Q2 2019 Earnings Call

July 31, 2019

[laughter].

Harley.

Unknown Attendee: Unknown Attendee Momentarily.

[noise].

Operator: Momentarily.

Operator: Good morning. May I please have your conference ID number?

Operator: BF-WATCH TV 2021 Good morning, now please have your conference ID number. Yep, one second, without earning the right to call.

Good mining now please have your conference I'd number.

Operator: Good morning. May I please have your conference ID number?

Second.

Michael Vich: Yep, one second. Oh, it's for the United Therapeutics earnings call.

Michael Michaelevich: Yep, one second. Oh, it's for the United Therapeutics earnings call.

[noise] Arts is for Gary.

Your next earnings call.

Sure Matt Please ask the spelling of your first and last name.

Operator: Sure, may I please have the spelling of your first and last name? Yep, my first name is Michael, M-I-C-H-A-E-L, and my last name is Vich, V-I-C-H. Thank you. May I please have your company name? It's A-R-R-A, A-I-E-R-A.

Operator: Sure. May I please have the spelling of your first and last name?

First things, Michael and I see H.L. last name is bitch VIP.

Michael Vich: Yep. First name is Michael, M-I-C-H-A-E-L. Last name is Vich, V-I-C-H.

Michael Michaelevich: Yep. First name is Michael, M-I-C-H-A-E-L. Last name is Vich, V-I-C-H.

Thank you ma'am. Please have your can you name.

Operator: Thank you. May I please have your company name?

Era.

Hi, Andy.

Michael Vich: It's Aiera, A-I-E-R-A.

Michael Michaelevich: It's Aiera, A-I-E-R-A.

Operator: Thank you. Your call is in progress. I'll join you now. Thank you. You're welcome.

Okay.

Thank you Carlos and progress how shine you now.

Operator: Thank you. Your call is in progress. I'll join you now.

Thank you.

You're welcome Maucher when products include the implantable system for Remodulin or higher SAR, and Remunity and TREVYENT, all three of which are pending FDA approval.

Michael Vich: Thank you.

Michael Michaelevich: Thank you.

Operator: You're welcome.

Martine A. Rothblatt: Remodulin products include the Implantable System for Remodulin, or ISR, and Remunity, and Treviant, all three of which are pending FDA approval, as well as RemoPro and RemoLife, both of which are in clinical development. All five of these products are differentiable from the older remodulin and have long patent lives.

Martine: Remodulin products include the implantable system for Remodulin, or ISR, RemUnity, and Trevyent, all three of which are pending FDA approval, as well as RemoPro and RemoLife, both of which are in clinical development. All five of these products are differentiable from the older Remodulin and have long patent lives. In addition, we can also triple our business by gaining approval for Tyvaso in two new markets, interstitial lung disease and COPD, as well as expanding it in all of its existing markets with novel inhalation technologies. The market for new Tyvaso technology in clinical development currently is even larger than the World Health Organization Group 1 pulmonary hypertension market that it currently leads. The new markets in clinical development are interstitial lung disease, pulmonary fibrosis, and COPD. All of these are known as World Health Organization Group 3 pulmonary hypertension.

Martine Rothblatt: Remodulin products include the implantable system for Remodulin, or ISR, RemUnity, and Trevyent, all three of which are pending FDA approval, as well as RemoPro and RemoLife, both of which are in clinical development. All five of these products are differentiable from the older Remodulin and have long patent lives. In addition, we can also triple our business by gaining approval for Tyvaso in two new markets, interstitial lung disease and COPD, as well as expanding it in all of its existing markets with novel inhalation technologies. The market for new Tyvaso technology in clinical development currently is even larger than the World Health Organization Group 1 pulmonary hypertension market that it currently leads. The new markets in clinical development are interstitial lung disease, pulmonary fibrosis, and COPD. All of these are known as World Health Organization Group 3 pulmonary hypertension.

As well as remote pro and remove life, both of which are in clinical development.

All five of these projects are differentiable from the older Remodulin and have long patent life.

In addition, we can also triple our business by gaining approval for Tyvaso into new markets interstitial lung disease and C O PD.

Martine A. Rothblatt: In addition, we can also triple our business by gaining approval for Tyvaso in two new markets, interstitial lung disease and COPD, as well as expanding it in all of its existing markets with novel inhalation technologies. The market for new Tyvasa technology in clinical development is currently even larger than the World Health Organization Group 1 pulmonary hypertension market that it currently leads. The new markets in clinical development are interstitial lung disease, pulmonary fibrosis, and COPD. All of these are known as World Health Organization Group 3 pulmonary hypertension.

As well as expanding it in all of its existing markets with novel inhalation technologies.

The market for our new Tyvaso technology.

In clinical development currently it's even larger than the World Health organization group, one pulmonary hypertension market that currently leads.

The new markets and clinical development, our interstitial lung disease pulmonary fibrosis and C O PD.

All of these are known as World Health organization group three pulmonary hypertension.

Third we also expect to triple our business by growing orenitram into comparability with Uptravi. Thanks to a much stronger new label, New indications in World Health organization group two pulmonary hypertension.

Martine A. Rothblatt: Third, we also expect to triple our business by growing Arenatram into comparableity with Optravi, thanks to a much stronger new label, new indications in World Health Organization Group 2 pulmonary hypertension, and new once-daily formulations. I'm also excited about our pharmacogenomic labeling initiative, which could target our drugs to those patients most likely to benefit from them. And finally, in addition to these multiple shots at business tripling, we have a longer-term pipeline of multiple new chemical entities, oncology initiatives, and organ manufacturing products. These new chemical entities, or NCEs, include RolenaPEG and our SAFIRE gene therapy, both now in Phase III trials for Group I pulmonary hypertension. They also include FM 4646 for pulmonary fibrosis and exosomes for bronchopulmonary dysplasia, which is now cleared to commence human testing.

Martine: Third, we also expect to triple our business by growing Orenitram into comparability with Uptravi, thanks to a much stronger new label, new indications in World Health Organization Group 2 pulmonary hypertension, and new once-daily formulations. I'm also excited about our pharmacogenomic labeling initiative, which could target our drugs to those patients most likely to benefit from them. Finally, in addition to these multiple shots at business tripling, we have a longer-term pipeline of multiple new chemical entities, oncology initiatives, and organ manufacturing products. These new chemical entities, or NCEs, include ralinepag and our SAPPHIRE gene therapy, both now in phase 3 trials for Group 1 pulmonary hypertension. They also include SM04646 for pulmonary fibrosis and exosomes for bronchopulmonary dysplasia, now cleared to commence human testing.

