Q1 2022 United Therapeutics Corp Earnings Call
Unknown Speaker: assumed no obligation to update these four looking states. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision making or to suggest that any products are safe and effective for any unimproved or investigational uses. Full prescribing information for the products are available on our website.
With these forward looking statements.
Today's remarks may discuss the progress when we felt our clinical trials or other developments with respect to our products. In these remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision, making or just is that.
Just that any products are safe and effective for any unapproved or investigational uses.
Prescribing information for the products are available on our web site.
Unknown Speaker: Now I'll turn the webcast over to Dr. Rothblatt for an overview of the first quarter 2022 financial results and business activities of United Therapeutics. Dr. Rothblatt. Thank you, Dewey.
Now I'll turn the ROE cost over to Dr. Ratbot for an overview of the first quarter of 2022 financial results and business activities of United Therapeutics Dr.
Martine Rothblatt: And good morning, everyone. Welcome to our first quarter 2022 financial results call. In my opinion, this is the best quarter we have ever reported, considering not only profits, patients, and our contributions to our planetary community. At $462 million in revenues, we are now on the cusp of a $2 billion revenue run rate.
Thank you Dewey and good morning, everyone welcome to our first quarter of 2022 financial results call.
My opinion. This is the best quarter, we have ever reported considering not only profits patients and our contributions to our planetary community at.
At $462 million in revenues, we are now on the cost of a $2 billion revenue run rate. This is a major milestone achievement for us.
Martine Rothblatt: This is a major milestone achievement for us. This $2 billion revenue run rate is what we expect based on the strong trends that are evident in this quarter, as well as what we expect in the coming quarters. Importantly, we see strength across our entire product portfolio. As a public benefit company, we focus on three P's, profitable cash flow, patient care, and planetary community, with respect to profit. That approximately $2 billion revenue run rate was accompanied by nearly a quarter billion dollars in quarterly profits.
This $2 billion revenue run rate is what we expect based on the strong trends that are evidenced in this quarter as well as what we expect in coming quarters.
Importantly, we see strength across our entire product portfolio.
As a public benefit company, we focus on three PS profitable cash flow patient care and planetary community.
With respect to profits.
That's approximately $2 billion revenue run rate was accompanied by nearly a quarter billion.
In quarterly profits.
Martine Rothblatt: We are making more money than we spend, which is one of our key financial metrics. But with respect to patient care, we are spending too much. Seven phase three studies are underway, and a new phase one study in RemoPro is just starting. And an exciting phase four study called Artisan designed to prove that strong dosing on remodulin followed by a rapid switch to remetram allows patients long-term good results for their treatment of pulmonary hypertension.
We are making more money than we spend which is one of our key financial metrics.
But with respect to patient care.
We're spending a lot.
Seven phase III studies are underway, our new phase one study in <unk> is just starting and then exciting phase four study called artisan designed to prove that strong dosing Unrwa module and.
Followed by a rapid switch to a rent a tram allows patients long term good results.
<unk> for the treatment of pulmonary hypertension, they will be able to live with pulmonary hypertension more than die from pulmonary hypertension.
Martine Rothblatt: They will be able to live with pulmonary hypertension more than die from it. And finally, with respect to our planetary community, we continue to lead by example with zero-carbon healthcare facilities that are amongst the best in our entire industry.
Finally, with respect to our planetary community. We continue to lead by example, with zero carbon healthcare facilities that are amongst the best in our entire industry.
For example.
Martine Rothblatt: Our clinical development operations work in the world's largest site-zero carbon building in Silver Spring, Maryland. We are now building a first-of-its-kind, zero-carbon footprint pharmaceutical inventory warehouse in North Carolina to store our ever-expanding production of pharmaceutical intermediates and pharmaceutical products. Speaking of products, I think that is a good opportunity for me to pass the baton to our President and Chief Operating Officer, Michael Benkowitz. Thanks, Martine, and good morning, everyone. In the first quarter, we continued our trend of year-over-year revenue growth, and we saw the highest quarterly revenue for Taibeso, as well as for our overall triprosthenal business.
Our clinical development operations work in the world's largest sites zero carbon building in silver spring, Maryland.
We are now building a first of its kind zero carbon footprint pharmaceutical inventory warehouse in North Carolina to store our ever expanding production.
Pharmaceutical intermediates and pharmaceutical products.
Speaking of products I think that is a good opportunity for me to pass the baton to our President and Chief operating Officer, Michael Bancorp's.
Yes.
Thanks, Martin and good morning, everyone in.
In the first quarter, we continued our trend of year over year revenue growth and we saw the highest quarterly revenue for <unk> as well as our overall <unk> business.
Michael Benkowitz: I'd like to dive into the underlying performance of our three troposinol products, Tyvaso, Remodulin, and Orenatram. As usual, I'm going to focus more on our patient metrics, and I'll remind everyone that our quarterly troposinol revenue does not always exactly track exactly with quarterly underlying patient demand due to specialty pharmacy ordering patterns. Starting with Tybaso, we increased our active patients to about 4,400 as of the end of the first quarter, putting us approximately halfway toward the goal we set last year of doubling the number of Tybaso patients from 3,000 to 6,000 by the end of this year.
