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- **$2.1B Strategic Deal**: Novo Nordisk collaboration provides $240M upfront and $100M near-term milestones.
- **Financial Turnaround**: Reduced debt by 80% to $17.1M; 2027 cash flow positive.
- **YARTEMLEA Launch**: FDA approval expected Q4; NTAP coverage secured.
- **Pipeline Expansion**: MASP-2 antibody (Phase 2), PDE7, and T-CAT programs advancing.

**【CEO Summary Section】**
- Announced a strategic collaboration with Novo Nordisk valued at up to $2.1 billion, including $240 million upfront payment and $100 million near-term milestones.
- Repositioned balance sheet with $36.1 million cash on hand and secured $20 million in debt repayment through the Novo transaction.
- YARTEMLEA (narsoplimab) FDA approval expected in Q4 2025 with commercial launch preparations finalized across 15+ transplant centers.
- Expanded pipeline includes MASP-2 antibody (OMS1029), PDE7, and T-CAT platforms, with Phase 2 studies initiated.

**【CFO Financial Commentary】**
- Q3 2025 net loss of $30.9 million ($0.47/share) vs. Q2 loss of $25.4 million ($0.43/share).
- Adjusted cash burn of $22 million, with $20 million raised through registered direct offering.
- Projected 2027 cash flow positivity post-Novo transaction.
- Repaid $67.1 million term loan and $17.1 million convertible notes, reducing debt by 80%.

**【Q&A Highlights】**
- FDA approval decision for YARTEMLEA expected in Q4; NTAP coverage discussions underway.
- Formulary access agreements secured with 75% of high-volume transplant centers.
- Historical control analysis validates YARTEMLEA's 30% survival benefit vs. standard care.
- 2026 operating expenses projected to increase 15% for launch-related costs.
- Novo collaboration excludes Omeros' MASP-2 small molecule programs, maintaining pipeline control.

Omeros Corporation (OMER) Q3 2025 Earnings Call Transcript

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