Martine Rothblatt: Third, we also expect to triple our business by growing Orenitram into comparability with Uptravi, thanks to a much stronger new label, new indications in World Health Organization Group 2 pulmonary hypertension, and new once-daily formulations. I'm also excited about our pharmacogenomic labeling initiative, which could target our drugs to those patients most likely to benefit from them. Finally, in addition to these multiple shots at business tripling, we have a longer-term pipeline of multiple new chemical entities, oncology initiatives, and organ manufacturing products. These new chemical entities, or NCEs, include ralinepag and our SAPPHIRE gene therapy, both now in phase 3 trials for Group 1 pulmonary hypertension. They also include SM04646 for pulmonary fibrosis and exosomes for bronchopulmonary dysplasia, now cleared to commence human testing.

And new once daily formulations.

I'm also excited about our Pharmacogenomic labeling initiative, which could target hard drugs to those patients most likely to benefit from them.

Finally in addition to these multiple shots AD business tripling, we have a longer term pipeline of multiple new chemical entities.

Oncology initiatives and orphan manufacturing products.

These new chemical entities, our NC ease include relented pag and our Sapphire gene therapy, both now in phase III trials for Groupon pulmonary hypertension.

They also include FM 40, 646 for pulmonary fibrosis, and Exosomes for Bronco pulmonary dysplasia now clear to commence human testing.

The oncology initiatives include a humanized form of our Unituxin drug that is saving many children's lives from neuroblastoma today, and our lung cancer phase three trial due to Unblind later this year.

Martine: The oncology initiatives include the humanized form of our Unituxin drug that is saving many children's lives from neuroblastoma today and our lung cancer phase 3 trial due to unblind later this year. We also have 4 different kinds of organ manufacturing products in clinical and preclinical development. Hopefully, our XenoKidney product will be able to transform the lives of over 100,000 people suffering on dialysis today. Based on this review of our current quarter and the exciting growth prospects that we have for tripling the business over the next few years, I'd like to now open the lines for any questions that could be directed to myself, Mr. Edgemond, or Mr. Benkowitz. Operator, could you please open the lines?

Martine Rothblatt: The oncology initiatives include the humanized form of our Unituxin drug that is saving many children's lives from neuroblastoma today and our lung cancer phase 3 trial due to unblind later this year. We also have 4 different kinds of organ manufacturing products in clinical and preclinical development. Hopefully, our XenoKidney product will be able to transform the lives of over 100,000 people suffering on dialysis today. Based on this review of our current quarter and the exciting growth prospects that we have for tripling the business over the next few years, I'd like to now open the lines for any questions that could be directed to myself, Mr. Edgemond, or Mr. Benkowitz. Operator, could you please open the lines?

Martine A. Rothblatt: The oncology initiatives include a humanized form of our unitoxin drug that is saving many children's lives from neuroblastoma today, and our lung cancer phase three trial due to start later this year. We also have four different kinds of organ manufacturing products in clinical and preclinical development. Hopefully, our xenokidney product will be able to transform the lives of over 100,000 people suffering on dialysis today. Based on this review of our current quarter and the exciting growth prospects that we have for tripling the business over the next few years, I'd like to now open the lines for any questions that could be directed to myself, Mr. Edgemond, or Mr. Benkowitz. Operator, could you please open the lines?

We also have four different kinds of Oregon manufacturing products in clinical and preclinical development.

Hopefully our xeno kidney product, we'll be able to transform the lives of over 100000 people suffering on dialysis today.

Based on this review of our current corridor and the exciting growth prospects that we have for tripling the business over the next few years I'd like to now open the lines for any questions that can be directed to myself. Mr. Edgemond are mr. banquets, operator could you. Please open the lines.

Thank you ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone telephone.

Operator: Thank you, ladies and gentlemen. If you have a question at this time, please press star, then the number one on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. To prevent any background noise, we ask that you please place your line on mute once your question has been stated. Our first question comes from the line of Hartaj Singh with Oppenheimer & Company. Your line is open, please go ahead.

Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press star then the 1 on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. To prevent any background noise, we ask that you please place your line on mute once your question has been stated. Our first question comes from the line of Hartaj Singh with Oppenheimer & Company. Your line is open. Please go ahead.

If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

To prevent any background noise, we ask that you. Please place your line on mute. Once your question has been stated.

Our first question comes from the line of our Taposh thing with Oppenheimer and company. Your line is open. Please go ahead.

Great. Thank you for the questions 14.

Hartaj Singh: Great. Thank you for the questions, Martine. I have a question, I apologize. The main question is about remodeling. I know that you've indicated today on the call and recently that, you know, you're not really seeing any change in patient patterns in the United States. I think you mentioned in the press release that there are some changes outside the US. Could you just give some more color on the domestic versus the international patterns now that, you know, there are generics? And then how do you sort of foresee progression, you know, for remodeling through the rest of the year? Is it still sort of historical, kind of getting stronger through the rest of the year? Thank you very much.

Hartaj Singh: Great. Thank you for the questions, Martine. A question. I apologize. The main question is on Remodulin. I know that you've indicated, or today on the call and recently, that you're not really seeing any change in patient patterns in the United States. I think you mentioned in the press release that there are some changes ex US. Could you just give some more color on the domestic versus the international patterns now that there are generics? How do you sort of foresee progression for Remodulin through the rest of the year? Is it still sort of historical kind of getting stronger through the rest of the year? Thank you very much.

A question I apologize the big question is on Remodulin I know that you indicated or today on the call and recently that you know you're not really seeing any.

Change in patient patterns in the United States.

I think you mentioned in the press release that there are some changes ex us could you just give some more color on the domestic versus the international patterns. Now that you know they are generics and then how do you sort of course see progression you to for Remodulin through the rest of the year as it builds from a historical kind of getting stronger through the rest of the year. Thank you very much.

Our target. Thank you so much for the question and good to hear your voice. This morning, I'd like to Mike Banquets, Our president is in charge of all commercialization activities at United Therapeutics, So I'd like to ask Mike. If you could please respond to your question Mike.

Martine A. Rothblatt: Hartaj, thank you so much for the question, and good to hear your voice this morning. I'd like to, Mike Benkowitz, our president, is in charge of all commercialization activities at United Therapeutics, so I'd like to ask Mike if he could please respond to your question. Mike?

Martine: Hartaj, thank you so much for the question. Good to hear your voice this morning. Mike Benkowitz, our President, is in charge of all commercialization activities at United Therapeutics. I'd like to ask Mike if he could please respond to your question. Mike?

Martine Rothblatt: Hartaj, thank you so much for the question. Good to hear your voice this morning. Mike Benkowitz, our President, is in charge of all commercialization activities at United Therapeutics. I'd like to ask Mike if he could please respond to your question. Mike?

Sure. Thanks, Martine Thanks archives.

Mike Benkowitz: Sure. Thanks, Martine. Thanks, Hartaj. Yeah. We're pleased to see that despite competing with generic in the US and to a lesser extent in the EU for a full quarter now, the patient demand metrics for Remodulin remain consistently strong. This is certainly evidenced by looking at quarter-over-quarter revenues. In the US, for instance, US Remodulin starts in Q2 were higher than in any quarter in almost 10 years. Our active patients in this quarter compared to Q2 of last year are up. Our dispenses of branded Remodulin across both the high and low concentrations are higher in Q2 this year versus Q2 of last year.

