argenx SE (NASDAQ:ARGX) Q4 2022 Earnings Call Transcript

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Tim Van Hauwermeiren: I would say that the review continues at a good cadence. The way we would describe the ongoing Q&A is rather routine, rather standard. We get your typical questions in review of the file. So no specific area to call out. So we believe in the strength of the date of our file and we see continued good progress in the review of the file. So we’re all hopeful for the June 20 PDUFA date.

Thomas Smith: Okay, great. Thanks. And if I could just squeeze in one follow-up just on the commercial — just on the commercial trajectory. If you could just comment on expectations, I guess, for Q1 relative to Q4? And how to think about combination of seasonality and kind of payer reset there would be very helpful. Thanks.

Tim Van Hauwermeiren: Keith, would you like to take this question please?

Karl Gubitz: So it’s Karl here. So I think for Q1, I mean, the launch — adding new patients, consistent growth. Two things to call out in Q1. We do see the impact of seasonality. If we lose the selling day because of an holiday or a winter storm, that sales do not move to the next day. We basically lose those sales. And also we do see re verification of benefits, which typically happens in Q1.

Thomas Smith: Understood. Thank you guys.

Tim Van Hauwermeiren: Thank you.

Operator: Your next question comes from the line of Yaron Werber from Cowen. Your line is open.

Brendan Smith: Hi, guys. This is Brendan on for Yaron. Thanks for taking the questions. First, quickly on CIDP. Can you maybe just tell us how many patients you have randomized into Stage B as of today? Is that something you’re able to share with us? And then just looking back at the (ph) studies, it looks like there may be some slight difference in the rate of relapse in treatment naive versus IVIg experience patients. So are you able to give us a little bit of a sense of what the breakdown of patients enrolled in here thus far is looking like, just in terms of background therapy? Thanks.

Tim Van Hauwermeiren: Yes, Brendan, thanks for the question. So we’re not public on the number of patients randomized in Stage B. I think what we said earlier is that, we have exceeded the number you would normally need to successfully come to the (ph) events. So, that all continues to progress well. In terms of representation of patients with the different backgrounds being newly diagnosed on naive, being on steroids or being on IVIg, I believe the last disclosure we did is a disclosure to go forward. I think that was about 40 patients in the process. We think there maybe a relative increase in IVIg patients. It was the second half of the trial, because we had more U.S. sites getting online and involved, but that’s my speculation.

From a biology point of view, looking at the mode of action of Cusatuzumab, I cannot think of the reason why an IVIg patient or a steroid patient would react differently to VYVGART’s mode of action. So let’s wait for the data and see whether we can create or see any correlations between, for example, baseline characteristic of prior therapy and your ability to respond on VYVGART? Thanks for the question.

Brendan Smith: All right. Great. Thanks, guys.

Operator: Your next question comes from the line of Yatin Suneja from Guggenheim Partners. Your line is open.

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