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- **Birtamimab Pivotal Year:** Phase 3 AFFIRM-AL trial targeting 59% mortality risk reduction (VITAL trial p=0.021), with U.S. launch potential in H2 2026.
- **Alzheimer's Pipeline Expansion:** PRX012 Phase 1 data mid-2025, PRX123 Fast Track with IND cleared for Phase 1.
- **Commercial Ambition:** Birtamimab projected as multi-billion dollar opportunity with 2026 U.S. launch; Alzheimer's programs address underserved early/symptomatic AD markets.
- **Financial Strength:** $472M cash as of Dec 2024, well-capitalized for 2025 ($171.5M net cash use) with no debt.

**【CEO Opening Remarks】**
- Prothena's mission is to develop transformational therapies for protein dysregulation diseases, with a focus on neurodegenerative and rare peripheral amyloid diseases.
- 2025 is a pivotal year with key readouts for wholly-owned programs: birtamimab (AL amyloidosis), PRX012 (Alzheimer's), and PRX123 (dual A-beta/tau vaccine).
- Birtamimab Phase 3 AFFIRM-AL trial expected to report Q2 2025, with potential U.S. launch in H2 2026 if successful.

**【Chad Swanson - Clinical Updates】**
- **Birtamimab (AL amyloidosis):**
  - Confirmatory Phase 3 AFFIRM-AL trial randomized 2:1, with primary endpoint of time to all-cause mortality (p ≤ 0.10 for success).
  - VITAL trial showed 59% risk reduction in Mayo Stage IV patients (p=0.021), supporting SPA agreement with FDA.
  - Coramitug (ATTR-CM) Phase 2 signal detection trial by Novo Nordisk expected to report H2 2025.
- **Alzheimer's Portfolio:**
  - PRX012 Phase 1 ASCENT-2 trial evaluating safety and PK/PD in early AD patients, with mid-2025 data readout.
  - PRX123 dual A-beta/tau vaccine granted Fast Track designation, with IND cleared for Phase 1.

**【Brandon Smith - Commercial Strategy】**
- **Birtamimab Market Potential:**
  - U.S. diagnosed and treated AL amyloidosis patients: ~16,000 (13,000 with cardiac involvement).
  - Peak penetration expected in Mayo Stage IV patients (~5,000 U.S., 5,000 Europe), with multi-billion dollar global opportunity.
  - Launch strategy: focused sales force targeting amyloidosis centers of excellence.
- **Alzheimer's Pipeline:**
  - PRX012 positioned for early AD market with once-monthly subcutaneous administration.
  - PRX123 vaccine approach targeting presymptomatic and early symptomatic AD populations.

**【Tran Nguyen - Financial Performance】**
- **2024 Results:**
  - Net cash used: $150.3M (low end of $148-160M guidance).
  - Net loss: $122.3M (low end of $120-135M guidance).
  - Cash balance: $472.2M as of Dec 31, 2024.
- **2025 Guidance:**
  - Net cash used: $168-175M (midpoint $171.5M).
  - Ending cash: ~$301M (midpoint of $297-305M range).
  - Key driver: estimated net loss of $197-205M, including $41M non-cash SBC.

**【Q&A Highlights】**
- **Birtamimab Market Dynamics:**
  - 80% of AFFIRM-AL patients on daratumumab, but no impact on early mortality (ANDROMEDA trial p=0.0657).
  - High demand for anti-amyloid therapy with favorable safety profile in high-risk patients.
- **PRX012 Development:**
  - ASCENT-2 trial expansion cohort (200mg, ~100 patients) to better characterize PK/PD and safety in APOE4 homozygous carriers.
  - Long-term data from ASCENT-3 open-label extension to inform Phase 2 design.
- **Regulatory Pathway:**
  - FDA SPA agreement for birtamimab requires p ≤ 0.10 for BLA submission; European regulators expected to align on risk-benefit profile.

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