Bempedoic acid

Adjusted EBITDA grew 19% in Q3 and 25% year-to-date Cash from operations grew 67% in Q3 and 121% year-to-date Announced new credit facility with lower rates, increased flexibility and reduced F/X risk Bempedoic acid approval expected in Q4 2025; preparations underway for Q2 2026 launch TORONTO, Nov. 13, 2025 /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 nine months ended September 30, 2025 ("Q3 2025" and "year-to-date"). All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q3 & YEAR-TO-DATE 2025 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2024 periods) Q3 2025 revenue was $13.5 million, Adjusted EBITDA1 was $4.9 million and cash from operations was $2.5 million, compared to $14.1 million, $4.1 million and $1.5 million, respectively. Year-to-date 2025 revenue was $40.3 million, Adjusted EBITDA was $13.9 million and cash from operations was $10.6 million, compared to $41.1 million, $11.1 million and $4.8 million, respectively. In local currency, combined Canadian product sales for Vascepa and Clozaril were down 4% in Q3 2025 and up 2% year-to-date. For the year-to-date period, unfavorable foreign exchange negatively impacted revenue by approximately $0.8 million in fiscal 2025. U.S. sales of Clozaril in Q3 2025 were flat year-over-year and were up 1% year-to-date. Excluding cost of sales, operating expenses decreased 22% in Q3 2025 and 20% year-to-date. Vascepa contributed $0.6 million to Adjusted EBITDA in Q3 2025, its most profitable quarter to date. Q3 2025 CORPORATE HIGHLIGHTS Secured new credit agreement with improved terms, reducing annual interest expense by approximately $1.5 million. Made principal repayments on the Company's long-term debt totalling $2.5 million ($13.9 million year-to-date). Repurchased $0.8 million of common stock in Q3 2025. The Company has purchased 517,776 common shares at a cost of $1.8 million since launching its buyback on March 17, 2025. "We are pleased with the solid growth in profitability and cash flow we delivered in Q3 and throughout 2025," said Craig Millian, CEO at HLS. "Adjusted EBITDA increased 19% in Q3 and 25% year-to-date, and builds on the consistent improvement achieved over the past two years. Our U.S. Clozaril business has outperformed expectations, but, in addition to FX impacts, our Canadian business has faced headwinds in 2025 that have impacted sales performance." "Vascepa prescriptions have grown 24% year-to-date, and the product achieved its highest level of profitability this quarter. Overall, prescription growth fell short of our targets, due in part to the sales force transition in the first half. This transition was necessary to strengthen our capabilities and prepare for the bempedoic acid launch, and the team is now fully deployed. Clozaril continues to generate strong profit and cash flow and has successfully maintained its leadership for over 20 years in a generic market. Importantly, while patient numbers are down 1% versus prior year, they are still up 1% since year-end 2023. Although patient numbers have remained relatively stable, inventory fluctuations and regional competitive pressures can impact financial results year-to-year, and we have experienced that in 2025. We've adjusted guidance accordingly in our outlook." "Looking to the future, with the expected approval of bempedoic acid this month, we are excited to launch this important therapy in Canada in the first half of next year. Bempedoic acid addresses a significant unmet need for more than half a million Canadians who require additional LDL-cholesterol lowering beyond currently available options. We will leverage the strong operational synergies with Vascepa and anticipate significant growth potential for this combined cardiovascular franchise as we build HLS into a leading Canadian CV company." "We remain committed to operational efficiency to further optimize profitability, while a strengthening balance sheet will enable HLS to pursue additional growth opportunities beyond bempedoic acid. We expect growth in both revenue and Adjusted EBITDA next year and will provide detailed guidance when year-end results are reported in March." UPDATED 2025 OUTLOOKRevenue projections for the Company's Canadian product portfolio are denominated in local currency to account for ongoing FX rate fluctuations. 