASO on ILD. I know you went to a broader prescriber audience sometime last year and you have the new sales force but just wondering if you can comment at all there. And then, can you provide the percentage of REMODULIN patients that are now on the REMUNITY pump? Thank you.

Unknown Attendee: Thanks for taking the question. Maybe it's a two-part question for me. I was just wondering what you're seeing now with respect to breadth of prescribing for Tyvezo and ILD. I know you went to a broader prescriber audience sometime last year and you have the new sales force, but just wondering if you can comment at all on that. And then, can you provide the percentage of remodulin patients that are now on the RemUnity pump? Thank you.

Lin: Provide the.

Unknown Attendee: Percentage of remodeling patients that are now on the Rem unity pump. Thank you.

Dewey Steadman: Thank you, Terrence, and congratulations on being over at Morgan Stanley now. Mike, given the cue, feel free to answer as much of that question as you feel time permits.

Unknown Attendee: Thank you Terrence and congratulations on being over at Morgan Stanley now Mike.

Dewey Steadman: Thank you, Terence and congratulations on being over at Morgan Stanley now. Mike, given the queue, feel free to answer as much of that question as you feel time permits.

Speaker Change: Mike given the queue feel free to answer as much of that question is you feel time permits yet.

Michael Benkowitz: Yeah, sure. So on the breadth of prescribing, I mean, overall, we're continuing to see growth in both breadth and depth. And I think a lot of that is attributable to, again, just the work and pounding the pavement that we've been doing over the last couple of years and gaining traction with new prescribers. As I said in my opening remarks, we now have the expanded sales force fully deployed. It's going to take time for them to build relationships. And so I think we'll really start to see the impact of that effort as we move into Q3, really. So there could be. We're expecting continued breadth as we move on.

Michael Benkowitz: Yeah, sure. So, on the breadth of prescribing -- I mean, overall, we're continuing to see growth in both breadths and [inaudible]. But I think a lot of that is attributable to, again, just the work and pounding the pavement that we've been doing over the last couple years and gaining traction with new prescribers. As I said in my opening remarks, we now have the expanded sales force fully deployed. It's going to take time for them to build relationships and so, I think we'll really start to see the impact of that effort as we move into the 3rd quarter, really.

Speaker Change: Yeah sure so on the breadth of prescribing in that I mean overall, we're continuing to see.

Michael I. Benkowitz: Growth in both breasts.

Michael I. Benkowitz: And that's I think a lot of that is attributable to a again just the work in pounding the pavement, we've been doing over the last last couple of years and gaining traction with.

Michael I. Benkowitz:

Michael I. Benkowitz: New prescribers I as I said in my opening remarks.

Michael I. Benkowitz: We now have that.

Michael I. Benkowitz: And that sales force fully deployed that's going to take time for them to build relationships and so I think we'll.

Michael I. Benkowitz: We start to see it.

Michael I. Benkowitz: The impact of that effort as we move into the third quarter really so there could be.

Michael I. Benkowitz: We're expecting continued breadth as we move on. One interesting statistic I was looking at, if you look at historically ILD physicians that didn't have experience writing for PAH products -- over the last 15 months, we've seen a 50%, so a 5-0% increase in breadth. And then the depth is, which we measured by that three-plus metric that I've mentioned on prior calls, has increased by [inaudible] 30%. So, we are really starting to get traction in the ILD community, not only on a referral basis, which we have but also on our actual writing basis. So, we're really happy to see that.

Michael I. Benkowitz: Expected continued continued breadth is as we move on one is interesting statistics I was I was lucky that is if you look at ILD historically ILD physicians that didn't that didn't have experience writing for ph products over the last 15 months, we've seen a 50% so size zero percent.

Michael Benkowitz: One interesting statistic I was looking at is if you look at ILD, historically, ILD physicians that didn't have experience writing for PAH products, over the last 15 months, we've seen a 50%, so 50%, increase in breadth. And then the depth, which we measure by that 3-plus metric that I've mentioned on prior calls, has increased by, and that group has increased by about 30%. So we are really starting to get traction in the ILD community, not only on a referral basis which we've had but also on an actual writing basis. So really happy to see that. Just quickly on Remunity, right now, we've got the vast majority of patients who are on Remunity. I think there's maybe a few hundred left that need to be transitioned.

