HLS Therapeutics (TSE:HLS) reported fourth-quarter and full-year 2025 results on Thursday, highlighting adjusted EBITDA growth, reduced leverage, and preparations for the Canadian launch of NILEMDO as the company works to expand its cardiovascular franchise.
2025 results: adjusted EBITDA growth and improved cash flow
For the fourth quarter, HLS reported revenue of $15.2 million, compared with $15.5 million in the prior-year period. Full-year revenue was $55.5 million, down from $56.6 million in 2024. Management said that excluding foreign exchange impacts and a decline in royalty revenue, product sales increased 1% for the year.
Cash flow also improved. Cash from operations was $6.5 million in Q4 and $17.1 million for the full year, which management said was up 114% compared to 2024. Hanna attributed the increase to improved profitability and lower interest expense, noting interest expense declined by $3.8 million, or 43%, compared with 2023.
Brand performance: Vascepa turnaround and Clozaril stabilization efforts
CEO Craig Millian said HLS is now seeing “signs that the changes we made in 2025 with our cardiovascular sales force are working.” Vascepa unit demand grew 23% for the year, including 19% unit growth in Q4. Management also pointed to a positive inflection in the second half in new-to-brand prescriptions, which it said had not been observed since before the Pfizer separation.
HLS emphasized improved profitability at Vascepa. Millian said Vascepa made a positive contribution to adjusted EBITDA for the full year for the first time. Hanna quantified the “direct brand contribution” to adjusted EBITDA at $0.3 million in Q4 and $1.0 million for 2025, compared with a ($3.6 million) loss in 2024. Chief Commercial Officer Brian Walsh said the gap between Vascepa unit growth and Q4 revenue performance was driven mainly by payer mix and the timing of shipments for year-end orders, and he added that changes to co-pay assistance and a greater focus on private payers contributed to payer-mix stabilization in Ontario and Quebec.
For Clozaril, Walsh described different dynamics in the U.S. and Canada. In the U.S., he said a specialty pharmacy program helped partially offset attrition in other channels, with strength continuing into Q1 2026. U.S. Clozaril sales were $3.3 million in Q4 and $12.4 million for the year, a 1.6% decline for 2025, which management characterized as an improvement from a four-year average annual decline of 6%.
In Canada, Walsh said Clozaril faced pressure in Ontario due to new group purchasing organization arrangements with some hospital accounts during 2025. He said HLS retained its largest and most strategic hospital accounts and maintained its position as the leading supplier in Ontario, but expects some additional revenue pressure in 2026 from those renegotiations. He added that HLS is gaining share in Western and Atlantic Canada and is maintaining strong patient retention in Quebec.
Cardiovascular franchise expansion: NILEMDO launch begins
Management reiterated that building a Canadian-based cardiovascular franchise is a central growth priority. HLS in-licensed NILEMDO (bempedoic acid) and NEXLIZET (bempedoic acid plus ezetimibe) in 2025, and received Health Canada approval for NILEMDO in November. The NEXLIZET application remains under review, and Millian said HLS is “actively engaging with Health Canada” and targeting approval by early 2027; Walsh later said the company is working toward approval and a launch in the first half of 2027.
Walsh said NILEMDO is now available through wholesalers and HLS began promoting initial shipments in March. The company plans a full commercial launch with its sales force in early April 2026. Management emphasized that commercialization will leverage the existing cardiovascular sales force and will not require additional headcount.
Millian outlined why he believes the opportunity is underappreciated, citing an estimated roughly half a million Canadians who could benefit from bempedoic acid, the outcomes data from the CLEAR Outcomes trial, and a list price of CAD 4.25 per day positioned against more costly injectables. He also said that within the targeted patient subset, even conservative share assumptions could translate into CAD 50 million to CAD 100 million in annual sales, which he said could more than double the size of HLS’s cardiovascular business.
On launch strategy, Walsh told analysts the company is “tempering” first-year expectations because initial uptake will be driven primarily by private coverage that rolls out throughout the year. He said HLS has had substantive private payer engagements, submitted reimbursement dossiers to CDA (formerly CADTH) and to private payers, and expects meaningful private coverage “over the next several months.” For public reimbursement, he said discussions will continue through 2026, with provincial listings targeted by early 2027.
Balance sheet actions, capital allocation, and 2026 guidance
HLS also highlighted deleveraging progress. During 2025, the company made principal repayments totaling CAD 17.8 million. Term loan principal was CAD 50.0 million at year-end, down from CAD 67.4 million at the end of 2024. Net debt ended the year at CAD 38.3 million, down 23% year over year and down 50% from three years ago, according to management.
On share repurchases, Hanna said HLS bought approximately 519,000 shares in 2025 for CAD 1.8 million. Millian described the normal course issuer bid as a key component of capital allocation but said restrictions have limited recent activity; in Q&A, Hanna cited blackout periods as a primary constraint.
Looking ahead, management provided 2026 guidance calling for revenue of $56 million to $60 million and adjusted EBITDA of $18.5 million to $21 million. Millian said the outlook reflects base business growth, conservative expectations for NILEMDO, and the investment required for a successful launch. He added that after substantial reductions in cardiovascular spending over the past two years, HLS plans a modest increase to avoid under-investing in launch activities, while still expecting the cardiovascular business to increase its positive adjusted EBITDA contribution in 2026.
In the analyst Q&A, management added color on assumptions underlying the outlook, including expectations for Vascepa growth “in the teens” and a conservative view on Clozaril (flat to a slight low single-digit decline), driven by Ontario dynamics that management expects to weigh more on early-year comparisons before stabilizing later in 2026.
HLS also reiterated its interest in additional business development and said it remains open to a strategic transaction to build scale, though executives indicated they would prefer not to use equity at current share prices, which they described as undervalued.
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.
