Clozapine

Q1 2026 revenue of $12.9 million, up 2% year-over-year; Vascepa net sales grew 15%, the strongest quarterly growth since Q2 2025 Cash from operations of $6.4 million in Q1 2026, up 80% year-over-year; net debt reduced to $31.9 million, down 32% from Q1 2025 NILEMDO™ full commercial launch in April 2026 financial guidance reaffirmed: revenue of $56–60 million and Adjusted EBITDA of $18.5–21 million TORONTO , May 15, 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 months ended March 31, 2026 ("Q1 2026"). All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q1 F2026 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2025 period) Q1 2026 revenue was $12.9 million, Adjusted EBITDA was $3.5 million and cash from operations was $6.4 million, compared to $12.6 million, $3.8 million and $3.5 million, respectively. Vascepa net sales increased 15% to $4.8 million in Q1 2026, compared to $4.2 million. Vascepa unit growth was 18% in Q1 2026, reflecting sustained demand growth. Canada and U.S. combined net sales of Clozaril were $7.8 million in Q1 2026, compared to $8.2 million. Q1 2026 direct brand contribution for Clozaril was $5.6 million and the cardiovascular portfolio had a break-even direct brand contribution inclusive of NILEMDO™ launch investment. Made principal repayments on long-term debt totaling $5.1 million in Q1 2026. Q1 F2026 CORPORATE HIGHLIGHTS Completed preparation for NILEMDO's April commercial launch; subsequent to quarter-end, Canada Life and Sun Life - representing ~40% of privately insured Canadians - listed NILEMDO with full benefit and no prior authorization. Clozaril patient volumes in Ontario returned to growth in March and April 2026, an encouraging indicator of business stabilization following the contracting dynamics experienced in 2025. "Q1 results were in line with our expectations and consistent with our annual guidance," said Craig Millian, Chief Executive Officer at HLS. "The increase in revenue was driven by Vascepa, which had its strongest quarterly growth since mid-2025 and is a validation of the changes we made to strengthen the cardiovascular sales team last year. As expected, Adjusted EBITDA was lower year-over-year as we made a modest increase in commercial investment to help ensure a successful NILEMDO launch. Cash from operations was up significantly, reflecting the operational improvements we have made and lower interest expense - the result of our new credit agreement and a debt balance that is down more than 30% from a year ago." "The NILEMDO launch is off to a positive start with weekly sales running ahead of forecast. In addition, Canada Life and Sun Life - two of the largest private payers in Canada – have added NILEMDO to their plans with no restrictions. These early results reflect the well-established clinical need for this medicine. For the estimated 500,000 Canadians who are not reaching their LDL targets on statins - whether due to intolerance or inadequate response - NILEMDO fills a meaningful treatment gap with an oral, well-tolerated option at a lower cost relative to injectable alternatives. Together, NILEMDO and NEXLIZET ® represent a franchise we believe can more than double the size of the Company." 2026 OUTLOOK HLS reaffirms its 2026 financial targets 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 Q1 performance gives us confidence that 2026 is unfolding as planned. Launch-related investment is largely front-loaded in the first half of the year, with margins expanding as NILEMDO revenue ramps. Near-term catalysts include expanded private payer coverage by mid-year and anticipated public reimbursement and the launch of NEXLIZET in the first half of 2027. Our investments in 2026 are building the foundation for sustainable growth in 2027 and beyond, and with our balance sheet in the best shape it has been in years, we have the financial flexibility to pursue business development opportunities that can accelerate that growth." Q1 F2025 FINANCIAL REVIEW The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three months ended March 31, 2026, are available at the Company’s website and at its pro SEDAR+ . Revenue Three months ended March 31, 2026 2025 Product sales Canada 9,965 9,708 United States 2,653 2,718 12,618 12,426 Royalties 246 197 12,864 12,623 Revenue for Q1 2026 increased by 2% compared to Q1 2025. The increase is due to growth in Vascepa net sales, which were $4.8 million, up 15% from Q1 last year, as well as appreciation of the Canadian dollar to the