Michael I. Benkowitz: The increase in breadth.

Michael I. Benkowitz: And then the depth.

Michael I. Benkowitz: Which we measure by that three plus metric that I've mentioned on prior calls.

Michael I. Benkowitz: <unk> has increased by that group has increased by about 30%. So we are we are we are really starting to get traction.

Michael I. Benkowitz: The ILD community not only on a referral basis with the pad, but also on absolute basis really happy just to see that just quickly on unremunerated right now we've got the vast majority of patients are.

Michael I. Benkowitz: So we're really happy to see that. Just quickly on immunity, right now we have the vast majority of patients on immunity. There are maybe a few hundred left that need to be transitioned. And as I said, I think specialty pharmacies are looking to probably get those transitioned over to immunity by the end of the year.

So we're really happy to see that.

Just quickly on REMUNITY. Right now, we've got the vast majority of patients on REMUNITY. I think there's maybe a few hundred left that need to be transitioned. And as I said, I think specialty pharmacies are looking to probably get those transitioned over to REMUNITY by the end of the year.

Michael I. Benkowitz: Autoimmunity I think there's maybe a few hundred left that needs to be transitioned.

Michael Benkowitz: And as I said, I think specialty pharmacies are looking to probably get those transitioned over to Remunity by the end of the year.

Michael I. Benkowitz: I'd say I think specialty pharmacies are looking to.

Michael I. Benkowitz: Probably get those transitions.

Michael I. Benkowitz: Hi.

Michael I. Benkowitz: The year.

Dewey Steadman: Thanks so much, Mike, for the fully comprehensive answer. Terrence, hopefully, that addressed all your concerns. Next question.

Dewey Steadman: Thanks so much, Mike, for the fully comprehensive answer. Terence, hopefully, that addressed all your concerns. Next question.

Speaker Change: Thanks, so much Mike for the fully comprehensive answer.

Martine A. Rothblatt: Hopefully that addressed your concerns next question.

Operator: The next question comes from Roanna Ruiz from Leerink. Please go ahead.

Martine A. Rothblatt: The next question comes from Roanna Ruiz from Leerink. Please go ahead.

Leigh Peterson: Good morning, everyone. So I was curious, what are your field reps hearing on the ground from physicians around the sotatercept approval and launch, if you're able to say? And bigger picture, what's your outlook on the future in terms of combined use of Tyvaso with sotatercept and prescribers' consideration of both these products?

Roanna Ruiz: Good morning, everyone. So I was curious, what are your field reps hearing on the ground from physicians around the sotatercept approval and launch, if you're able to say? And bigger picture, what's your outlook on the future in terms of combined use of Tyvaso with sotatercept and prescribers' consideration of both these products?

Roanna Ruiz: Great. Morning, everyone. So, I was curious, what are your field reps hearing on the ground from physicians around the SOTATERCEPT approval and launch? If you're able to say. And a bigger picture, what's your outlook on the future in terms of combined use of TYVASO with SOTATERCEPT and prescribers' consideration of both these products?

Roanna Ruiz: Great. Good morning, everyone. So I was curious what are your field reps hearing on the ground from physicians around the <unk> approval and launch if you're able to say and a bigger picture. What's your outlook on the future in terms of combined <unk> with your cat Herceptin prescribers consideration of both these products.

Dewey Steadman: Great. That would also be within President Benkowitz's purview. So, Mike, take it away.

Dewey Steadman: Great. That would also be within President Benkowitz's purview so, Mike, take it away.

Speaker Change: Great that would also be within prestige banker, which is per view, so Mike take it away.

Michael Benkowitz: Sure. Thanks for the question. So with sotatercept, it's been in terms of the launch, it's actually been relatively quiet. I mean, I think what we've heard through the rumor mill is they're supposed to launch this week, but it's been a little bit quiet. So I mean, it's probably a question best directed to Merck on what their launch plans are. The second point on what's our outlook for the use of our products with sotatercept, I think, as we've said in prior quarters and as I mentioned in my opening remarks, we really look at this as being a complementary product to the existing products that are on the market. It's not a cure. It's not a replacement for prostacyclin. We don't expect the existing patients are going to be transitioned off of a prostacyclin as a result of sotatercept.

