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- **FDA Approval Momentum**: Aficamten on track for U.S. approval in December 2025, with EU decision expected H1 2026 and China filing via Sanofi partnership.
- **Clinical Differentiation**: MAPLE-HCM demonstrated aficamten superiority vs. metoprolol, with 15% YoY revenue growth and 5% operating expense decline.
- **Commercial Readiness**: 20+ year experienced sales team, patient navigator program, and REMS-aligned launch strategy for rapid HCP engagement.
- **Financial Strength**: $1.25 billion cash balance, $327M convertible notes, and $100M Royalty Pharma loan support 2025-2026 launch and pipeline advancement.
- **Pipeline Progress**: ACACIA-HCM readout Q2 2026, COMET-HF enrollment ongoing, and AMBER-HFpEF progressing toward 2026 data.

**【CEO Summary Section】**
- Cytokinetics achieved significant progress toward FDA approval of aficamten for oHCM, with a late-cycle meeting confirming a differentiated risk mitigation profile and label expectations.
- Completed GCP inspections without issues and finalized commercial readiness, including a 20+ year experienced sales team and patient navigator program.
- Presented MAPLE-HCM results showing aficamten superiority over metoprolol, driving potential expanded label filing post-approval.
- EU regulatory interactions continue, with EMA Day 180 responses submitted and potential approval in H1 2026.

**【CFO Financial Commentary】**
- Q3 2025 cash balance: $1.25 billion (up from $1.0 billion Q2), supported by $327 million convertible note proceeds and $100 million Royalty Pharma loan.
- R&D expenses: $99.2 million (17% YoY increase), driven by clinical trial advancements.
- G&A expenses: $69.5 million (22% YoY increase), reflecting commercial readiness investments.
- Net loss: $306.2 million (153% YoY increase), including $121.2 million debt conversion expense.
- Full-year 2025 GAAP operating expense guidance narrowed to $680-$700 million.

**【Q&A Key Highlights】**
- **ACACIA-HCM Trial Design**: Dual primary endpoints (KCCQ and pVO2) with 0.025 alpha split; no plans to adjust weighting pre-unblinding. Fady Malik emphasized powering for clinically meaningful effects (5-point KCCQ delta, 1.0 pVO2 improvement).
- **REMS Program Execution**: Andrew Callos highlighted a streamlined REMS with 2 specialty pharmacies and limited data reporting, aiming for 80%+ prescriber engagement within weeks of launch.
- **Pricing Strategy**: Andrew Callos indicated aficamten pricing will align with mavacamten, with potential flexibility based on clinical differentiation.
- **Financial Preparedness**: Sung Lee confirmed $1.2 billion cash runway, sufficient for U.S. launch and EU expansion, with $175 million Royalty Pharma tranche available for future needs.
- **MAPLE-HCM Impact**: Robert Blum stated supplemental NDA filing post-approval to expand label, potentially by end-2026, driven by MAPLE's challenge to beta-blocker efficacy.

Cytokinetics, Incorporated (CYTK) Q3 2025 Earnings Call Transcript

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CYTK

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