U.S. dollar. Product sales – Canada 000's of CAD Three months ended March 31, 2026 2025 % change Clozaril 7,016 7,929 (11.5) % Vascepa 6,552 5,978 9.6 % Other 98 32 13,666 13,939 (2.0) % In local currency, Canadian product sales decreased 2% to C$13.7 million in Q1 2026, with Vascepa net sales growth offset by an expected decline in Clozaril. The Clozaril decrease reflects the residual year-over-year impact from Ontario contracting changes in 2025, which is expected to be concentrated in the first half of 2026. Clozaril patient numbers in Ontario grew sequentially in March and April, signaling stabilization in that business. Vascepa net sales growth reflects the commercial changes made in 2025. Product Sales – United States In the U.S. market, Clozaril revenue for Q1 2026 decreased 2% compared to Q1 2025, in line with expectations. The Company's specialty pharmacy program continues to help offset patient attrition. Royalty revenues Royalty revenue for Q1 2026 increased to $0.25 million compared to $0.2 million in Q1 2025. The Company received a final royalty payment related to the Eraxis royalty interest that was liquidated in Q4 2025. Operating Expenses Three months ended March 31, 2026 2025 Cost of product sales 2,681 2,398 Selling and marketing 2,984 2,830 Medical, regulatory and patient support 1,509 1,436 General and administrative 2,227 2,139 9,401 8,803 Cost of product sales for Q1 2026 increased due primarily to higher Vascepa sales volumes. Operating expenses for Q1 2026, comprising sales and marketing, G&A, and medical, regulatory, and patient support, increased 5% compared to Q1 2025, reflecting incremental NILEMDO launch investment. Adjusted EBITDA 1 Three months ended March 31, 2026 2025 Net loss for the period (2,297) (4,436) Stock-based compensation 142 651 Amortization and depreciation 5,536 5,360 Finance and related costs, net (7) 1,972 Other costs 87 296 Income tax expense (recovery) 2 (23) Adjusted EBITDA 3,463 3,820 Adjusted EBITDA for Q1 2026 was $3.5 million compared to $3.8 million in Q1 2025, reflecting incremental investment in the NILEMDO launch, partially offset by revenue growth from the base business. For Q1 2026, the direct brand contribution from Clozaril to Adjusted EBITDA was $5.6 million. The cardiovascular portfolio delivered a break-even direct brand contribution in Q1 2026, even after absorbing pre-launch investment ahead of the April NILEMDO launch. HLS expects the brand contribution from the cardiovascular portfolio to be positive for the year. Net Loss Q1 2026 net loss was ($2.3) million, or ($0.07) per share, compared to a net loss of ($4.4) million, or ($0.14) per share, in Q1 2025. The improvement reflects lower finance and related costs and higher revenue, partially offset by incremental NILEMDO launch investment. Cash from Operations and Financial Position Cash generated from operations for Q1 2026 was $6.4 million, up 80% compared to $3.5 million in Q1 2025. HLS continues to strengthen its balance sheet through disciplined capital allocation. During Q1 2026, HLS made debt principal repayments totaling $5.1 million, reducing total borrowings under the credit agreement to $44.2 million at March 31, 2026, a decrease of 31% compared to $64.5 million at March 31, 2025. Net debt decreased to $31.9 million at March 31, 2026, a decrease of 32% compared to $46.8 million at March 31, 2025. Cash was $12.3 million at March 31, 2026, an increase from $11.7 million at December 31, 2025. This growth reflects an increase in cash from operations and lower interest expense, offset in part by debt principal repayments. Q1 F2026 CONFERENCE CALL HLS will hold a conference call today at 10:00 am Eastern Time to discuss its Q1 2026 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: 88954 DATE: Friday, May 15, 2026 TIME: 10:00 a.m. ET WEBCAST LINK: 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: TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 88954# 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 . 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: 1 CAUTIONARY 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 May 14, 2026, both of which have been filed on SEDAR+ and can be accessed at . 