Ascendis Pharma A/S (NASDAQ:ASND) Q4 2022 Earnings Call Transcript

Jan Mikkelsen: Let me start first on the daily growth hormone, because I believe that is a textbook that really — and if I have segment it’ll be potential in my studies and my final project, but it’s really, really what I call a textbook . Growth amount or the daily growth among market was the first, I got biosimilar where Sandoz and Teva entered with their bioequivalent version on it. And there, Sandoz had six players, it is daily market segment, all of them providing exactly the same entity, the same treatment. So you can change this back and forth between the product dependent on rebate and other things like that that was different in formulation, that was a little bit different in devices and other things like that. So what we saw for about three, four years when they came out with our Phase 2 data, we saw already that some of the big player — many started some way to reconsider how to be really played when that’s coming and superior treatment into this segment.

And that will be — which will be highly different stages compared to what we call the daily market segment. At that time, we already saw three of the company’s basic removing their sales forms, this is step one, as I call. Your remove sales force. The second one is that you go to the next stage, you remove the , then you stop up manufacturing, which I think three or four them have done it now. And then you basically are in a position where you are providing many patients that already are on your product, because you have no hope where you can change and take new patient in and you’re providing them. What happen in setting up for the patient now that it look like a normal audience, when they two showed us of multiple products, multiple presentation of their growth hormone.

And because that consolidation of the daily growth hormone happen and really is in the final place, I believe none of the other one could take over. So you actually see a shortage of growth hormone treatment in the US. And sure, I need to accept that the benefit of that is a great thing for us, because it’s both accelerating at the same time where people really see the benefit, get the clinical experience how we differentiate it, be having patient for one year or something on treatment. So they really, really, really see this benefit. And I think this is a great thing, sure for us and we’re really hopeful we can help as many, many as patients to avoid going into a shortest of the treatment effect. Your second question?

Josh Schimmer: Actually, I was going to ask whether, given your view of the differentiation of TransCon CNP, if you’d considered filing for breakthrough designation?

Jan Mikkelsen: Yes. First of all, Josh, you also have the question reflecting about potential, the entrant of Novo Nordisk long acting product. When I look on the paradigm shift, I call it paradigm shift, because it comes from the time where all the daily growth hormone were identical, the same treatment, the same mode of action. When you go over to the long acting, all of them are providing complete different clinical profile. They’re the only one that really match an improved version of the daily growth hormone where you get all the benefit endocrine benefit, both related to changing not only linear growth in the periodic setting but also the other — associated endocrine benefit like body composition, metabolic profile, lipid , cognitive effect and everything that you see, because we have the same unmodified somatrope molecule.