Operator: Thank you. Our next question will come from the line of Paul Choi from Goldman Sachs. Your line is open.
Paul Choi: Hi, good afternoon and thanks for taking our questions. I also want to ask on TransCon CNP for the — your Phase III ApproaCH study. Can you maybe just share what metrics or details you’ll provide with the topline results? And what is your medical conference presentation plans for that data? And then second, on the regulatory strategy. Can you maybe just help us understand the urgency to file the NDA in the same quarter? Just kind of what the reasoning behind that is just potentially concerned about a full approval for BioMarin’s, VOXZOGO? And just maybe some color there would be helpful. Thank you very much.
Jan Mikkelsen: It’s pretty simple about the filing. Ascendis’ process to do it as fast as possible in the highest quality. And if anyone else is working with the company and not living up to this aspect, they should leave. So, if I can get someone to do the filing in the same quarter, we get the data, we should do it. When we come to the Phase III data, yes, we have a primary endpoint because that got established as a traditional way of our primary endpoint is that really an rational endpoint for achondroplasia? I have my doubt. I think it’s more a third grade marker annualized height velocity. A treatment is to change the comorbidity of the disease. So, the primary end point for me is like a surrogate mother as [indiscernible] is for adult growth hormone deficiency.
This is not really the key treatment objective in adult growth hormone deficiency. You see other aspect of the treatment that’s more important. But it’s an established endpoint. So, when we go to the secondary endpoint, and I said it’s really very, very, very simple in my text. We’re going in and look on the effect on comorbidities. And we do it on a lot of different anchors. And we want to be sure that we’re calling in the best possible way. And the best possible way we can do it is to look on the comorbidities basic that is developed into what we can measure in different physical function, daily function. We do a lot of radiological because we know the texture of the child needs to be perfect. So, we’re 100% sure, we had developed different health-related outcome measuring.
And I believe that taking all this aspect into it, we will find benefit that never had been seen and I hope it will both come for quality of life, body composition, physical function, and also the radiological endpoint that basically providing a different way of how we improve the texture.
Paul Choi: And on the medical meeting–
Jan Mikkelsen: I think the summary are not driven by medical meetings. There are some people that are saying that delay data out because of medical meeting. I think when you have material data, you should come out it, so everyone can see the data. We are not waiting with disclosing data just because of medical meetings.
Operator: Thank you. Our next question comes from the line of Andreas Argyrides from Wedbush. Your line is open.
Andreas Argyrides: Hey guys. Congrats on all the progress and thanks for taking our questions. Just a couple here from us. When you think about CNP, can you give us a little bit of your thoughts around the rationale to expand into adults with achondroplasia instead of going into hypochondroplasia like the other companies in this space? And then looking at VOXZOGO and the growth that they’ve seen primarily driven by ex-US. Maybe you can give us a sense of why it’s offered off to a slower start in the US? And is it driven by the fact that they have been focusing on height versus other quality of life measures? And then just one last one on the oncology programs. If you don’t find a partner to bring these programs, so would you consider spinning them off like you did with the ophthalmology programs? Thanks.
Jan Mikkelsen: Okay. Let me start on the last one because it’s very easy. We are here to do the optimal for the patient to get our product being penetrated to as many as possible patients. And we believe that we are in a position when we have seen all the data that will come out end of this year. We already have seen the interest in our programs now. We feel pretty confident we will do the optimum where we see the fastest, best way to come out to the patient and we create most value for Ascendis shareholders. That will be the driver from our decision. Then you had two comments to CNP. The first one was.
Andreas Argyrides: Why not hypochondroplasia?
Jan Mikkelsen: Why not hypochondroplasia, that is a pretty good interesting perspective for us because this is something we are discussing a lot because hypochondroplasia is a mild form for achondroplasia. And I think we will not move over to hypochondroplasia before we really have provided the optimal treatment, the best treatment that really addressing comorbidity in achondroplasia. Why jump over to something where your basic have not provided a treatment option, but potentially only providing some few linear growth. And the linear you could get that for the last 20 years, just by giving daily growth hormone. So, I don’t see that as really a treatment benefit that is just providing linear growth. What we’re trying to address is basic — the comorbidity of the disease.
And we will continue to do that until we find the best possible solution to give them a meaningful improvement in quality of life. And the other thing is that I think these two things are related to each other. I don’t believe being short is a disease, even I’m pretty tall. So, I actually don’t believe being short is a disease. And I have to think you should never consider short to be in disease. I believe that taking just a linear growth, in some way is more appealing in some countries than others. And definitely in US, it’s not a disease to be sure.
Operator: Thank you. And our next question will come from the line of Yaron Werber from TD Cowen. Your line is open.
Unidentified Analyst: Hey guys. This is [Indiscernible] on for Yaron. Thanks for taking our question. Just maybe hoping to get your thoughts on the emerging competitive landscape for hypopara, you’re clearly had market, but there’s another one PTH analog in Phase III. And then there are a couple of others in the pipeline behind it, some looking to develop oral candidates or once-weekly candidates. So just any thoughts or comments there would be great. Thank you.
Jan Mikkelsen: Thanks a lot. When I took a look from endocrinology perspective and look on the biological system in the body, the complexity of that, how really to provide an treatment of an hormone replacement therapy in a situation where the biology has been extremely, extremely multiple organs effect, having the right growth, not too hyper, not too hypo and see what we did in — with SKYTROFA. We provided the somatropin molecule that really are being produced by the endogenous client. And I believe — when I also go to hypopara, this patient needs to have a physiological level of PTH than providing the same mode of action. I actually went to a conference and heard some of the questions for physicians on some of the other competitive products.
And one of the key questions that came up, we know PTHs have effect on so many, many different organs. When you change the entire mode of action, how can you really prove and believe you can create the same normal physiological system that you will expect to get with a normal endogenous PTH. First, how we designed TransCon PTH to provide a normal same as endogenous PTH with exactly the same part to give the mode of action in the physiological levels. And I don’t think any treatment that changing that will provide the same holistic benefit on all aspects of hypopara for any patient.
Unidentified Analyst: Thank you.
Operator: Thank you. And our next question comes from line of Leland Gershell from Oppenheimer. Your line is open.
Leland Gershell: Hey thanks for taking our questions. Two from us, one each on SKYTROFA and TransCon PTH. On SKYTROFA, Jan, you mentioned in the past commentary about the decreasing investment among the daily growth hormone companies and products. Wanted to just hear any updated color you may be able to share with respect to the marketplace in terms of the dailies if that’s a continuing trend that you’re seeing? With respect to TransCon PTH, as we anticipate approval and then launch third quarter this year, if you could remind us the number of patients you have available in the states between both those in the open-label studies as well as those who are in the EAP? Thank you.
Jan Mikkelsen: Yes. You’re right. We have discussed a lot what we call the long-term or many years perspective of the consolidation in the growth hormone market. And the trend is happening exactly as expected. Specific with the entrance of the two other long-acting the basic, the daily growth hormone is starting to disappear more and more. Because these two companies that is providing them the key element where we have seen them taking market is basically taking their own product, their own product on the daily growth hormone class and then transform over to the long-acting where we take it from everywhere because our improved treatment outcome. So, I see our market share being basic, the same as we somewhere predicted from three, four years.