I'd like to dive into the underlying performance of our three cost of our products.
Our modular <unk> as usual I'm going to focus on more on our patient metrics and I'll remind everyone that our quarterly progress on our revenue does not always track exactly with quarterly underlying patient demand due to specialty pharmacy ordering patterns.
Starting with <unk>. So we increased our active patients to about 4400 as of the end of the first quarter, putting us approximately halfway toward the goal. We set last year of doubling the number of <unk> patients from three 6000 by the end of this year as I do in every setting like this I want to remind everyone that achieving this goal assumes no COVID-19 related.
Michael Benkowitz: As I do in every setting like this, I want to remind everyone that achieving this goal assumes no COVID-related impact on healthcare practitioner access and patient initiation of therapy, and the path to doubling will not be linear. Uptake in January and February was a little more gradual than in prior months, but this is not atypical for a serious, chronic, life-threatening condition where doctors want to be extra cautious about adding therapy. Having said that, in March, we saw a nice acceleration of patient additions with historically strong referrals and new starts along the lines of what we saw in Q2 and Q3 of last year, and this momentum has continued into April.
Pat to health care practitioner access and patient initiation of therapy, and the path to doubling we will not be linear.
Uptake in January and February was a little more gradual than in prior months, but this is not atypical for a serious chronic life life threatening condition, where doctors want to be extra cautious about adding therapies, having said that in March we saw nice acceleration of patient additions with historically strong referrals in new starts.
Along the lines of what we saw in Q2 and Q3 of last year and this momentum has continued into April .
Michael Benkowitz: Our continued path to 6,000 patients will be aided by three factors. First, assuming approval later this month, the launch of Tyvaso DPI, which we believe will expand Tyvaso's use in both groups one and group three, pulmonary hypertension, for the reasons I mentioned earlier. The recent CMS coverage update to include Tyvaso for PHILD, that's our second factor.
Our continued path to 6000 patients will be aided by three factors first assuming approval later this month the launch of <unk> DPI, which we believe will expand <unk> use in both groups, one and group III pulmonary hypertension for the reasons I mentioned earlier the recent CMS coverage update to include today so for PHA.
That's our second factor despite the availability of our patient access programs for Medicare patients.
Michael Benkowitz: Despite the availability of our patient access programs for Medicare patients, before a coverage decision, we are aware that many physicians were waiting for a CMS coverage decision before referring their PHILD patients on Medicare for Types of Therapy. And third, continued growth in the Tybaso prescriber base, particularly among ILBs. As I've mentioned on prior calls, many of these physicians have been on the frontlines treating COVID patients. Now that COVID cases and hospitalizations hopefully seem to be on the decline, and with Tybaso DPI and a CMF coverage decision, we expect to see more growth in prescriptions from these physicians over the next few quarters and beyond.
Before a coverage decision we are aware that many physicians were waiting for a CMS coverage decision before where if youre, referring to <unk> ph ILD patients on Medicare for tightening so therapy and third continued growth in the <unk> prescriber base, particularly among ILD traders as I've mentioned on prior calls many of these physicians have.
And then on the front lines treating COVID-19 patients now that Covid cases, and hospitalization hopefully seem to be on the decline and what <unk> epi and our CMS coverage decision, we expect to see more growth in prescriptions from these positions over the next few quarters and beyond.
Michael Benkowitz: Moving on to Orinatram, we saw yet another quarter of record patient counts as of the end of the first quarter. As we've discussed before, we believe this uptick is driven by the FreedomEV label expansion now that we're able to have more robust interactions with prescribers about the data.
Moving to our rental term, we saw yet another quarter of record patient counts as at the end of the first quarter as we've discussed before we believe this uptick is driven by the freedom EV label expansion now that we're able to have more robust interactions with prescribers about the data.
Finally, moving on to our module in in the first quarter, we saw the highest level of our module and referral since 2014 and relative resilience and stability in our business. Despite the launch of a subcutaneous form of generic Coprostanol last year the.
Michael Benkowitz: In the first quarter, we saw the highest level of remodulin referral since 2014, and relative resilience and stability in the business, despite the launch of a subcutaneous form of generic triprocinol last year. The relaunch of the Remunity pump is proceeding well, and we're accepting referrals for starting patients on Remunity, and we've been doing that since about mid-March. We expect Remunity to start picking up through the balance of the year and into 2020.
The relaunch of our unity pump is proceeding well and we're accepting of referrals for starting patients on <unk> and we've been doing that since about mid March we expect community starts to pick up through the balance of the year and into 2023.
