Q2 2021 United Therapeutics Corp Earnings Call
We'll speak a little bit more about the commercial success that were experiencing I'd like to.
Martine A. Rothblatt: I'd like to talk a little bit about our pipeline, which is quite robust and doing very well. We have a number of studies in Phase 3, and I'd like to highlight a few of them.
Talk a little bit about our pipeline, which is quite robust and doing very well.
We have a number of studies in phase III.
I'd like to highlight a few of them.
Martine A. Rothblatt: Two of our studies are outside of group 1 PAH, the PERFECT study in COPD, specifically a form of COPD that's associated with pulmonary hypertension, and another phase 3 study in idiopathic pulmonary fibrosis, also known as IPF. That study is called the Teton Study within United Therapeutics. In addition to those Phase III studies, we have additional Phase III studies within Group 1 pulmonary hypertension. Two of those Phase III studies are using our once-a-day drug called Relenopak, and both of those studies are growing quite nicely.
2 of our studies are outside of group 1 ph the perfect study in COPD, specifically a form of COPD, that's associated with pulmonary hypertension.
And another phase III study in idiopathic pulmonary fibrosis also known as IP App.
That study is called the Teton study within United Therapeutics.
In addition to those phase III studies, we have additional phase III studies within group 1.
Pulmonary hypertension.
2 of those phase III studies are using our once a day drug called relent on pack.
And both of those studies are growing quite nicely.
Martine A. Rothblatt: In addition, we have a lot of next-generation troprostenal development activity that will be some of it's in phase one and then moving into bioequivalence testing over the next year or two. So that will provide an ongoing pipeline of next-generation troprostenal products for group one and possibly also group three pulmonary hypertension. Looking a little bit at the longer term, we're working on cures for pulmonary hypertension, either through gene therapy, and we do have a gene therapy trial also in phase three, or actually manufactured lungs, lungs that are manufactured in our laboratories and then transplanted into patients to completely cure either their pulmonary hypertension, pulmonary fibrosis, or many other end-stage lung diseases.
In addition, we have a lot of our next generation <unk> development activity that will be in.
Some of it's in phase 1 and then moving into bioequivalence testing over the next year or 2.
So that will provide an ongoing pipeline of next generation <unk> products for group 1.
And possibly also group 3.
Pulmonary hypertension.
Looking a little bit of a longer term, we are working on cures for pulmonary hypertension, either through gene therapy, and we do have a gene therapy trial also in phase III are actually manufactured lungs lungs that are manufactured in our laboratories, and then transplanted into patients.
To completely cure either their pulmonary hypertension pulmonary fibrosis or many other end stage lung diseases.
In the meantime on the clinical side, there is increasing evidence that current amount of sense.
Martine A. Rothblatt: In the meantime, on the clinical side, there is increasing evidence that current medicines dosed appropriately may, in fact, convert pulmonary hypertension into a lifelong manageable condition, and a lot of these data come from Europe and Japan.
Dosed appropriately.
They in fact convert pulmonary hypertension into a lifelong bound simple condition.
And.
A lot of these data are coming from Europe and Japan.
Michael I. Benkowitz: I think you're going to soon see more reports from the United States. But it's really startling to see reports with patients, more than 90 percent of the patients in the cohort living 20 years longer than 10 years with current medications but dosed differently than the kind of traditional dosing, dosing a dose according to a very specific protocol. So that's tremendously exciting for us in the pulmonary hypertension field to be able to turn pulmonary hypertension into a lifelong manageable condition.
I think youre going to soon see more reports from the United States, but it's it's really startling to see reports with patients.
More than 90% of the patients in the cohort living 20 years over 10 years.
With our current medications, but dose.
Differently than kind of the traditional dosing dosing dose according to a very specific protocol.
So that's tremendously exciting for us in the pulmonary hypertension field to be able to convert pulmonary hypertension into a lifelong manageable condition and indeed the goal of our next generation <unk> products is to make these kind of lifelong manageable protocols as easy as possible for the.
Michael I. Benkowitz: And indeed, the goal of our next generation proprosonal products is to make these kinds of lifelong manageable protocols as easy as possible for the patients, because they'll be on them for literally decades. Well, with that introduction to our pipeline and clinical development activities, I'd like to pass the microphone over to Mike Benkowitz to talk about our commercial operations.
Patients because there'll be on them for literally decades.
With that introduction to our pipeline and clinical development activities I'd like to pass the microphone over to Mike <unk> to talk about the commercial operations Mike.
Michael I. Benkowitz: Thanks, Martine. And good morning, everyone. The second quarter was a very exciting quarter for United Therapeutics on the commercial front, as we began our push into new rare lung disease indications outside of pulmonary arterial hypertension. I'm pleased to report that we achieved several milestones in the second quarter at the traprosimal franchise level. First, we ended the second quarter with a record number of U.S. patients on our traprosomal therapies, marking the fourth consecutive quarter of total traprosomal patients.
Thanks, Martine and good morning, everyone.
The second quarter was a very exciting quarter for United Therapeutics on the commercial front as we began our push into new rare lung disease indications outside of pulmonary arterial hypertension I.
I am pleased to report that we achieved several milestones on the second quarter at a profitable franchise level first.
First we ended the second quarter with a record number of U S patients on our cross sell therapies, marking the fourth consecutive quarter of total coprostanol patient growth.
