argenx SE (ARGX) Q1 2023 Earnings Call Transcript

For the period ending March 31, 2023

May 4, 2023 8:30 a.m. ET

Prepared Remarks

Questions and Answers

Call Participants

Prepared Remarks:

Operator

Good morning. My name is Rob, and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Thank you.

I'd like to introduce Beth DelGiacco, Vice President of Corporate Communications and Investor Relations. You may begin your conference.

Beth DelGiacco

Thank you, operator.

A press release was issued earlier today with our first quarter 2023 financial results and our recent business update. This can be found on our website along with the presentation for today's webcast.

Before we begin, I'd like to remind you on Slide 2 that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law.

I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Karen Massey, Chief Operating Officer.

I'll now turn the call over to Tim.

Tim Van Hauwermeiren

Thank you, Beth, and welcome, everyone.

Slide 3: I'm pleased to be today to share another quarter of strong execution with our global VYVGART launch. We continue to deliver results both in our ability to reach patients and drive revenue, but also with the progress we are making on the regulatory side. We recently announced regulatory approvals in Israel and the U.K., marking our fourth and fifth approvals globally, and we expect more to follow later this year. This is a remarkable achievement from our global submission teams.

We are preparing for additional regulatory milestones with the potential approval of subcu efgartigimod in the United States. Our PDUFA date of June 20 is fast approaching, as to which we hope to have the broadest gMG offering for patients, both with an IV infusion and a simple subcutaneous injection. We know that gaining traction in early line patients will be important for the continued trajectory of our launch, hence the approval of subcu products may help us achieve this.