Good afternoon. My name is Liisa Bayko. I'm a SMID Cap analyst here at Evercore ISI, and welcome to HealthCONx. I'm joined on stage here by Rick and Aziz from Theravance. Theravance is a company that has a marketed drug and a pipeline asset. We're going to get into all those details. I'm going to turn it over to Rick. I think we'll start with a company overview.
Sure. Thanks, Liisa, and thanks Evercore for inviting us here to the meeting. Theravance Biopharma, you know, exciting, obviously exciting company, and we're at an exciIing point in our evolution with a marketed product, YUPELRI. We market it in conjunction with Viatris in the United States to treat COPD. And then we have our pipeline product, ampreloxetine, which is targeting a rare neurological condition called multiple system atrophy. And patients with multiple system atrophy develop neurogenic orthostatic hypotension. Ampreloxetine treats the neurogenic orthostatic hypotension. We're in phase three. We'll talk quite a bit about that today. And then we have worked for many years with GSK on a medicine called Trelegy. And we have some economic rights on the tail of Trelegy milestones, as well as royalties that come back to us at the end of the decade. So we're in a very strong financial position.
Aziz can get into that strong financial position, exciting portfolio with ampreloxetine in phase 3, and looking forward to finishing the open label and enrolling the last patient in the open label portion of the phase 3 study in the middle of next year.
Okay, great. Let's start with YUPELRI, your marketed product. You had really significant growth last quarter. So just stepping back, tell us a little bit more about YUPELRI, where it fits into the COPD market, and why you're seeing such great traction.
Yeah, so YUPELRI is a long-acting muscarinic antagonist, one of really the three classes of inhaled medicines that treat chronic obstructive pulmonary disease, or COPD. And YUPELRI is the only long-acting muscarinic antagonist that's delivered by a nebulizer. And nebulizers are used by about one in ten COPD patients. And that particular portion of the COPD patients' patient market has used nebulizers at that rate for the last 25 years. Regardless of what new technology comes out on the handheld side, about one in ten COPD patients use nebulizers. YUPELRI's gold standard therapy, meaning all COPD patients should receive a long-acting muscarinic antagonist. YUPELRI is the only product like that that can be delivered in a nebulizer. So we have a unique product. It's the only product like it, again, in a nebulizer.
And we sell both. We sell into the hospital, and our partner Viatris sells into the community. Our role in the hospital is really to get the product onto formulary, achieve therapeutic interchange. Anytime a drug of a similar class is prescribed, it's shifted to YUPELRI. And then most importantly, get the patients out of the hospital on YUPELRI as they go into the community, and then keep those patients on YUPELRI into the community. I think the success is. It's really driven by the quality of the product. We hear from patients. They feel it. They feel YUPELRI helps them breathe better. So it really performs consistent with the product's promise. And it occupies a space that no other product can occupy, which is a nebulized LAMA.
It's really up to us and our partner to continue to execute, because the growth from here is, we're really just still scratching the surface of the opportunity. Aziz, would I miss?
No, just to put the financials perhaps in perspective. Last quarter, $62.2 million of net sales, so close to $250 million annual run rate. From a profitability perspective, the cash profit on the brand to Theravance alone is about $10 million a quarter, so $40 million, call it annual run rate of cash profit. It's a bit challenging to digest from a P&L perspective. The collaboration revenue is a bit challenging, but that's the financial perspective. And any incremental dollar of sales, 35% of it flows to the bottom line on top of that $40 million annual run rate of cash profit. So if you look forward into next year and beyond, assuming the cost base stays flat, it may actually go down a little bit. The margins should expand significantly more than they are today. So it's a really nice product for Theravance.
The profits are so substantial to us, it's essentially funding our ampreloxetine phase 3 study, Cypress, that Rick can get into in a little bit. So that from a bottom line perspective, we're only burning $3 million-$4 million cash per quarter, which is obviously pretty unique for a biotech company. So that's really setting us up for this transformational event, hopefully kind of towards the end of next year in the Cypress data readout.
Okay, great. Just back to YUPELRI, and we'll get into ampreloxetine in a minute. But you said 10% of patients are on nebulized products, and that's pretty consistent. Why that? You talked about all the introduction of these new technologies that are obviously more convenient. Why do some people choose nebulized?
