HLS Therapeutics Announces Fiscal 2025 Financial Results

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HLS Therapeutics Announces Fiscal 2025 Financial Results

Canada NewsWire

  • Adjusted EBITDA1 grew 18% to $19.6 million in fiscal 2025
  • Cash from operations grew 114% to $17.1 million in fiscal 2025
  • In-licensed NILEMDO and NEXLIZET® for the Canadian market; NILEMDO approved by Health Canada in November 2025 and is now commercially available
  • Announced new credit facility with lower rates, increased flexibility and reduced F/X risk; reduced long term debt by 26%, achieving 43% reduction in annual interest expense  

TORONTO, March 12, 2026 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces its financial results for the three and twelve months ended December 31, 2025 ("Q4 2025" and "fiscal 2025"). All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated.

Q4 & F2025 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2024 periods)

  • Fiscal 2025 revenue was $55.5 million, Adjusted EBITDA was $19.6 million and cash from operations was $17.1 million, compared to $56.6 million, $16.6 million and $8 million, respectively.
  • Q4 2025 revenue was $15.2 million, Adjusted EBITDA was $5.7 million and cash from operations was $6.5 million, compared to $15.5 million, $5.6 million and $3.2 million, respectively.
  • Canadian product sales increased 1.5% in fiscal 2025 in local currency and decreased 0.5% in Q4 2025. Foreign exchange negatively impacted fiscal 2025 reported revenue by approximately $0.8 million.
  • U.S. Clozaril sales decreased 1.6% in fiscal 2025, an improvement from the prior four-year average annual decline of 6%, reflecting the success of the Company's specialty pharmacy program. Q4 2025 sales decreased 9% due primarily to timing of year-end customer shipments.
  • Excluding cost of sales, operating expenses decreased 17% in fiscal 2025 and 6% in Q4 2025.
  • For direct brand contribution to Adjusted EBITDA in fiscal 2025 - Clozaril contributed $26.9 million and Vascepa contributed $1 million, marking a pivot to full year profitability for Vascepa.

Q4 & F2025 CORPORATE HIGHLIGHTS

  • Expanded cardiovascular portfolio by licensing Canadian rights to NILEMDO and NEXLIZET® from Esperion Therapeutics. Received Health Canada approval for NILEMDO in Q4 2025 with product available as of March 2026.
  • Made principal repayments on long-term debt totaling $17.8 million for fiscal 2025, including $5.0 million in Q4 2025.
  • Secured new credit agreement with improved terms, helping to reduce fiscal 2025 interest expense by 43% compared to fiscal 2024.

"In 2025, HLS made considerable progress against our objectives to drive profitable growth, strengthen our balance sheet, and lay the foundation for future growth," said Craig Millian, Chief Executive Officer at HLS. "We achieved 18% Adjusted EBITDA growth for the full year while generating $17.1 million in cash from operations, up 114% compared to 2024. Changes to our cardiovascular sales force are making an impact, with Vascepa unit growth of 23% for the year and strengthening new-to-brand momentum. We've de-levered our balance sheet, reduced our cost structure, and executed on our business plan. In 2026, we will leverage the efficiency and profitability gains we've made to advance towards our next stage of growth " 

"NILEMDO and NEXLIZET represent a significant opportunity. NILEMDO offers physicians and patients an effective, well-tolerated oral treatment option at a fraction of the cost of injectable alternatives. With an estimated 500,000 eligible patients in Canada and compelling data from the CLEAR Outcomes trial, we believe this franchise will more than double the size of our cardiovascular business. We were pleased to announce that NILEMDO is now available with a full commercial launch coming in early April."

2026 OUTLOOK

2026 financial targets are as follows:

  • Consolidated revenue of $56-60 million, representing mid-single-digit percentage growth.
  • Consolidated Adjusted EBITDA of $18.5-21 million, representing relatively flat year-over-year performance largely due to NILEMDO launch costs.
  • Of note, future results could be impacted by continued exchange rate volatility.

Mr. Millian added: "Our 2026 guidance reflects modest growth in our base business along with some increased investment to drive a successful NILEMDO launch. The real growth story accelerates beyond this year as NILEMDO gains traction throughout 2026, as we expand public payer access in early 2027, and then launch NEXLIZET in 2027. Our base business is stable and profitable, our balance sheet is strong, and we have financial flexibility to pursue additional portfolio expansion. We've built the foundation and are now positioned to drive sustained profitable growth."

Q4 & F2025 FINANCIAL REVIEW

The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and twelve months ended December 31, 2025, are available at the Company's website and at its profile at SEDAR+.

