Icosapent Ethyl

Adjusted EBITDA grew 21% in Q2 and 29% year-to-date Cash from operations grew 83% in Q2 and 147% year-to-date Made principal repayments on the Company's long-term debt totalling $8.5 million Expanded cardiovascular portfolio by licensing Canadian rights to NEXLETOL® and NEXLIZET® from Esperion Therapeutics TORONTO, Aug. 14, 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 six months ended June 30, 2025 ("Q2 2025" and "year-to-date"). All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q2 & YEAR-TO-DATE 2025 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2024 periods) Q2 2025 revenue was $14.2 million, Adjusted EBITDA1 was $5.2 million and cash from operations was $4.6 million, compared to $14.5 million, $4.3 million and $2.5 million, respectively. Year-to-date 2025 revenue was $26.8 million, Adjusted EBITDA was $9.0 million and cash from operations was $8.1 million, compared to $27 million, $7 million and $3.3 million, respectively. In local currency, combined Canadian product sales for Vascepa and Clozaril were flat in Q2 2025 and were up 6% year-to-date. US sales of Clozaril were up 1% in Q2 2025 and were up 2% year-to-date. Excluding cost of sales, operating expenses decreased 18% in Q2 2025 and 19% year-to-date. Vascepa made a positive contribution to Adjusted EBITDA in Q2 2025 for the third straight quarter. Q2 2025 CORPORATE HIGHLIGHTS Announced in-license agreement with Esperion Therapeutics Inc. (NASDAQ:ESPR) to commercialize NEXLETOL2 and NEXLIZET2 in Canada. Made principal repayments on the Company's long-term debt totalling $8.5 million. Repurchased $0.8 million of common stock in Q2 2025. Year-to-date, the Company has purchased $1.0 million of common stock at an average price of C$4.56 per share. "Our year-to-date results reflect continued execution on our key strategic priorities as we position the Company to resume its growth trajectory," said Craig Millian, Chief Executive Officer at HLS. "We remain on track to achieve full-year guidance, with strong underlying performance demonstrated by 29% year-to-date Adjusted EBITDA growth, robust cash flow generation, and continued balance sheet strengthening through significant debt repayments." "Looking ahead, we're excited to introduce NEXLETOL and NEXLIZET in Canada, addressing an important treatment need for at-risk Canadian patients. These medicines have the potential to more than double the size of our cardiovascular business and will further establish HLS as a leading Canadian-based company focused on cardiovascular risk reduction. With Health Canada approval expected by year-end and launch planned for Q2 2026, we believe HLS is well-positioned for our next phase of growth." Q2 & YEAR-TO-DATE 2025 FINANCIAL REVIEWThe Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and six months ended June 30, 2025, are available at the Company's website and at its profile at SEDAR+. Revenue Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Product sales Canada 10,521 10,637 20,229 19,791 United States 3,502 3,462 6,220 6,104 14,023 14,099 26,449 25,895 Royalty revenue 148 420 345 1,097 14,171 14,519 26,794 26,992 Revenue for Q2 2025 decreased 2%, due primarily to lower royalty revenues and FX rate fluctuations. Year-to-date 2025, revenue was essentially flat with 2% growth in product revenue being offset by a 69% drop in royalty revenue. Product sales – Canada 000's of CAD Three months ended June 30, Six months ended June 30, 2025 2024 % change 2025 2024 % change Clozaril 8,589 9,131 (5.9) % 16,518 16,996 (2.8) % Vascepa 5,884 5,407 8.8 % 11,862 9,878 20.1 % Other 76 14 108 27 14,549 14,552 0.0 % 28,488 26,901 5.9 % Canadian product sales in local currency were flat in Q2 2025 and up 6% year-to-date, compared to the same periods last year. The Q2 2024 period benefited from the timing of certain orders shifting from Q1 2024 because of the Easter holiday timing last year. 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 the three and six months ended June 30, 2025, increased 1% and 2%, respectively, compared to the same prior year periods. Royalty revenues As expected, following the sale of the Xenpozyme royalty interest in Q2 2024, royalty revenue has declined. Royalty revenue for the three and six months ended June 30, 2025, was down 65% and 69%, respectively, compared to the same periods last year. HLS has one remaining royalty interest which generated $0.15 million in revenue in Q2 2025. Operating Expenses Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Cost of product sales 2,505 2,303 4,903 4,077 Selling and marketing 3,046 4,561 5,876 9,087 Medical, regulatory and patient support 1,366 1,420 2,802 2,685 General and administrative 2,084 1,977 4,223 4,178 9,001 10,261 17,804 20,027 Cost of product sales increased for the three and six months ended June 30, 2025, due primarily to higher Vascepa sales volumes. Operating expenses in Q2 2025, excluding cost of product sales, decreased by 18% compared to Q2 2024, and by 19% for the year-to-date period. 