other material
confidence high
sentiment negative
materiality 0.65
Esperion discloses DSE dispute over $300M milestone payments on CLEAR Outcomes data
Esperion Therapeutics, Inc.
- NEXLETOL reduced MACE-4 by 13%, MACE-3 by 15%, heart attack by 23%, coronary revascularization by 19% vs placebo.
- Company expects to submit FDA/EMA filings in H1 2023 for label inclusion of CV risk reduction.
- Entitled to $200M-$300M milestone from DSE if EU label includes specific risk reduction; DSE disputes eligibility.
- DSE argues primary endpoint MACE-4 reduction was 12.98%, below 20% threshold; company cites 23% MI reduction.
- Company intends to enforce contractual rights; delay in payment could impact capital needs.