Michael I. Benkowitz: Sure. Thanks, Martine. Thanks, Hartaj.

Yes, so we're pleased to see that despite competing with generic.

Michael I. Benkowitz: So we're pleased to see that despite competing with generics in the U.S. and to a lesser extent in the EU for a full quarter now, the patient demand metrics for remodulin remain consistently strong, and this is certainly evidenced by looking at quarter-over-quarter revenues. In the U.S., for instance, U.S. remodulin starts in Q2 were higher than in any quarter in almost 10 years. Our active patients in this quarter, compared to Q2 of last year, are up. Our dispenses of brandy remodulin across both the high and low concentrations were higher in Q2 this year versus Q2 of last year. And on a more qualitative basis, what we're seeing through our conversations with PAH doctors is that they continue to express a preference for brandy remodulin because of many of the things that we've talked about on prior calls, including the established safety profile, the patient support programs, and the So we're pleased to see how this is playing out. A similar story with a couple differences in the EU.

In the U.S. and to a lesser extent in the EU for four quarters now.

The patient demand metrics for Remodulin remain consistently strong.

Certainly evidenced by looking at quarter over quarter revenues.

Any you asked for instance, U.S. Remodulin starts in Q2.

Were higher than any quarter in almost 10 years.

Our active patients in this quarter compared to Q2 of last year our.

Our up.

Our dispensers, a branded remodulin across both the high and low concentrations are higher in Q2, this year versus Q2 of last year and.

You know mark more qualitative basis, what we're seen through our conversations with with ph doctors as they continue to express a preference for a brand to remodulin because of many of the things that we've talked about on prior calls including in the established safety profile the patient support programs and the development projects, we have underway that martine touched on.

Mike Benkowitz: On a more qualitative basis, what we're seeing through our conversations with PAH doctors is they continue to express a preference for branded Remodulin because of many of the things that we've talked about on prior calls, including the established safety profile, the patient support programs, and the development projects we have underway that Martine touched on, to continue to have Remodulin be a differentiated product and a more convenient product for patients. We're pleased to see how this is playing out. Similar story with a couple of differences in the EU. Demand remains quite strong for Remodulin. I think in terms of generic competition, it's still limited at this point. Really, the only country to launch is Austria, to a lesser extent than Germany. That may or may not pick up as we move later into the second half of the year.

To continue to have a module I'd be a differentiated product in a more convenient product for.

For patients so.

Yes, we're pleased to see how this is playing out.

Similar story.

With a couple of differences in the E U.

Demand remains quite strong for Remodulin I think in terms of generic competition, where it's still limited at this point really the only country to launch as Austria to a lesser extent and Germany.

Michael I. Benkowitz: Brandy Remodulin remains quite strong for remodulin. I think in terms of generic competition, it's still limited at this point. Really, the only country to launch is Austria to a lesser extent than Germany. That may or may not pick up as we move later into the second half of the year. But as it stands right now, there is limited competition and limited generic competition in the EU. So we continue to remain very bullish and very confident in the benefits of brandy remodulin as we move into the second half of the year and beyond for the reasons I just outlined.

That may or may not pick up as we move later into the move into the second half of the year, but.

As it stands right now there's there's limited competition.

Mike Benkowitz: As it stands right now, there's limited generic competition in the EU. We continue to remain very bullish and very confident in the benefits of branded Remodulin as we move into the second half of the year and beyond for the reasons I just outlined.

And when the generic competition and you. So we continue to remain very very bullish and very confident and the benefits of branded remodulin as we move into the second half of the year and beyond for.

For the reasons I just outlined.

Thanks, so much Mike.

Martine A. Rothblatt: Thanks so much, Mike. Thank you, Hartaj. Operator, could you offer up the next question?

Martine: Thanks so much, Mike. Thank you, Hartaj. Operator, could you offer up the next question?

Hartaj Singh: Thanks so much, Mike.

Thank you heart Taj operator could you offer up the next question.

Martine Rothblatt: Thank you, Hartaj. Operator, could you offer up the next question?

Our next question comes from the line of Jeff.

Operator: Our next question comes from the line of Jessica Fye with J.P. Morgan. Your line is open.

With JP Morgan your line is open.

Great. Good morning, Thanks for taking my question.

Jessica Fye: Great, good morning. Thanks for taking my question. Martine, I'm curious how you think about capital deployment these days. Is there any current priority around share repurchase with your stock at these levels, or is your focus more on business development to expand and diversify the long-term portfolio?

Operator: Great. Good morning. Thanks for taking my question. Martine, I'm curious how you think about capital deployment these days. Is there any current priority around share repurchase with your stock at these levels, or is your focus more on business development to expand and diversify the long-term portfolio?

Jessica Fye: Great. Good morning. Thanks for taking my question. Martine, I'm curious how you think about capital deployment these days. Is there any current priority around share repurchase with your stock at these levels, or is your focus more on business development to expand and diversify the long-term portfolio?

Martine I'm curious, how you think about capital deployment these days.

Is there any current priority around share repurchase with your stock at these levels or is your focus more on business development to expand and diversify the long term portfolio.

Thanks, Jessica for the question, we've got on the line with US James Edgemond, Our Chief Financial Officer, who oversees all those capital deployment types of questions. So James could you respond to just because call.

Martine A. Rothblatt: Thanks Jessica for the question. We've got on the line with us James Edgemond, the Chief Financial Officer who oversees all those capital deployment types of questions. So James, could you respond to Jessica's call?

Martine: Thanks, Jessica, for the question. We've got on the line with us James Edgemond, our Chief Financial Officer, who oversees all those capital deployment types of questions. James, could you respond to Jessica's call?

Martine Rothblatt: Thanks, Jessica, for the question. We've got on the line with us James Edgemond, our Chief Financial Officer, who oversees all those capital deployment types of questions. James, could you respond to Jessica's call?

Your first question, Yes sure thing.

James C. Edgemond: Sure, thanks. Thanks, and Jess, good morning, and thanks for the question.

Mike Benkowitz: Sure. Thanks, Martine.

James Edgemond: Sure. Thanks, Martine.

Martine: Jessica's question?

Martine Rothblatt: Jessica's question?

Mike Benkowitz: Sure. Thanks. Thanks. Jess, good morning. Thanks for the question. Thinking about our capital allocation priorities, they remain fairly consistent and unchanged as to what we've outlined historically. They do include share repurchase, but it is still the third kind of leg for us. Our first priority is still investing in research and development opportunities that we want to support our business mission with. Second is investing in value-creating business development activities. Third is share repurchase. Those capital allocation priorities remain consistent. With respect to investing in our R&D budgets, our first capital allocation priority, one thing to keep in mind, which is consistent with our prior discussions, is around our annual expense budget algorithm, which we've consistently applied, which will not allow us to exceed really 50% of our prior year revenue.