Martine Rothblatt: To wrap up, we're pleased with the continued momentum in the arenatrium and remodulin business and progress with Tybaso and PHIL. Expected second quarter events such as CMS coverage and PHILD, the Tybaso DPI launch and approval, not to mention the increased buzz around PHILD we're seeing at HCP conferences, particularly now that these are in person again, have us well positioned to achieve our 6,000 patient goal by With that, I'll turn the call over to Martine to give answers to your questions. Thanks so much, Mike. That was perfect!
To wrap up we're pleased with the continued momentum in the <unk> and the <unk> and our modular business and progress with <unk> in ph ILD.
Expected second quarter events, such as CMS coverage in ph ILD, the <unk> ACO DPI launch and approval not to mention the increase buzz around ph ILD, we're seeing at HCP conferences, particularly now that these are in person again have us well positioned to achieve our 6000 patient goal by the end of the year.
With that I'll turn the call over to Martine quarterbacking answers to your questions.
Operator: Operator, you may open the lines. Thank you. And at this time, I would like to remind everyone in order to ask a question, press star, then number one on your telephone keypad, and we'll pause for just a moment to compile the Q&A roster. And we will take our first question from Eun Yang with Jefferies. Your line is open. Thank you very much. Yeah, great quarter. Question on type A SODPI
Thanks, So much Mike that was perfect operator, you may open the lines.
Thank you and at this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad and we'll pause for just a moment to compile the Q&A roster.
Okay.
And we will take our first question from <unk> Yang with Jefferies. Your line is open.
Thank you very much and great quarter.
Eun Yang: So as we await FDA approval, once approved on time, what do you think the conversion rate to DPI from type A SODP will be from type A SODP, and whether you think that it's going to help to expand into new patients? Thank you. Thank you so much.
Question on <unk>.
Oh wait FDA approval.
As a point of time, what do you think could that conversion rate GDP from tavy.
And whether you think Tibet.
Okay.
Sandy can you patients. Thank you.
Martine Rothblatt: And nice to hear your voice after that. It's been a while since we've been able to see each other face to face, so thanks for dialing in. That question is something that I think on this call, Mike would have the most details and ability to address. So Mike, can you give us a response on that one? Sure, happy to.
Thanks, so much and nice to hear your voice after it's been a while since we've been able to see each other face to face. So thanks for dialing in.
Question is something that I think on this call Mike would be the have the most detailed and the ability to address so Mike can you give us a response on that one.
Sure happy to.
Yes, I think what Youll see is youll see this play out over a little bit of time as I said in my opening remarks, we're dealing with chronic life threatening.
Michael Benkowitz: Yeah, I think what you'll see is this play out over a little bit of time. As I said in my opening remarks, we're dealing with chronic, life-threatening diseases here, and I think patients, or, I'm sorry, physicians and patients can be a little bit cautious in terms of switching therapy, switching delivery devices, what have you. We do see and hear a lot of excitement among both physicians and patients for Tybaso DPI, so we do believe that there will be a lot of interest in switching over to Tybaso DPI.
Diseases here, and I think patients I'm, sorry, physicians and patients.
Can be a little bit cautious in terms of.
Switching therapy switching delivery devices, what have you we do we do see and we hear a lot of excitement among both physicians and patients for the <unk>. So.
So we do believe that there will be a lot of interest and switching over to <unk>.
Michael Benkowitz: I think as this plays out, as we expand the use of Tybaso into Group 1 and Group 3, over time, you know, my estimate is that we'll probably see somewhere around 60% of the patients on Tybaso DPI and about 40% of the patients in Group 1, on the nebulizer. I'd say that's, I think that's a pretty good estimate for Group One. I think group three may be a little bit more 50-50 just because of the disease we're talking about and the severity, and some patients, for whatever reason, may decide that the nebulizer's a better option for them than the DPI. Thanks, Mike. You know, Eun, just to give you a little bit more color.
I think as this plays out as we expand the use of high VSO into Groupon in group three.
Overtime.
My estimate is that we'll probably see somewhere around 60% of the patients on <unk> epi and about 40%.
On on the Nebulizer, I'd say that Thats.
I think thats, a pretty good estimate for group, what I think group three.
Maybe a little bit more 50, 50, just because of the disease, we're talking about and the severity in some patients for whatever reason they decided that they did.
<unk> is a better option for them.
Then the DPI.
Martine Rothblatt: As you know, my daughter has pulmonary hypertension. So I meet with a lot of parents and, and even their adult children with pulmonary hypertension. And I'm astonished, actually, that when I have lunch or something with them, one of them will tell me that their daughter or their son is still taking flow land from the old legacy pump, which weighs as much as, you know, maybe a small brick, not a fat brick, but a small brick.
Thanks, Mike, Yes, just to give you a little bit more color as you know my daughter has pulmonary hypertension, so I meet with a lot of parents and.
And even their adult children with pulmonary hypertension, and I'm astonished actually that when I have a lunch or something with them. One of them will tell me that their daughter Theyre Sun is still taking slow land from the old legacy pump, which.