2025 financial targets have been updated and are as follows: Consolidated Adjusted EBITDA of $19.5-20.5 million (17-23% growth) is unchanged Consolidated revenue of $55-56 million, consisting of: Vascepa revenue growth in the mid-teen percentages (compared to prior estimate of 18-26% growth) Canada Clozaril revenue decline of 4-5% (compared to prior estimate of flat year-over-year revenue) U.S. Clozaril revenue decline of 2-4% year-over-year is unchanged Royalty revenue of $0.6-0.75 million (50-60% decline) is unchanged Vascepa revenue growth in the mid-teen percentages (compared to prior estimate of 18-26% growth) Canada Clozaril revenue decline of 4-5% (compared to prior estimate of flat year-over-year revenue) U.S. Clozaril revenue decline of 2-4% year-over-year is unchanged Royalty revenue of $0.6-0.75 million (50-60% decline) is unchanged Future results could be impacted by continued exchange rate volatility. Q3 & YEAR-TO-DATE 2025 FINANCIAL REVIEWThe Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and nine months ended September 30, 2025, are available at the Company's website and at its profile at SEDAR+. Revenue Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Product sales Canada 10,519 11,087 30,748 30,878 United States 2,813 2,803 9,033 8,907 13,332 13,890 39,781 39,785 Royalty revenue 179 195 524 1,292 13,511 14,085 40,305 41,077 Revenue for Q3 2025 decreased 4%, due primarily to lower Clozaril Canada revenue, lower royalty revenues and FX rate fluctuations, offset in part by revenue increases from Vascepa and Clozaril U.S. For the year-to-date period, revenue decreased 2% with flat product revenue offset by FX rate fluctuations and a 59% drop in royalty revenue. For the year-to-date period, unfavorable foreign exchange negatively impacted revenue by approximately $0.8 million in fiscal 2025. Product sales – Canada 000's of CAD Three months ended September 30, Nine months ended September 30, 2025 2024 % change 2025 2024 % change Clozaril 8,222 9,013 (8.8) % 24,740 26,009 (4.9) % Vascepa 6,207 6,077 2.1 % 18,069 15,955 13.2 % Other 65 27 173 54 14,494 15,117 (4.1) % 42,982 42,018 2.3 % Canadian product sales in local currency decreased 4% in Q3 2025 due to lower Clozaril Canada sales that were largely attributable to competitive dynamics and inventory burn at select hospitals. This was partially offset by 2% growth in Vascepa. For the year-to-date period, Canadian product sales increased 2%, with a 13% increase in Vascepa sales offset, in part, by a 5% decline in Clozaril Canada sales. The timing of orders can impact quarterly results, and for this reason, the Company views year-to-date revenue as a more relevant measure for the comparison of year-over-year revenue performance. Product Sales – United States In the U.S. market, Clozaril revenue for Q3 2025 was up slightly year-over-year, while revenue for the year-to-date period increased 1% compared to the same prior year period last year. Royalty revenues As expected, royalty revenue has declined since the sale of the Xenpozyme royalty interest in Q2 2024. Royalty revenue for the three and nine months ended September 30, 2025, was down 8% and 59%, respectively, compared to the same periods last year. HLS has one remaining royalty interest which generated $0.18 million in revenue in Q3 2025. Operating Expenses Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Cost of product sales 2,537 2,235 7,440 6,312 Selling and marketing 2,669 4,208 8,545 13,295 Medical, regulatory and patient support 1,272 1,439 4,074 4,124 General and administrative 2,111 2,077 6,334 6,255 8,589 9,959 26,393 29,986 With operating expenses, HLS continues to demonstrate strong operational discipline, helping to drive increases in Adjusted EBITDA and cash flow. For the three and nine months ended September 30, 2025, operating expenses, comprising sales and marketing, G&A, and medical, regulatory, and patient support, were down 22% and 20% compared to the same periods