Esperion Partner HLS Therapeutics Announces Approval of NILEMDO(TM) for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease

Executive Summary

• Health Canada approved Esperion’s NILEMDO® (bempedoic acid) for LDL‑cholesterol reduction in Canadians at risk of cardiovascular disease.
• Commercial launch of NILEMDO in Canada is slated for Q2 2026, expanding the company’s market presence beyond the United States.
• The approval underscores Esperion’s global strategy to broaden access to its non‑statin lipid‑lowering therapies.

Key Details

• Approval: Health Canada granted marketing authorization for NILEMDO® (bempedoic acid) for LDL‑cholesterol reduction in patients at cardiovascular risk.
• Partner: HLS Therapeutics Inc. (TSX: HLS), Esperion’s Canadian commercialization partner, will handle launch activities.
• Launch Timeline: Commercial availability in Canada expected in the second quarter of 2026.
• Target Population: Approximately 2.6 million Canadian adults (≈1 in 12) diagnosed with heart disease; a leading cause of death in Canada.
• Strategic Impact: Adds a new geographic market for Esperion’s FDA‑approved oral, once‑daily non‑statin therapy, supporting revenue growth and diversification.
• CEO Quote: Sheldon Koenig emphasized the milestone as part of expanding access to bempedoic acid products for patients needing better LDL‑C management.

Notable Quotes

“This approval marks another important milestone in our global strategy to expand access to bempedoic acid products for patients who urgently need better options to manage their LDL‑C and reduce cardiovascular risk.” – Sheldon Koenig, President and CEO, Esperion.