Revenue


Three months ended

December 31,

Year ended

December 31,


2025

2024

2025

2024






Product sales





  Canada

11,637

11,694

42,385

42,572

  United States

3,337

3,661

12,370

12,568


14,974

15,355

54,755

55,140

Royalty revenue

221

187

745

1,479


15,195

15,542

55,500

56,619

Revenue for fiscal 2025 decreased 2% to $55.5 million compared to $56.6 million in fiscal 2024. Excluding the impact of foreign exchange, revenue from marketed products increased 1%, with Vascepa growth offset, in part, by Clozaril regional competitive dynamics as noted in the Company's Q3 2025 reporting.

Revenue for Q4 2025 decreased 2% to $15.2 million compared to $15.5 million in Q4 2024, primarily due to softer revenue in the U.S. business. 

Product sales – Canada

000's of CAD

Three months ended

December 31,

Year ended

December 31,


2025

2024

% change

2025

2024

% change








Clozaril

9,637

9,712

(0.8) %

34,377

35,721

(3.8) %

Vascepa

6,540

6,595

(0.8) %

24,609

22,550

9.1 %

Other

55

6


228

60



16,232

16,313

(0.5) %

59,214

58,331

1.5 %

For fiscal 2025, Canadian product sales in local currency increased 1.5%. Vascepa sales and unit volumes grew 9% and 23%, respectively, reflecting the Company's sales force changes and expanded provincial access, while Clozaril Canada sales declined 4% due to regional competitive dynamics. Canadian product sales for Q4 2025 decreased 0.5%.

Product Sales – United States

In the U.S. market, Clozaril revenue for fiscal 2025 decreased 1.6% compared to fiscal 2024, a considerable improvement over the prior four-year average annual decline of 6%. This reflects the success of the Company's specialty pharmacy program in offsetting patient attrition. Q4 2025 revenue decreased 9% year-over-year primarily due to timing of orders and shipments.

Royalty revenues

Royalty revenue for fiscal 2025 decreased 50% compared to fiscal 2024, as expected following the sale of the Company's Xenpozyme royalty interest in Q2 2024. The Company's remaining royalty interest in Obizur generated $0.22 million in Q4 2025 compared to $0.19 million in Q4 2024.

Operating Expenses


Three months ended

December 31,

Year ended

December 31,


2025

2024

2025

2024






Cost of product sales

2,643

2,685

10,083

8,997

Selling and marketing

2,841

3,438

11,386

16,733

Medical, regulatory and patient support

1,634

1,539

5,708

5,663

General and administrative

2,366

2,323

8,700

8,578


9,484

9,985

35,877

39,971

Cost of product sales for fiscal 2025 increased due primarily to higher Vascepa sales volumes and were relatively flat in Q4 2025.

HLS continues to demonstrate strong operational discipline. Operating expenses for fiscal 2025, comprising sales and marketing, G&A, and medical, regulatory, and patient support, decreased 17% compared to fiscal 2024. This reflects the Company's August 2024 discontinuation of co-promotional activities and ongoing cost optimization initiatives. For Q4 2025, operating expenses decreased 6% year-over-year.

Adjusted EBITDA1


Three months ended

December 31,

Year ended

December 31,


2025

2024

2025

2024






Net loss for the period

(1,335)

(3,023)

(12,430)

(19,655)

Stock-based compensation

11

423

1,912

1,617

Amortization and depreciation

5,463

5,434

21,817

22,717

Finance and related costs, net

1,702

2,295

7,391

10,293

Other costs (income)

517

343

1,378

(2,397)

Income tax expense (recovery)

(647)

85

(445)

4,073

Adjusted EBITDA

5,711

5,557

19,623

16,648

Adjusted EBITDA for fiscal 2025 increased 18% compared to fiscal 2024, driven by strong operational discipline and cost optimization initiatives, partially offset by foreign exchange fluctuations and the decline in royalty revenue. Adjusted EBITDA for Q4 2025 increased 3% year-over-year, reflecting continued operational efficiencies.  

For fiscal 2025, the direct brand contribution from Clozaril to Adjusted EBITDA was $26.9 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved to $1 million from negative $3.6 million in fiscal 2024. In Q4 2025, the direct brand contribution from Clozaril to Adjusted EBITDA was $7.7 million, while the direct brand contribution from Vascepa to Adjusted EBITDA was $0.3 million.

Net Loss

Fiscal 2025 net loss was ($12.4) million, or ($0.39) per share, compared to a net loss of ($19.7) million, or ($0.62) per share, in fiscal 2024. Q4 2025 net loss was ($1.3) million, or ($0.04) per share, compared to a net loss of ($3.0) million, or ($0.10) per share, in Q4 2024. Net loss improved in both periods of 2025 due in part to the previously noted factors that have positively impacted Adjusted EBITDA this year.

