Ezetimibe

Total Product revenue grew 5% compared to Q1 2024, with growth across both the US and Canada Canadian Product revenue grew 13% (in local currency) compared to Q1 2024, driven by 34% year-over-year growth in Vascepa net sales Adjusted EBITDA grew 41% (or 78% excluding royalty revenue) compared to Q1 2024 HLS expands Cardiovascular portfolio by securing Canadian rights to NEXLETOL® and NEXLIZET® from Esperion Therapeutics TORONTO, May 8, 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 months ended March 31, 2025. All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q1 2025 FINANCIAL HIGHLIGHTS (comparisons are to Q1 2024) Revenue was $12.6 million, Adjusted EBITDA1 was $3.8 million and cash from operations was $3.5 million, compared to $12.5 million, $2.7 million and $0.8 million, respectively. Revenue for Vascepa increased 34% in local currency. Revenue for Clozaril Canada increased 1% in local currency. Revenue for Clozaril US increased 3%. Excluding cost of sales, operating expenses decreased 20%. Vascepa made a slightly positive contribution to Adjusted EBITDA in Q1 2025, compared to a negative $1.6 million contribution in Q1 2024. OTHER CORPORATE HIGHLIGHTS Announced an agreement with Esperion Therapeutics Inc. (NASDAQ:ESPR) to in-license and commercialize NEXLETOL2 and NEXLIZET2 in Canada. See full press release details here. Launched Normal Course Issuer Bid. Christine Elliott, ex-Minister of Health in Ontario, joined the Board of Directors. "Our Q1 financial results demonstrated solid execution across the business, with product revenues and Adjusted EBITDA growing in line with expectations. We also made progress in building the foundation for future growth by expanding our product portfolio," said Craig Millian, CEO at HLS. "Product revenue in Canada increased by 13% in local currency, driven by growth in both Vascepa and Clozaril, while Clozaril sales in the U.S. rose by 3%. Our focus on operational efficiencies led to a 20% reduction in operating expenses, resulting in a 41% increase in Adjusted EBITDA, or 78% when excluding passive royalty revenue." "The strengthening of our financial position has created new opportunities to enhance shareholder value. We initiated a share buyback program in Q1 while continuing to pursue strategic growth opportunities such as portfolio expansion. Today's announcement of our agreement with Esperion Therapeutics to in-license NEXLETOL and NEXLIZET for the Canadian market reflects this balanced approach to capital allocation." "These promising therapies are strategically aligned with our portfolio, complementing Vascepa and leveraging our established cardiovascular infrastructure in the Canadian market, which will minimize incremental costs. The products address significant unmet medical needs and represent a substantial growth opportunity. In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for NEXLETOL and NEXLIZET, with approval expected by late 2025 and preparations in progress for commercial launch in early 2026." Q1 2025 FINANCIAL REVIEW The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three months ended March 31, 2025, are available at the Company's website and at its profile at SEDAR+. Revenue Three months ended March 31, 2025 2024 Product sales Canada 9,708 9,154 United States 2,718 2,642 12,426 11,796 Royalty revenue 197 677 12,623 12,473 Revenue for the three months ended March 31, 2025, increased 1%, due to growth of the Company's marketed products and was offset, in part, by lower royalty revenues and FX rate fluctuations. Excluding royalties, Q1 2025 revenue for the Company's marketed products (Vascepa and Clozaril) increased 5% from Q1 2024. Product sales – Canada 000's of CAD Three months ended March 31, 2025 2024 % change Clozaril 7,929 7,865 0.8 % Vascepa 5,978 4,471 33.7 % Other 32 13 13,939 12,349 12.9 % For the three months ended March 31, 2025, Canadian sales of Vascepa and Clozaril increased 13% in local currency compared to Q1 2024, driven primarily by the 34% growth of Vascepa. However, when converted to U.S. dollars, the growth was only 6% due to the decline in the CAD/USD exchange rate. Product Sales – United States In the U.S. market, Clozaril revenue for the three months ended March 31, 2025, increased 3% compared to Q1 2024. Royalty revenues As expected, royalty revenues for the three months ended March 31, 2025, were down 71% compared to Q1 2024. Following the sale of the Xenpozyme royalty interest in Q2 2024, HLS has one remaining royalty interest which generated $0.2 million in revenue in Q1 2025. Operating Expenses Three months ended March 31, 2025 2024 Cost of product sales 2,398 1,774 Selling and marketing 2,830 4,526 Medical, regulatory and patient support 1,436 1,265 General and administrative 2,139 2,201 8,803 9,766 Cost of product sales was up for the three months ended March 31, 2025, due primarily to higher Vascepa sales volumes. Operating expenses