last year. This was primarily due to lower selling and marketing expenses following the Company's discontinuation of co-promotional activities with its marketing partner in August 2024 as well as several staff vacancies during 2025 that have now been filled. Cost of product sales increased for the three and nine months ended September 30, 2025, due primarily to higher Vascepa sales volumes. Adjusted EBITDA1 Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net loss for the period (3,918) (4,844) (11,095) (16,632) Stock-based compensation 785 511 1,901 1,194 Amortization and depreciation 5,511 5,508 16,354 17,283 Finance and related costs, net 2,027 2,389 5,689 7,998 Other costs (income) 534 621 861 (2,740) Income tax expense (recovery) (17) (59) 202 3,988 Adjusted EBITDA 4,922 4,126 13,912 11,091 Adjusted EBITDA for the three and nine months ended September 30, 2025, increased 19% and 25%, respectively, compared to the same periods last year. The increases were primarily due to the ongoing focus on cost management and were partially offset by FX fluctuations and the previously mentioned decline in royalty revenue. In Q3 2025, the direct brand contribution from Clozaril to Adjusted EBITDA was $6.3 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $0.6 million in Q3 2024 to positive $0.6 million. Year-to-date, the direct brand contribution from Clozaril to Adjusted EBITDA was $19.2 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $3.8 million to positive $0.7 million. Net LossQ3 2025 net loss was ($3.9) million, or ($0.12) per share, compared to a net loss of ($4.8) million, or ($0.15) per share, in Q3 2024. Year-to-date net loss was ($11.1) million, or ($0.35) per share, compared to a net loss of ($16.6) million, or ($0.52) per share, in the same period last year. Net loss improved in both periods of 2025 due primarily to the previously noted factors that have positively impacted Adjusted EBITDA this year. Cash from Operations and Financial PositionCash generated from operations for the three and nine months ended September 30, 2025, was $2.5 million and $10.6 million, compared to $1.5 million and $4.8 million in the same periods last year. This represents year-over-year increases of 67% and 121%, respectively. Total borrowings under the credit agreement at September 30, 2025, were $53.1 million compared to $67.4 million at December 31, 2024, representing a reduction of 21%. Year-to-date, HLS has made debt principal repayments of $13.9 million and under its share buyback program, has purchased 517,776 shares at a cost of $1.8 million since launching the buyback on March 17, 2025. Cash was $10.8 million at September 30, 2025, compared to $17.5 million at December 31, 2024. The decrease reflects the debt principal repayments, and the share buyback activity described previously, offset, in part, by the significant increase in cash from operations. Q3 2025 CONFERENCE CALLHLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q3 and year-to-date 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: 19299 DATE: Thursday, November 13, 2025 TIME: 8:30 a.m. ET WEBCAST LINK: https://app.webin ar.net/0d539rj9qEn 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/4pZWp5i TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 19299# 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 MEASURESThis 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 INFORMATIONThis 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 12, 2025, and Management's Discussion and Analysis dated November 12, 2025, 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. INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION Unaudited [in thousands of U.S. dollars] As at As at September 30, 2025 December 31, 2024 ASSETS Current Cash 10,778 17,456 Accounts receivable 8,183 7,454 Inventories 7,106 9,058 Income taxes recoverable 80 71 Other current assets 1,389 1,361 Total current assets 27,494 35,400 Property, plant and equipment 1,267 997 Intangible assets 109,675 122,122 Deferred tax asset 1,247 857 Other non-current assets 545 528 Total assets 140,228 159,904 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 