Cash from Operations and Financial Position

Cash generated from operations for fiscal 2025 was $17.1 million, up 114% compared to $8.0 million in fiscal 2024. For Q4 2025, cash from operations was $6.5 million, up 103% compared to $3.2 million in Q4 2024.

In 2025, the Company strengthened its balance sheet through disciplined capital allocation. During fiscal 2025, HLS made debt principal repayments totaling $17.8 million, reducing total borrowings under the credit agreement to $50.0 million at December 31, 2025, compared to $67.4 million at December 31, 2024. Net debt decreased to $38.3 million at December 31, 2025, compared to $50.0 million at December 31, 2024.

Under its Normal Course Issuer Bid, the Company purchased 519,366 shares at a cost of $1.8 million during fiscal 2025.

Cash was $11.7 million at December 31, 2025, compared to $17.5 million at December 31, 2024. The decrease reflects the debt principal repayments and share buyback activity, offset in part by the significant increase in cash from operations.

Q4 2025 CONFERENCE CALL

HLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q4 and fiscal 2025 financial results. The call will be hosted by Mr. Craig Millian, CEO, Mr. John Hanna, CFO and Mr. Brian Walsh, CCO. To view the slides that accompany management's discussion, please use the webcast link.

CONFERENCE ID: 88550

DATE: Thursday, March 12, 2026

TIME: 8:30 a.m. ET

WEBCAST LINK: https://app.webinar.net/vM10bgxNP5g

TRADITIONAL DIAL-IN NUMBER: 1-888-699-1199 or 1-416-945-7677

RAPIDCONNECT: To instantly join the conference call by phone, please use the following URL to easily register and be connected into the conference call automatically: https://emportal.ink/4jRnIfD

TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450

REPLAY CODE: 88550#

The taped replay will be available for seven days and the archived webcast will be available for 365 days.

A link to the live audio webcast and replay of the conference call will also be available on the events page of the investors section of HLS Therapeutics' website at www.hlstherapeutics.com.

ABOUT HLS THERAPEUTICS INC.

Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com

1CAUTIONARY NOTE REGARDING NON-IFRS MEASURES

This press release refers to certain non-IFRS measures. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of HLS's results of operations from management's perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of HLS's financial information reported under IFRS. HLS uses non-IFRS measures to provide investors with supplemental measures of its operating performance and thus highlight trends in its core business that may not otherwise be apparent when relying solely on IFRS financial measures. HLS also believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. HLS's management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets and assess HLS's ability to meet its future debt service, capital expenditure and working capital requirements.

In particular, management uses Adjusted EBITDA as a measure of HLS's performance.  To reconcile net income (loss) for the period with Adjusted EBITDA, each of (i) "stock-based compensation", (ii) "amortization and depreciation", (iii) "finance and related costs, net", (iv) "other costs (income)", and (v) "income tax expense (recovery)" appearing in the Consolidated Statement of Net Income (Loss) are added to net income (loss) for the period to determine Adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies.  Adjusted EBITDA should not be considered in isolation or as a substitute for net income (loss) prepared in accordance with IFRS as issued by the IASB.

FORWARD LOOKING INFORMATION

This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities, expectations regarding financial performance, and the NCIB and ASPP. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 11, 2026, and Management's Discussion and Analysis dated March 11, 2026, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

HLS THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

[in thousands of U.S. dollars]






As at

As at



December 31, 2025

December 31, 2024





ASSETS




Current




Cash


11,723

17,456

Accounts receivable


7,862

7,454

Inventories


8,139

9,058

Income taxes recoverable


71

Other current assets


1,370

1,361

Total current assets


29,094

35,400

Property, plant and equipment


1,338

997

Intangible assets


105,626

122,122

Deferred tax asset


1,143

857

Other non-current assets


328

528

Total assets


137,529

159,904





LIABILITIES AND SHAREHOLDERS' EQUITY




Current




Accounts payable and accrued liabilities


10,438

8,709

Provisions


10,456

8,367

Debt and other liabilities


4,817

5,317

Income taxes payable


410

152

Total current liabilities


26,121

22,545

Debt and other liabilities


46,678

61,944

Deferred tax liability


3,060

4,074

Total liabilities


75,859

88,563





Shareholders' equity




Share capital


256,338

260,595

Contributed surplus


16,164

15,136

Accumulated other comprehensive loss


(6,680)