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 March 31, 2026 December 31, 2025 ASSETS Current Cash 12,326 11,723 Accounts receivable 8,132 7,862 Inventories 7,362 8,139 Other current assets 1,128 1,370 Total current assets 28,948 29,094 Property, plant and equipment 1,174 1,338 Intangible assets 99,633 105,626 Deferred tax asset 1,010 1,143 Other non-current assets 322 328 Total assets 131,087 137,529 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 9,926 10,438 Provisions 13,699 10,456 Debt and other liabilities 4,716 4,817 Income taxes payable 481 410 Total current liabilities 28,822 26,121 Debt and other liabilities 40,837 46,678 Deferred tax liability 2,858 3,060 Total liabilities 72,517 75,859 Shareholders' equity Share capital 256,338 256,338 Contributed surplus 16,392 16,164 Accumulated other comprehensive loss (7,711) (6,680) Deficit (206,449) (204,152) Total shareholders' equity 58,570 61,670 Total liabilities and shareholders' equity 131,087 137,529 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended March 31, 2026 2025 Revenue 12,864 12,623 Expenses Cost of product sales 2,681 2,398 Selling and marketing 2,984 2,830 Medical, regulatory and patient support 1,509 1,436 General and administrative 2,227 2,139 Stock-based compensation 142 651 Amortization and depreciation 5,536 5,360 Finance and related costs, net (7) 1,972 Other costs 87 296 Loss before income taxes (2,295) (4,459) Income tax expense (recovery) 2 (23) Net loss for the period (2,297) (4,436) Net loss per share: Basic and diluted $(0.07) $(0.14) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Unaudited [in thousands of U.S. dollars] Three months ended March 31, 2026 2025 Net loss for the period (2,297) (4,436) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment (1,031) 312 Comprehensive loss for the period (3,328) (4,124) 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, 2025 256,338 16,164 (6,680) (204,152) 61,670 Stock option expense -- 228 -- -- 228 Net loss for the period -- -- -- (2,297) (2,297) Unrealized foreign currency translation adjustment -- -- (1,031) -- (1,031) Balance as at March 31, 2026 256,338 16,392 (7,711) (206,449) 58,570 Balance as at 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 as at March 31, 2025 260,136 14,893 (9,898) (198,333) 66,798 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended March 31, 2026 2025 OPERATING ACTIVITIES Net loss for the period (2,297) (4,436) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 142 651 Amortization and depreciation 5,536 5,360 Accreted interest expense 106 308 Foreign exchange (793) -- Deferred income taxes (69) (289) Net change in non-cash working capital balances related to operations 3,742 1,949 Cash provided by operating activities 6,367 3,543 INVESTING ACTIVITIES Additions to Intangible assets (383) -- Additions to property, plant and equipment -- (21) Cash provided by (used in) investing activities (383) (21) FINANCING ACTIVITIES Shares repurchased -- (176) Repayment of credit agreement borrowing (5,099) (2,960) Lease payments (162) (143) Cash used in financing activities (5,261) (3,279) Net increase in cash during the period 723 243 Foreign currency translation (120) 35 Cash, beginning of period 11,723 17,456 Cash, end of period 12,326 17,734 SOURCE HLS Therapeutics Inc.

Poster presentation will highlight Phase 1b data on RDX-002, an investigational, first-in-class, gut-restricted inhibitor of intestinal MTP in development for atypical antipsychotic-induced weight gain, a leading driver of treatment discontinuation among patients on atypical antipsychotics FALLS CHURCH, Va.--(BUSINESS WIRE)-- #AIWG --Response Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing therapies for weight management and metabolic health in high-need populations, today announced that data from its Phase 1b clinical trial evaluating RDX-002 in subjects receiving olanzapine will be presented at the American Psychiatric Association (APA) 2026 Annual Meeting, taking place May 16-20 in San Francisco, CA. RDX-002 is the company’s investigational, first-in-class, gut-restricted small molecule inhibitor of intestinal microsomal triglyceride transfer protein (iMTP), the protein responsible for packaging dietary fat and cholesterol into chylomicrons for absorption into the body. RDX-002 is in development for the prevention of antipsychotic-induced weight gain (AIWG). “Highly effective antipsychotic treatments are often hampered by rapid weight gain and associated increases in cardiometabolic risk factors that can ultimately result in treatment discontinuation and significant increases in cardiovascular risk," said William Sasiela, PhD, Chief Medical Officer of Response Pharmaceuticals. "In this study, we looked to shed light on one of the drivers of that weight gain and provide