Michael I. Benkowitz: Second, we achieved an all-time high in two of our key underlying U.S. demand metrics, total proprosinol prescriptions and total proprosinol actual patient starts. Finally, while we always caution that revenues don't necessarily reflect underlying demand for our products due to the ordering patterns of our specialty pharmacy and distribution partners, we're excited to have achieved record triprocin revenue in the quarter. Now, I'd like to spend a few minutes talking about individual product performance.
We achieved an all time high in 2 of our key underlying U S demand metrics total to cross on prescriptions and total to approximately actual patient starts.
Finally, while we always caution on net revenues don't necessarily reflect underlying demand for our products due to the ordering patterns of our specialty pharmacy and distribution partners. We're excited to have achieved record <unk> revenue on the quarter.
Now I'd like to spend a few minutes talking about individual product performance of course, we're very excited to have launched high day. So at the pulmonary hypertension associated with interstitial lung disease at the beginning of the second quarter.
Michael I. Benkowitz: Of course, we're very excited to have launched Kaideso for pulmonary hypertension associated with interstitial lung disease at the beginning of the second quarter. Earlier this year, we established a goal to double the number of patients on Tygaso by the end of next year, assuming no COVID-related impact on HCP access and patient initiation of therapy and importantly, recognizing that the path to doubling may not be linear. In the first quarter of the launch, we established strong momentum, and as of the end of Q2, we're already more than one-sixth of the way to our goal of doubling the number of patients on Tybaso through the PHILD label extension.
Earlier this year, we established a goal to double the number of patients on high day. So by the end of next year.
Semi no COVID-19 related impact to HCP access and patient initiation of therapy, and importantly, recognizing that the path to doubling may not be linear.
In the first quarter of the launch we have established strong momentum and as the end of <unk>.
The end of Q2, we're already more than $1.6 of the way tour to our goal of doubling the number of patients on high day, so through the ph ILD label expansion.
Michael I. Benkowitz: We're also very encouraged by the prescription and start patterns in Q2, which are double or more than double the quarterly referral and start levels in 2020. On the reimbursement front, we continue to work with CMS to update their policy to cover Tybaso for the treatment of PHILD. We remain confident that this update will happen, but cannot predict its timing due to the government's processes and procedures.
We're also very encouraged by the prescription and start patterns in Q2, which are double on more than double the quarterly referral and start levels in 2020.
On the reimbursement front, we continue to work with CMS to update their policy to cover today, so for the treatment of ph ILD.
We remain confident that this update will happen, but cannot predict timing.
Timing due to the government's processes and procedures in the meantime, Medicare Medicaid patients can apply and have been applied to our patient assistance program.
Michael I. Benkowitz: In the meantime, Medicare and Medicaid patients can apply, and have been applying, to our patient assistance program. If they meet our patient assistance program eligibility criteria, they can initiate tybaso therapy immediately. Once CMS updates their coverage policy, Medicare and Medicaid patients will be able to start on commercial drugs. Moving on to remodulans, we were very pleased to see in Q2 the highest number of prescriptions and starts for remodulans in the past 12 years. We believe there are several factors contributing to that.
If they meet our patient assistance program eligibility criteria. They can initiate K based on therapy immediately.
On CMS updated their coverage policy Medicare Medicaid patients will be able to start on commercial drug.
Moving on to our module and we were very pleased to see in Q2, the highest number of prescriptions on starts for our module on in the past 12 years. We believe there are several factors contributing to this first as we mentioned last year, where module on therapy initiation. It was most impacted by the pandemic for a period of time as many patients were unable to come into.
Michael I. Benkowitz: First, as we mentioned last year, remodulant therapy initiation was most impacted by the pandemic for a period of time, as many patients were unable to come into the hospital to start on remodulants. We believe this created a so-called warehousing of patients that started to open up in Q3 of last year and continued in Q2. In addition, there is renewed appreciation of the clinical benefits of vermagelin for PAH patients, for example, the ability to move patients to a low risk status and then potentially transition them to oral prostacyclin, such as Renatran.
The hospital to start on a module and we believe this created a so called warehousing of patients that started to open up in Q3 of last year and continued into Q2.
In addition, there is renewed appreciation of the clinical benefits of from module and for pediatric patients for example, the ability to move patients to low risk status.
And then potentially transition to oral prostacyclin, such as a rent a tram and as Martine mentioned on recently published retrospective data showing that user per module and can reduce impact our mean pulmonary arterial pressure and the impact is.
Michael I. Benkowitz: And as Martine mentioned, recently published retrospective data showing that the use of vermagelin can reduce MPAP, or mean pulmonary arterial pressure. And if MPAP is reduced below 40 millimeters of mercury, there can be a dramatic improvement in long-term survival.
<unk> below 40 millimeters of Mercury, there can be a dramatic improvement in long long term survival.
Michael I. Benkowitz: The competitive landscape did change in the second quarter for our module as a generic form of subcutaneous preposterol became available. At this point, the sub-Q generic launch looks very similar to the IV generic launch we saw in 2019. There has been an initial bolus of sub-q remodulin patients, similar in quantity to what we saw with IV, and primarily these dual-eligible Medicare-Medicaid patients that have been forced-switched to generic preposterous. However, the base of patients we have now is higher than when IV generic launched. We still see that PAH docs prefer Branded or Modulant over the generic alternative when they are filling out their prescriptions, and we have yet to see widespread payer management of these patients.
The competitive landscape did change on our second quarter firm module on as a generic form of subcutaneous per possible became available.
