The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Congrats on the approval. A couple from me. First, can you please explain which part of the data investors should look to in the label that reflects
the superiority of SKYTROFA's efficacy over GENOTROPIN? Is it the lower bound of the 95% confidence interval in Table 4 of the clinical study
section?
Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst
: Okay. How does this timing of approval impact your payer conversations, if at all? Is it possible you can catch the late summer window for coverage
discussions? And what's the list price per milligram going to be?
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: Congratulations. I'm also a very happy Michelle. I noticed the label. It looks very, very similar to daily growth hormone. I guess just with this in mind,
do you think physicians will see SKYTROFA as interchangeable with daily growth hormone in the way that the labels are in? And do you anticipate
there will be any pull-through demand beyond the initial indication into the other growth hormone approved indications?
Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst
: And if I can also add a follow-up, how do you plan to communicate SKYTROFA's differentiation from other long-acting growth hormones if they
are approved in the future? I know you mentioned the immunogenic profile in your prepared remarks.
Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Congratulations on the approval. So I guess -- or maybe you could help me understand this a little bit. I know you mentioned earlier that it's going
to take some time for the drug to get on the formulary. So are you kind of providing some kind of support to accelerate the prior authorizations
to provide accelerated patient access? And then I just wanted to know, regarding your application in the European region, are you still expecting
approval in Q4?
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