HLS Therapeutics Inc. (TSX: HLS), a specialty pharmaceutical company focused on cardiovascular and psychiatric treatments, has expanded Canadian reimbursement access for NILEMDO, its oral cholesterol-lowering medication.
The company said it has secured reimbursement agreements with Canada’s largest private payers, which it estimates represent approximately 80% of privately insured Canadians. Most patients covered by those plans can access NILEMDO as a full benefit without restrictions. Some agreements are already active, while the remaining agreements are expected to take effect during the third quarter of 2026.
NILEMDO, also known as bempedoic acid, is approved in Canada to reduce low-density lipoprotein cholesterol and the risk of major cardiovascular events in adults who require additional cholesterol reduction because existing therapies are insufficient or because they cannot tolerate statins.
HLS commercially launched NILEMDO in Canada in April 2026 after receiving Health Canada approval in November 2025. The company holds exclusive Canadian commercialization rights to the medication through a licensing agreement with Esperion Therapeutics Inc. (Nasdaq: ESPR).
On the public-plan side, Canada’s Drug Agency has issued a final recommendation that NILEMDO be reimbursed with conditions. The Canadian Drug Expert Committee voted 13–0 in favor of recommending reimbursement.
The recommendation is not the same as a provincial listing. HLS must still negotiate with the pan-Canadian Pharmaceutical Alliance before individual public drug plans decide whether to provide coverage. The company said it intends to begin those negotiations later in 2026 and is targeting initial provincial listings during the first half of 2027.
The agency’s conditions include patient eligibility requirements, prescribing criteria and a price reduction. Its assessment also identified uncertainty regarding the medication’s comparative clinical value against some injectable cholesterol-lowering treatments and the potential budget impact of public reimbursement.
“We are pleased with our progress on securing market access for NILEMDO,” HLS Chief Executive Officer Craig Millian said.
In its first-quarter results, HLS reported revenue of US$12.9 million, a net loss of US$2.3 million and US$6.4 million in cash generated from operations. As of March 31, 2026, the company reported US$12.3 million in cash and US$44.2 million in borrowings under its credit agreement.
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The remaining private-payer reimbursement agreements are expected to take effect during the third quarter of 2026.
HLS intends to begin negotiations with the pan-Canadian Pharmaceutical Alliance later in 2026. The company is targeting initial provincial public-plan listings during the first half of 2027, although the timing and outcome of those negotiations remain uncertain.
Sources
- HLS Therapeutics Provides Update on NILEMDO Market Access — August 5, 2026, via Canada Newswire
- Bempedoic Acid (NILEMDO) Final Reimbursement Recommendation — July 2026, via Canada’s Drug Agency
- HLS Therapeutics Announces NILEMDO Commercial Availability in Canada — March 5, 2026, via HLS Therapeutics
- HLS Therapeutics Announces First-Quarter 2026 Financial Results — May 15, 2026, via HLS Therapeutics
Editorial Disclosure
This article is based entirely on publicly available information, including press releases, regulatory documents and publicly available news sources. Securities discussed or referenced include HLS Therapeutics Inc. (TSX: HLS) and Esperion Therapeutics Inc. (Nasdaq: ESPR). Next Gen Tech Stocks has not received any compensation from any company mentioned, its management, investor relations representatives or any third party for this specific article. Next Gen Tech Stocks may have current or past paid business relationships with other companies, which does not influence the content or conclusions of this article. No staff member or principal of Next Gen Tech Stocks holds a position in any security mentioned at the time of publication.
Sources include HLS Therapeutics’ August 5, 2026, press release distributed through Canada Newswire; Canada’s Drug Agency’s July 2026 final reimbursement recommendation for bempedoic acid; HLS Therapeutics’ March 5, 2026, commercial-launch announcement; and the company’s first-quarter financial results released May 15, 2026.
Canada’s Drug Agency recommended that NILEMDO be reimbursed only if specified conditions are met. The recommendation does not guarantee reimbursement by participating public drug plans. HLS must complete negotiations with the pan-Canadian Pharmaceutical Alliance before individual provincial and territorial plans determine whether to list the medication. The timing, terms and outcome of those negotiations remain uncertain. The estimate that the secured private payers represent approximately 80% of privately insured Canadians was provided by HLS.
For the quarter ended March 31, 2026, HLS reported a net loss of US$2.3 million. As of March 31, the company reported US$12.3 million in cash and US$44.2 million in borrowings under its credit agreement. These figures reflect information available as of the stated reporting date, and readers should verify current financial information.
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