Martine Rothblatt: And, and, you know, we're just talking, and I'm, I'm obviously not selling, I'm just talking, you know, parent to parent, but I say, you know, there are, there are much smaller devices available, and ones that can go subcutaneously, and, You know, I'm just, you know, I know you're aware of this, you know, I'm just curious, you know, why your And they always give the same answer, which is very consistent with what Mike just said.
Waste as much as maybe a small brick.
At brick, but a small chain.
And.
We're just talking and I'm, obviously, not selling I'm, just talking parent to parent but stay like they are there are much smaller devices available and once that can go subcutaneously.
Yes.
I know you are aware of this and I'm just curious why your daughter's son has never transition.
And they always give the same answer which is very resonant with what Mike just said they said.
Martine Rothblatt: They said, you know, this has kept our child alive. This, you know, legacy flow lamp, you know, brick, if you will, has kept our daughter alive or kept our son alive. And we just don't, you know, if it's not broken, we don't want to fix it.
This has kept our child alive this legacy flow land.
Rick if you will.
<unk> kept our daughter alive kept our son alive and we just don't.
If it's not broken we don't want to fix it.
So that just gives you a little bit more color on what Mike was saying that when patients have the type of condition.
Martine Rothblatt: And so that just gives you a little bit more color on what Mike was saying that when patients have this type of condition, if the nebulizer is, you know, I don't want to say keeping them alive because I don't think that's in the label, but if the nebulizer is what they feel has made their pulmonary hypertension livable, it's just human nature to be very cautious about, you know Now, for new patients, a totally different story. If you tell somebody you want a big thing or a small thing, almost everybody will take the small thing.
The nebulizer.
Is.
I don't want to say keeping them alive, because I don't think that's in the label, but the nebulizer is what they feel has made their pulmonary hypertension are livable.
Just human nature to be very cautious about flipping that to a different therapeutic modality now for new patients totally different story. If you tell somebody you want a big thing or a small thing almost everybody will take the smartphone next question. Please.
Operator: Next question, please. Our next question comes from Joseph Thome with Cowen and Company. Your line is open.
Our next question comes from Joseph Cowen with Cowen <unk> Company. Your line is open.
Joseph Thome: Good morning. Thank you for taking my question and congratulations on the quarter. It was interesting that you mentioned there was an uptick in PH ILD, either patient starts or referrals, particularly what you mentioned in March and continuing into April. Just a little bit of color in terms of, you know, why do you think maybe this was the case?
Good morning, Thank you for taking my question and congratulations on the quarter.
Interesting that you mentioned there is an uptick in ph ILD.
Patient starts of referrals I forget what you mentioned in March and continuing into April .
A little bit of color in terms of.
Why do you think maybe this was the case.
Michael Benkowitz: And are you seeing an increased number of conventional ILD physicians using the therapy? Thanks, Joseph. Mike, handoff to you. Sure, great question. I think there's a number of factors at play.
You're seeing an increased number of conventional ILD position.
Using the therapy.
Thanks, Joseph Mike Handoff to you.
Michael Benkowitz: One is, yes, we are continuing to, day by day, week by week, continuing to grow our Tybasol prescriber base in the ILD community, and that will just continue to play out over really, I think, years, this year and the next year and beyond. So we're really focused on the breadth of the prescribing community, and so that is certainly a contributing factor to that. I think the other things that have kind of played into that are, I know Martine talked a little bit about the impact of COVID on clinical trial enrollment in the market, generally.
Sure, Yes, great Great question, I think there's a number of factors at play.
One is yes, we are continuing to it day by day week by week continue continuing to grow our.
Today's a prescriber base and the ILD community and that that will that will just continue to play out over really I think yours.
This year into next year and beyond and so we're really focused on.
Breadth of the prescribing community and so so that is certainly a contributing factor to that.
I think the.
Other things that.
Kind of played into that or.
Martina talked a little bit about the impact of Covid on clinic.
Clinical trial enrollment enrollment and the market generally.
I think in hindsight looking at <unk> and the impact it had an impact more than maybe we realized at the time just in terms of us being able to get out and talk to physicians and patients and physicians willing to really take the time to.
Michael Benkowitz: I think, in hindsight, looking at Omicron and the impact, I think it had an impact more than maybe we realized at the time, just in terms of us being able to get in and talk to physicians, and physicians willing to really take the time to understand PHILD, think about Tybaso, think about their patients, and move them to Tybaso. And I think what we've seen really in the last, I would say, six to eight weeks is, as I said, with the cases coming down, hospitalizations coming down, there's just, I think, physicians have a lot more time to really dig into this, and so we're starting, I think that's contributing to the increase in referrals and the starts that we've seen in the last.
Understand ph ILD.
Think about <unk> think about their patients and move them to tie the ACO and I think what we've seen really in the last I would say six to eight weeks as I said with the cases cases coming down at hospitalizations coming down.
There's just I think the physicians have a lot more time to really dig into this and so we're starting I think that's what's contributing to the increase in the referral and the starts that we've seen in the last.
