argenx SE (ARGX) Q4 2022 Earnings Call Transcript

Prepared Remarks

Questions and Answers

Call Participants

Prepared Remarks:

Operator

Good morning. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the call. 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 now begin your conference.

Beth DelGiacco

Thank you, operator. A press release was issued earlier today with our full year 2022 financial results and the 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 developments, 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 Keith Woods, Chief Operating Officer.

I will now turn the call over to Tim.

Tim Van Hauwermeiren

Thank you, Beth, and welcome, everyone. Next slide. Reflecting on 2022, it was a year of many achievements for argenx as we evolved from an R&D organization into a fully integrated R&D and commercial organization. We launched our first in class FcRn blocker VYVGART in the U.S., Japan and Germany and exceeded our own expectations, generating $401 million in global net product revenue.

I'm very proud of the team for the strategy they built and executed, solidifying our reputation with our key stakeholders. With this significant momentum, we start 2023 in a position of strength. We also have our marching orders in hand for multi-dimensional expansion to reach more patients with VYVGART through anticipated regulatory approvals and launches in new regions and by driving usage earlier in the gMG treatment paradigm.

Next slide. This year, we also generated a significant amount of data on our first in class FcRn blockers through clinical trial readout, installation research and pre reviewed publications. We reported 50 data from our subcu bridging study in gMG, which demonstrated non inferiority to the IV, based on IgG lowering, as well as consistency across secondary efficacy endpoints and safety. We have now filed for approval with the FDA, EMA and PMDA and have a PDUFA target action date in the U.S. of June 20, 2023. We received a communication from the FDA in January notifying a three month clock extension. Since that time, the FDA's review continues and we are engaging regularly with the agency being responsive to inquiries as we advance towards an anticipated approval.