James Edgemond: Sure. Thanks. Thanks. Jess, good morning. Thanks for the question. Thinking about our capital allocation priorities, they remain fairly consistent and unchanged as to what we've outlined historically. They do include share repurchase, but it is still the third kind of leg for us. Our first priority is still investing in research and development opportunities that we want to support our business mission with. Second is investing in value-creating business development activities. Third is share repurchase. Those capital allocation priorities remain consistent. With respect to investing in our R&D budgets, our first capital allocation priority, one thing to keep in mind, which is consistent with our prior discussions, is around our annual expense budget algorithm, which we've consistently applied, which will not allow us to exceed really 50% of our prior year revenue.

Thanks, and Jeff Good morning, and thanks for the question.

It thinking about our capital allocation priorities they may they remain.

James C. Edgemond: Thinking about our capital allocation priorities, they remain fairly consistent and unchanged as to what we've outlined historically. They do include share repurchase, but it is still the third kind of leg for us. Our first priority is still investing in research and development opportunities that we want to support our business mission with. Business Development Activities, and third is share repurchase. So those capital allocation priorities remain consistent. And with respect to investing in our R&D budgets, our first capital allocation priority, one thing to keep in mind which is consistent with our prior discussions is around our annual expense budget algorithm, which we've consistently applied, which will not allow us to exceed really 50% of our prior year revenue. And this methodology forces us to continuously evaluate each of our research and development opportunities on a really ongoing basis.

Fairly consistent and unchanged as to what we've outlined historically they do include share repurchase but it is still the third kind of leg for us. Our first priority is still investing in research and development opportunities.

That we want to support our business mission with.

Second is investing in value creating.

Business development activities and third is share repurchase so those capital allocation priorities remain consistent and with respect to investing in our R&D budgets, our first capital allocation priority.

One thing to keep in mind, which is consistent with our prior discussions is around our annual expense budget algorithm.

Which we've consistently applied.

Which will not allow us to exceed really 50% of our prior year revenue and this methodology forces us to continually continuously evaluate each of our research and development opportunities on a really an ongoing basis.

Mike Benkowitz: This methodology forces us to continuously evaluate each of our research and development opportunities on really an ongoing basis. When you get into the second capital allocation priorities with respect to M&A, we continue to place an emphasis on the strategic impact of targets in terms of the attractiveness of the therapeutic area, opportunity for near-term revenues, and really the incremental value that could be added by adding UT among other filters. These include therapeutic areas like cardiology, pulmonology, and oncology, although we're not just limited to these areas. Again, I just wanted to give you, in addition to share repurchase, how we continue to think about capital allocation. Thanks for the question.

James Edgemond: This methodology forces us to continuously evaluate each of our research and development opportunities on really an ongoing basis. When you get into the second capital allocation priorities with respect to M&A, we continue to place an emphasis on the strategic impact of targets in terms of the attractiveness of the therapeutic area, opportunity for near-term revenues, and really the incremental value that could be added by adding UT among other filters. These include therapeutic areas like cardiology, pulmonology, and oncology, although we're not just limited to these areas. Again, I just wanted to give you, in addition to share repurchase, how we continue to think about capital allocation. Thanks for the question.

When you get into the second capital allocation priorities with respect to M&A.

James C. Edgemond: When you get into the second capital allocation priority with respect to M&A, we continue to place an emphasis on the strategic impact of targets in terms of the attractiveness of the therapeutic area, the opportunity for near-term revenues, and really the incremental value that could be added by adding UT or by UT, among other filters, and these include therapeutic areas like cardiology, pulmonology, and oncology, although we're not just limited to these areas. So again, I just wanted to give you, in addition to the shares we've purchased, how we continue to think about capital allocation. So, thanks for the question.

We continue to place an emphasis on the strategic impact of targets in terms of the attractiveness of the therapeutic area.

Opportunity for near term revenues.

And really the incremental value that could be added by adding new T added by UTI. Among other filters and these include therapeutic areas like cardiology, pulmonology and oncology or that we're not just limited to these areas.

So again I just wanted to give you. An addition to share repurchase how we continue to think about capital allocation. So thanks for the question.

James Thanks for excellent answer operator next question. Please.

Martine A. Rothblatt: James, thanks for an excellent answer. Operator, next question, please.

Martine: James, thanks for your excellent answer. Operator, next question, please.

Martine Rothblatt: James, thanks for your excellent answer. Operator, next question, please.

Our next question comes from the line.

Operator: Our next question comes from the line of Leanne Mousentos with Wetbush Securities. Your line is open. Please go ahead.

Operator: Our next question comes from the line of Liana Moussatos with Wedbush Securities. Your line is open. Please go ahead.

With Wedbush Securities. Your line is open. Please go ahead.

Thank you for taking my question could you give us a little more detail on the status of the transplant organs program that you mentioned the Xeno, but also three d. and other approaches.

Liana Moussatos: Thank you for taking my question. Could you give us a little more detail on the status of the transplant organs program? You mentioned the Xeno, but also 3D and other approaches.

Leanne Mousentos: Thank you for taking my question. Could you give us a little more detail on the status of the transplant organs program? You mentioned Zeno, but also 3D and other approaches.

Yes. Thank you for your question.

Martine A. Rothblatt: Yes, Leanna, thank you for your question. We have several different approaches that we are using in our organ manufacturing project. And they run the range from taking organs that are donated after a person's suffering brain death but are deemed to be unusable for transplantation and would always be thrown away. Now, we have technology that is able to restore these organs back to transplantability and then send them on to the transplant center anywhere in the country to be transplanted. So that technology, generically known as eVLP, and it's routinely resulted in saving the lives of people.

Martine: Yes, Leanne. Thank you for your question. We have several different approaches that we are doing in our organ manufacturing project. They run the range from taking organs that are donated after a person's suffering brain death but are deemed to be unusable for transplantation and would always be thrown away. We have a technology that is able to restore these organs back to transplantability and then send them on to the transplant center anywhere in the country to be transplanted. That technology generically is known as EVLP, and it's routinely resulting in saving the lives of people. In fact, just last week, there was a widely reported news story of a young lady cystic fibrosis sufferer who was the sickest person on the nationwide transplant list, meaning that she was basically in as bad shape as could be.

Martine Rothblatt: Yes, Leanne. Thank you for your question. We have several different approaches that we are doing in our organ manufacturing project. They run the range from taking organs that are donated after a person's suffering brain death but are deemed to be unusable for transplantation and would always be thrown away. We have a technology that is able to restore these organs back to transplantability and then send them on to the transplant center anywhere in the country to be transplanted. That technology generically is known as EVLP, and it's routinely resulting in saving the lives of people. In fact, just last week, there was a widely reported news story of a young lady cystic fibrosis sufferer who was the sickest person on the nationwide transplant list, meaning that she was basically in as bad shape as could be.

So we have several different approaches that we are doing in our Oregon manufacturing project.

And they run the range from taking organs that on a donated.

