Health Canada granted approval for NILEMDO, Esperion’s bempedoic acid therapy, on November 18, 2025. The decision allows HLS Therapeutics to market the drug in Canada for the reduction of LDL‑cholesterol in patients at risk of cardiovascular disease, marking the first regulatory clearance outside the United States for this product line.
The Canadian market represents a sizable opportunity. Approximately 2.6 million Canadians aged 20 and older have diagnosed heart disease, and many of them are either statin‑intolerant or require additional LDL‑lowering therapy. With HLS Therapeutics handling commercialization, Esperion will receive royalty revenue from Canadian sales, providing a new income stream that complements its existing U.S. and European royalty agreements.
Esperion’s recent financial performance underscores the strategic importance of this approval. In the third quarter of 2025, the company reported revenue of $87.3 million, up 69% year‑over‑year, while posting a net loss of $31.3 million. The approval is positioned to accelerate royalty growth and support the company’s goal of achieving sustainable profitability in 2026, as management has indicated a focus on scaling its bempedoic acid portfolio.
The approval aligns with Esperion’s broader global strategy, which includes partnerships with Daiichi Sankyo Europe and Otsuka Pharmaceutical in Japan. By securing Health Canada clearance, the company strengthens its presence in key international markets and demonstrates the global viability of its non‑statin, oral LDL‑lowering platform. This regulatory milestone also signals to investors that the company’s pipeline is progressing through multiple jurisdictions.
CEO Sheldon Koenig emphasized that the Canadian 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.” The statement highlights the company’s commitment to addressing unmet medical needs and positions NILEMDO as a critical component of its future growth strategy.
In summary, the Health Canada approval for NILEMDO expands Esperion’s commercial footprint, opens a new royalty revenue stream, and reinforces the company’s global expansion plan. The decision is expected to contribute to the company’s financial trajectory as it moves toward profitability while meeting the needs of patients who lack effective LDL‑lowering options.
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