What HLS Therapeutics (HLS) Said on Its Q3 Earnings Call

Key Points

• Q3 revenue rose 5% to $14.2 million, as cardiovascular growth—led by NILEMDO—offset lower Canadian Clozaril sales. Adjusted EBITDA was $5 million, up from $4.9 million a year earlier.
• HLS expects 2026 revenue near the midpoint of its $56 million–$60 million guidance, but adjusted EBITDA in the lower half of its $18.5 million–$21 million range, citing launch spending, a shift toward lower-margin cardiovascular products, and weaker-than-expected U.S. Praluent revenue.
• NILEMDO sales climbed 91% quarter over quarter to more than CAD $800,000, and HLS expects provincial listings in the first half of 2027. The company also plans to distribute Bayer’s VERQUVO in Canada from 2027, with more meaningful financial benefits expected in later years.

HLS Therapeutics TSE: HLS reported higher third-quarter revenue as growth in its cardiovascular portfolio offset a decline in Canadian Clozaril sales, and said it expects revenue and adjusted EBITDA growth to increase in 2027.

Revenue for the three months ended Sept. 30 rose 5% year over year to $14.2 million, while adjusted EBITDA increased to $5 million from $4.9 million. The company’s cardiovascular portfolio generated approximately 21% net sales growth in local currency, helped by the launch of cholesterol-lowering medicine NILEMDO.

CEO Craig Millian said the company expects 2026 revenue to be around the midpoint of its existing $56 million to $60 million guidance range. Adjusted EBITDA is expected in the lower half of its $18.5 million to $21 million range, reflecting additional launch spending and a faster shift toward cardiovascular products, which have lower margins than Clozaril.

CFO John Hanna said the two factors accounted for roughly equal portions of the change in adjusted EBITDA expectations. He added that U.S. Praluent revenue, a high-margin product, was weaker in the second half than the company had expected.

NILEMDO Sales Rise as Coverage Expands

NILEMDO generated more than CAD $800,000 in third-quarter net sales, up 91% from the prior quarter. COO Brian Walsh said approximately 1,700 patients started the medicine during the quarter, bringing the total to 2,900 since launch.

Millian said the launch was ahead of the company’s initial projections for the year and that the ramp had continued into the fourth quarter. By the end of September, approximately one in five targeted prescribers had started a patient on NILEMDO, according to Walsh.

Agreements with private payers cover more than 80% of privately insured Canadians, Walsh said, and the company expects negotiations with the pan-Canadian Pharmaceutical Alliance to begin in November. HLS continues to expect initial provincial listings in the first half of 2027.

HLS also expects a Health Canada decision by year-end on NEXLIZET, a fixed-dose combination of bempedoic acid and ezetimibe. If approved, the company anticipates a launch in the first half of 2027.

Millian reaffirmed a combined peak sales opportunity of CAD $50 million to CAD $100 million for NILEMDO and NEXLIZET. He said peak sales in Canada typically take six to seven years, though HLS would seek to accelerate that timeline. While NEXLIZET could replace some use of NILEMDO, he said the company sees it primarily as an opportunity to expand the market.

VASCEPA, the company’s other cardiovascular product, posted approximately 8% net sales growth in local currency in the quarter, with unit demand up 14%. HLS continues to expect double-digit VASCEPA net sales growth for the full year.

Bayer Deal Extends Cardiovascular Portfolio

Under an agreement announced Nov. 3, HLS will take responsibility for distribution, promotion and medical education support for Bayer’s heart failure medicine VERQUVO in Canada starting in the first quarter of 2027. Bayer will retain the market authorization and responsibility for regulatory safety and pricing matters.

HLS will book net sales and pay Bayer a royalty, plus potential commercial milestone payments. Millian said the company expects minimal revenue and adjusted EBITDA impact in 2027, with more substantial economic benefits in later years. In response to an analyst’s question, he estimated VERQUVO could generate $5 million to $10 million in peak sales.

Walsh said HLS’s existing medical team will lead the initial effort with heart failure specialists. The current cardiovascular sales team will not initially support the product, and the company plans to add targeted promotional resources as adoption broadens.

Clozaril and Financial Position

Canadian Clozaril net sales declined 2.6% in local currency in the quarter, while U.S. sales were unchanged at $2.8 million. Millian said patient volumes had increased sequentially for eight consecutive months but remained below their 2025 peak following competitive pressure in Ontario.

The cardiovascular portfolio contributed $0.7 million to adjusted EBITDA in the quarter after breaking even in the first half, Hanna said. Clozaril contributed $6.3 million.

HLS ended September with $11.4 million in cash and $29.9 million in net debt, down 22% from the end of 2025. Through Oct. 31, the company had repurchased more than 1.1 million shares for CAD $4.3 million under its buyback program.

Millian said HLS plans to provide more detailed 2027 guidance with its fourth-quarter results, when it expects greater clarity on the NEXLIZET regulatory decision and NILEMDO reimbursement negotiations.

About HLS Therapeutics (TSE:HLS)

HLS Therapeutics Inc is a specialty pharmaceutical company. It is focused on the acquisition and commercialization of branded pharmaceutical products in the North American markets. The company is focused on treatment products for the central nervous system (CNS), and cardiovascular specialties. The company products include Clozaril, Absorica, Vascepa, CSAN Pronto, Trinomia and Perseris. The company earns revenue in the form of product sales and royalties, out of which product sales contribute to the majority of the revenue.

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