Michael Benkowitz: I think the third factor, too, is I mentioned this in my opening remarks about the conferences. And I think, again, none of these are acting by themselves. I think driving it is a combination of a number of things.
The last two months I think the third factor too as I mentioned this in my opening remarks about the conferences.
I think but again none of these are just by themselves.
Driving and it's a combination of a couple of things but.
Michael Benkowitz: But I was at the ISHLT conference last week, which was very well attended in person. And I think just the fact that physicians were there, they were able to attend presentations live, in-person. There were a lot of really nice discussions around PHILD, around the use of Tybason PHILD. You're able to have those hallway or coffee conversations.
I was at the <unk> Conference last week, which was very well attended in person.
And I think just the fact that physicians were there they were able to 10 presentations and presentations live in person.
There are a lot of really nice discussions around ph ILD around the use of <unk> in ph ILD youre able to have those hallway or coffee conversation until we're able to get out in front of these physicians and have really I think detailed conversations with them, but after the state.
Michael Benkowitz: We're able to get out in front of these physicians and have really, I think, detailed conversations with them about the disease state and the drug. I think it helps. The peer-to-peer interactions, our interactions, that will continue into the balance of the spring and the summer. I think ATS is, from what I understand, going to be an even better participant at ISHLT, and we've got a lot of, I think, great presentations going on there.
Yes.
And the drug.
I think helps I think the peer to peer interactions our interactions that will continue into the into the balance of the spring in the summer I think Ats is from what I understand is going to be even better attendant <unk> and we've got a lot of I think great presentations going on there. So I think it's just really a combination of all of those things.
Michael Benkowitz: So I think it's just really a combination of all of those things that has led to kind of a return to where we were, to return to the kind of strong referral and start patterns that we saw in the middle of last year. And then you layer on top the factors that I mentioned in my opening remarks, particularly the CMS coverage, which, you know, for everybody I talk to, that's really important and is going to increase their use of Tybaso along with the DPI, which, as I said, I think has us really well positioned to hit our goal by the end of the year. Thanks so much, Mike. Excellent, excellent. Operator, next questioner. Our next question comes from Jessica Fye with JP Morgan. Your line is open.
Have led to kind of the return to where to.
To return to the kind of struggling deferral and start patterns that we saw in the middle of last year, and then you layer on top of the factors that I mentioned in my opening remarks, particularly the CMS coverage, which.
Everybody I talk to you so that thats kind of Thats really important and that is going to increase their use of <unk> along with the DPI as I said I think have us really well positioned.
To hit our goal by the end of the year.
Thanks, So much Mike excellent excellent operator next question.
Our next question comes from Jessica Fye with Jpmorgan. Your line is open.
Jessica Fye: Hey, good morning. Thanks for taking my question. And I have a backup if you can't answer this, but with the Tybaso DPI PDUFA approaching, can you say if you've seen an updated draft label at this point? And what's your backup, so we have them all queued up?
Ian Good morning, Thanks for taking my question.
And the backup that you can't answer this but with the Televisa DPI produce protein can you say if <unk> seen an updated draft label at this point.
And what's your backup so we have a molecule.
<unk>.
What are your latest expectations for enrollment completion and data for the perfect and Teton trials.
Martine Rothblatt: What are your latest expectations for enrollment completion and data for the PERFECT and TETOM trials? Okay, so first, Jess. Good morning. And nice, nice to hear your voice again. And I'm excited to speak. Further about what Mike mentioned about the in-person presence, I'm excited to hear that J.P. Morgan will be fully in-person this year. So congratulations on leading our industry back to face-to-face healthcare conferences. So we really try to stay away from talking about decisions within the FDA and even decisions which are imminent.
Okay. So first test good morning, and nice nice to hear your voice again and I am excited speaking.
Further about what Mike mentioned on the in person.
<unk> I'm excited to hear that Jpmorgan will be fully in person. This year. So congratulations on meeting our industry back to face to face health care conferences.
So we really tried to stay away from talking about decisions within the FDA and even decisions, which are imminent. So we'll just we'll just leave it at that and we will issue. The press release as soon as we get the good news.
Martine Rothblatt: So we'll just leave it at that, and we'll issue the press release as soon as we get the good news. We are successfully enrolling all of our different clinical trials. It's really not possible to predict when any given trial will be completely enrolled. They are all enrolling, as we mentioned in the beginning of the remarks. And maybe just to provide a little bit of color around your question of what kind of factors are affecting enrollment in our clinical trials, I'd like to turn the microphone over to our Head of Product Development, Dr. Leigh Peterson. Okay?
We are successfully enrolling all of our different clinical trials.
It's really not possible to predict when any given trial will be completely enrolled.
There are they are all enrolling as we mentioned in the beginning of the remarks.
And.
Maybe just to provide a little bit of color around your question of what kind of factors are affecting enrolment in our clinical trials I would like to turn the microphone over to our head of product development and Dr. Leigh Peterson Lee.