At this point the sub Q Dineric launch looks very similar to the IV generic launch we saw in 2019.
There has been on initial bolus of <unk> locations similar on quantity to what we saw with IV and primarily these dual eligible Medicare Medicaid patients that had been force switch to generic copaxone.
However, the base of patients we have now is higher than on IV generic launched we still see that PIH docs prefer branded or module on over the generic alternative when they're throwing out their prescriptions and we have yet to see widespread payer management of these patients.
Michael I. Benkowitz: It's also important to note some of the potential limitations around generic subcute availability. It's our understanding that this product is only being offered by one of the specialty pharmacies that distribute PAH medicine. It's also our understanding that the sub-q pumps that are currently being used with generic propinol are limited in supply.
It's also important to note some of the potential limitations around generic availability. It's our understanding that this product is only being offered by 1 of the specialty pharmacies that distribute ph medicines.
It's also our understanding that the subsea pumps that are currently being used with generic or possible are limited in supply.
Michael I. Benkowitz: Meanwhile, we have invested in a supply of pumps and disposables, including the newer Immunity Pump, and believe that we're well-positioned to serve remodeling patients for the long term. Rettatram also had a strong quarter, posting new prescriptions and starts in the second quarter that were one of the highest since the product's launch, and total patients on therapy that were the highest ever. I've mentioned in previous calls and investor conferences that while we saw an uptick on Oranatram following the Freedom EV label expansion, the launch trajectory was blunted by COVID.
Meanwhile, we have invested on our supply of pump supply of pumps and disposables, including the new immunity pump and believe that we're well positioned to serve a module on patients for the long term.
<unk> also had a strong quarter posting new prescriptions and start from the second quarter that were 1 of the highest since the product's launch and total patients on therapy that were the highest ever.
I've mentioned in previous calls and investor conferences that while we saw an uptick on our rent a tram following the free the freedom EV label expansion.
The launch trajectory was blunted by Covid in the second quarter of this year, we were able to have consistently more robust interactions with prescribers about freedom EV and a total of <unk> value proposition and we believe that translated into the underlying demand performance we're seeing.
Michael I. Benkowitz: In the second quarter of this year, we were able to have consistently more robust interactions with prescribers about freedom ED and the total Oranatran value proposition, and we believe that translated into the underlying demand performance we're seeing. If we can maintain this momentum going forward, we expect this to show up on the revenue line in subsequent quarters as patients titrate to an efficacious dose and ordering by specialty pharmacies, which often lags behind underlying demand, catches up.
If we can maintain this momentum going forward. We expect this to show up on the revenue line in subsequent quarters as patients titrate to an efficacious dose and ordering by specialty pharmacies with often lags underlying demand catches up.
Michael I. Benkowitz: With respect to Unituxin, we are extremely pleased to see second quarter demand continue at a similar pace to the first quarter. We have limited visibility into how the drug is being used, but we know use has increased in the U.S. Moreover, Unituxin was approved in Japan in the second quarter with an indication that's actually broader than the U.S. label. Consequently, our Japanese distribution partner, Ohara, ordered a larger than expected amount of Unituxin in the quarter.
With respect to unit toxin, we are extremely pleased to see second quarter demand continue at a similar pace to the first quarter.
We have limited visibility into how the drug is being used but we know used has increased in the U S. Moreover, our unit cost on that was approved in Japan on the second quarter with an indication thats actually broader than the U S label. Consequently, our Japanese distribution partner O'hara ordered a larger than expected amount of unit toxin on the quarter.
Michael I. Benkowitz: Finally, we're excited about our pending application at FDA for Tybasium DPI. We're pleased that the PAI, a general facility inspection, at our partner Mankind's Danbury, Connecticut, facility has commenced, has been scheduled, and is ongoing. Our producer action date is in October of this year, and we're working hard to build launch quantities and mobilizing our commercial teams to support a launch soon after approval. So there are a lot of positive things happening on the commercial front. We remain focused on executing against our plans through the second half of the year and, importantly, making progress toward our near-term goal of doubling the number of patients on Tyvaso by the end of 2022.
Finally, we are excited about our pending application at FDA for Chinese goods Epi, we're pleased that the <unk>.
In general facility inspection at our partner Mankind, Danbury, Connecticut facility has commenced as scheduled and as ongoing.
Our producer action date is on October of this year, and we're working hard to build launch quantities and mobilizing our commercial teams to support a launch soon after approval.
So theres a lot of positive things happening on the commercial front, we remain focused on executing against our plans through the second half of the year and importantly, making progress toward our near term goal of doubling the number of patients on <unk> by the end of 2022.
Martine A. Rothblatt: With that, Martine, I'll turn the call back over to you. Thanks so much, Mike. Great review. So, Operator, we can now open up the lines for any questions, and whatever questions come in, I'll direct them either to James, our CFO, to Mike, our president, or any questions of a scientific, medical, or technical nature to Dr. Peterson. Operator? Thank you. Once again, as a reminder, if you would like to ask an audio question, please press star followed by the number one on your telephone, and your first question to the line of Jessica Fye with J.P. Morgan.
With that Martine I'll turn the call back over to you.
Thanks, So much Mike Great review.
So operator, we can now open up the lines for any questions.
Whatever questions come in I'll direct them either to James our CFO to Mike our precedent or any questions of a scientific medical technical nature to Dr. Peterson operator.
Once again as a reminder, if you would like to ask an audio question. Please press star followed up on number 1 on your telephone.
