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- **Revenue milestone**: $1.13B Q3 product sales, 96% YoY growth, fueled by PFS adoption in gMG and CIDP.
- **Pipeline acceleration**: 3 Phase III assets advancing, with Graves' disease trial set for 2026 and 4 new Phase I molecules by year-end.
- **Financial strength**: $4.3B cash balance, 11% gross margin, and disciplined expense growth (~$2.6B for 2025).
- **Strategic focus**: Seronegative gMG (60% MSE in Phase II) and CIDP expansion, with Graves' disease as next frontier in thyroid autoimmunity.

**【CEO Summary Section】**
- Q3 2025 revenue milestone: $1.13 billion in product net sales, up 96% YoY, driven by VYVGART's prefilled syringe (PFS) launch in gMG and CIDP.
- Pipeline progress: 3 Phase III assets (efgartigimod, empasiprubart, ARGX-119) and 4 new Phase I molecules by year-end. Discontinuation of empasiprubart in dermatomyositis (DM) due to enrollment challenges, while efgartigimod Graves' disease trial set to begin early 2026.
- Strategic investments: $4.3 billion cash balance, expansion of U.S. manufacturing with FUJIFILM, and scaling commercial infrastructure for global growth.

**【CFO Financial Commentary】**
- Q3 2025 financial highlights: $346 million operating profit, $344 million net profit, and year-to-date cash balance of $4.3 billion.
- Expense management: R&D and SG&A expenses expected to total ~$2.6 billion for the year, with single-digit growth for Q4.
- Gross margin: 11% year-to-date, reflecting scale benefits and operational efficiency.

**【COO Commercial Update】**
- PFS adoption: 50% of new VYVGART patients in Q3 used PFS, with 260 new prescribers in the U.S. since launch.
- Market expansion: U.S. sales grew 20% QoQ, Japan CIDP launch, and Europe approvals for PFS in gMG and CIDP.
- Patient impact: 15,000+ patients treated globally, with 70% of new MG patients coming from oral therapy conversion.

**【Q&A Highlights】**
- **Pipeline differentiation**: Efgartigimod's FcRn mechanism in Graves' disease (potential 2026 Phase III) and Sjögren's (UNITY trial) vs. broad B-cell suppression.
- **Commercial strategy**: Focus on seronegative gMG (60% MSE in ADAPT-SERON) and ocular MG (2026 label expansion), with CIDP targeting 12,000 addressable patients.
- **Operational decisions**: Graves' trial prioritization over lupus nephritis due to Phase II data, and DM enrollment challenges in empasiprubart trial.

argenx SE (ARGX) Q3 2025 Earnings Call Transcript

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