argenx (ARGX) Goldman Sachs 45th Annual Global Healthcare Conference summary

Key catalysts and regulatory milestones

• Anticipates potential CIDP approval with a PDUFA date set for June 21, with launch readiness and payer discussions underway.

• Multiple important data readouts expected by year-end, including phase II results for POTS and myositis subsets, and a decision on bullous pemphigoid.

• Prefilled syringe (PFS) filing for both MG and CIDP on track before end of June, with possible approval by year-end or Q1 next year.

• R&D day planned to outline strategic vision for the next five to six years.

CIDP launch strategy and market positioning

• Innovative trial design demonstrated a 69-70% response rate and 61% reduction in relapse risk, supporting broad use in CIDP.

• Initial patient population expected to come from those with IVIG experience, with focus on broad access and payer policy development.

• Pricing per vial for CIDP will match MG, with details on utilization and net pricing to be communicated at launch.

• Launch trajectory expected to be slower than MG due to established competition and payer policy timelines.

• Commercial infrastructure and field teams expanded, leveraging overlap with MG prescribers for efficient launch.

Myasthenia Gravis (MG) growth and competitive landscape

• Strategy centers on early-line use of VYVGART, aiming to be the first-line biologic after orals, supported by real-world efficacy and safety data.

• Prefilled syringe and multiple formulations are key to expanding patient and physician adoption.

• MG market expansion continues despite new FcRn competition, with VYVGART maintaining leadership as first-line therapy.

• European launches progressing well, with strong uptake in Germany, Italy, Spain, and Belgium; ongoing negotiations in France and UK.

• Market dynamics show patients move from orals to VYVGART, with non-responders transitioning to complement therapies.