And your first question is from the line of Jessica Fye with JP Morgan.
Hey, nice quarter. This morning you.
Jessica Fye: Hey, nice quarter this morning. You guys said you're well on your way to the goal of doubling the number of patients on PAY-VASO, but you also said the path may not be linear. So can you share your latest thinking on the shape of the curve to get to that year-end 22 goal? And related to that, you also mentioned that ordering patterns can factor into revenue not perfectly aligning with patient demand? So how should we think about that dynamic going forward, say, in the back half of the year? Thank you.
You guys said youre well on your way to the goal of doubling the number of patients on <unk>, but also from the past may not be linear. So can you share your latest thinking on the shape of the curve to get to that year end 'twenty 2 goal and related to that you also mentioned the ordering patterns in factoring revenue not perfectly aligning with patient demand. So how should we think about that dynamic going forward.
And the back half of the year.
Thank you.
Thanks, Jeff Nice to hear your voice. This morning, both of those questions seem to be squarely in Mike's bailiwick.
Sure I think.
The first the first part of the question around the shape of the curve I think we are.
Martine A. Rothblatt: Thanks, Jess. It was nice to hear your voice this morning.
Michael I. Benkowitz: Both of those questions seem to be squarely in Mike's bailiwick. Sure, I think on the first part of the question around the shape of the curve, I think we're still trying to get better visibility into what that looks like. And I think the question that we're still trying to get some insight into is the patients that are residing with the PHILD treaters and how quickly those patients are getting referred, either getting referred over to the PAH clinic, or these PHILD treaters are starting to treat patients on their own. And so, you know, we're still getting insights into that. We don't have perfect clarity.
Trying to get better visibility into what that looks like and I think that the.
The question that we're still trying to get some insight into his.
The patients that are residing with the ph ILD treaters and and how quickly. They are those patients are getting referred either getting referred over to ph clinic or these ph ILD treaters are starting to.
Activate entry patients on their own and so.
We're still gaining insights on that we don't have perfect clarity I think I'm, hoping to get through Q3 into Q4, we'll get a better sense of that so.
So that's why I'm still thinking about it.
Maybe not going to necessarily be a linear and maybe.
Michael I. Benkowitz: I think, you know, I'm hoping through Q3 and Q4, we'll get a better sense of that. So, yeah, that's still why I'm still thinking that it's maybe not going to necessarily be linear and maybe potentially, you know, more of a hockey stick as we get into 2022. But I think we'll have a little bit better visibility on that as we get into, you know, later into the second half of the year. On the ordering patterns, I mean, it's, you know, it's, this is always an issue.
Potentially more hockey stick as we get into 2022, but I think we'll have a little bit better visibility on that.
As we get into later into the second half of the year.
On the ordering patterns.
This is always an issue we've always had.
The.
The specialty pharmacies have.
Data on inventory requirements per our contracts that they have to keep.
Keep on hand.
We have an algorithm they look at that takes into account historical shipment data as well as perspective.
Michael I. Benkowitz: We've always had them. Specialty pharmacies have days on inventory requirements per our contracts that they have to keep on hand. They have an algorithm they look at that takes into account historical shipment data as well as prospective estimated demand. And with that, we've got an agreed-upon level of hoarding that has to happen. You know, beyond that, it's really just sort of, you know, the normal course of business. And so, you know, as we start to kind of see referrals and start on the high day, so. I would expect the orders to pick up as we go along. Perfect. Thanks so much, Mike.
Estimated demand and with that we've got on agree upon level operating that has to happen and so.
Beyond that it's really just sort of kind of normal course of business and so as we start to kind of see referrals and starts on Friday. So.
Side of things pick up I would expect.
Orders to pick up.
We go on.
Perfect. Thanks, so much Mike.
Next question please.
The next question is from the line of amortize staying with Oppenheimer <unk> company.
Hi, good morning.
Hey, good morning.
Good to hear your book.
Thank you for the questions and a nice quarter.
The.
Michael I. Benkowitz: Your next question is from the line of Hartaj Singh with Oppenheimer & Company. Hi Hartaj, good morning. Hey, good morning, Martine. A pleasure to hear your voice. Thank you for the question.
Quick question on hospitals on COPD and IPF Mark to your point those out at the beginning.
In terms of your prepared script could you just talk a little bit about the scientific rationale behind Polysome Gail for COPD.
Hartaj Singh: The question I had was about COPD and ICF. Martine, you pointed those out at the beginning of your presentation.
And then specifically when do you expect the Readouts for both on patient enrollment to complete and Readouts to happen for COPD.
Martine A. Rothblatt: We're going to talk a little bit about the scientific rationale behind, you know, Tyrazone gel for COPD and IPF. And then, specifically, when do you expect the readouts for both the inpatient enrollment to complete, and readouts to happen for COPD and IPF? Yeah, great question, Hartaj.
Yes, great question, our Tosh <unk> I'll speak for a moment or 2 about the.
Group 3.
COPD.
Pulmonary hypertension.
And.
While I'm doing doubt on Dr. Peterson, if you could queue up your thoughts on the scientific rationale in IPF, which is.
Unique in the sense that it has nothing to do with pulmonary hypertension adult and Dr. Peterson has studied debt scientific rationale quite a bit.
Martine A. Rothblatt: I'll speak for a moment or two about group 3 COPD, pulmonary hypertension, and while I'm doing that, Dr. Peterson, if you could queue up your thoughts on the scientific rationale for IPF, which is unique in the sense that it has nothing to do with pulmonary hypertension at all. And Dr. Peterson has studied that scientific rationale quite a bit.
