Janssen&Janssen schreef op 17 maart 2023 21:03:
Hartaj Singh
I mean just from being at ASH and talking to physicians and whatnot, that's our sense also in call checks. Just another question I got of to your regulatory question. I know you're very close to the approval. But just where are you in terms of any FDA audits or facility inspections and have you already have the laboring discussions and all? And thanks for all the questions.
Anurag Relan
Sure. So I can't comment on any specifics other than to say we're engaged in regular contact with FDA and those -- that contact includes the routine types of things, including inspections, audits as well as labeling discussions that have -- that are occurring.
Christian Glennie
Hi. Good afternoon guys. Thanks for taking my questions. The first question on -- so let's start with RUCONEST. Just to get an idea of about the 3% growth last year in the U.S. sort of price versus the volume mix in terms of what was driving that and what your expectations are for the 2023?
Anurag Relan
Yeah. Yeah, we stated that we took a price decrease below the CPI. That's our normal modes and over the -- has been a normal modes over the years. So I think the price increase, of course, is the biggest driver of this growth.
So you could say that the underlying volume growth is more or less flat to slightly maybe going up or down and there some quarterly fluctuations there as well. But I think that's how you should see that.
So it means that nucleus continues to basically be prescribed by a wider audience of physicians. We think that's important. As I was saying in my earlier part of the presentation, also by more -- used by more patients and used by more prescribers, reflecting the fact that there is a continued need for this product in terms of especially, the breakthrough attacks that continue to occur under all the prophylactic treatments that are available in the market.