I believe that is a key element for how we really can work with that and help the patient group here. And I think when we saw the data, we believe that is first time we really seen any compound that basically ever, ever have shown this effect. Related to the labeling, we are — did this year as a post hoc analysis. You can say, yes, we should have included in our key [indiscernible] there already from the beginning when we saw this major impact, but still for us, it was really unbelievable when we really have seen the data and how well it is. And we will soon when we are presenting this data into publication to interaction with patient groups. So they really also understand the benefits that can get for TransCon PTH in there. We will go out and also talk with regulatory agencies.
But we also believe that having it in peer reviewed publication is the key element for us really to be in a position really to communicate about this fantastic data.
Andreas Argyrides: Fantastic. And then, comments on the kidney stones?
Jan Mikkelsen: The kidney stones, I believe, I have not seen data on that point, but potentially I can ask them if there is a post hoc analysis, we also can do a specific related to kidney stones. I cannot recall I’ve seen anyone.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of David Lebovitz with Citi. Your line is open.
David Lebovitz: Thank you very much for taking my question. Could you run us through the differences of the new linker you were talking about? And you have a preclinical data for a GLP-1. When might we see that candidate move towards the clinic? Additionally, what other types of candidates do you see applying this towards?
Jan Mikkelsen: Yeah. We are really, really extremely [appreciative] (ph) of this expanding of the TransCon technology, because we believe we need to be everywhere where the patients are. And it’s building on the same principle again. So, when you think about the TransCon linker, they are identical or exactly the same kind that you have seen on both TransCon growth hormone TransCon PTH and TransCon CMP all the other project also in oncology, all the same we can use are the same linker. The only changes that we had developed what we call a novel carrier system. This novel carrier system, we wanted to make one example on. And one example was to go into a GLP-1 analog, because there you really demand really, really, really high level of capability to produce mass production of drugs.
You need to do it on extremely low cost. So your basic potential have a [indiscernible] more non-expensive manufacturing process by having less injection and other things like that. And it was why we developed the new novel platform. We believe it can be used many, many places. And specific, we can have 10 targets in metabolic diseases. We have 10 targets now looking on in cardiovascular and other things like that. So it’s really moving up and open up for scientists to move into new areas that we basically not really couldn’t address with the two TransCon carrier platform we already had established our soluble carrier and the hydrogel carrier. Thank you for taking my questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.
Unidentified Analyst: Hi. This is Joyce on for Yaron. Thanks so much for taking our question. Maybe just a follow-up first on the previous question for your GLP-1. If you could just clarify whether you plan to file an IND in the future? And if so, how do you think this will fare relative to some of the drugs from your competitors with double and triple [MOAs] (ph)? And then I just had a follow-up on SKYTROFA.
Jan Mikkelsen: Yeah. First of all, we — as we said, we used semaglutide because we felt there was a good the GPL-1 analog really to make an example of our tech new technology platform. but also at the same time, semaglutide is also an interesting product opportunity itself and with the TransCon technology be released a complete unmodified semaglutide. So, we’re not changing the mode of action because we are long-acting product technology. Would make it both unique related to clinical trials, but also relate unique to regulatory pathways. So from that perspective is when we look in our pipeline, we are still discussing a lot with the optimal product opportunities because we can also utilize other GPL-1. So, this is where we still are having internal discussion where we really want to position it that and the day we really are moving it into a situation where we will be ready start to generate a clinical data, we will come back to you and explain what is exactly the analog we are working on.
Unidentified Analyst: Okay, great. And then for my follow-up for SKYTROFA, can you provide any additional color on how much share you’ve gained while Novo has had supply constraints for their daily growth hormone? And then also, does your new fiscal year ’23 guidance reflect competition from once weekly drugs from Novo and Pfizer? Thank you.
Jan Mikkelsen: The guidance we have within the competitive landscape that is out there and the guidance we are fully integrated what we see the threat or you can say how it really are helping us basically to convert it over to a much more long acting. But I also think you need some way to take the perspective of the shortest of daily growth hormone, which is a long-term process that basically or partly driven by what we call the consolidation of a daily growth hormone. We are facing they are leaving the market and there will be very few player left in the data growth hormone. So, what we see here, we just see as we have basic predicted in the last one to two years, the development of the competitive landscape. And we feel really, really, really confident with how SKYTROFA will continue to basically be in a proceeding to be the leading product in value and continue to be it in the future.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Caroline Palomeque with Berenberg Capital Markets. Your line is open.
Unidentified Analyst: Hi, this is Lucy for Caroline. Thank you so much for taking my question. So, I’m just curious about the planned for launching EU for the TransCon PTH. So you set, like, first you were going to launch in the Germany, then what would be the, next steps? So, we’d love to learn more about that. Thanks.
Jan Mikkelsen: Thanks a lot. First of all, we are not looking — EU is one place where we basically are launching now, but we’re not stopping there. We’re also going for the international operation. We have a strong person that is leading our global commercial effort, Camilla. She has a very, very strong background in Europe and international operation. We are launching in Germany as the first country [indiscernible], but it will not be a single launch because we first actually launching with SKYTROFA, which we’re doing this month here. We’re launching SKYTROFA here this month in Germany and we’re starting to launching PTH in the — expected in the beginning of next year, really, really in the beginning of next year. And we will then roll out in all the different EU countries where we expect to get the approval and including UK, which we still can apply for in a very fast manner.
And then we are starting to progress in the international operation, meaning is this country where you can support the launch of a product either from an EU approval or from a U.S. approval. So this is how we really are going to build our global commercial strategy.
Unidentified Analyst: Okay. Thank you very much for taking my questions and congrats with all of the progress. Thank you.
Jan Mikkelsen: Thanks so much.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Leland Gershell with Oppenheimer. Your line is open.