I think, you know, a nebulized patient tends to be an older patient, tends to have more advanced COPD, have a mechanical issue or coordination issue with using a dry powder inhaler or a metered dose inhaler to get their medicine. And the aspect that is attractive about nebulization to them or to their caregiver is they get. They're confident they're getting the medicine. And they're getting five to eight minutes of nebulization. They're getting the medicine. They're getting all the medicine that they need for a drug like YUPELRI for the entire day. So if one five to eight minute administration, they can breathe better for the entire day. And they don't have to fight the mechanical issues that might be present with a handheld device.
I think in general, that's why this ratio of about one in ten patients using nebulization has remained so constant, almost regardless of what new technology, and there has been significant new technology introduced in handheld, regardless of that, one in ten patients use nebulizers.
You've been pretty involved in the therapeutic interchange in the hospital, which is super interesting. Can you maybe talk about why people should be switched to YUPELRI automatically when they prescribe something else?
Yeah, so you know we've got about 5,000 acute care hospitals in the United States, and about 1,200 of those hospitals for us are what we call high target hospitals. And of that 1,200, about 20%-23%, we have been able to achieve a therapeutic interchange, which means whenever a long-acting muscarinic antagonist is written inside that hospital system, a prescription for one, it's automatically shifted to YUPELRI. And we've been able to do that by first getting the product on formulary and getting the product on formulary with a very thorough understanding of the benefits to the institution. Many times it's replacing either a medicine delivered twice a day or a medicine delivered four to six times a day. So the respiratory therapy savings that a facility is able to enjoy by going to YUPELRI is quite significant.
The other aspect of it is just the characteristics of the product. I mean, patients will say, "I feel better," and just a once a day administration of a product that is, and saying they feel better back to the nurse, the therapist, their pulmonologist, that's another positive attribute, and finally, we reduce waste significantly because YUPELRI is sold in unit of use. So hospitals are only buying what they need, and they're not buying seven days of therapy or 28 days of therapy in a potential handheld product when the average COPD patient only spends three and a half days in a hospital. It's that both product characteristics as well as economic benefits that's allowed us to position this product to get on formulary and then to achieve that therapeutic interchange.
And in fact, there are actually papers that are being published on how to achieve an all nebulization protocol within a hospital, primarily because the patient knows they're getting therapy. If they take a nebulizer, there's no additional risk. We've shown a viral transmission or anything like that. And for a product like YUPELRI, it's once a day.
Wonderful. Okay, you talked about kind of it's really on you and your partner to kind of execute because the market is there. Sort of where is the opportunity for growth?
Yeah, I think there's two big segments of opportunity. One of them is just continued penetration into the community in those patients, one in ten patients that in fact are candidates for nebulization, identification of the patient. And if that patient is currently on a nebulized LABA or long-acting beta agonist, making sure in the community that YUPELRI is added to that long-acting beta agonist so that they can literally get gold standard therapy, a LAMA LABA. That's one big segment of opportunity for us. The second segment is making sure that every patient that we put on in the hospital, that patient is discharged with a prescription for YUPELRI, and that prescription is filled, and there's a follow-up plan for that patient post-discharge.
And I think we're working closely with Viatris and the discharge nurses in key hospitals and discharge planners to affect this such that they go right into care with some sort of specialty distributor or durable medical equipment supplier, such that they can achieve continuity of care. Now, the hospitals know that this is the best way to treat these patients, because if you can ensure continuity of care, it reduces the probability that the patient will return with an exacerbation. So it's both discharge, capturing all those patients that are on YUPELRI, getting them discharged into the community on YUPELRI, and then adding that LAMA to a LABA therapy once they're in the community.
How big of a product do you think this can be?
You know, as Aziz said, we're running at about a $250 million run rate today. I mean, we're clearly, we think that there's still significant opportunity for this product going forward. Obviously, you know, the product has intellectual property out to 2039. There's a long runway of growth of expanding on that baseline of 250 that we've got today.
Excellent. Okay, let's turn to ampraloxetine in the Cypress study. So first of all, just like lay of the land, tell us about NOH and then a little bit more about the Cypress study.
Sure. Patients with multiple system atrophy develop a dysautonomia, or their autonomic nervous system begins to malfunction or dysfunction. Part of that causes these patients to have neurogenic orthostatic hypotension. This dysautonomia affects many parts of their lives. It affects their vision. It affects their strength. They become dizzy, et cetera. What ampreloxetine does for these patients with MSA and NOH is it increases the levels of norepinephrine in the synapse, which then increases the blood pressure in these patients. It doesn't make them hypertensive, but it makes it such that when they go from a sitting to a standing position, or in fact lying down to a sitting position, their blood pressure is able to adjust to achieve blood perfusion into their organ systems, which reduces all these symptoms. We measure these symptoms through something called a composite score, OHSA composite score.