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. While selling and marketing expenses will remain below 2024 levels throughout the year, quarterly selling and marketing expenses are expected to be moderately higher for the remainder of 2025 as several staff vacancies have now been filled. Adjusted EBITDA1 Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net loss for the period (2,741) (5,682) (7,177) (11,788) Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Finance and related costs, net 1,690 2,942 3,662 5,609 Other costs 31 (3,361) 327 (3,361) Income tax expense 242 4,076 219 4,047 Adjusted EBITDA 5,170 4,258 8,990 6,965 Adjusted EBITDA for the three and six months ended June 30, 2025, increased 21% and 29%, respectively, compared to the same periods last year. The increases were primarily due to steady performance from the Company's marketed products and the ongoing focus on cost management and were partially offset by FX fluctuations and the previously mentioned decline in royalty revenue. Excluding royalty revenue, Adjusted EBITDA for the three and six months ended June 30, 2025, would have increased 31% and 47%, respectively, compared to the same periods last year. In Q2 2025, the direct brand contribution from Clozaril to Adjusted EBITDA was $7.1 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $1.6 million in Q2 2024 to positive $0.1 million. Year-to-date, the direct brand contribution from Clozaril to Adjusted EBITDA was $12.9 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $3.2 million to positive $0.1 million. Net LossQ2 2025 net loss was ($2.7) million, or ($0.09) per share, compared to a net loss of ($5.7) million, or ($0.18) per share, in Q2 2024. Year-to-date net loss was ($7.2) million, or ($0.23) per share, compared to a net loss of ($11.8) million, or ($0.37) 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 six months ended June 30, 2025, was $4.6 million and $8.1 million, compared to $2.5 million and $3.3 million in the same periods last year. This represents year-over-year increases of 83% and 147%, respectively. Total borrowings under the credit agreement at June 30, 2025, were $56.0 million compared to $67.4 million at December 31, 2024, and $84.9 million at June 30, 2024. This represents a reduction of 34% from June 30, 2024. During Q2 2025, HLS made principal payments on its term loan totaling $8.5 million and spent $0.8 million to purchase shares for cancellation under its Normal Course Issuer Bid. Year-to-date, HLS has made debt principal repayments of $11.4 million and under its share buyback program, has purchased 308,928 shares at a cost of $1 million since launching the buyback on March 17, 2025. Cash was $12.2 million at June 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. 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 are unchanged and as follows: Vascepa revenue of C$26.5-28.5 million (18-26% growth) Canada Clozaril sales of C$35.5-36 million (flat year-over-year) U.S. Clozaril sales of $12-12.3 million (2-4% decline) Royalty revenue of $0.6-0.75 million (50-60% decline) Consolidated Adjusted EBITDA of $19.5-20.5 million (17-23% growth) Future results could be impacted by continued exchange rate volatility. Q2 2025 CONFERENCE CALLHLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q2 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: 66543 DATE: Thursday, August 14, 2025 TIME: 8:30 a.m. ET WEBCAST LINK: https://app.webinar.net/Zo9wjb9V5KR 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/4kiYlSu TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 66543# The taped replay will be available for 14 days and the archived webcast will be available for 365 days. A link to the live audio webcast of the conference call will also be available on the events page of the investors section of HLS Therapeutics' website at www.hlstherapeutics.com. Please connect at least 15 minutes before the conference call to ensure enough time for any software download required to hear the webcast. 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. REFERENCES2: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada are to be confirmed upon approval by Health Canada. 