So with regard to the COPD, we're not treating the COPD per se, but we're treating only the pulmonary hypertension that those patients have who also have COPD.
Martine A. Rothblatt: So, with regard to COPD, we're not treating COPD per se, but we're treating only the pulmonary hypertension that those patients have who also have COPD. We do this based on previous work from Dr. Waxman and others that showed that when patients in group 3 with COPD were treated off-label with Tyvaso, they had dramatically improved 6-minute block scores for Hartaj. And it was based on that data that we were able to size our PERFECT study.
We're doing this based on previous work from Dr. Waxman, and others that showed that when group III patients with COPD were treated off label with <unk>.
Good day.
Has dramatically improved 6 minute walk score is hard times and it was based on that day that we were able to size our perfect study.
Martine A. Rothblatt: It's about roughly 100 patients, a bit more than 100 patients, and felt very confident with that sizing because of the very dramatic data that had come out earlier. So it is the mechanism of action is the same as it would be for treating any other type of pulmonary hypertension. We've got the ability of triprostanol to, for example, you know, dilate the smooth muscles in the pulmonary arteries, which are causing the vasoconstriction, and we also have the ability of type A, so inhaled, to reduce the platelet aggregation in those tiny arterioles, which also contribute to ultimately an afterload in the right heart and actually spells a worse morbidity and mortality picture for the COPD patients who have pulmonary hypertension than for those who don't.
It's about roughly 100 patients a bit more than 100 patients.
And felt very confident with that sizing because of the very dramatic data that.
That had come out earlier.
So it is the mechanism of action is the same as it would be for treating any other type of pulmonary hypertension.
Got the ability on.
<unk> 2.
<unk> for example.
Dilate, the smooth muscles in the on pulmonary arteries, which are causing the vessel constriction.
And we also have the ability of Taipei, so inhaled to reduce the platelet aggregation in those tiny arterials, which also contribute to ultimately.
After load and the right heart.
And.
Actually spells a a worse morbidity and mortality picture for the COPD patients who have pulmonary hypertension.
Those who don't there are a lot of patients on <unk>.
Martine A. Rothblatt: There are a lot of patients, Hartaj, with the COPD form of pulmonary hypertension, in fact, over 100,000 in the U.S. alone. So there is a real great opportunity for us to do good there, and I think the scientific rationale, the empirical data upon which we sized and based the PERFECT study were very solid, and we have high expectations for success. Dr. Peterson, would you like to talk about the scientific rationale for pulmonary fibrosis because that's something really, very new?
Cash from with the COPD.
Form of pulmonary hypertension in fact over 100000 in the U S alone.
So there is a real great opportunity for us to do good there and I think the scientific rationale the empirical data upon which we.
Size and based on the perfect study was very solid and we have high expectations for success.
Dr Peterson, but you'd like to talk about the scientific rationale in pulmonary fibrosis, because that's something really very new.
Leigh Peterson: That came out of the INCREASE study, in addition to meeting our primary implant and everything that's been published so far, including New England Journal, is that we published a paper in The Lancet recently, and it described the surprise sort of thing that we saw, which was that we saw an improvement in FBC, which is forced vital capacity. And this indicated that Tyveso might not only work on the pulmonary hypertension component of the disease, but it might actually work on the fibrotic disease in patients with PHILD.
Yeah, Yeah sure. Thanks, Martine and thanks for the question Joe.
Really what became 1 of the things that came out of the increased debt. In addition to meeting our primary endpoint.
And everything Thats been published so far including New England Journal.
We.
Published a paper in the lancet recently.
The surprise sort of debt.
Which was that we saw an improvement in SBC, Richard forced vital capacity.
There are indicated that.
Hi, Ray might not only work on the pulmonary hypertension component of the disease, but it might actually work on the fibrotic.
Patients with ph ILD.
Leigh Peterson: And that's actually supported by So we saw this clinically, and it's actually supported by non-clinical evidence where there have been several studies that have shown the anti-fibrotic effect of caprocinol. So that together made us think about what's going on and think that possibly this could also work in patients with IPF without pulmonary hypertension. So, again, evidence of an increase and evidence in non-clinical studies, both in vitro and in vivo. [inaudible] Due to these other effects of troprosinol, troprosinol binds to multiple receptors on multiple cell types and has multiple mechanisms of action. There are additional actions, such as fibrosis, that can work specifically in patients with fibrotic lung disease, and there's even a bronchodilation effect that could also help patients with obstructive lung conditions such as COPD.
And Thats actually supported by.
So we started as clinically and that's actually supported by non clinical evidence where their strength. Several studies that have shown anti fibrotic effect.
So that together.
All right.
Nadir.
Dine in you know think about what's going on and think that possibly this could also work in patient with IPF without pulmonary hypertension, so again evidenced in increase.
And evidenced in non clinical studies, both inventory and then depot and.
This debt.
To reiterate what Martin just debt so for ph ILD and ph COPD I'm, obviously ex U.
Mentioned various debt common pathogenesis per the ph.
Each component, but in fact.
Due to these other effects after practice now to approximately by multiple receptors on multiple cell types and has multiple mechanisms of action there are additional.
Martine A. Rothblatt: Perfect. Thanks so much, Dr. Peterson. Operator, next question, please.
