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- **FDA Breakthrough**: First siRNA therapy approved for FCS, addressing 6,500 high-risk patients with $60k/year pricing.
- **Pipeline Expansion**: 20+ clinical candidates, including Phase III zodasiran (HoFH) and novel dual-target ARO-DIMER-PA.
- **Strategic Wins**: $400M from Novartis/Sarepta, extending cash runway to 2028.
- **CNS Innovation**: ARO-MAPT achieves 75% tau knockdown in monkeys, targeting Alzheimer's with CNS delivery.

**【CEO Summary Section】**
- **FDA Approval Milestone**: REDEMPLO approved for FCS, the first siRNA therapy for this indication, targeting 6,500 U.S. patients with triglycerides 10-100x normal levels.
- **Pricing Strategy**: One-REDEMPLO model sets $60,000 annual price across all indications, emphasizing value for high-risk patients with triglycerides >880 mg/dL.
- **Pipeline Progress**: Zodasiran (HoFH) in Phase III, ARO-DIMER-PA (mixed hyperlipidemia) files Phase I/II, and ARO-MAPT (Alzheimer's) initiates CNS delivery trials.
- **Strategic Deals**: $200M upfront from Novartis for Parkinson's collaboration, $200M milestone from Sarepta for ARO-DM1.

**【CFO Financial Commentary】**
- **FY25 Financials**: Net loss $2M (vs. $599M prior), revenue $829M (84% from Sarepta). Operating expenses $731M (+21%), driven by R&D (+33%) and commercial prep.
- **Cash Position**: $919M as of Q4, with runway to 2028. Received $200M from Novartis and $200M Sarepta milestone post-period.
- **Revenue Drivers**: Sarepta ($697M), Sanofi ($130M), GSK ($2.6M). FY26 expects no material REDEMPLO impact, focusing on pipeline.

**【Q&A Key Highlights】**
- **Pancreatitis Studies**: SHASTA-3/4 (SHTG) powered for triglyceride reduction, SHASTA-5 designed for acute pancreatitis as primary endpoint.
- **Obesity Drugs**: ARO-INHBE Phase I data due Q1 2026, targeting 20M mixed hyperlipidemia patients.
- **CNS Innovation**: ARO-MAPT achieves 75% tau knockdown in monkeys, with CSF data expected Q2 2026.
- **Pediatric Plans**: Developing weight-based dosing for REDEMPLO to address childhood FCS.
- **Dimer Potential**: ARO-DIMER-PA aims to lower LDL and triglycerides with quarterly dosing, CVOT planned post-Phase I/II.

Arrowhead Pharmaceuticals, Inc. (ARWR) Q4 2025 Earnings Call Transcript

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