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 August 13, 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 June 30, 2025 December 31, 2024 ASSETS Current Cash 12,153 17,456 Accounts receivable 8,968 7,454 Inventories 6,823 9,058 Income taxes recoverable 80 71 Other current assets 2,011 1,361 Total current assets 30,035 35,400 Property, plant and equipment 1,048 997 Intangible assets 116,047 122,122 Deferred tax asset 1,386 857 Other non-current assets 556 528 Total assets 149,072 159,904 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 8,339 8,709 Provisions 11,814 8,367 Debt and other liabilities 7,025 5,317 Income taxes payable 411 152 Total current liabilities 27,589 22,545 Debt and other liabilities 50,799 61,944 Deferred tax liability 4,125 4,074 Total liabilities 82,513 88,563 Shareholders' equity Share capital 258,063 260,595 Contributed surplus 14,788 15,136 Accumulated other comprehensive loss (6,458) (10,210) Deficit (199,834) (194,180) Total shareholders' equity 66,559 71,341 Total liabilities and shareholders' equity 149,072 159,904 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenue 14,171 14,519 26,794 26,992 Expenses Cost of product sales 2,505 2,303 4,903 4,077 Selling and marketing 3,046 4,561 5,876 9,087 Medical, regulatory and patient support 1,366 1,420 2,802 2,685 General and administrative 2,084 1,977 4,223 4,178 Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Finance and related costs, net 1,690 2,942 3,662 5,609 Other costs (income) 31 (3,361) 327 (3,361) Loss before income taxes (2,499) (1,606) (6,958) (7,741) Income tax expense 242 4,076 219 4,047 Net loss for the period (2,741) (5,682) (7,177) (11,788) Net loss per share: Basic and diluted $(0.09) $(0.18) $(0.23) $(0.37) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net loss for the period (2,741) (5,682) (7,177) (11,788) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment 3,440 (963) 3,752 (3,336) Comprehensive income (loss) for the period 699 (6,645) (3,425) (15,124) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY Unaudited [in thousands of U.S. dollars] 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 (2,532) — — 1,523 (1,009) Change in share purchase obligation — (878) — — (878) Stock option expense — 530 — — 530 Net loss for the period — — — (7,177) (7,177) Unrealized foreign currency translation adjustment — — 3,752 — 3,752 Balance as at June 30, 2025 258,063 14,788 (6,458) (199,834) 66,559 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 — 433 — — 433 Net loss for the period — — — (11,788) (11,788) Unrealized foreign currency translation adjustment — — (3,336) — (3,336) Balance as at June 30, 2024 260,595 14,598 (6,174) (186,313) 82,706 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 OPERATING ACTIVITIES Net loss for the period (2,741) (5,682) (7,177) (11,788) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Gain on royalty sale — (3,381) — (3,381) Accreted interest expense 302 277 610 559 Fair value adjustment on financial assets and liabilities — 318 — 505 Deferred income taxes (189) 3,861 (478) 3,800 Net change in non-cash working capital balances related to operations 1,284 843 3,233 1,144 Cash provided by operating activities 4,604 2,519 8,147 3,297 INVESTING ACTIVITIES Intangible asset acquisition (1,000) — (1,000) — Additions to property, plant and equipment (87) — (108) (2) Proceeds from royalty sale — 13,250 — 13,250 Cash provided by (used in) investing activities (1,087) 13,250 (1,108) 13,248 FINANCING ACTIVITIES Shares repurchased (833) (317) (1,009) (600) Repayment of credit agreement borrowing (8,481) (1,493) (11,441) (3,568) Debt costs — (658) — (1,191) Lease payments (151) (112) (294) (255) Cash used in financing activities (9,465) (2,580) (12,744) (5,614) Net increase (decrease) in cash during the period (5,948) 13,189 (5,705) 10,931 Foreign currency translation 367 (117) 402 (368) Cash, beginning of period 17,734 19,443 17,456 21,952 Cash, end of period 12,153 32,515 12,153 32,515 SOURCE HLS Therapeutics Inc.

精彩内容 日前，新华制药发布公告，其全资子公司山东淄博新达制药的非那雄胺片以仿制4类报产获批，视同过评。米内网数据显示，非那雄胺片在2024年中国三大终端六大市场（统计范围详见本文末）销售额超过10亿元，是生殖泌尿系统和性激素类药物（化+生）TOP4产品。 非那雄胺片适用于治疗和控制良性前列腺增生（BPH）以及预防泌尿系统事件：降低发生急性尿潴留的危险性；降低需进行经尿道切除前列腺（TURP）和前列腺切除术的危险性。该产品可使肥大的前列腺缩小，改善尿流及改善前列腺增生有关的症状。 近年中国三大终端六大市场非那雄胺片销售情况（单位：万元） 来源：米内网格局数据库 非那雄胺片在2024年中国三大终端六大市场销售额超过10亿元，是生殖泌尿系统和性激素类药物（化+生）TOP4产品，欧加农制药的市场份额最大。 米内网数据显示，非那雄胺片有33家企业拥有生产批文，山东淄博新达制药、杭州康恩贝制药、扬子江四川海蓉药业等19家过评，鲁抗医药赛特、江苏知原药业、四川依科制药等6家均以仿制4类报产在审，获批后视同过评。 新华制药表示，此次山东淄博新达制药的非那雄胺片获批，有利于公司丰富产品系列，开拓新的市场领域。 新华制药今年以来获批产品 来源：米内网中国申报进度（MED）数据库 今年以来，新华制药已有9款产品获批上市，涵盖生殖泌尿系统和性激素类药物、心脑血管系统药物、全身用抗感染药物等多个治疗大类，在2024年中国三大终端六大市场，非那雄胺片和恩格列净片是10亿元级别重磅品种，二十碳五烯酸乙酯软胶囊、普瑞巴林口服溶液分别是大涨1409%、128%的潜力品种。 资料来源：公司公告、米内网数据库等 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