Ampraloxetine as a norepinephrine reuptake inhibitor simply increases the levels of norepinephrine to the right level, such that these patients' symptoms of orthostatic hypotension improve significantly. At least that's what we've seen in an earlier study. We're not talking about simply somebody feeling better, but this is a difference between someone being forced to stay on a couch or stay in a chair versus being able to go up and garden or go out and enjoy parts of their life. The disease itself is so debilitating that just being able to engage with their family members being up and treating this orthostatic hypotension provides a significant improvement to their lives.
So tell us more about the Cypress study?
The Cypress study is a mimic. We're trying to mimic an earlier study that we did, Study 170. With Cypress, what we have is a 12-week open label period followed by an eight-week randomized withdrawal period. About a little over 100 patients coming into the open label to get about 60 out of the randomized withdrawal period. They come in, they go through the open label period.
Everyone's on drug.
Everybody's on drug. They come in, everybody's on drug. There's an enrichment measurement about midway through the open label period to really make sure that the patient can record the symptom improvement. If they hit this enrichment criteria, then they progress to the end of the open label, and then they're randomized either to placebo or they stay on ampraloxetine. At the end of the eight-week period, we measure the difference between placebo and those patients on ampraloxetine using the OHSA composite score as the primary endpoint. Now, so what makes a difference? A difference of about one point in a composite score has shown to be clinically significant.
What is in the composite score?
So the composite score covers weakness, vision, dizziness, coat hanger pain, and stability and one other metric. So it's really those six measures that is combined in the composite score, and we're seeking to make a one point or more improvement. In the earlier study, we saw an improvement of 1.6 points.
Tell us about the competitive landscape for NOH?
You want to talk about that, Aziz?
Yeah, and before that, just to plug, we did an investor event earlier this year focused on ampreloxetine. So I would encourage everyone to take a look where we went through the clinical rationale, MSA, NOH, ampreloxetine. We had two excellent KOLs speak, and they did go through the unmet need and the other products that are out there, but really nothing out there that works at all. A lot of the times people talk about droxidopa, that's formerly known as Northera. That has, I think they had their confirmatory study last year essentially failed. They were required to do one. fludro and midodrine are also generic competitors out there, significant shortcomings for all of these drugs. And Rick can talk to them a bit more, but those are kind of the competitive landscape we're going against. There's really nothing out there. So significant unmet need for ampreloxetine.
In our study, in the Cypress study, patients are on fludrocortisone. They're on rescue midodrine. Then ampreloxetine is being added to those two therapies. I think we're set up to be successful based on the earlier data. We're set up to show an improvement in a composite score, hopefully with the study, which no other medicine has shown. That should enable an uptake because we don't have competition in the space, and there's really nothing for these patients today.
Have you done any pricing research?
We're just beginning on pricing research, meeting with payers, doing payer advisory boards, and I think we're going to land in a rare neurological product pricing band, which is pretty encouraging.
Which is what kind of range?
I think we're not done yet. You're looking at $200,000 or greater per year price. I think for the value that this delivers, i.e., this actually makes people mobile from immobile. This is a great trade-off for an orphan condition, 40,000 patients with MSA and NOH in the United States. If we capture a piece of that 40,000 at rare neurological pricing bands, then it promises to be a very valuable product.
This is something you would market yourself.
Yeah, our plan is really to prepare for the product. We'll do more work in 2025 than we did in 2024. Hopefully get data around the end of 2025 or early 2026, and then set the product up for review and approval, and then be prepared to launch the product post an approval.
Your IP on.
Existing IP goes out to 2037 for the product.
Okay. And then you talked about you're getting through the open label period. In terms of that enrichment, what percentage of patients have kind of met the enrichment criteria?
Yeah, most of the patients meet the enrichment criteria. So, they go forward, and enrichment criteria is OHSA 1. It's not the composite score. It's just simply dizziness, and it's simple to measure. That's why we chose dizziness as a.
In other words, they can detect the dizziness.
That's right. That's right, and it could be used, at the time, either measured in a remote setting or in the clinic, and the other aspect of dizziness is the market is somewhat sensitive to dizziness, meaning the treaters, such as if we have an effect on dizziness, it's a pay-to-play, and then the rest of the composite score is a terrific benefit to patients.
Are you thinking about this as an ex-U.S. product as well?
We are both. It has opportunity in Europe as well as Japan and China. If you look at the percent of population with MSA in all of those geographies, it's about the same.