Home after a person's suffering brain death.

But are deemed to be unusable for transplantation and wood.

Always be thrown away and we have a technology that is able to restore peace oregons.

Back to transplant ability.

And Dan.

Send them on to the transplant center.

Anywhere in the country to be transplanted.

So that technology generically is known as LP and its routinely resulting in saving the lives of people.

In fact, just last week there was a widely reported new story.

Martine A. Rothblatt: In fact, just last week, there was a widely reported news story of a young lady, a cystic fibrosis sufferer, who was the sickest person on the nationwide transplant list, meaning that she was basically in as bad shape as could be. Had the individual had to wait for some ideal lungs, who knows what would have happened, but she had a very successful transplant with lungs that were otherwise would have been discarded but were sent to our In fact, just next month, we'll be opening up our second lung restoration center in partnership with the Mayo Clinic, so that will be an exciting event toward the end of August.

From a young Lady cystic fibrosis.

Suffer.

Who.

What's the sickest person on the nationwide transplant list, meaning that.

She was fine basically as bad shape as could be.

Had the individual had to wait for like some ideal lungs.

Martine: The individual had to wait for some ideal lungs. Who knows what would have happened? She had a very successful transplant with lungs that otherwise would have been discarded but were sent to our Silverspring, Maryland, facility, were restored to transplantability, and then were flown on to her hospital in Virginia with a successful outcome. In fact, just next month, we'll be opening up our second set lung restoration center in partnership with the Mayo Clinic. That will be an exciting event toward the end of August. In addition to that, we have an active xenotransplantation program. That's the transplantation of genetically modified pig organs into people once the genetic modifications have been shown to reduce risks of rejection to such a level that they really are no different than an allograft transplant.

Martine Rothblatt: The individual had to wait for some ideal lungs. Who knows what would have happened? She had a very successful transplant with lungs that otherwise would have been discarded but were sent to our Silverspring, Maryland, facility, were restored to transplantability, and then were flown on to her hospital in Virginia with a successful outcome. In fact, just next month, we'll be opening up our second set lung restoration center in partnership with the Mayo Clinic. That will be an exciting event toward the end of August. In addition to that, we have an active xenotransplantation program. That's the transplantation of genetically modified pig organs into people once the genetic modifications have been shown to reduce risks of rejection to such a level that they really are no different than an allograft transplant.

Who knows what would have happened, but she had a very successful trans Pac. Thanks lung sets were otherwise would have been discarded were sent to our silver spring, Maryland facility were.

Restored to transplant stability and then we're flowing onto her hospital in Virginia.

With the successful outcome.

In fact, just next month, we'll be opening up our second south.

Lung restoration center.

In partnership with the Mayo clinic, so that will be and exciting event.

Towards the end of August .

In addition to that we have a active xeno transplantation program.

Martine A. Rothblatt: In addition to that, we have an active xenotransplantation program, that is, the transplantation of genetically modified pig organs into people once the genetic modifications have been shown to reduce risks of rejection to such a level that they really are no different than an allograft transplant. In the Xeno program, we're focusing, as I mentioned in my introductory remarks, on the XenoKidney, which has a very large standby demand of over 100,000 people and has also a more graceful, I think, commercialization pathway because, should there be a problem with the xenograft, there's a ready step back to dialysis. So, the Xeno program is focused on the kidney. The most exciting news flow, I think, associated with that is that in the coming year, Leanna will be opening up two, what are called designated pathogen-free facilities for the XenoKidneys. It's the equivalent in the drug business of what you would call a GMP or a GTP facility. In other words, a facility from which the outcome is deemed; the output is deemed safe by the FDA to put into a person.

That's the transplantation of genetically modified pig organs.

Into people once the genetic modifications have been shown to reduce.

Our risks of rejection to such a level that they really are no different than an allograft transplant.

Indeed, Xeno program, we're focusing as I mentioned in my introductory remarks on the Xeno kidney of which has a very large standby demand of over 100000 people.

Martine: In the Xeno program, we're focusing, as I mentioned in my introductory remarks, on the XenoKidney, which has a very large standby demand of over 100,000 people and has also a more graceful, I think, commercialization pathway because should there be a problem with the xenograft, there's already a step back to dialysis. The Xeno program is focused on the kidney. The most exciting news flow, I think, associated with that is that in the coming year, Leanne, we'll be opening up two, what are called, designated pathogen-free facilities for the XenoKidneys. It's the equivalent in the drug business of what you would call a GMP or a GTP facility. In other words, a facility from which the output is deemed safe by the FDA to put into a person.

Martine Rothblatt: In the Xeno program, we're focusing, as I mentioned in my introductory remarks, on the XenoKidney, which has a very large standby demand of over 100,000 people and has also a more graceful, I think, commercialization pathway because should there be a problem with the xenograft, there's already a step back to dialysis. The Xeno program is focused on the kidney. The most exciting news flow, I think, associated with that is that in the coming year, Leanne, we'll be opening up two, what are called, designated pathogen-free facilities for the XenoKidneys. It's the equivalent in the drug business of what you would call a GMP or a GTP facility. In other words, a facility from which the output is deemed safe by the FDA to put into a person.

And has also a more graceful I think.

Commercialization pathway, because should there be a problem with the xeno craft theres, a ready step back to dialysis. So the Xeno program is is focused on the kidney.

Big most exciting news flow I think associated with that is that in the coming year Leanna will be.

Opening up too.

Hi, what are called dense ignite designated pathogen free facilities for the Xeno kidneys. It's it's the equivalent in the drug business of what you would call a GMP or a GTP.

Facility and other words of facility from which the outcome is deemed the output is deemed safe by the FDA to put into a person. So we'll have to independent.

Martine: We'll have 2 independent facilities operating in 2020 from which we can transplant the output into people, subject, of course, to FDA satisfaction with the results in earlier NHP studies, non-human primate studies. Third, we have an active program in which we create scaffolds of organs, especially the lung, which can then be cellularized for transplantation. The cellularization can be done in 1 of 2 ways. We can allogenically cellularize the scaffolds using purchased cell lines from companies such as Lonza, which we then greatly expand. We've established cell expansion as, I think, a real nice core competency at United Therapeutics. This year, we will expand our cell populations to over 1 trillion cells will be manufactured at UT. That's really remarkable. A given organ such as a heart or a lung or a kidney needs somewhere between 5 and 10 billion cells.

Martine A. Rothblatt: So, we'll have two independent facilities operating in 2020 from which we can transplant the output into people, subject, of course, to FDA satisfaction with the results in earlier NHP studies, non-human primate studies. Third, we have an active program in which we create scaffolds of organs, especially the lung, which can then be cellularized for transplantation. And the cellularization can be done in one of two ways.