Michael I. Benkowitz: Sure. Thanks for the question. So, with SOTATERCEPT, in terms of the launch -- it's actually been relatively quiet. I mean, I think what we've heard through the rumor mill, as they're supposed to launch this week but it's been a little bit quiet. So, I think it's probably a question best directed to Merck on what their launch plans are. The second point, you know, what's our outlook for the use of our products with SOTATERCEPT -- yeah, I think as we said in prior quarters and as I mentioned in my opening remarks, we really look at this as being a complementary product to the existing products that are on the market. It's not a cure, it's not a replacement for prostacyclin -- we don't expect the existing patients are going to be transitioned off of the prostacyclin as a result of SOTATERCEPT. almost 70% of the patients in their clinical trial were on background prostacyclin therapy so, certainly, we think -- and based on conversations -- we think, largely, SOTATERCEPT can be used in combination with the prostacyclin therapy. You know, if it works well and patients are able to live longer then, that means they're staying on our products longer, which helps us from a financial standpoint. So, yeah, that's kind of what we've been hearing for the last, I would say, six to nine months and then what we heard during the 1st quarter.

Michael Benkowitz: Sure. Thanks for the question. So, with SOTATERCEPT, in terms of the launch -- it's actually been relatively quiet. I mean, I think what we've heard through the rumor mill, as they're supposed to launch this week but it's been a little bit quiet. So, I think it's probably a question best directed to Merck on what their launch plans are. The second point, you know, what's our outlook for the use of our products with SOTATERCEPT -- yeah, I think as we said in prior quarters and as I mentioned in my opening remarks, we really look at this as being a complementary product to the existing products that are on the market.

Mike: Sure. Thanks for the question so what's the status that that's been.

Michael I. Benkowitz: In terms of the launch.

Michael I. Benkowitz: The relatively quiet I mean, I think what we've heard.

Michael I. Benkowitz: You know through the through the rumor mill as they're supposed to watch this week, but it's.

Michael I. Benkowitz: It's been a little bit quiet so.

Michael I. Benkowitz: It's probably a question that's correct to Merck on what their watch part of that.

Michael I. Benkowitz: The second point.

Michael I. Benkowitz: Our outlook for the use of our products with.

Michael I. Benkowitz: What's the titer SAP.

Michael I. Benkowitz: Yeah, I think as we've said in prior quarters and as I mentioned in my opening remarks.

Michael I. Benkowitz: Yeah, I think, as we've said in prior quarters and as I mentioned in my opening remarks, we really look at this as being a complementary product to the existing products that are on the market. It's, you know, it's not a cure, it's not a replacement for prostacyclin. We don't expect existing patients are going to be transitioned off of prostacyclin as a result of cicatriceps. As you know, almost 70% of the patients in their clinical trial were on background prostacyclin therapy.

Michael I. Benkowitz: You look at this as being a complementary product to the existing products that are.

Michael I. Benkowitz: That are off market.

Michael I. Benkowitz: Yes.

It's not a cure, it's not a replacement for prostacyclin -- we don't expect the existing patients are going to be transitioned off of the prostacyclin as a result of SOTATERCEPT. almost 70% of the patients in their clinical trial were on background prostacyclin therapy so, certainly, we think -- and based on conversations -- we think, largely, SOTATERCEPT can be used in combination with the prostacyclin therapy. You know, if it works well and patients are able to live longer then, that means they're staying on our products longer, which helps us from a financial standpoint. So, yeah, that's kind of what we've been hearing for the last, I would say, six to nine months and then what we heard during the 1st quarter.

Michael I. Benkowitz: It's not a cure lateral placement for prostacyclin.

Michael I. Benkowitz: Yeah, we don't expect existing patients are gonna be transitioned off of the prostacyclin as a result as opposed to tied herself.