Leigh Peterson: Yeah. Hi, everyone. Thank you for the question. So we do have, Actually, we were able to progress. As Michael said, we were probably impacted by COVID for enrollment of the trios a little bit more than we had realized as we learned more and more about sites we're closing due to the pandemic, but... They're opening now.
Yes, hi, everyone.
Thank you for the question. So we do have.
Actually we were able to progress as Michael said, we were probably impacted by coke, but for enrolment of the trial.
A little bit more than we had realized.
We learn more and more about sites were closing.
Due to the pandemic.
But.
They are opening now we're getting more and more we're getting bolus of patients.
Leigh Peterson: We're getting more and more. We're getting boluses of patients coming in that we hadn't had before. And so we're really looking forward to completing the enrollment. Again, we can't really give you a specific timeline. But we really haven't been inhibited by any of the drugs in our study. I hope that's the type of color you're looking for.
Coming in that we hadn't that we hadn't had before.
So we're really.
Looking forward to completing enrollment again, we can't really give you a specific timeline.
But we're really.
We haven't been inhibited.
Two yes, probably.
Probably not a patient either.
Either I mean, there's a little bit.
We get the patients in the study. So obviously critical that we continue to to to watch what happens Paolo and make sure that the sites are open have access to the medicine, and everything and and we've actually had.
No problems with that and.
We even have a site in the Ukraine.
Active patients that we're able to continue to follow and get medicine in our study so.
I hope that the type of color you're looking for again apologies, we can't really give you the.
Leigh Peterson: Again, apologies. We can't really give you the specific enrollment dates, as it is impossible for any clinical study, really. Thanks so much, Dr. Peterson. And just to, you know, provide a little more color to your question, Jess.
The specific enrollment dates.
Is it possible for any clinical study.
Okay.
Thanks, So much Dr. Peterson and then just two.
Provide a little more color to your question Jess.
Martine Rothblatt: I think it has been proven over and over that clinical trial enrollment is a core competency at United Therapeutics. It's something that we do very, very well. Two examples that are, out of many I could give, I myself am blown away at how our team successfully delivered our medicines to patients in Wuhan, China, the ground zero of COVID, yet we continued delivering medicines. We were able to have local clinical trial monitors continue to take all the measurements like Dr. Peterson said.
I think it's it has been proven over and over that clinical trial enrollment is a core competency at United Therapeutics, It's something that we do very very well.
Two examples that are.
Many I could give.
Cellphone blown away at how our teams successfully during Covid early days delivered our medicines to patients in Wuhan China.
Ground zero.
Of Covid, yet we continue delivering medicines, we were able to have local.
Clinical trial monitors continued to take all the measurements like Dr. Peterson said.
Martine Rothblatt: Then a more recent example, as Dr. Peterson just said, we have this center in the Ukraine, and it's part of our outcome study. Fortunately, they are not in the part that's actively under bombardment from the Russians.
And then a more recent example is Dr. Peterson just said.
We have the center in the Ukraine.
And.
It's part of our outcome study and it's a fortunately they are not in the part that's actively under.
Martine Rothblatt: But it's not far from there, and I just, it's just, you know, amazing to me that our team is able to work to conduct these studies even in places of very, very difficult circumstances. Of course, here in the US, we're able to do much better; things are peaceful. And we've even worked out backup measures with the FDA, for example, in PERFECT, where we can take endpoint measurements using things like act, I don't remember the exact word, like actimetric. It's a kind of thing that measures how much you're walking.
Bombardment.
From the Russians, but it's not far from there and I just.
Amazing to me that our team is able to work to conduct these studies even in places.
Very very difficult circumstances of course here in the U S. We're able to do much better things are peaceful and we've even worked out backup measures with the FDA for example, and perfect where we can take endpoint measurements using things like <unk>.
<unk>.
Remember the exact word like after metric its a kind of thing that measures how much youre walking and it's an analogy to six minute walk endpoint studies. So we have we have adapted to doing clinical trials during COVID-19.
Martine Rothblatt: And that's an analogy to six-minute walk endpoint studies. So we have, you know, adapted to doing clinical trials during COVID. And I think we've adapted very, very well, as you can see from, for example, the outcomes of the increased trials and the FDA approval have increased and are ongoing. All seven of our trials are in phase three trials and are enrolling patients. As I mentioned, we're now beginning to enroll a new phase one trial for RemoPro.
And I think we've adapted very very well as you could see from for example, the outcomes of the increased trial and the FDA approval of increase in our ongoing all seven of our trials are phase III trials are enrolling.
And we're now beginning to enroll a new phase one trial for <unk>, we're enrolling a phase four trial artisan. So it's a core competency of our company to carry these things out even during difficult times next question. Please.
Martine Rothblatt: We're enrolling a phase four trial, Artisan. So it's a core competency of our company to carry these things out, even during difficult times. Next question, please. Our next question comes from Andreas Argyrides. Assuming approval, can you elaborate on the initial launch dynamics for DPI, given that it'll be a first-to-market product? Also, what is the timeframe for achieving the previously described breakdown between DPI and Nebulizer? And then lastly, just an update on the Xenoprogram. Thanks, Andreas.
