Victor Floch

Victor Floch asked about a peer asset (SRM) that leveraged Phase 2 data to advance to PDUFA and is soon to report Phase 3 data in TED. He questioned if these upcoming data sets are a relevant proxy for VYVGART's odds of success in TED.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, stated it's difficult to comment on third-party timelines. He viewed the peer's Phase 2 work as a 'proof of biology' for FcRn's role in autoantibody-driven disease but cautioned against cross-comparing between FcRn molecules, as not all are equal, and VYVGART is uniquely engineered.

Victor Floch from BNP Paribas asked if upcoming Phase III data from a competitor's FcRn asset, which argenx previously leveraged for its TED strategy, would serve as a relevant proxy for VYVGART's odds of success in TED.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, stated that while a peer's Phase II data established proof of biology for FcRn antagonists in autoantibody-driven diseases, he cautioned against direct cross-comparison between molecules in the same class, emphasizing VYVGART's unique Fc fragment engineering and the potential for differentiation.

Victor Floc'h from BNP Paribas asked for an update on the ITP launch in Japan, specifically on physician feedback regarding its positioning against TPO-RAs, and if argenx could share its market share in that indication.

Answer

CEO Tim Van Hauwermeiren reported that the ITP launch in Japan is going well, with real-world data mirroring the clinical trial's ~50% response rate. He noted the drug is currently being used in last-line, highly refractory patients but is landing well due to its rapid action and safety profile. He expects it will gradually move up in the treatment paradigm over time, in line with the initial plan.

Victor Floch asked about the company's expectations for incremental volume growth from the pre-filled syringe (PFS) launch and the potential sales opportunity from the upcoming Phase III trial in seronegative gMG.

Answer

Chief Operating Officer Karen Massey expressed confidence that the PFS will drive significant volume growth, noting its optimal label and positive patient feedback. She highlighted early data showing 50% of PFS prescriptions are for new-to-VYVGART patients, supporting the market expansion strategy. CEO Tim Van Hauwermeiren added that the seronegative gMG population represents about 15% of all MG patients and that the company feels very strong about the opportunity, which he equated in size to the ocular MG opportunity.

Victor Floch asked if investors are overlooking the 2025 news flow, such as the seronegative MG trial and PFS launch, and inquired about the importance of self-administration for Hytrulo's penetration in ex-U.S. markets.

Answer

CEO Tim Van Hauwermeiren agreed that the PFS launch and seronegative MG readout are significant 2025 catalysts. COO Karen Massey explained that in ex-U.S. markets where self-administration is available, it provides crucial optionality for patients and physicians to choose the best administration route based on lifestyle, though not all patients switch from IV.

Victor Floch asked about SG&A spending for the CIDP launch and requested an update on efforts to expand the ITP indication beyond Japan.

Answer

CEO Tim Van Hauwermeiren addressed ITP, stating that insights from the Japanese PMDA approval have equipped the team to re-engage with the FDA. CFO Karl Gubitz clarified that SG&A expenses increased by $27 million in Q1, driven by the expansion of the U.S. commercial team for gMG and the potential CIDP launch, as well as investments in new European markets.