(10,210)

Deficit


(204,152)

(194,180)

Total shareholders' equity


61,670

71,341

Total liabilities and shareholders' equity


137,529

159,904

 

HLS THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF LOSS

Unaudited

[in thousands of U.S. dollars, except per share amounts]




Three months ended

December 31,

Year ended

December 31,



2025

2024

2025

2024







Revenue


15,195

15,542

55,500

56,619







Expenses






Cost of product sales


2,643

2,685

10,083

8,997

Selling and marketing


2,841

3,438

11,386

16,733

Medical, regulatory and patient support


1,634

1,539

5,708

5,663

General and administrative


2,366

2,323

8,700

8,578

Stock-based compensation


11

423

1,912

1,617

Amortization and depreciation


5,463

5,434

21,817

22,717

Finance and related costs, net


1,702

2,295

7,391

10,293

Other costs (income)


517

343

1,378

(2,397)

Loss before income taxes


(1,982)

(2,938)

(12,875)

(15,582)

Income tax expense (recovery)


(647)

85

(445)

4,073

Net loss for the period


(1,335)

(3,023)

(12,430)

(19,655)





Net loss per share:




Basic and diluted


$(0.04)

$(0.10)

$(0.39)

$(0.62)

 

HLS THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

Unaudited

[in thousands of U.S. dollars]




Three months ended

December 31,

Year ended

December 31,


2025

2024

2025

2024






Net loss for the period

(1,355)

(3,023)

(12,430)

(19,655)






Item that may be reclassified subsequently to net loss





   Unrealized foreign currency translation adjustment

1,018

(5,194)

3,530

(7,372)

Comprehensive loss for the period

(317)

(8,217)

(8,900)

(27,027)

 

HLS THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

[in thousands of U.S. dollars]








Share

capital

Contributed

surplus

Accumulated other
comprehensive loss

Deficit

Total








Balance, December 31, 2023


262,127

13,865

(2,838)

(175,457)

97,697

Shares repurchased


(1,532)

932

(600)

Change in share purchase  obligation


300

300

Stock option expense


971

971

Net loss for the year


(19,655)

(19,655)

Unrealized foreign currency   translation adjustment


(7,372)

(7,372)

Balance, December 31, 2024


260,595

15,136

(10,210)

(194,180)

71,341

Shares repurchased


(4,257)

2,458

(1,799)

Stock option expense


1,028

1,028

Net loss for the year


(12,430)

(12,430)

Unrealized foreign currency   translation adjustment


3,530

3,530

Balance, December 31, 2025


256,338

16,164

(6,680)

(204,152)

61,670

 

HLS THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

Unaudited

[in thousands of U.S. dollars]




Three months ended

December 31,

Year ended

December 31,


2025

2024

2025

2024






OPERATING ACTIVITIES





Net loss for the period

(1,335)

(3,023)

(12,430)

(19,655)

Adjustments to reconcile net loss to cash provided

  by operating activities





Stock-based compensation

11

423

1,912

1,617

Amortization and depreciation

5,463

5,434

21,817

22,717

Gain on royalty sale

(3,381)

Accreted interest expense

115

314

2,056

1,226

Foreign exchange

773

341

Fair value adjustment on financial assets and liabilities

3

526

Deferred income taxes

(76)

59

(1,300)

3,812

Net change in non-cash working capital balances related to  operations

2,240

(5)

4,734

1,141

Cash provided by operating activities

6,507

3,205

17,130

8,003






INVESTING ACTIVITIES





Intangible asset acquisition

(1,000)

Other intangible additions

(283)

(498)

Additions to property, plant and equipment

(33)

(205)

(15)

Proceeds from royalty sale

13,250

Payment of purchase consideration

(13)

(1,500)

Cash provided by (used in) investing activities

(316)

(13)

(1,703)

11,735






FINANCING ACTIVITIES





Shares repurchased

(7)

(1,799)

(600)

Repayment of old credit agreement borrowing

(2,510)

(67,441)

(21,043)

New credit agreement borrowing

57,236

Repayment of new credit agreement borrowing

(5,032)

(7,550)

Debt costs

(168)

(1,388)

(1,191)

Lease payments

(161)

(144)

(614)

(530)

Cash used in financing activities

(5,368)

(2,654)

(21,556)

(23,364)






Net increase (decrease) in cash during the period

823

538

(6,129)

(3,626)

Foreign currency translation

122

(622)

396

(870)

Cash, beginning of period

10,778

17,540

17,456

21,952

Cash, end of period

11,723

17,456

11,723

17,456

SOURCE HLS Therapeutics Inc.