Yes.
Our next question comes from Andreas <unk> with Wedbush Securities. Your line is open.
Hi, good morning, Thanks for taking your question.
Assuming approval can you elaborate on the initial launch dynamics for DPI given that it will be a first to market products also.
What the timeframe is to achieving that.
The previously described breakdown between <unk> and <unk>.
And then lastly, just an update on the programs. Thanks.
Martine Rothblatt: While Mike is putting together some answers to the first two questions that you asked, I'd like to have the Zeno question addressed by Dr. Peterson because she is now also in charge of our ZenoHeart and ZenoKidney clinical development, so she can give you a general overview of the type of things that we're doing on Zeno. And before I leave the introductory part of your answer, please give our best to Leanna. Alright, Leigh, would you, while you're thinking about the Zeno response, Mike, do you want to start with the first two questions he asked?
Thanks, Andreas while Mike is chewing up some answers to the first two questions.
You asked.
I would like to have.
No question addressed by Dr. Peterson, because she is now also in charge of Arsino heart and kidney.
<unk> development. So she can give you a general overview of the type of things that we're doing on casino and before I leave the introductory part of your answer I'll. Please give our best to Liana.
Alrighty.
<unk> would you while youre thinking about the seasonal response on Mike do you want to start with the first two questions yes.
Martine Rothblatt: Sure, so in terms of launch dynamics or launch timing, our expectation is that if we receive an approval this month, in accordance with our action date, we'll be able to commence promotional activities immediately. We have all of our promotional materials queued up and ready to go, and our sales reps trained, so they'll be able to go out and start talking to physicians immediately. There'll be a little bit of a lag in terms of getting...
Sure.
No.
I think in terms of <unk>.
Launch dynamics or launch timing.
Our expectation is that if we receive an approval.
This month in accordance with our option date, we'll be able to commence promotional activities immediately.
So we have all of our promotional materials queued up and ready to go in our.
Our sales reps trained.
So it will be able to go out and start talking to physicians immediately.
Bobby.
Little bit of a lag in terms of getting.
Michael Benkowitz: Product of Specialty Pharmacy and be able to start patients, but we would expect that patients will be able to start, start out therapy. So you're just talking about a few weeks of life there, which is actually faster than normal between an approval and an approval at a launch. So, and then for us, it's, you know, doing what we do from a sales and marketing standpoint, going out and communicating with physicians and communicating with patients and getting them to understand the benefits of DPI and helping physicians and patients identify the appropriate patient to either start Genova or transition over to DPI.
Product and specialty pharmacy.
And be able to start patients, but we would expect that patients will be able to start.
Start off therapy.
Sometime in June .
Just talking about a few weeks lag there, which is which is actually faster than normal between between an approval.
At a launch so and then for us.
Julian what we do from a sales and marketing standpoint, and going out and communicating with physicians and communicate with patients.
Getting them to understand.
The benefits of DPI, and helping helping physicians or patients identified the appropriate patient to either start to novo or transition over to the DPI.
Michael Benkowitz: In terms of the timing for the breakdowns that I mentioned earlier, sort of like the clinical trial question, I hesitate to put a timeline on that because it always seems to move a little bit slower than we think for the reasons that Martine gave and because of the types of patients we're dealing with. I am optimistic that this will happen, maybe quicker than what we typically see in this space just because of all of the pre-launch or pre-approval buzz and excitement there is around this product. It's awesome, Mike.
In terms of the timing for the breakdowns that I that I mentioned earlier.
Sort of like the clinical trial.
Question I hesitate to put a timeline on that because it always seems to move a little bit slower.
Then what we think for the reasons that Martine. The example of our team gave because of the types of patients were.
We're dealing with I am optimistic that this will happen maybe quicker than.
What we typically see in this space just because of all of the prelaunch or preapproval Buzz and excitement there is around this product.
Michael Benkowitz: Totally, totally awesome. All right, Leigh, people are interested in what we can expect next on Xeno. Yeah, so as everyone knows, the world is very, very excited about what's going on here. And we have reports of institutions doing work in humans, one case that's coming out where the XenoHeart was placed into a human patient. And that worked, the case study of that coming out in a major medical journal. So please look for those details in that report. We're excited for that to come out soon.
Awesome, Mike totally totally awesome.
Alright.
People are interested about what we can expect next time Zeno.
Yeah.
As everyone knows the world has.
Very very excited on what's going on here and.
And we have reports.
Institution.
Doing doing work in in.
In human <unk>.
That's coming out.
Where where there'd be no hearts.
Which was placed into.
Human patients.
That work is that the case study of that coming out in a major medical journal so.
Please look for those.
Details on that report, we're excited for that to come out.
Leigh Peterson: But what we do is we are really interested in doing the clinical studies that prove if a product is as efficacious as we expect. And so in order to do the more formal phase one sponsored clinical studies, we're required to continue to do some preclinical work, per FDA. And we're working with FDA to understand specifically what we should do in order to prepare ourselves for the IND and prepare them. As everyone knows, this is an entirely new field.