Martine Rothblatt: We'll have 2 independent facilities operating in 2020 from which we can transplant the output into people, subject, of course, to FDA satisfaction with the results in earlier NHP studies, non-human primate studies. Third, we have an active program in which we create scaffolds of organs, especially the lung, which can then be cellularized for transplantation. The cellularization can be done in 1 of 2 ways. We can allogenically cellularize the scaffolds using purchased cell lines from companies such as Lonza, which we then greatly expand. We've established cell expansion as, I think, a real nice core competency at United Therapeutics. This year, we will expand our cell populations to over 1 trillion cells will be manufactured at UT. That's really remarkable. A given organ such as a heart or a lung or a kidney needs somewhere between 5 and 10 billion cells.

Facilities operating in 2020.

From which we can transplant the output into people.

Subject of course to FDA satisfaction with the results seen in earlier.

NHP studies non human Primate studies.

Third we have an active program in which we create scaffolds of Orkins.

Especially the lung, which can then be cellular rise to four transplantation.

And the fair realization can be done in one of two ways we can.

Allogenic lease cyber rise the scaffolds.

Martine A. Rothblatt: We can allogenically cellularize the scaffolds using purchase cell lines from companies such as Lonza, which we then greatly expand. We've established cell expansion as, I think, a really nice core competency at United Therapeutics. This year, we will expand our cell populations to over a trillion cells will be manufactured at UT. That's really remarkable.

Using purchase cell lines from companies such as long term.

Which we then greatly expand how we've created we've established cell expansion as I think a real nice core competency at United Therapeutics.

This year, we will we will expand our cell populations too.

Over a trillion sales will be manufactured at UTI, Thats, thats really remarkable or give an orphan.

Martine A. Rothblatt: A given organ, such as a heart or a lung or a kidney, needs somewhere between five and ten billion cells. So you can see by being able to expand our cells and have them healthy at numbers of over a trillion, we really have demonstrated scale-up capability for commercialization. We're also working on applying that scale-up capability that we have at United Therapeutics to an individual's own iPSC cells, which have been re-differentiated back into different types of cell lines. The beauty about cellularizing these scaffolds with an individual's own cells is that they'll require no immunosuppression after the organ is transplanted back to them. They will have literally grown their own replacement organ. So that gives you a kind of a flyover of the exciting different types of organ manufacturing activities going on at UT. Thanks for the question, Liana. Operator, can you queue up the next question, please?

Such as a heart or lung, we're kidney need somewhere between five and 10 billion cells. So you can see by being able to.

Martine: You can see by being able to expand our cells and have them healthy at the numbers of over 1 trillion, we really have demonstrated scale-up capability for commercialization. We're also working on applying that scale-up competency that we have at United Therapeutics to an individual's own iPSC cells, which have been redifferentiated back into endothelial, epithelial, mesenchymal, etc., different types of cell lines. The beauty about cellularizing these scaffolds with an individual's own cells is that they'll require no immunosuppression after the organ is transplanted back to them. They will have literally grown their own replacement organ. That gives you a kind of a flyover of the exciting different types of organ manufacturing activities going on at UT. Thanks for the question, Liana. Operator, can you queue up the next question, please?

Martine Rothblatt: You can see by being able to expand our cells and have them healthy at the numbers of over 1 trillion, we really have demonstrated scale-up capability for commercialization. We're also working on applying that scale-up competency that we have at United Therapeutics to an individual's own iPSC cells, which have been redifferentiated back into endothelial, epithelial, mesenchymal, etc., different types of cell lines. The beauty about cellularizing these scaffolds with an individual's own cells is that they'll require no immunosuppression after the organ is transplanted back to them. They will have literally grown their own replacement organ. That gives you a kind of a flyover of the exciting different types of organ manufacturing activities going on at UT. Thanks for the question, Liana. Operator, can you queue up the next question, please?

Expand ourselves and have them healthy at the numbers of over a trillion, we really have demonstrated to scale up capability for commercialization.

We're also working on applying that scale up competencies that we have at United Therapeutics.

Two and individuals own IP SC cells, which have been.

Read differentiated back into and the CTO at the field investment time et cetera different types of cell lines. The beauty about cellular I think the scaffolds, what's an individual's own cells is filled require no immunosuppression. After the orkin is transplanted back to them. They will have literally grown their own replacement orkin.

So that gives you a kind of fly over of the exciting different types of organ manufacturing activities going on acuity. Thanks for the question Leon Leon.

Operator can you keep up the next question. Please.

Our next question comes from the line of Chris.

Operator: Our next question comes from the line of Krish Bhutani with Cowan. Your line is open. Please go ahead.

Operator: Our next question comes from the line of Chris Shibutani with Cowen. Your line is open. Please go ahead.

So Tammy with Cowen Your line is open. Please go ahead.

Thank you good morning, Martina and team I wanted to ask a question about rolling it pag in that program.

Krish Bhutani: Thank you. Good morning Martine and team.

Chris Shibutani: Thank you. Good morning, Martine and team. I wanted to ask a question about ralinepag and that program. Can you confirm for us whether the plans and the timelines, as communicated by Arena prior to your acquisition of this program, are the same and if those programs are on track? In particular, for one of the studies, which involves transitioning patients over, can you talk about what you guys feel is the most important endpoint in order to compel clinicians to think that ralinepag is a drug worth switching patients over to or to be competitive? Thank you.

Martine A. Rothblatt: I wanted to ask a question about Relinipeg and that program. Can you confirm for us whether the plans and the timelines as communicated by ARENA prior to your acquisition of this program are the same, and if those programs are on track? And in particular for one of the studies which involves transitioning patients over, can you talk about what you guys feel is the most important endpoint in order to compel clinicians to think that Relinipeg is a drug worth switching patients over to or to be competitive? Thank you.

Can you confirm for us whether the plans and the timelines as communicated.

By arena prior to your.

Acquisition of this program are the same and if those programs are on track and in particular for one of the studies, which involves transitioning patients over.

Can you talk about what you guys feel.

Is the most important endpoint in order to compel.

Clinicians to think that drilling a pad is a drug switching patients over two or can be competitive. Thank you.

Yeah, I'd say, it's a very good in the air detailed question thanks for asking it.

Martine A. Rothblatt: Yeah, it's a very good and detailed question. Thanks for asking it.

Martine: Yeah. I'd say it's a very good and detailed question. Thanks for asking it. Generally speaking, I can't really remember or even know everything that Arena said, but the program is on schedule. It's doing well. It's enrolling patients. When we took over the patient from the program from Arena, there actually were no Phase 3 patients yet enrolled. Now we're actively enrolling. It's the top Phase 3 trial on which we are spending money. The program's being enrolled as quickly as we can, consistent with, of course, good clinical practices and all that sort of stuff. In terms of whether or not the results will persuade physicians to prescribe ralinepag in lieu of, say, Uptravi, I think we have to wait until the results are out. Certainly, from the Phase 2 data, there were compelling indications that ralinepag was the best-in-class drug compared to Uptravi.

