Ascendis Pharma A/S Announces Phase 3 PaTHway Trial Results Conference Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : I guess I have two. First, just bigger picture, when we think about how physicians may interpret this result, it seems like it shows that standard of care carries a liability in higher urinary calcium relative to treatment with TransCon PTH. I'm curious kind of how you think physicians will interpret that safety finding as they kind of think about how to take care of their patients. Second is, what explains the gap -- I think there's maybe a 16 percentage point gap between the 79% who met the primary endpoint and 95% of TransCon patients coming off of conventional therapy. Did those patients tend to be above or below the normal serum calcium range? And -- just trying to figure out kind of why -- what explains that delta.

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Congratulations on the results here this morning. Maybe one on the safety. Can you elaborate a bit more on the 4 patients that experienced adverse events related to hyper- or hypocalcemia that led to hospitalization or urgent care visits? I know there was the one that was misdosed, but could you give us a sense of, I guess, when in the course of the 26 weeks did these events occur, and was hyper or hypocalcemia more common on the treatment arm? And then maybe just one follow-up there too. Can you confirm that the patient that died wasn't one of the patients that was hospitalized? I know you mentioned the patient had normal serum calcium at the time of the event. And then a second question on urinary calcium. You talked about the importance of that urinary calcium signal. At baseline, 25% of patients had a history of kidney stones and 5 patients had a history of renal insufficiency. Is there anything trending or improving, I guess, in terms of those underlying kidney disease for those patients? Or is this too short of a period of the trial?