Michael I. Benkowitz: So certainly, you know, we think, and based on conversations, we think, you know, largely, cicatriceps can be used in combination with prostacyclin therapy. You know, and if it works well, and patients are able to live longer, then that means they're staying on our products longer, which, you know, helps us from a financial standpoint. Yeah, that's kind of what we've been hearing for the last, I would say, you know, six to nine months and then what we heard during the first quarter.

Michael Benkowitz: I think it was almost 70% of the patients in their clinical trial were on background prostacyclin therapy. So certainly, we think and based on conversations, we think largely, sotatercept's going to be used in combination with prostacyclin therapy. And if it works well and patients are able to live longer, then that means they're staying on our products longer, which helps us from a financial standpoint. So that's kind of what we've been hearing for the last, I would say, six to nine months and what we heard during Q1.

Michael I. Benkowitz: So it goes almost 70% of the patients in a clinical trial.

Michael I. Benkowitz: Background prostacyclin therapy.

Michael I. Benkowitz: Certainly.

Michael I. Benkowitz: We think based on our conversations we think largely.

Michael I. Benkowitz: Subsequent to use in combination with the prostacyclin therapy.

Michael I. Benkowitz: You know and if it works well and patients are able to live longer than that.

Michael I. Benkowitz: That means that they're staying on our products all of which helps us from a financial standpoint. So.

Michael I. Benkowitz: Yeah. That's that's what we've been hearing for the last I would say six to nine months and what we heard that the first quarter.

Dewey Steadman: Excellent, Michael. Thank you so much. Operator, we have time for about two more questions. Next question?

Dewey Steadman: Excellent, Michael. Thank you so much. Operator, we have time for about two more questions. Next question.

Speaker Change: Excellent Michael Thank you so much operator, we have time for about two more questions next question.

Operator: The next question comes from Ash Verma from UBS. Please go ahead.

Michael I. Benkowitz: The next question comes from Ash Verma from UBS. Please go ahead.

Ash Verma: Hi, good morning. Thanks for taking my question. Congrats on all the progress. So, I have to, like, for xenotransplantation, can you comment on how do you decide which and how many genes are modified? There's another player in this field which is using a slightly different approach, how confident are you that your level and selection of gene modification is the most appropriate approach here?

Ashwani Verma: Hi. Good morning. Thanks for taking my question. Congrats on all the progress. So, I have two for xenotransplantation, can you comment on how do you decide which and how many genes are modified? There's another player in this field which is using a slightly different approach. How confident are you that your level and selection of gene modification is the most appropriate approach here? And then secondly, I wanted to understand some of the pricing pushes and pulls for 2025 across your portfolio. I mean, clearly, there is a benefit that you get from the copay normalization with IRA, out-of-pocket going to 2,000, but then also the doughnut hole impact. Net-net, does that shake out as a headwind or tailwind on 2025 pricing? Thanks.

Ash Verma: Hi. Good morning. Thanks for taking my question. Congrats on all the progress. So, I have two for xenotransplantation, can you comment on how do you decide which and how many genes are modified? There's another player in this field which is using a slightly different approach. How confident are you that your level and selection of gene modification is the most appropriate approach here? And then secondly, I wanted to understand some of the pricing pushes and pulls for 2025 across your portfolio. I mean, clearly, there is a benefit that you get from the copay normalization with IRA, out-of-pocket going to 2,000, but then also the doughnut hole impact. Net-net, does that shake out as a headwind or tailwind on 2025 pricing? Thanks.

Ashwani Verma: Hi, Good morning, Thanks for taking my question Congrats on all the progress so I have to like four zero transplantation can you comment on how do you decide which and how many gene modified there's another player in this field using slightly different approach. How confident are you that yard level and selection of gene modification is the.

Ashwani Verma: Most appropriate approach here and then secondly, I wanted to understand the some of the pricing pushes and pulls for 2025 across your portfolio I mean anybody other than the benefit that you get from the copay normalization with Iot.

Unknown Attendee: And then, secondly, I wanted to understand some of the pricing pushes and pulls for 2025 across your portfolio. I mean, clearly, there is a benefit that you get from the co-pay normalization, with IRA out-of-pocket going to $2000 but then, also, the donut hole impact. Net-net, does that shake out as a headwind or tailwind on 2025 pricing? Thanks.