Actions such as the fibrosis that can work specifically in patients with fibrotic lung disease and there is even a broncho dilation effect that could also help the patients with obstructive lung conditions such as sales.
Joseph John: Your next question is from the line of Joseph Tom with Cowan & Company.
Joseph John: Hi there. Good morning, and thank you for taking my question.
Perfect. Thanks, so much Dr. Peterson operator next question please.
Michael I. Benkowitz: Congratulations on all the great progress. Maybe one more, just a little bit on the reimbursement environment for PHILD. If you can comment a little bit more on that, how many patients, if they're prescribed the therapy, are they able to actually get Tyleza right now, for the most part? And obviously, we know this is essentially the first therapy formally approved in this indication. Are you seeing any sort of considerations for prior therapies that patients need to have seen or a specific level of disease burden?
Your next question is from the line of Joseph Thome with Cowen <unk> Company.
Good morning, and thank you for taking my question and congratulations on Great progress, maybe 1 more just a little bit on the reimbursement environment for ph ILD.
If you can comment a little bit more on.
On that how many kind of patient if they're prescribed the therapy or they're able to actually get 10 days on right now.
Gross part and obviously, we know this is essentially the first there'd be formally approved in this indication are you seeing any sort of considerations for prior therapies efficiencies, you've seen or specific levels of disease burden.
Michael I. Benkowitz: Yeah, thanks for the question. All of our strategic operations and managed markets activities report to Mike. So Mike, if you could provide some insight on that question, sure.
Yes, thanks for the question.
All of our strategic operations and managed market activities, how I'm reporting to Mike. So Mike if you could provide some insight on that question.
Sure.
Michael I. Benkowitz: So in terms of disease severity or prior therapies, we're not seeing any requirements there. As I think you know, this is really the first and only treatment that's on the market to treat the pulmonary hypertension associated with ILD. The other drugs are treating the underlying lung disease, so we're not seeing any issues there.
Joe.
In terms of.
Disease severity or.
Prior therapies, we're not seeing any requirements there.
So I think.
This is really the first and only treatment.
That's on the market to treat the pulmonary hypertension associated with ILD with ILD. The other drugs are treating current per treating an underlying 1.
On disease. So we're not seeing any issues there I would say on the on the kind of the private payer side of things.
Michael I. Benkowitz: I would say on the private payer side of things, those prescriptions that are coming in for PAH ILD patients are going through with little to no issue. Like I said, on the CMS side, we're waiting for CMS. Approval, which that process is ongoing. They've accepted our application. They're just going through their, like I said, policies and procedures, and we're optimistic and hopeful that that will happen shortly. So those patients, like I said, are eligible to apply for a patient assistance program. If they're eligible, they can come in and start, start, and then once we have CMS approval, presumably they could start, and become workable. Perfect. Thanks so much, Mike. Operator, next question, please.
Those.
Those prescriptions that are coming on for ph ILD patients are going through.
With little to no issue.
And then on like I said on the on the C&I side, we are waiting for the CNS.
Approval.
Which that process is ongoing and that accepted accepted our application and they're just going through there like I said their policies and procedures.
We're optimistic and hopeful that that's coming shortly so.
Those patients like I said are eligible to apply for a patient assistance program and then.
If they are eligible they can come in and start start to then once once we have CMS approval.
Presumably they could they could.
Become commercial patient.
Perfect.
Thanks, So much Mike Operator next question please.
Eun Kyung Yang: Your next question is from the line of Eun Yang of Jeff.
Your next question is from the line of UN Yang of Jefferies.
Eun Kyung Yang: Thank you, great quarter, congratulations. Recently, J&J received the approval of intravenous Optravi, so I want to ask you how you think this might or might not impact your modeling franchise. Thank you.
Thank you great quarter congrats.
Let me from Tony J&J and received approval on the Intel Venus, Charlie So I Wanna asking Lee.
Howard Dean.
Mike on my not in thank you Martine franchise. Thank you.
Martine A. Rothblatt: Thanks for the question, Eun. It was nice to hear your voice this morning, and thanks for the congratulations.
Thanks for the question you are nice to hear your voice this morning, and thanks for the congratulations.
Martine A. Rothblatt: We at present really would have no idea to comment about, you know, what kind of impact intravenous TRAVI might have. We do feel that the intravenous route is important, although the same amount of efficacy can be achieved with the subcutaneous route. And that's, of course, ordinarily much easier on the patient and certainly much easier on their ongoing lifestyle. So, you know, that's really the question to be assessed there.
We have at present really would have no idea to comment about.
What kind of impact intravenous <unk> might have.
We do feel that.
The intravenous route is important.
Although.
On the same amount of efficacy can be achieved with the subcutaneous route and that's of course.
Ordinarily much easier on the patient and can certainly much easier on their ongoing lifestyle.
So that's really the question to be assessed assess there.
Terence C. Flynn: In terms of... You know, over the longer term, I think what Mike was referring to, and I was referring to earlier, is that patients tend to have the best experience. According to these recent reports from both Europe and Japan, when they are on the parenteral route for a relatively short period of time, in order to aggressively reduce their pressures down below 40 millimeters of mercury and relieve the afterload on the right heart.
In terms of.
Over the longer term.
What Mike was referring to when I was referring to earlier.
That the patients tend to.
<unk>.
Have the best experience.
According to these recent reports from both of you.
Europe and Japan when they are on the current role route for a relatively short period of time in order to cash.
Aggressively reduce their pressures on down below 40 millimeters of Mercury and relieve the.
