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

Stina Singel: In oncology, we are evaluating for proof of concept efficacy in seven different tumor types. You’re right, we do have one of our priority areas is head and neck cancer. We are evaluating in first or second line metastatic head and neck cancer as a dose expansion cohort single arm in the IL-βelieγe study, and those patients will be — will have had no more than one line of chemotherapy containing regimen in the advanced metastatic setting. And the randomized Phase 2 study, βelieγe-IT-201 study will be in the neoadjuvant setting. So these are patients in a non-metastatic setting before they get surgery, they will get systemic treatment before surgery and we’re looking at pathologic response as our primary endpoint to look for evidence of proof of concept efficacy.

Operator: Our next question is coming from Derek Archila of Wells Fargo.

Derek Archila: So just two really quick ones from us. Jan, I just wanted to confirm, I thought I caught you saying that you were in labeling discussions for TransCon PTH. So I just wanted to confirm that. And then also, I guess, when should we expect additional updates from ACcomplisH, is that something we should see, again, first half of this year, second half of this year?

Jan Mikkelsen: When you go through an approval process, I think, for me, is sort of plan process, four months before an expected approval date three months before an expected approval two months before that. And so if anyone somewhere had been to an approval process, and I think we have 10 weeks before the PDUFA date now. If you’re not have started at labeled discussion, the risk of not getting approval is high. So therefore, I believe this is a way by tracking how we are progressing to the approval process, are we really on track of what everything needs to happen in that expected time, is it that’s not happening. I will be extremely worried and find out what is going on. And so yes, we are in a labeling discussion, because you should be that at least three months before an expected approval.

And this is why I feel that I’m confident that I have not seen anything that not give me a belief that TransCon PTH isn’t product that is approved. I believe and I cannot really remember all our corporate milestones now. Sorry for that, because that’s a little bit too many of them. But I believe that is in Q4 we will give you an update, again, related to that 57 patients that will come out from the ACcomplisH tribe. So it will be in the second half of this year.

Operator: The next question is coming from Josh Schimmer of Evercore.

Josh Schimmer: First on SKYTROFA. Could you elaborate a little further on what you’re seeing in terms of daily growth hormone options withdrawn from the market? I know there have been some reported shortages, but it didn’t realize that reflected the outfall withdrawals. So who have you seen this drawing and do you expect others to follow? And then how do you anticipate the impact of Novo Nordisk potentially launching a once a week growth hormone option as well iun the market later this year?