Unknown Attendee: Out of pocket going to 2000, but then also the donut hole impact.

Unknown Attendee: Net net does that shake out as a headwind or tailwind on 2025 pricing. Thanks.

Dewey Steadman: So Ash, thank you for your questions and great analyst coverage. But there's only going to be time to answer the first question. Each of those questions would take an hour to fully delve into. Fortunately, we have on the call our Executive Vice President for product development and xenotransplantation, Dr. Peterson. And Leigh, can you answer the xeno question?

Dewey Steadman: So, Ash, thank you for your questions and great analyst coverage but there's only going to be time to answer the first question. Each of those questions would take an hour to fully delve into. Fortunately, we have on the call our Executive Vice President for Product Development and Xenotransplantation, Dr. Peterson. And Leigh, can you answer the xeno question?

Speaker Change: Thank you for your questions and great to analyst coverage, but there's only going to be time to answer. The first question. The EBIT each of those questions would take an hour to like fully delve into Fortunately, we have on the call our executive Vice President for product development and renal transplantation, Dr. Peterson and Lee can you answer there is no question yes.

Leigh Peterson: Yes, of course. Thanks for this question. So as you know, at United Therapeutics, we believe on multiple shots on goal. In fact, we have our 10-gene pig that we're developing two different organs, our 10-gene xenokidney as well as our 10-gene xenoheart. And then we also are developing our thymokidney, which is from a pig with a single genetic modification. And this was the organ that was transplanted into the recent NYU patient. And we actually have good scientific rationale as well as preclinical evidence that both of these products, again, with a single genetic modification as well as the 10-gene pig, are effective. And again, there's advantages to both, at least from the scientific rationale. But really, to establish the scientific safety and efficacy of each, we need to conduct clinical studies.

Dr. Leigh Peterson: Yes, of course. Thanks for this question. And so, as you know, at United Therapeutics, we believe on multiple shots on goal. So, in fact, we are developing -- we have our 10-gene pig that we have; we're developing two different organs, our 10-gene xenokidney as well as our 10-gene xenoheart. And then, we also are developing our ThymoKidney, which is from a pig with a single genetic modification -- and this was the organ that was transplanted into the recent NYU patient. And we actually have good scientific rationale, as well as pre-clinical evidence, that both of these products, again, with a single genetic modification as well as the 10-gene pig, are effective.

Leigh: Of course, thanks for this this this question and so.

Leigh Peterson: So as you know at United Therapeutics, We believe on multiple shots on goal. So in fact, we are developing.

Leigh Peterson: And so, as you know, at United Therapeutics, we believe in multiple shots at goal. So, in fact, we are developing, we have our 10 gene pig that we have; we're developing two different organs, our 10 gene xeno kidney, as well as our 10 gene xeno heart. And then we also are developing our thymokidney, which is from a pig with a single genetic modification, and this was the organ that was transplanted into the recent NYU patient.

Leigh Peterson: We have our 10 gene.

Leigh Peterson: Pig that we have where we're developing.

Leigh Peterson: Developing two different organs are 10 gene.

Leigh Peterson: No kidney as well as our Tianjin.

Leigh Peterson: Zeno Heart and then we also are developing our Sino kidney.

Leigh Peterson: Which is from a take it with a single genetic modification and this was the Oregon that was transplanted into the recent NYU patient and we.

Leigh Peterson: And we actually have good scientific rationale, as well as preclinical evidence, that both of these products, again, with a single genetic modification, as well as the 10-gene pig, are effective. And again, there are advantages to both, at least from the scientific rationale. But really, to establish the scientific safety and efficacy of each, we need to conduct clinical studies, and we're planning on doing those for both of these products. And ideally, we will receive approval for multiple products, which will allow different options for patients and enhance the available supply. So, again... Your question is the obvious question, you know, which is better? Well, again, there are advantages to both. And we'll be testing those in our clinical studies in the near future.

And we actually have good scientific rationale, as well as preclinical evidence, that both of these products, again, with a single genetic modification, as well as the 10-gene pig, are effective.