But what we do.
It is.
Interested in doing the clinical studies that prove it.
Our product is efficacious.
As we expect and in order to do the very the more formal phase one sponsored clinical studies were required to continue.
<unk> continued to do some preclinical work.
And per FDA, and we're working with FDA to.
Understand specifically.
What we should do in order to prepare ourselves for the IMD.
Leigh Peterson: And so we're working really closely together to make sure that we do this right. So we're spending time now working with our academic partners and doing the non-clinical work and making sure everything is in order for our phase one, and everything being the specific immunosuppression regimen that will be used, the specific product, and all of the procedures that are associated with that. So once we have that completed, we will be submitting our IND to start phase one studies with the xeno organs. Excellent Thank you so much, Leigh.
And prepare them.
Everyone knows this is an entirely new new field and so we're working very closely together to make sure that we do this right.
So we're spending time.
Now working with our academic partners and doing the non clinical work and making sure everything is in order for phase, one and everything being specific.
Suppression regimen that will be used this specific product.
And in all of the procedures that are associated with that so once we have that.
<unk>, we will be submitting our AMD to start to start the phase one studies.
With the with the Dino Oregon.
Martine Rothblatt: You know, I'm going to call on one more person, Pat Poisson, who's our Executive Vice President for Technical Operations. Those of you who know me know that I kind of geek out on pharma biologic manufacturing things. I just, you know, I just really love it.
Excellent. Thank you so much.
To call out one more person Pat <unk> Who's our executive Vice President Technical operations. Those of you who know me know that I kind of geek out on pharma biologic manufacturing things I, just I, just really love it and it's.
Martine Rothblatt: And it's amazing, you know, to manufacture a xeno kidney and xeno heart. That is, it's a biological, obviously. But it requires manufacturing facilities, the likes of which, you know, have not existed before. And it is under Pat Poisson, who's our EVP of Technical Operations, that we are building the manufacturing facility for the clinical trials that Dr. Peterson just referred to because, you know, for a clinical trial, whether it's a small molecule, a biologic, or a whole organ, you have to have a higher level of attention and care to GMP-type processes.
It's amazing to manufacturer Zeno kidney and heart that is a it's a biologic obviously.
But it requires manufacturing facilities.
Really the likes of which have not existed before.
And it is under.
At <unk>, our EVP tectum cooperations.
That we are building the manufacturing facility for the clinical trials.
Dr Peterson, just referred to because.
For a clinical trial.
It's a small molecule or biologic oral whole, Oregon Hugh.
You have to have a higher level of attention and care to GMP type of processes. So loan path, which just have liked by the minutes left in the call, but if you could kind of give us an overview of.
Martine Rothblatt: So Pat, we just have about a minute left on the call, but if you could kind of give us an overview of the kind of stuff that you're overseeing in terms of preparing a clinical trial, if I could say material or organ for Dr. Peterson's trial. Yeah, thanks, Martine.
The kind of stuff that you're overseeing in terms of preparing a clinical trial, if I can say material or Oregon for Dr. Petersen's trial.
Patrick Poisson: So certainly, us in operations are very excited about the prospects with Zeno and, uh, Joseph Thome. We are undertaking building a clinical, call it a manufacturing facility that will produce organs for the trials that Dr. Peterson will run. And this is going to be a first of kind Greenfield facility. Western Virginia, and it'll be state-of-the-art, as we do with all of our facilities, working closely with FDA. So we are kicking that program off. It's underway, and design work is happening as we speak.
Yes, Thanks Martijn.
Certainly.
US and operations are very excited about the prospects.
And.
We are undertaking building.
Call It manufacturing facility that will produce oregon's.
For the trials go to Dr. Peterson will run.
This is going to be a first in kind.
A greenfield facility.
Western Virginia, and it will be state of the art as we do with <unk>.
All of our facilities working closely with FDA.
So we are taking that program off it's underway and design work.
As we speak.
So we will be prepared to supply Oregon's when the strong start.
Okay.
Thank you so much Pat.
Patrick Poisson: So we will be prepared to supply organs when these trials start. Thank you so much, Pat. Operator, it's been a wonderful call. Like I said at the beginning, in my opinion, the best quarter we've ever had the pleasure to share with everybody, considering revenues, pipeline, and even these amazing manufacturing activities. So, Operator, you may now wrap up the call. Thank you. And thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the events and presentations section of the United Therapeutics Investor Relations website at ir.unither.com. [inaudible]
Operator, it's been a wonderful call like I said at the beginning in.
In my opinion, the best quarter, we've ever.
Ever had the pleasure to share with everybody and considering revenues pipeline.
Even these amazing manufacturing activities. So operator, you may now wrap up the call.
Thank you and 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 presentation section of the United Therapeutics Investor Relations website at IR Dot.
You and I th Edr Dot com.
Okay.
Okay.