Okay. Well, great. I think we're out of time, but that was a really good discussion. I really appreciate it.
Yeah, thank you so much, Liisa.
Good. Market a drug and a pipeline asset. We're going to get into all those details. I'm going to turn it over to Rick. I think we'll start with a company overview.
Sure. Thanks, Liisa, and thanks, Evercore, for inviting us here to the meeting. Theravance Biopharma, obviously exciting company, and we're at an exciting point in our evolution with a marketed product, YUPELRI. We marketed it in conjunction with Viatris in the United States to treat COPD, and then we have our pipeline product, ampreloxetine, which is targeting a rare neurological condition called multiple system atrophy, and patients with multiple system atrophy develop neurogenic orthostatic hypotension. Ampreloxetine treats the neurogenic orthostatic hypotension. We're in phase three. We'll talk quite a bit about that today, and then we have worked for many years with GSK on a medicine called Trelegy, and we have some economic rights on the tail of Trelegy milestones as well as royalties that come back to us at the end of the decade, so we're in a very strong financial position. Aziz can get into that.
Strong financial position, exciting portfolio with ampreloxetine in phase three and looking forward to finishing the open label and really the last patient in the open label portion of the phase three study in the middle of next year.
Okay, great. Let's start with YUPELRI, your marketed product. You had really significant growth last quarter. So just stepping back, tell us a little bit more about YUPELRI, where it fits into the COPD market and why you're seeing such great traction.
Yeah, so YUPELRI is a long-acting muscarinic antagonist, one of really the three classes of inhaled medicines that treat chronic obstructive pulmonary disease or COPD. And YUPELRI is the only long-acting muscarinic antagonist that's delivered by a nebulizer. And nebulizers are used by about one in 10 COPD patients. And that particular portion of the COPD patient market has used nebulizers at that rate for the last 25 years. Regardless of what new technology comes out on the handheld side, about one in 10 COPD patients use nebulizers. YUPELRI's gold standard therapy, meaning all COPD patients should receive a long-acting muscarinic antagonist. YUPELRI's the only product like that that can be delivered in a nebulizer. So we have a unique product. It's the only product like it, again, in a nebulizer. And we sell into the hospital, and our partner Viatris sells into the community.
Our role in the hospital is really to get the product onto formulary, achieve therapeutic interchange. Anytime a drug of a similar class is prescribed, it's shifted to YUPELRI. And then most importantly, get the patients out of the hospital on YUPELRI as they go into the community and then keep those patients on YUPELRI into the community. I think the success is it's really driven by the quality of the product. We hear from patients, they feel it. They feel YUPELRI helps them breathe better. So, it really performs consistent with the product's promise, and it occupies a space that no other product can occupy, which is a nebulized LAMA. And it's really up to us and our partner to continue to execute because the growth from here is we're really just still scratching the surface of the opportunity. Aziz, would I miss?
No, just to put the financials perhaps in perspective. Last quarter, $62.2 million of net sales, so close to $250 million annual run rate. From a profitability perspective, the cash profit on the brand to Theravance alone is about $10 million a quarter, so $40 million, call it annual run rate of cash profit. It's a bit challenging to digest from a P&L perspective. The collaboration revenue is a bit challenging, but that's the financial perspective. And any incremental dollar of sales, 35% of it flows to the bottom line on top of that $40 million annual run rate of cash profit. So, if you look forward into next year and beyond, assuming the cost base stays flat, it may actually go down a little bit. The margins should expand significantly more than they are today.
It's a really nice product for Theravance, and the profits are so substantial to us. It's essentially funding our ampreloxetine phase three study, Cypress, that Rick can get into in a little bit. That from a bottom line perspective, we're only burning $3 million or $4 million cash per quarter, which is obviously pretty unique for a biotech company. That's really setting us up for this transformational event, hopefully kind of towards the end of next year in the Cypress data readout.
Okay, great. Just back to Yupelri, and we'll get into ampreloxetine in a minute. But you said 10% of patients are on nebulized products, and that's pretty consistent. Why that? You talked about all the introduction of these new technologies that are obviously more convenient. Why do some people choose nebulized?
I think a nebulized patient tends to be an older patient, tends to have more advanced COPD, have a mechanical issue or coordination issue with using a dry powder inhaler or a metered-dose inhaler to get their medicine. The aspect that is attractive about nebulization to them or to their caregiver is they're confident they're getting the medicine. They're getting five to eight minutes of nebulization. They're getting the medicine. They're getting all the medicine that they need in a drug like YUPELRI for the entire day. If one five-to-eight-minute administration, they can breathe better for the entire day. They don't have to fight the mechanical issues that might be present with a handheld device.