in Q1 2025, excluding cost of product sales, decreased by 20% compared to Q1 2024, 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 expenses are expected to be moderately higher for the remainder of 2025 than in Q1. This difference is due to Q1 2025 benefiting from several staff vacancies and a one-time vendor credit, neither of which are expected to recur in upcoming quarters. Adjusted EBITDA1 Three months ended March 31, 2025 2024 Net loss for the period (4,436) (6,106) Stock-based compensation 651 256 Amortization and depreciation 5,360 5,919 Finance and related costs, net 1,972 2,667 Other costs 296 — Income tax recovery (23) (29) Adjusted EBITDA 3,820 2,707 Adjusted EBITDA for the three months ended March 31, 2025, increased 41% primarily due to the growth in the Company's marketed products and ongoing focus on cost management, and was partially offset by the previously mentioned decline in royalty revenue. Excluding royalty revenue, Adjusted EBITDA for Q1 2025 would have been $3.6 million compared to $2.0 million in Q1 2024, representing an increase of 78%. The direct brand contribution from Clozaril to Adjusted EBITDA in Q1 2025 was $5.9 million, compared to $6.1 million in Q1 2024. Vascepa achieved a slightly positive direct brand contribution to Adjusted EBITDA in Q1 2025, compared to a brand loss of $1.6 million in Q1 2024. This was the second consecutive quarter of a positive contribution from Vascepa to Adjusted EBITDA. Net LossNet loss for the three months ended March 31, 2025, was ($4.4) million, or ($0.14) per share, compared to a net loss of ($6.1) million, or ($0.19) per share, in Q1 2024. Net loss improved in Q1 2025 due primarily to higher revenue from marketed products, lower operating expenses and lower amortization and depreciation expenses, which were offset, in part, by lower royalty revenue. Cash from Operations and Financial PositionCash generated from operations for the three months ended March 31, 2025, was $3.5 million compared to $0.8 million in Q1 2024. Cash was $17.7 million at March 31, 2025, compared to $17.5 million at December 31, 2024. Total borrowings under the credit agreement at March 31, 2025, were $64.5 million compared to $67.4 million at December 31, 2024, and $86.4 million at March 31, 2024. During Q1 2025, HLS made principal payments on its term loan totaling $3.0 million and spent $0.2 million to purchase shares for cancellation under its Normal Course Issuer Bid, which was launched on March 17, 2025. 2025 OUTLOOKRevenue projections for the Company's Canadian product portfolio are denominated in local currency to account for ongoing FX rate fluctuations. Importantly, the 2025 guidance fully incorporates all anticipated financial impacts from pre-launch activities related to the newly in-licensed NEXLETOL and NEXLIZET. 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. Q1 2025 CONFERENCE CALLHLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q1 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: 41562 DATE: Thursday, May 8, 2025 TIME: 8:30 a.m. ET WEBCAST LINK: https://app.webinar.net/EpY5Lzpk6d8 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/43us1qX TAPED REPLAY: 1-888-660-6345 or 1-646-517-4150 REPLAY CODE: 41562# 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. REFERENCES 2: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada 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 May 7, 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. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION Unaudited [in thousands of U.S. dollars] As at As at March 31, 2025 December 31, 2024 ASSETS Current Cash 17,734 17,456 Accounts receivable 7,732 7,454 Inventories 7,483 9,058 Income taxes recoverable 71 71 Other current assets 1,048 1,361 Total current assets 34,068 35,400 Property, plant and equipment 972 997 Intangible assets 117,177 122,122 Deferred tax asset 1,200 857 Other non-current assets 530 528 Total assets 153,947 159,904 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 8,682 8,709 Provisions 8,561 8,367 Debt and other liabilities 6,203 5,317 Income taxes payable 394 152 Total current liabilities 23,840 22,545 Debt and other liabilities 59,181 61,944 Deferred tax liability 4,128 4,074 Total liabilities 87,149 88,563 Shareholders' equity Share capital 260,136 260,595 Contributed surplus 14,893 15,136 Accumulated other comprehensive loss (9,898) (10,210) Deficit (198,333) (194,180) Total shareholders' equity 66,798 71,341 Total liabilities and shareholders' equity 153,947 159,904 HLS THERAPEUTICS INC. CONSOLIDATED STATEMENTS OF LOSS Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended March 31, 2025 2024 Revenue 12,623 12,473 Expenses Cost of product sales 2,398 1,774 Selling and marketing 2,830 4,526 Medical, regulatory and patient support 1,436 1,265 General and administrative 2,139 2,201 Stock-based compensation 651 256 Amortization and depreciation 5,360 