10,587 8,709 Provisions 7,725 8,367 Debt and other liabilities 4,754 5,317 Income taxes payable 390 152 Total current liabilities 23,456 22,545 Debt and other liabilities 51,109 61,944 Deferred tax liability 3,924 4,074 Total liabilities 78,489 88,563 Shareholders' equity Share capital 256,351 260,595 Contributed surplus 15,909 15,136 Accumulated other comprehensive loss (7,698) (10,210) Deficit (202,823) (194,180) Total shareholders' equity 61,739 71,341 Total liabilities and shareholders' equity 140,228 159,904 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Revenue 13,511 14,085 40,305 41,077 Expenses Cost of product sales 2,537 2,235 7,440 6,312 Selling and marketing 2,669 4,208 8,545 13,295 Medical, regulatory and patient support 1,272 1,439 4,074 4,124 General and administrative 2,111 2,077 6,334 6,255 Stock-based compensation 785 511 1,901 1,194 Amortization and depreciation 5,511 5,508 16,354 17,283 Finance and related costs, net 2,027 2,389 5,689 7,998 Other costs (income) 534 621 861 (2,740) Loss before income taxes (3,935) (4,903) (10,893) (12,644) Income tax expense (recovery) (17) (59) 202 3,988 Net loss for the period (3,918) (4,844) (11,095) (16,632) Net loss per share: Basic and diluted $(0.12) $(0.15) $(0.35) $(0.52) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Unaudited [in thousands of U.S. dollars] Three months ended September 30, Nine months ended September 30, 2025 2024 2025 2024 Net loss for the period (3,918) (4,844) (11,095) (16,632) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment (1,240) 1,158 2,512 (2,178) Comprehensive loss for the period (5,158) (3,686) (8,583) (18,810) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY Unaudited [in thousands of U.S. dollars] Notes Share capital Contributed surplus Accumulated other comprehensive loss Deficit Total Balance as at December 31, 2024 260,595 15,136 (10,210) (194,180) 71,341 Shares repurchased 7 (4,244) — — 2,452 (1,792) Stock option expense 7, 10 — 773 — — 773 Net loss for the period — — — (11,095) (11,095) Unrealized foreign currency translation adjustment — — 2,512 — 2,512 Balance as at September 30, 2025 256,351 15,909 (7,698) (203,261) 61,739 Balance as at 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 7, 10 — 742 — — 742 Net loss for the period — — — (16,632) (16,632) Unrealized foreign currency translation adjustment — — (2,178) — (2,178) Balance as at September 30, 2024 260,595 14,907 (5,016) (191,157) 79,329 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Nine months ended September 30, 2025 2024 2025 2024 OPERATING ACTIVITIES Net loss for the period (3,918) (4,844) (11,095) (16,632) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 785 511 1,901 1,194 Amortization and depreciation 5,511 5,508 16,354 17,283 Gain on royalty sale — — — (3,381) Accreted interest expense 1,331 353 1,941 912 Foreign exchange (432) — (432) — Fair value adjustment on financial assets and liabilities — 18 — 523 Deferred income taxes (62) (47) (540) 3,753 Net change in non-cash working capital balances related to operations (739) 2 2,494 1,146 Cash provided by operating activities 2,476 1,501 10,623 4,798 INVESTING ACTIVITIES Intangible asset acquisition — — (1,000) — Other intangible additions (215) — (215) — Additions to property, plant and equipment (64) — (172) (2) Proceeds from royalty sale — — — 13,250 Payment of purchase consideration — (1,500) — (1,500) Cash provided by (used in) investing activities (279) (1,500) (1,387) 11,748 FINANCING ACTIVITIES Shares repurchased (783) — (1,792) (600) Repayment of old credit agreement borrowing (56,000) (14,965) (67,441) (18,533) New credit agreement borrowing 57,236 — 57,236 — Repayment of new credit agreement borrowing (2,518) — (2,518) — Debt costs (1,220) — (1,220) (1,191) Lease payments (159) (131) (453) (386) Cash used in financing activities (3,444) (15,096) (16,188) (20,710) Net decrease in cash during the period (1,247) (15,095) (6,952) (4,164) Foreign currency translation (128) 120 274 (248) Cash, beginning of period 12,153 32,515 17,456 21,952 Cash, end of period 10,778 17,540 10,778 17,540 SOURCE HLS Therapeutics Inc.