HLS Therapeutics launches Nilemdo in Canada

Executive Summary

• HLS Therapeutics Inc. has commercially launched Nilemdo (bempedoic acid) in Canada for the reduction of LDL-cholesterol in patients at risk of cardiovascular disease.
• The company in-licensed exclusive rights to Nilemdo and Nexlizet from Esperion Therapeutics Inc. in May 2025, following Health Canada approval of Nilemdo in November 2025.
• HLS is advancing the regulatory submission for Nexlizet (bempedoic acid and ezetimibe), anticipating a 2027 commercial launch, while currently seeking reimbursement for Nilemdo.

Key Details

• Product Launch: Nilemdo (bempedoic acid) is now available by prescription nationally in Canada.
• Licensing Agreement: HLS in-licensed exclusive rights to Nilemdo and Nexlizet (bempedoic acid and ezetimibe) for the Canadian market from Esperion Therapeutics Inc. in May 2025.
• Regulatory Status: Health Canada approved Nilemdo in November 2025.
• Indication: Nilemdo is indicated to reduce low-density lipoprotein cholesterol (LDL-C) and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to inability to reach target levels with current therapies or due to statin intolerance.
• Market Opportunity: HLS estimates that more than half a million Canadians may benefit from Nilemdo.
• Clinical Evidence: Approval is supported by the Clear Outcomes trial, a landmark randomized, double-blind study involving nearly 14,000 high-risk patients unable to take recommended statin therapy. The trial demonstrated that bempedoic acid significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization).
• Mechanism of Action: Nilemdo offers a novel oral pathway for LDL-C lowering with a lower likelihood of muscle-related side effects compared to statins. It can be used alone or in combination with statins, ezetimibe, and PCSK9 inhibitors.
• Reimbursement Status: Nilemdo has been submitted for reimbursement under private and public plans. HLS expects meaningful private payer coverage in the second quarter and potential public reimbursement in late 2026.
• Future Pipeline (Nexlizet): HLS is responding to Health Canada's outstanding requirements for Nexlizet (a combination pill of bempedoic acid and ezetimibe). Clinical trials demonstrated approximately 38% LDL-C reduction. HLS anticipates a 2027 commercial launch.

Notable Quotes

• "Despite considerable evidence and guideline recommendations, too many Canadians are still not reaching their LDL-C targets," said Dr. Lawrence Leiter, professor of medicine and nutritional sciences at the University of Toronto. "Bempedoic acid (Nilemdo) offers a new option for Canadian patients who cannot achieve their LDL-C goal or are intolerant to statins."
• "With the launch of Nilemdo, Canadians who have been unable to reach their LDL-C targets now have a new oral treatment option supported by robust cardiovascular outcomes data," said Craig Millian, chief executive officer of HLS Therapeutics. "Nilemdo strengthens our cardiovascular portfolio and, along with Vascepa, positions HLS as a leader in bringing novel oral cardiovascular medicines to the Canadian market."