argenx (ARGX) TD Cowen 46th Annual Health Care Conference summary

Strategic vision and growth priorities

• Focus remains on growth and innovation, aiming for 50,000 patients, 10 labeled indications, and 5 late-stage molecules by 2030.

• Short-term growth driven by upcoming readouts in myositis, MMN, and Sjögren's, with CIDP and empasiprubart in the pipeline.

• Midterm strategy centers on FcRn platform expansion with two next-generation molecules and an oral peptide.

• Long-term plans include early-stage programs and new partnerships, such as the Tensegrity deal.

• Emphasis on applying industry learnings from successful franchises to maintain leadership in FcRn.

Product pipeline and clinical development

• VYVGART continues to show strong fundamentals and consistent growth, with a PDUFA date in May for seronegative MG and positive ocular MG data.

• FcRn franchise includes ARGX-213 (monthly dosing, phase 3 ready) and ARGX-124, with differentiation strategies based on dosing, indications, and pricing.

• Oral peptide FcRn program in collaboration with UMP is in development.

• Myositis phase 3 trial is a basket study across subtypes, designed for flexibility in regulatory approval.

• Sjögren's program is advancing rapidly, with phase 2 data comparable to competitors and phase 3 readout expected in the second half of 2027.

Market positioning and competitive landscape

• VYVGART is the leading biologic in MG, capturing 6 out of 10 new biologic patients and expanding into seronegative and ocular MG.

• FcRn therapies are used first-line in MG, with C5s and IVIg reserved for refractory cases.

• CIDP launch achieved blockbuster status, with 2,500 patients and strong payer access; majority of patients transition from IVIg.

• ADAPT-NXT data supports flexible dosing for VYVGART, addressing convenience and efficacy concerns.