5,919 Finance and related costs, net 1,972 2,667 Other costs 296 — Loss before income taxes (4,459) (6,135) Income tax recovery (23) (29) Net loss for the period (4,436) (6,106) Net loss per share: Basic and diluted $(0.14) $(0.19) HLS THERAPEUTICS INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Unaudited [in thousands of U.S. dollars] Three months ended March 31, 2025 2024 Net loss for the period (4,436) (6,106) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment 312 (2,373) Comprehensive loss for the period (4,124) (8,479) 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, December 31, 2024 260,595 15,136 (10,210) (194,180) 71,341 Shares repurchased (459) — — 283 (176) Change in share purchase obligation — (495) — — (495) Stock option expense — 252 — — 252 Net loss for the period — — — (4,436) (4,436) Unrealized foreign currency translation adjustment — — 312 — 312 Balance, March 31, 2025 260,136 14,893 (9,898) (198,333) 66,798 Balance, December 31, 2023 262,127 13,865 (2,838) (175,457) 97,697 Shares repurchased (768) — — 485 (283) Stock option expense — 131 — — 131 Net loss for the period — — — (6,106) (6,106) Unrealized foreign currency translation adjustment — — (2,373) — (2,373) Balance, March 31, 2024 261,359 13,996 (5,211) (181,078) 89,066 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended March 31, 2025 2024 OPERATING ACTIVITIES Net loss for the period (4,436) (6,106) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 651 256 Amortization and depreciation 5,360 5,919 Accreted interest 308 282 Fair value adjustment on financial assets and liabilities — 187 Deferred income taxes (289) (61) Net change in non-cash working capital balances related to operations 1,949 301 Cash provided by operating activities 3,543 778 INVESTING ACTIVITIES Additions to property, plant and equipment (21) (2) Cash used in investing activities (21) (2) FINANCING ACTIVITIES Shares repurchased (176) (283) Repayment of credit agreement borrowing (2,960) (2,075) Debt costs — (533) Lease payments (143) (143) Cash used in financing activities (3,279) (3,034) Net increase (decrease) in cash during the period 243 (2,258) Foreign currency translation 35 (251) Cash, beginning of period 17,456 21,952 Cash, end of period 17,734 19,443 SOURCE HLS Therapeutics Inc.

– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians – HLS will leverage existing organizational capabilities and commercial infrastructure – Already approved and commercially available in the U.S. and Europe, NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year – Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives TORONTO, May 8, 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 that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ: ESPR) to in-license and commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated. In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial. Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe. "We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease," said Craig Millian, CEO at HLS. "Adding NEXLETOL and NEXLIZET to the HLS product portfolio is aligned with our stated BD strategy and will strengthen our position in the Canadian cardiovascular market." "We are pleased to partner with HLS to provide advanced cardiovascular treatment options to patients across Canada," said Sheldon Koenig, President and CEO of Esperion. "HLS is highly regarded within Canada for their strong capabilities and relationships in the cardiovascular therapeutic area. This collaboration furthers Esperion's commitment to addressing cardiovascular and cardiometabolic diseases globally." The agreement includes an upfront payment of $1 million, an additional $1 million upon Health Canada approval, customary royalties on future sales, and potential milestone payments tied to pricing and reimbursement and achievement of significant commercial sales targets. HLS will fund all upfront and milestone-based payments, along with associated launch costs, through existing cash reserves without requiring additional financing. Furthermore, the company intends to leverage current commercial infrastructure and does not anticipate a significant increase in operating expenses will be required. 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 that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. 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 ABOUT ESPERION THERAPEUTICS Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms. Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and https://x.com/EsperionIncX. REFERENCES 1: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada to be confirmed upon approval by Health Canada. 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 and expectations regarding financial performance. 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 May 7, 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. SOURCE HLS Therapeutics Inc.