I think in general, that's why this ratio of about one in 10 patients using nebulization has remained so constant, almost regardless of what new technology, and there has been significant new technology introduced in handheld, regardless of that, one in 10 patients use nebulizers.
So you've been pretty involved in the therapeutic interchange in the hospital, which is super interesting. Can you maybe talk about why people should be switched to YUPELRI automatically when it's prescribed something else?
Yeah. So, we've got about 5,000 acute care hospitals in the United States, and about 1,200 of those hospitals for us are what we call high target hospitals. And of that 1,200, about 20%, 23%, we have been able to achieve a therapeutic interchange, which means whenever a long-acting muscarinic antagonist is written inside that hospital system, a prescription for one, it's automatically shifted to YUPELRI. And we've been able to do that by first getting the product on formulary and getting the product on formulary with a very thorough understanding of the benefits to the institution. Many times, it's replacing either a medicine delivered twice a day or a medicine delivered four to six times a day. So, the respiratory therapy savings that a facility is able to enjoy by going to YUPELRI is quite significant. The other aspect of it is just the characteristics of the product.
I mean, patients will say, "I feel better." And just a once-a-day administration of a product and saying they feel better back to the nurse, the therapist, their pulmonologist, that's another positive attribute. And finally, we reduce waste significantly because YUPELRI is sold in unit of use. So, hospitals are only buying what they need, and they're not buying seven days of therapy or 28 days of therapy in a potential handheld product when the average COPD patient only spends three and a half days in a hospital. It's that both product characteristics as well as economic benefits that's allowed us to position this product to get on formulary and then to achieve that therapeutic interchange. And in fact, there are actually papers that are being published on how to achieve an all nebulization protocol within a hospital, primarily because the patient knows they're getting therapy.
If they take a nebulizer, there's no additional risk. We've shown a viral transmission or anything like that. And for a product like YUPELRI, it's once a day.
Wonderful. Okay. You talked about kind of it's really on you and your partner to kind of execute because the market is there. Sort of where is the opportunity for growth?
Yeah, I think there's two big segments of opportunity. One of them is just continued penetration into the community in those patients, one in 10 patients that in fact are candidates for nebulization, identification of the patient, and if that patient is currently on a nebulized LABA or long-acting beta agonist, making sure in the community that YUPELRI is added to that long-acting beta agonist so that they can literally get gold standard therapy, a LAMA LABA. That's one big segment of opportunity for us. The second segment is making sure that every patient that we put on in the hospital, that patient is discharged with a prescription for YUPELRI, and that prescription is filled, and there's a follow-up plan for that patient post-discharge.
And I think we're working closely with Viatris and the discharge nurses in key hospitals and discharge planners to affect this such that they go right into care with some sort of specialty distributor or durable medical equipment supplier such that they can achieve continuity of care. Now, the hospitals know that this is the best way to treat these patients because if you can ensure continuity of care, it reduces the probability that the patient will return with an exacerbation. So, it's both discharge, capturing all those patients that are on YUPELRI, getting them discharged into the community on YUPELRI, and then adding that LAMA to a LABA therapy once they're in the community.
So how big of a product do you think this can be?
You know, as Aziz said, we're running at about a $250 million run rate today. I mean, we're clearly, we think that there's still significant opportunity for this product going forward. Obviously, the product has intellectual property out to 2039. There's a long runway of growth of expanding on that baseline of 250 that we've got today.
Excellent. Okay. Let's turn to Ampraloxetine in the Cypress study. So first of all, just lay of the land, tell us about NOH and then a little bit more about the Cypress study.
Sure. Patients with multiple system atrophy develop dysautonomia, or their autonomic nervous system begins to dysfunction. Part of that causes these patients to have neurogenic orthostatic hypotension. This dysautonomia affects many parts of their lives. It affects their vision. It affects their strength. They become dizzy, et cetera. Ampreloxetine does for these patients with MSA and NOH is it increases the levels of norepinephrine in the synapse, which then increases the blood pressure in these patients. It doesn't make them hypertensive, but it makes it such that when they go from a sitting to a standing position or in fact lying down to a sitting position, their blood pressure is able to adjust to achieve perfusion, blood perfusion into their organ systems, which reduces all these symptoms. We measure these symptoms through something called the OHSA composite score.