Martine Rothblatt: Yeah. I'd say it's a very good and detailed question. Thanks for asking it. Generally speaking, I can't really remember or even know everything that Arena said, but the program is on schedule. It's doing well. It's enrolling patients. When we took over the patient from the program from Arena, there actually were no Phase 3 patients yet enrolled. Now we're actively enrolling. It's the top Phase 3 trial on which we are spending money. The program's being enrolled as quickly as we can, consistent with, of course, good clinical practices and all that sort of stuff. In terms of whether or not the results will persuade physicians to prescribe ralinepag in lieu of, say, Uptravi, I think we have to wait until the results are out. Certainly, from the Phase 2 data, there were compelling indications that ralinepag was the best-in-class drug compared to Uptravi.

So generally speaking I can't really.

Martine A. Rothblatt: So generally speaking, I can't really, you know, remember or even know everything that ARENA said, but the program is on schedule, it's doing well, and it's enrolling patients. When we took over the program from ARENA, there actually were no Phase III patients yet enrolled, so now we're actively enrolling. It's the top Phase III trial on which we are spending money, and so, you know, the program is being enrolled as quickly as we can, consistent with, of course, good clinical practices and all that sort of stuff. In terms of whether or not the results will persuade physicians to prescribe Volenopeg in lieu of, say, Optravi, I think we have to wait until the results are out. Certainly, from the phase two data, there were, you know, compelling indications that Volenopeg was the best-in-class drug compared to Optravi.

Remember, even though everything debt arena said, but the the program is on schedule, it's doing well, it's enrolling patients when we took over the patient from the program from arena.

They are actually were no phase three patients enrolled so now we are actively enrolling it's the top phase three trial on which we are spending money and.

So the programs being enrolled as quickly as we can consistent with of course, good clinical practices and all that sort of stuff.

In terms of phone whether or not the results will.

Persuade physicians to prescribe dilemma peg in lieu of say Uptravi I think we have to wait until the results are out certainly from the phase two data there were compelling indications that filling a peg was the best in class drug.

Compared to Uptravi, but dose for phase two compelling indications and all of that has to be confirmed in a.

Martine: Those were phase 2, compelling indications, and all of that has to be confirmed in a phase 3 trial. I believe that the trials are sized appropriately to produce some compelling results, and we're certainly hopeful to have those results. We'll just have to wait through the normal couple of years of phase 3 enrollment to have those answers. Thanks for the question. Operator, next question, please.

Martine A. Rothblatt: But those were phase two compelling indications, and all of that has to be confirmed in a phase three trial. So I believe that the trials are sized appropriately to produce some compelling results, and we're certainly hopeful to have those results. But we'll just have to wait through the normal couple years of phase three enrollment to have those answers. Thanks for the question. Operator, next question, please.

Martine Rothblatt: Those were phase 2, compelling indications, and all of that has to be confirmed in a phase 3 trial. I believe that the trials are sized appropriately to produce some compelling results, and we're certainly hopeful to have those results. We'll just have to wait through the normal couple of years of phase 3 enrollment to have those answers. Thanks for the question. Operator, next question, please.

Phase three trial, so I believe that the trials are sized appropriately.

To produce some compelling results and we're certainly hopeful to have those results, but we'll just have to wait through the normal couple of years of phase three enrollment to to have those answers.

Thanks for the question Operator next question please.

And again, ladies and gentlemen, if you do have a question at this time. Please press Star then one on your Touchtone.

Operator: And again, ladies and gentlemen, if you do have a question at this time, please press star and then one on your touchtone telephone. Our next question does come from the line of Martin Oster with Credit Suisse. Your line is open. Please go ahead.

Operator: Again, ladies and gentlemen, if you do have a question at this time, please press star, then one, on your touchstone telephone. Our next question does come from the line of Martin Auster with Credit Suisse. Your line is open. Please go ahead.

Our next question does come from the line of Matt.

I'll start with credit Suisse.

Please go ahead.

Thanks for taking the question I appreciate it.

Martine A. Rothblatt: Thanks for taking the question. Appreciate it. I had a question for you Martine about the litigation between you and Smith against Sandoz and RareGen. I was curious if you could provide us an update on when you expect an initial ruling or potential, I believe you filed for dismissal of that case, and maybe also if you could kind of outline what the next steps would be after the initial rulings are made. Thanks.

Martin Auster: Thanks for taking the question. Appreciate it. I had a question for you, Martine, about the litigation between you and Smith against Sandoz and RareGen. I was curious if you could provide us an update on when you expect an initial ruling or potential, I believe you filed for dismissal of that case. Maybe also if you could kind of outline what next steps would be after the initial rulings are made. Thanks.

My other question for you Martine about the litigation.

Genuine you in Smith.

Against Sandoz and merger I'm, just curious if you could provide us an update on when you expect an initial ruling or potential I believe you filed for for dismissal that case and maybe also if you could kind of outline what next steps would be after the initial rulings or me. Thanks.

Thanks, Marty good to hear your voice this morning.

Martine: Thanks, Marty. Good to hear your voice this morning. Yeah. I'm really glad that I shifted into biotechnology rather than law like some 20-plus years ago because legal proceedings are, by their nature, long. Even though we feel that the RareGen-Sandoz litigation is literally meritless, I cannot really predict the outcome in terms of judges' rulings on particular motions as they'll come up during the course of the proceeding. Litigation, generally speaking, once you're in litigation, one thing that I have seen is that it just drags on and on. I can't really predict how long this one is going to drag on. In terms of the merits of the case, we really feel that the complaint was meritless, and we will continue to defend vigorously and carry on with our business. Thanks for the question, Marty, and good hearing your voice this morning.

Martine Rothblatt: Thanks, Marty. Good to hear your voice this morning. Yeah. I'm really glad that I shifted into biotechnology rather than law like some 20-plus years ago because legal proceedings are, by their nature, long. Even though we feel that the RareGen-Sandoz litigation is literally meritless, I cannot really predict the outcome in terms of judges' rulings on particular motions as they'll come up during the course of the proceeding. Litigation, generally speaking, once you're in litigation, one thing that I have seen is that it just drags on and on. I can't really predict how long this one is going to drag on. In terms of the merits of the case, we really feel that the complaint was meritless, and we will continue to defend vigorously and carry on with our business. Thanks for the question, Marty, and good hearing your voice this morning.

Martine A. Rothblatt: Thanks, Marty. It's good to hear your voice this morning. Yeah, I'm really glad that I shifted into biotechnology rather than law, like, you know, some 20 plus years ago, because legal proceedings are, by their nature, long. So even though we feel that the rare gen Sandoz litigation is literally meritless, I cannot really predict the outcome in terms of judges' rulings on particular motions, as they'll come up during the course of the proceeding. Litigation, you know, generally speaking, once you're in litigation, one thing that I have seen is that it just drags on and on. And I can't really predict how long this one is going to drag on. But in terms of the merits of the case, we really feel that the complaint was meritless.

No I'm really glad that shifted into biotechnology, rather than long haul flights.

Some 20 plus years ago because.