The.
Afterload on the right heart.
Terence C. Flynn: So whatever goes on there is, I would say, not part of the bigger picture of pulmonary hypertension because the total amount of time on parenteral therapy is relatively short compared to the total amount of time on Renatram or another oral therapy. So hopefully, that gives you a little bit of insight into what might be going on in the parenteral space.
So whatever goes on there is I would say not part of the biggest picture of pulmonary hypertension, because the total amount of time on the parental therapy.
Is relatively short.
Compared to the total amount of time on a rent a tram or another oral therapy.
Hopefully that gives you a little bit of insight into what might be going on in the parental.
Optionality space.
Terence C. Flynn: Your next question is from the line of Terence Flynn with Goldman Sachs.
Next question please.
Your next question is from the line of current plan with Goldman Sachs.
Martine A. Rothblatt: Hi. Thanks so much for taking the question. I was just wondering if you could comment at all about the breadth of prescribing you're seeing on the ILD side. Are you seeing a mix of both new prescribers and existing prescribers? And then the second part of the question is just how should we think about the treatment duration for the PHILD setting relative to PAH for Tyvaso. Thanks so much.
Hi, Thanks, so much for taking the question I was just wondering if you could comment at all about the breadth of prescribing youre seeing.
ILD side are you seeing on.
A mix of both new prescribers or existing prescribers and then the second part of the question is just how should we think about the treatment duration for the ph ILD setting relative to ph for Taipei. So thanks, so much.
Yeah.
Michael I. Benkowitz: Yeah, great question. Mike, would you like to handle that one? Sure. You know, on the prescribing breath, I mean, as it stands right now, I'm not surprised. And I think this got a little bit, I think we can adjust this question around whether the uptake is linear or not. It's, you know, more heavily weighted.
Great question.
Mike do you like to handle that 1.
Sure.
On the prescribing breadth.
As it stands right now and not surprising and I think that's got a little bit I think on <unk> question around.
What are the uptake is linear or not.
It's more heavily weighted so if the answer is we're getting both PHH and in ph ILD I would say is as we sit here today, it's more constant.
Michael I. Benkowitz: So if the answer is we're getting both PAH and PHILD, I would say, as we sit here today, it's more constant; the weight is more towards the PAH side. But we fully expect that as the watch evolves, as we continue to engage with physicians, that that will start to even out and maybe even potentially shift to PHILD. I think it's really going to depend on the center, where the physicians are, do they have a PAH clinic? And do that, you know, do those PHILD physicians want to actually treat versus refer? From our standpoint, we don't really care who treats them.
The way it is more towards the <unk> side.
But we fully expect that.
As the launch evolves as as we continue to engage with physicians that that will start to even out and maybe even potentially shift to <unk>.
<unk>.
I think it's really going to depend on on the center, where the physicians are do they have a ph clinic and do do those ph ILD physicians want to actually free versus refer from our from our standpoint, we.
We don't really care, who treats.
Michael I. Benkowitz: We do want to make sure that those patients are caught earlier in their disease because we think that this gets into the second part of your question. We think that the earlier they start on TIDASO, the more and the longer they can benefit. And so, you know, from a timing standpoint, in terms of, you know, duration of therapy, it's really going to be a question of where they are in their disease progression and what's sort of the dominant part of the disease.
Do want to make sure that those patients are getting caught earlier in their disease. Because we think that this gets into the second part of your question, we think that the earlier they start on today. So.
And the longer they can benefit and so from a timing standpoint in terms of duration of therapy is really going on I think the question of.
Where they are on their disease progression and what's sort of the dominant part of the diseases at the ILD or is it the pulmonary hypertension on it so if you've got it.
Michael I. Benkowitz: Is it the ILD or is it the pulmonary hypertension? And so if you've got, you know, really severe ILD, less on the PH, they go on TIDASO, I think, you know, those patients probably won't be on as long versus patients that are, you know, it's really more PAH, less on the ILD, where I think we would expect to see duration of treatment, you know, along the lines of what we see in, if not longer, in PAH.
Really severe ILD.
Les on the ph. They go on holiday. So I think those patients probably won't be on his long versus patients that are really more PIH less on the ILD, where I think we would expect to see duration of treatment along the lines of what we see.
If not longer and ph.
Martine A. Rothblatt: Perfect. Thanks so much, Mike. Excellent response and very comprehensive. So, operator, we've got time for just one more question.
Perfect. Thanks, so much Mike excellent response, and a very comprehensive.
Operator, we've got time for just 1 more question.
Jeff Meecham: Your final question is from the line of Jeff Meecham, founder of AmeriCorps. Good morning, this is Jason.
Your final question is from the line of Geoff Meacham from Bank of America.
Good morning. This is Jason on for Jeff. Thanks, So much for taking my question and congratulations on the quarter.
Jeff Meecham: Good morning, this is Jason on behalf of Jeff. Thanks so much for taking our question and congratulations on the quarter. Just thinking ahead in terms of the second half of the year, I know you were projecting growth, but there were some, you know, obvious one-time benefits, including Unituxin, the Japanese order, and OUS for Modulin, and just wanted to get your sense of how confident you are in kind of moving forward on the trajectory for the second half of the year. Thanks so much. Okay, Jeff.
Just thinking ahead in terms of the second half of the year on I know you were projecting growth, but there were some obvious from onetime benefits, including tucks from.