Ampreloxetine as a norepinephrine reuptake inhibitor simply increases the levels of norepinephrine to the right level such that these patients' symptoms of orthostatic hypotension improve significantly. At least that's what we've seen in an earlier study. We're not talking about simply somebody feeling better, but this is a difference between someone being forced to stay on a couch or stay in a chair versus being able to go up and garden or go out and enjoy parts of their life. The disease itself is so debilitating that just being able to engage with their family members being up and treating this orthostatic hypotension provides a significant improvement to their lives.
So tell us more about the Cypress study?
So, the Cypress study is a mimic. We're trying to mimic an earlier study that we did, Study 170. And with Cypress, what we have is a 12-week open label period followed by an eight-week randomized withdrawal period. About a little over 100 patients coming into the open label to get about 60 out of the randomized withdrawal period. So, they come in, they go through the open label period.
So, everyone's on drug.
Everybody's on drug. They come in, everybody's on drug. There's an enrichment measurement about midway through the open label period to really make sure that the patient can record the symptom improvement, and if they hit this enrichment criteria, then they progress to the end of the open label, and then they're randomized either to placebo or they stay on ampreloxetine, and at the end of the eight-week period, we measure the difference between placebo and those patients on ampreloxetine using the OHSA composite score as the primary endpoint. Now, so what makes a difference? A difference of about one point in a composite score has shown to be clinically significant.
What is in the composite score?
So, the composite score covers weakness, vision, dizziness, coat hanger pain, and stability and one other metric. So, it's really those six measures that is combined in the composite score, and we're seeking to make a one point or more improvement. In the earlier study, we saw an improvement of 1.6 points.
So tell us about the competitive landscape for NOH?
You want to talk about that, Aziz?
Yeah. And before that, just a plug, we did an investor event earlier this year focused on ampraloxetine. So I would encourage everyone to take a look where we went through the clinical rationale, MSA, NOH, ampraloxetine. We had two excellent KOLs speak, and they did go through the unmet need and the other products that are out there, but really nothing out there that works at all. A lot of the times people talk about droxidopa, that's formerly known as Northera. That has, I think they had their confirmatory study last year essentially failed. They were required to do one. fludro and midodrine are also generic competitors out there, significant shortcomings for all of these drugs. And Rick can talk to them a bit more, but those are kind of the competitive landscape we're going against. There's really nothing out there. So significant unmet need for ampraloxetine.
In our study, in the Cypress study, patients are on fludrocortisone. They're on rescue midodrine. Then ampreloxetine is being added to those two therapies. I think we're set up to be successful based on the earlier data. We're set up to show an improvement in a composite score, hopefully with the study, which no other medicine has shown. That should enable an uptake because we don't have competition in the space, and there's really nothing for these patients today.
Have you done any pricing research?
We're just beginning on pricing research, meeting with payers, doing payer advisory boards, and I think we're going to land in a rare neurological product pricing band, which is pretty encouraging for us.
Which is what kind of range?
I think we're not done yet.
I understand.
But you're looking at $200,000 or greater per year price. And I think for the value that this delivers, i.e., this actually makes people mobile from immobile. This is a great trade-off for an orphan condition, 40,000 patients with MSA and NOH in the United States. And if we capture a piece of that 40,000 at rare neurological pricing bands, then it promises to be a very valuable product for the community.
This is something you would market yourself.
Yeah. Our plan is really to prepare for the product. We'll do more work in 2025 than we did in 2024. Hopefully get data around the end of 2025 or early 2026 and then set the product up for review and approval, and then be prepared to launch the product post an approval.
Your IP on.
IP goes out, existing IP goes out to 2037 for the product.
Okay. And then you talked about you're getting through the open label period. In terms of that enrichment, what percentage of patients have kind of met the enrichment criteria?
Yeah, most of the patients meet the enrichment criteria. So they go forward and enrichment criteria is OHSA 1. It's not the composite score. It's just simply dizziness. That's why we chose dizziness as a.
In other words, they can detect the dizziness.
That's right. That's right. And it could be, at the time, could be used either measured in a remote setting or in the clinic. And the other aspect of dizziness is the market is somewhat sensitive to dizziness, meaning the treaters, such as if we have an effect on dizziness, it's a pay-to-play, and then the rest of the composite score is a terrific benefit to patients.
Are you thinking about this as an ex-US product as well?
We are both. It has opportunity in Europe as well as Japan and China. If you look at the percent of population with MSA in all of those geographies, it's about the same.
Okay. Well, great. I think we're out of time, but that was a really good discussion and really appreciate it.
Yeah, thank you so much, Liisa.