Legal proceedings are by their nature long.

So even though we feel that the.

Rare Gen Sandoz litigation is literally meritless.

I cannot really predict the outcome in terms of.

Judges rulings on particular motions as they'll come up during the course of the proceeding.

Our litigation.

Generally speaking once you're in litigation one thing that I have seen is that you know it just drags on and on and I can't really predict how long. This fund is going to drag on but in terms of the.

The merits of the case, we really feel that the the complaint was meritless and we will continue to defend vigorously and carry on with our business.

Martine A. Rothblatt: And we will continue to defend vigorously and carry on with our business. But thanks for the question, Marty, and good to hear your voice this morning. Next question, operator?

But thanks for the question Marty and good hearing your voice this morning.

Next question operator in there too.

Martine: Next question, operator.

Martine Rothblatt: Next question, operator.

I'm not showing any further questions at this time.

Martin Auster: You too.

Operator: You too?

Operator: I'm not showing any further questions at this time.

Operator: I'm not showing you any further questions at this time.

Excellent well, let me go ahead and give a couple of words of wrap up here.

Martine A. Rothblatt: Excellent. Well, let me go ahead and give a couple of words of wrap-up here.

Martine: Excellent. Well, let me go ahead and give a couple of words of wrap-up here. James and I will be at the Wedbush Securities Conference in New York in August to give a full review of everything that we're doing and answer further questions. In summary, the company's core business, Remodulin, Tyvaso, Orenitram, and Unituxin, which we didn't have too much chance to talk about during this call, is very strong. We now have our first commercialized, FDA-approved organ treatment technology, what I call organ manufacturing technology, known as the XPS system due to our partnership with XVIVO. It's really nice having these five independent, commercialized lines of business. As I mentioned in my opening remarks, certainly the top three of them, Remodulin, Tyvaso, and Orenitram, I feel very confident each can triple our current level of revenues and business.

Martine Rothblatt: Excellent. Well, let me go ahead and give a couple of words of wrap-up here. James and I will be at the Wedbush Securities Conference in New York in August to give a full review of everything that we're doing and answer further questions. In summary, the company's core business, Remodulin, Tyvaso, Orenitram, and Unituxin, which we didn't have too much chance to talk about during this call, is very strong. We now have our first commercialized, FDA-approved organ treatment technology, what I call organ manufacturing technology, known as the XPS system due to our partnership with XVIVO. It's really nice having these five independent, commercialized lines of business. As I mentioned in my opening remarks, certainly the top three of them, Remodulin, Tyvaso, and Orenitram, I feel very confident each can triple our current level of revenues and business.

James and I will be at the Wedbush Securities Conference in New York in August to give a full review.

Martine A. Rothblatt: James and I will be at the Wedbush Securities Conference in New York in August to give a full review of everything that we're doing and answer further questions. But, in summary, the company's core business, Remodulin, Pivaso, Ornatram, Unituxin, which we didn't have too much chance to talk about during this call, is very strong. We now have our first commercialized FDA-approved organ treatment technology, you know, what I call organ manufacturing technology, known as the XPS system due to our partnership with Xvivo. So it's really nice having these five independent commercialized lines of business. And as I mentioned in my opening remarks, certainly the top three of them, Remodulin, Pivaso, and Ornatram, I feel very confident that each can triple our current level of revenues and business.

Of everything that we're doing it and answer further questions.

But in summary, the company's core business Remodulin, Tyvaso, Orenitram, Unituxin, which we didnt have too much chance to talk about during this call.

Is very strong we now have our first commercialized FDA approved Oregon.

The treatment technology, you know what I call can manufacturing technology known as the Xps system due to our partnership with X FIFO. So it's really nice having these five independent commercialize clients for business.

And as I mentioned in my opening remarks.

Certainly the top three of them Remodulin, Tyvaso and Orenitram I feel very confident each can triple our current level of revenues and and business. So we've got by three independent shots on a tripling on a goal of tripling our business from its current level.

Martine A. Rothblatt: So we've got like three independent shots at a goal of tripling our business from its current level. Pending the outcome of the Unituxin lung cancer study, which we call distinct, and we expect to accrue the necessary number of events sometime later this year, that could portend a major expansion of the way we view ourselves at United Therapeutics into much more of an oncology company. And finally, on the organ manufacturing and regenerative medicine front, it's very exciting to have a first technology that's already approved for commercialization by the FDA, as well as to have industry-leading activities going on in all the different types of organ manufacturing that I described in response to Leanna's question. Thank you very much, everybody, for joining our conference call and look forward to seeing as many of you as possible at Wedbush. Operator, you can now wrap up the call.

Martine: We've got 3 independent shots on a goal of tripling our business from its current level. Pending the outcome of the Unituxin lung cancer study, which we call DISTINCT, and we expect to accrue the necessary number of events sometime later this year, that could portend for a major expansion of the way we view ourselves at United Therapeutics into much more of an oncology company. Finally, on the organ manufacturing and regenerative medicine front, it's very exciting to have a first technology that's already approved for commercialization by the FDA as well as having industry-leading activities going on in all the different types of organ manufacturing that I described in response to Liana's question. Thank you very much, everybody, for joining our conference call, and look forward to seeing as many of you as possible at Wedbush. Operator, you can now wrap up the call.

Martine Rothblatt: We've got 3 independent shots on a goal of tripling our business from its current level. Pending the outcome of the Unituxin lung cancer study, which we call DISTINCT, and we expect to accrue the necessary number of events sometime later this year, that could portend for a major expansion of the way we view ourselves at United Therapeutics into much more of an oncology company. Finally, on the organ manufacturing and regenerative medicine front, it's very exciting to have a first technology that's already approved for commercialization by the FDA as well as having industry-leading activities going on in all the different types of organ manufacturing that I described in response to Liana's question. Thank you very much, everybody, for joining our conference call, and look forward to seeing as many of you as possible at Wedbush. Operator, you can now wrap up the call.

Pending the outcome of the.

Unituxin lung cancer study, which we call distinct.

And we expect to accrue the necessary number of events sometime later this year.

That could portend for a major expansion of the way, we view ourselves at United Therapeutics into much more from oncology company and finally on the organ manufacturing of regenerative medicine front, it's very exciting to have a first technology. That's already approved for commercialization by the FDA as well as having industry leading activities going on in all the different types of arc in manufacturing that I described in response to lean on this question.

Thank you very much everybody for joining our conference call and look forward to seeing as many of you as possible at Wedbush Operator, you can now wrap up the call.

Thank you for participating in today's United Therapeutics.

Operator: Thank you for participating in today's United Therapeutics Corporation conference call. Every podcast will be available for replay for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406 and using access code 30660. 89. Thank you, and have a great day.

Operator: Thank you for participating in today's United Therapeutics Corporation's conference call. Our repodcast will be available for replay for one week by dialing 1-855-859-2056 with international callers dialing 1-404-537-3406 and using access code 3066089. Thank you and have a great day.

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