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

Paul Choi: I want to ask, given that you’re using the same infrastructure to market PTH in the US that you’re currently using for SKYTROFA. I guess, are there any learnings that you might share on the — from launch SKYTROFA that you would think be applicable, or what changes would you make I guess in terms of either your thoughts on approaching your payor access and/or contracting compared to SKYTROFA? And then I have a pipeline question as a follow-up.

Jan Mikkelsen: We are utilizing the same infrastructure. Sure, we have dedicated sales force, we have dedicated people for the two different products. But you know there’s a huge difference to be the first product to go out and launch where you establish all the infrastructure, IT systems, all the different necessary teams that is necessary to really to launch a commercial product. We have big risk at that now. We coming from a stage where we launch and form an already successful status, commercial infrastructure built from Joe and the other people in Princeton here in the US. So what we’re doing is that we basically are placing what I call TransCon PTH into an infrastructure that already has proven it’s capability with a product, I believe, really addressing huge unmet medical need whereas no alternative treatment. I think this is a fundamental — a huge success.

Paul Choi: And then as a follow-up, just in terms of the pipeline. Do you plan to publish the baseline patient characteristics for the 80 children that are being enrolled in the ApproaCH trial? And then could you also specify in terms of your oncology program, the head and neck population that you’re planning to pursue, is it just HPV positive or is it post PD-1 and post , if you can maybe add a little color on that, that’d be great? Thank you for taking our questions.

Jan Mikkelsen: I think Stina will take number two, or you can take one on . Let me take a number one, it’s a very, very interesting question, because I do not know if the question the words really are addressing, because I actually think we have published all the demographic from our patient population and demographic that have been into the accomplish trial, the 57 that’s still in it. So I — somewhat little bit puzzling with that question, because all data is out/ then you can say, hey, why did you not come in with the analyze high velocity prescreening, because it’s totally irrelevant for the clinical efficacy of it, you cannot use and analyze high velocity that have been collected before they go into the trial, because we have 40% of the channel between two and five, which you look and place nearly built the normal analyze high velocity.

And the first four years, you have a heavily deceleration of analyze high velocity. So if you take and analyze high velocity just collected up to 12 months before they go into a trial, it’s not reflecting any meaningful value that go in and compare to the analyze high velocity you compare in this patient group, because the start on the already two. This is why you do what is obvious in drug development, you’re making a placebo group. This is why you have a placebo group, and I think that is the key element to do, look at our dosing from 6 to 100 and then you can take six like nearly like also placebo group and then you can take the six and — or the placebo movement into the achondroplasia specific high efficiency of a matching, they’re matching 100%.

But compare this it’s my basic scientific nonsense and only are misleading and have not reflecting any kind of solid scientific value in interpolating the data. Stina?