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- **Revenue Surge**: FILSPARI sales up 155% YoY to $90.9M, driven by guideline adoption and REMS simplification.
- **FSGS Approval Path**: FDA clears way for January 2026 approval, with no advisory committee needed.
- **Global Expansion**: Japan's Chugai acquisition of Renalys accelerates sparsentan trials; Europe sees expanded access via CSL Vifor.
- **Financial Strength**: $254.5M cash, no near-term capital needs, and non-GAAP net income up 48% YoY.
- **Pipeline Momentum**: Pegtibatinase manufacturing complete; HARMONY study restarts in 2026 for classical HCU.

**【CEO Summary Section】**
- **Revenue Growth**: U.S. net product sales for FILSPARI reached $90.9 million in Q3, up 155% YoY, driven by strong demand and new prescribers. Global partners like CSL Vifor and Renalys (acquired by Chugai) are expanding access in Europe, Japan, and beyond.
- **FILSPARI Expansion**: FDA removed REMS embryo-fetal toxicity restrictions, aligning monitoring with clinical practice. KDIGO guidelines now recommend FILSPARI as a first-line therapy for IgA nephropathy (IgAN), reinforcing its nephroprotective role.
- **FSGS Milestone**: FDA no longer requires an advisory committee for the sNDA in FSGS, advancing potential approval in January 2026. FILSPARI is the only dual ERA-RAS inhibitor with 2-year data showing 50% proteinuria reduction.
- **Pipeline Progress**: Pegtibatinase manufacturing scale-up complete, enabling HARMONY study restart in 2026 for classical HCU. Japan's PMDA approved Phase III trials for sparsentan in FSGS and Alport syndrome.

**【CFO Financial Commentary】**
- **Top Line**: Total revenue $164.9 million (Q3), including $90.9M FILSPARI sales and $40M milestone from CSL Vifor. Non-GAAP net income $52.8M ($0.59 EPS), up from $35.6M ($0.46) YoY.
- **Cost Management**: R&D $51.9M (flat YoY), SG&A $86.5M (+32% YoY) due to FSGS launch prep. Cash balance $254.5M post-convertible note repayment, with no near-term capital needs.
- **Gross to Net**: <2% benefit in Q3, expecting higher discounts in Q4. Full-year gross to net ~20%.

**【Q&A Key Highlights】**
- **REMS Impact**: Physicians welcomed quarterly liver monitoring, boosting access for lower-risk patients. Q3 saw highest daily patient starts, with 731 new prescribers despite summer seasonality.
- **Competitive Dynamics**: FILSPARI outperformed despite launches of iptacopan and atrasentan, driven by guideline alignment and real-world evidence.
- **FSGS Launch Prep**: 30% of IgAN prescribers also treat FSGS. Teams ready for January 2026 launch, with incremental SG&A investments for targeted outreach.
- **PEGtibatinase Supply**: First commercial batches manufactured, with FDA interactions planned for 2026 study restart.
- **Japan Expansion**: Renalys' acquisition by Chugai accelerates sparsentan trials, with Phase III data expected in Q4 2025 for IgAN.


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