The Japanese order in O U S from module and just wanted to get your sense of how confident you are in kind of moving forward on the trajectory for the second half of the year. Thanks, So much.
Okay Jeff.
Martine A. Rothblatt: So, basically, you're just asking what we expect to see from here toward the end of the year. Well, sure, I was looking at the 10-Q, continued revenue growth in the second half of 2021 compared to 2020, given the one-time benefits of this quarter, and the confidence in the growth trajectory of the second half of 2021. Yeah, I don't think I would really buy into the hypothesis about a huge amount of one-time growth benefits this quarter.
So.
Basically youre just asking what we expect to see from here towards the end of the year.
Well sure I was looking at the 10-Q.
Continued revenue growth from the second half of 2021 compared to 2020.
Given the onetime benefits of this quarter.
<unk>.
Gross trajectory of the second half of 2021.
Yes, I don't think I wouldn't really buy into the hypothesis about huge amount of onetime gross benefits. This quarter I know Mike are referred to the warehousing of the remodel in patients, but I wouldn't like translate that into being a onetime benefit because those patients have to book their appointments.
Martine A. Rothblatt: I know Mike referred to the warehousing of the remodeling patients, but I wouldn't translate that into being a one-time benefit because those patients have to book their appointments with the doctors and come in, and there's going to be a continual upward swell coming from patients who were pushed back due to COVID. So I don't see this as a one-time event.
With the doctors and come in and this can be a continual.
Upward swell.
Coming from patients who were.
Pushed back due to Covid, So I don't I don't see this as a as a 1 time.
Martine A. Rothblatt: I really see it more as what Mike has been talking about, and we've been talking about that we're building steadily toward our goals of doubling the number of type ASO patients by the end of next year and having 25,000 patients by the end of 2025. And any given quarter, there's, of course, always ups and downs, but what you're seeing, I think, in this quarter is the new revenue track for United Therapeutics going forward, a revenue track that is consistent with doubling the number of type ASO patients by the end of next year and a revenue track that's consistent with having 25,000 patients by the end of 2025. Gotcha. Thanks so much for the color.
Hum.
And I really see it more as what Mike has been talking about we've been talking about debt. We're building steadily toward our goals of doubling the number of <unk> patients by the end of next year.
Having 25000 patients.
By the end of 2025.
In any given quarter there is of course always on.
<unk> helps them down.
But.
What you are seeing I think in this quarter is the new revenue track for United Therapeutics going forward, our revenue track, which is consistent with doubling the number of <unk> patients by the end of next year and our revenue track Thats consistent with having 25000 patients by the end of <unk>.
2025.
Got you. Thanks, so much for the color.
Michael I. Benkowitz: Excellent. Mike, did you want to add something about Unituxin to that last question? Yeah, I would just say, just to add maybe two granular points, so the Unitux, and I wouldn't look at it necessarily as a one-time event, as Martine mentioned, when I referenced the larger order from Japan, that really was a function of the fact that we had a larger than what we were forecasting because we weren't expecting the broader label than what we got.
Excellent.
Linked.
Mike did you want to add something about June rituxan on debt last question.
Yes, I would just say just to add maybe 2 maybe.
Granted on a point so unit toxin I wouldn't look at it necessarily being a 1 kind of that.
As Martine mentioned, the large the larger Japan, when I referenced the larger order from Japan that really was a function of the fact that we have largely on what we're forecasting because we weren't expecting the broader label.
Michael I. Benkowitz: So now that we have the broader label, I think the orders that we expect from Japan would be on par with what we saw in this quarter over time. I would also say on the international side, we always see some lumpiness there. Part of what we saw last year with the generic entrant into Europe was Ferrer, our partner, having to draw down their inventory. So that's been done. And I think we'll still see lumpy orders internationally, but over the course of a year, I think that'll level out. Exactly, exactly, Mike. I totally agree.
On what we got so now that we have the broader label I think the orders that we expect from Japan would be.
On par with what we saw.
And this quarter overtime.
I would also say on the on the international side.
We always see some lumpiness there part of what we saw last year with the generic entrant into.
Into Europe was.
<unk>, our partner having to draw down our inventory so that's been drawn down.
I think we'll still see lumpy orders internationally, but that over over the course of the year I think that will level out.
Exactly exactly my totally agree on.
Martine A. Rothblatt: Operator, you can please now wrap up. And we'd like to thank everybody for participating in our second quarter earnings call. It's been an extremely exciting quarter with all of the top-level results that Mike reported on the best in numerous different categories, solidly on track for our announced goals, and a very exciting pipeline to continue propelling our growth through the balance of the 2020s. Operator, you can now wrap up. Thank you. Thank you for participating in today's United Therapeutics Corporation meeting.
Operator, you can please now I'll wrap up and we'd like to thank everybody for participating in our second quarter earnings call. It's been a extremely exciting quarter with all of the top level results debt.
Mike reported on best in numerous different categories solidly on track for our announced goals and a very exciting pipeline to continue propelling our growth through.
Through the balance of the 2000 Twenty's operator, you can now wrap up.
Operator: Thank you. Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of the webcast will be available for replay for one week by visiting the events and presentations section of the United Therapeutics Industry Relations website at ir.unitha.com.
Thank you. Thank you for participating in today's United Therapeutics Corporation webcast, a rebroadcast of the webcast will be available for replay for 1 week.
And presentations section of the United Therapeutics Investor Relations website at IR Dot unit net dot com.
Approval may come at the first moment of the vaccine, at 9.34.
Yeah.