Morgan

Morgan asked for argenx's thoughts on Johnson & Johnson announcing a head-to-head trial for Amavi versus VYVGART in gMG. She also requested guidance on OpEx for the next 12 months, considering the numerous pipeline indications and ongoing trials.

Answer

Luc Truyen, Chief Medical Officer, stated that the J&J head-to-head trial would not provide significant new information for patients due to its primary endpoints and timing, as the return of IgGs to baseline after stopping FcRn antagonists is already known. He emphasized that the study design does not align with real-world VYVGART usage and offers no meaningful differentiation. Tim Van Hauwermeiren, Chief Executive Officer, highlighted VYVGART's 60% MSE rate with 85% sustained for at least eight weeks. Karl Gubitz, Chief Financial Officer, reiterated the current year's OpEx guidance of $2.6-$2.7 billion, stating that while next year's guidance is not yet available, the increases seen in Q3 are expected to continue.

Morgan from Morgan Stanley asked for argenx's thoughts on Johnson & Johnson's announced head-to-head trial comparing Amavi to VYVGART in gMG. She also requested OpEx guidance for the next 12 months, considering the numerous pipeline indications and ongoing trials.

Answer

Luc Truyen, Chief Medical Officer, stated that the J&J head-to-head trial design would not provide significant new patient value due to chosen primary endpoints and timing, as VYVGART's real-world use involves individualized dosing. Karl Gubitz, Chief Financial Officer, reiterated the year-end OpEx guidance of $2.6-$2.7 billion, confirming continued single-digit expense growth for future investments without providing specific 12-month guidance.