And again, there's advantages to both, at least from the scientific rationale. But really, to establish the scientific safety and efficacy of each, we need to conduct clinical studies and we're planning on doing those for both of these products. And ideally, we will receive approval for multiple products, which will allow different options for patients and enhance the available supply. So, again, your question is the obvious question, you know, which is better? Well, again, advantages to both and we'll be testing those in our clinical studies in the near future.

Leigh Peterson: We actually have good scientific rationale as well as preclinical evidence that.

Dewey Steadman: Thanks so much, Leigh. Fantastic answer. Operator, last question, please.

Leigh Peterson: Both of these.

Leigh Peterson: <unk> again with a single genetic.

Leigh Peterson: Adaptation as long as the Tianjin tank.

Leigh Peterson: Our effective and.

Leigh Peterson: And again, there's advantages to both at least from the scientific rationale so but really to establish the scientific.

Leigh Peterson: Safety and efficacy of each we need to conduct clinical studies and we're planning on doing those for both of these products and ideally we will receive approval for multiple products and.

Leigh Peterson: We're planning on doing those for both of these products. Ideally, we will receive approval for multiple products, which will allow different options for patients and enhance the available supply. Again, your question is the obvious question, which is better? Well, again, advantages to both, and we'll be testing those in our clinical studies in the near future.

Leigh Peterson: Which will allow different options for patients.

Leigh Peterson: And enhanced available supply so again.

Speaker Change: So question is is the <unk>.

Leigh Peterson: Obvious question.

Leigh Peterson: Which is better well again advantages to both and we'll be testing those in in <unk>.

Leigh Peterson: Clinical studies in the near future.

Dewey Steadman: Thanks so much, Leigh. Fantastic answer. Operator, last question, please.

Speaker Change: Thanks, So much leak fantastic answer operator last question. Please.

Operator: The next question comes from Joseph Thome from TD Cowen. Please go ahead.

Leigh Peterson: Our next question comes from Joseph Thome from TD Cowen. Please go ahead.

Leigh Peterson: Hi there. Good morning. Thank you for taking my question, and congrats on the progress. Maybe one more on the xenotransplantation side. Maybe where do you see the importance of using a CD40/CD154 product in a xenotransplantation? I know preclinically, I think you looked at both with and without. Maybe what'll impact your decision to take a CD40/154 into the human clinical study or not? Thank you.

Joseph Thome: Hi there. Good morning. Thank you for taking my question, and congrats on the progress. Maybe one more on the xenotransplantation side. Maybe where do you see the importance of using a CD40/CD154 product in a xenotransplantation? I know preclinically, I think you looked at both with and without. Maybe what'll impact your decision to take a CD40/154 into the human clinical study or not? Thank you.

Joseph Thome: Hi there, good morning. Thank you for taking my question and congrats on the progress. Maybe one more on the xenotransplantation side. Maybe, where do you see the importance of using a CD40, CD154 product in xenotransplantation? I know, pre-clinically, you looked at both with and without. Maybe, what will impact your decision to take a CD40, 154 into the human clinical study or not? Thank you.

Joseph John: Hi, there good morning. Thank you for taking my question and congrats on the progress maybe one more on the Zeno transplantation side, maybe where do you see the importance of using the C. D 41 54.

Joseph John: Product in as you know transplantation I know preclinical I think you've looked at both with and without maybe what'll what'll impact your decision to take a CD 41 54 into the human clinical study or not thank you.

Dewey Steadman: Okay. Very good. Dr. Peterson, would you like to also address that question?

Dewey Steadman: Okay, very good. Dr. Peterson, would you like to also address that question?

Speaker Change: Okay very good Dr. Peterson would you like to also address that question.

Leigh Peterson: Yeah. Well, the main difference is that the CD40, there's no agents with the CD40 blockade mechanism of action approved by FDA for use in any indication, actually. And so what we chose to do is if you look at the background and the history, most xenotransplantation, at least with the preclinical models, those studies were done with the CD40 blockade. But our study that we're doing, we actually have two arms, CD40 blockade as well as with conventional immunosuppression in our baboon IND enabling studies. And we're getting good results with both. And in fact, there was a publication that recently came out by Ivenson et al., 2024, that discusses a case, a really significant case where a baboon was transplanted with standard of care regimen and survived for 9 and a half months, which has absolutely never been seen. And we have some reasons why that happens.