initial evidence for RDX-002 as a potential preventative treatment.” The APA presentation will provide the full data set from a Phase 1b trial, in which RDX-002 met its primary endpoint and reduced postprandial triglycerides by 82% versus olanzapine alone (p<0.001), while limiting body weight gain to 0.4 kg in subjects receiving RDX-002 added to olanzapine, compared with 1.7 kg in subjects on olanzapine alone (p=0.016), over the second week of treatment. Presentation Details Title: RDX-002, a Novel Intestinal Microsomal Triglyceride Transfer Protein Inhibitor, Prevented Olanzapine-Induced Weight Gain in Human Volunteers Abstract Number: 5044 Presenter: William J. Sasiela, PhD, Chief Medical Officer, Response Pharmaceuticals Authors: William J. Sasiela, PhD; Kurt Rasmussen, PhD; Elliot Ehrich, MD Poster Session: 6 Session Date and Location: Sunday May 17, 2026 from 1:30-3:30 pm PDT, Moscone Center Hall A “Psychiatrists are on the front line of managing antipsychotic-induced weight gain, and the data we are presenting at APA represent important findings supporting the potential of RDX-002 to address this clinically meaningful side effect," said Eric Keller, Chief Executive Officer of Response Pharmaceuticals. "We are continuing to develop RDX-002 in antipsychotic-induced weight gain and look forward to advancing RDX-002 into a planned Phase 2 study in patients taking atypical antipsychotics . ” About Antipsychotic-Induced Weight Gain (AIWG) Atypical antipsychotics (AAPs), including olanzapine, clozapine, quetiapine, and others, are foundational treatments for schizophrenia, bipolar disorder, and major depressive disorder. They are commonly associated with rapid weight gain, hyperlipidemia, and hyperglycemia, a constellation of metabolic effects that is a leading driver of treatment non-adherence and discontinuation. Approximately 4 million U.S. patients are treated with AAPs, and up to 70% experience clinically meaningful weight gain, with 20 to 35 pounds of weight gain frequently observed within the first year of therapy. Antipsychotic-induced weight gain contributes meaningfully to the cardiometabolic morbidity and reduced life expectancy seen in patients with serious mental illness, and no therapy has been approved specifically to prevent it. About Response Pharmaceuticals Response Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapies for weight management and metabolic health in high-need populations. The company’s lead programs focus on addressing antipsychotic-induced weight gain (AIWG) in patients with serious mental illness and supporting individuals transitioning off weight loss drugs in maintaining their weight loss and cardiometabolic benefits. Adjunctive Phase 2 studies are being explored in settings marked by significant weight gain or metabolic disruption, including potential combination use with other therapies. The company is planning to initiate a Phase 2 study evaluating RDX-002 in antipsychotic-induced weight gain, a population with elevated cardiometabolic risk and limited treatment options. About RDX-002 RDX-002, Response Pharmaceuticals’ lead candidate, is an investigational first-in-class, potent, selective, and gut-specific small molecule inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). The overall effect of iMTP inhibition is a reduction in the post-meal uptake of triglycerides (fat)—and thus calories—and cholesterol by the body. RDX-002 is being developed as a therapy to address drug-induced weight gain and decrease cardiometabolic risk, including a 9-month study in patients discontinuing GLP-1 RAs for the treatment of obesity. In a recently completed study, RDX-002 achieved a clinically meaningful mean preservation of 57% of the weight loss seen with a GLP-1 RA at 36 Weeks. RDX-002 has been studied in multiple Phase 1 and Phase 2 clinical trials in more than 450 healthy subjects and patients dosed up to 252 days. In these studies, RDX-002 lowered post-prandial triglyceride levels and circulating levels of low-density lipoprotein cholesterol (LDL-C), and reduced weight. RDX-002 was generally well-tolerated, with adverse events restricted to mostly mild to moderate gastrointestinal effects. No serious adverse events have been attributed to RDX-002. RDX-002 is being developed under an exclusive world-wide license from Sanofi S.A. For more information, please visit . Contacts Press and Investor Contact Sabine Bisson, PhD Chief Operating Officer, Response Pharmaceuticals Inc. press@responsepharmaceuticals.com