Dr. Leigh Peterson: Yes. Well, the main difference is that the CD40 -- there's no agents that, with the CD40 blockade mechanism of action, approved by FDA for use in any indication, actually. And so, what we chose to do is, if you look at the background and the history, most xenotransplantation -- at least for the pre-clinical models -- those studies were done with the CD40 blockade. But our study that we're doing, we actually have two arms -- CD40 blockade as well as conventional immunosuppression in our baboon IND-Enabling Studies. And we're getting good results with both.

Leigh Peterson: Yes, well the main difference is that D. C. D 40, there's no agents.

Leigh Peterson: But with the C. D 40, a blockade mechanism of action approved by FDA for use in any indication actually.

Leigh Peterson: And we're getting good results with both. And in fact, there was a publication that recently came out by Ivinson et al., 2024, that discusses a really significant case where a baboon was transplanted into the standard of care regimen and survived for nine and a half months, which has never, absolutely never, been seen before. And we have some reasons why that happens. So we prefer to go into a clinical study with approved medicines to not introduce another variable into the study. And again, we're backing it up with our preclinical studies, and we're seeing good results in the model. So that's where we're going first.

And we're getting good results with both.

Leigh Peterson: So what we chose to do is if you look at the background and the history lets you know transplantation at least with our clinical and preclinical models.

And in fact, there was a publication that recently came out by Ivinson et al., 2024, that discusses a really significant case where a baboon was transplanted with standard of care regimen and survived for nine and a half months -- which has never, absolutely never, been seen and we have some reasons why that happens. So, we prefer to go into a clinical study with approved medicines, to not introduce another variable into the study. And again, we're backing it up with our pre-clinical studies and we're seeing good results in the model. So, that's where we're going first.

Dewey Steadman: Thank you so much, Dr. Peterson. Very comprehensive answer. Operator, you can now conclude the call.

Leigh Peterson: Those studies were done with the CD 40 blockade, but our study.

Speaker Change: We're doing you actually have to arm C. D 40 blockade as well as as with conventional immunosuppression in our in our bathroom.

Leigh Peterson: I IND, enabling studies and we're getting good results with with both and in fact, there was a publication that recently came out.

Leigh Peterson: I I Vinson at all 2024.

Leigh Peterson: Discusses a case.

Leigh Peterson: The.

Leigh Peterson: That's really a significant case, where he was transplanted with standard of care regimens and survived for nine and a half months, which has never absolutely never been seen in and we have some.

Leigh Peterson: Reasons why that happens so we prefer to go into a clinical study with with the approved medicines to not introduce another variable into the study and again, we're backing it up with our with our preclinical.

Leigh Peterson: So we prefer to go into a clinical study with approved medicines to not introduce another variable into the study. And again, we're backing it up with our preclinical studies, and we're seeing good results in the model. So that's where we're going first.

Leigh Peterson: Studies and we're seeing good results in the model. So that's that's why we're going first.

Dewey Steadman: Thank you so much, Dr. Peterson. Very comprehensive answer. Operator, you can now conclude the call.

Leigh Peterson: Thank you so much Dr. Peterson very comprehensive answer operator, you can now conclude the call.

Operator: Thank you for participating in today's United Therapeutics Corporation earnings webcast. Every broadcast of this webcast will be available for replay for one week by visiting the events and presentation section of the United Therapeutics Investor Relations website at ir.unithr.com. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Operator: Thank you for participating in today's United Therapeutics Corporation Earnings Webcast. A re-broadcast 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. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Speaker Change: 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 Dot U N I T G R Dot com.

Unknown Attendee: That is great!

Unknown Attendee: France has now concluded. Thank you for attending today's presentation you may now disconnect.

Michael Benkowitz: That is great.

Unknown Attendee: That is correct.

Unknown Attendee: Yes.

Q1 2024 United Therapeutics Corp Earnings Call

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