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TORONTO, Aug. 8, 2024 /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, 2024. All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. KEY HIGHLIGHTS Q2 2024 revenue was $14.5 million, Adjusted EBITDA1 was $4.3 million and cash from operations was $2.5 million, compared to $16.4 million, $5.5 million and $2.7 million, respectively, in Q2 2023. Sold the Xenpozyme royalty asset in a transaction valued at up to $45.75 million. Excluding royalty portfolio revenue, Q2 2024 revenue increased 9% to $14.1 million and Adjusted EBITDA increased 86% to $3.8 million, compared to $13.0 million and $2.1 million, respectively, in Q2 2023. Completed a Product Listing Agreement with the province of Alberta, for the listing and public reimbursement of Vascepa, effective August 1, 2024. "In Q2 we generated solid growth from our marketed products - Clozaril and Vascepa - particularly in Canada where sales grew 11% in local currency over prior year," said Craig Millian, CEO at HLS. "We also made progress against our strategic initiatives to drive future revenue growth and profitability, in part through effective cost management; of note, we reduced operating expenses by 13% while still generating growth from our marketed products. In addition, we strengthened our balance sheet and long-term financial flexibility by completing the sale of the Xenpozyme royalty interest, a non-strategic asset." Q2 2024 OTHER HIGHLIGHTS Clozaril revenue in Canada increased by 5% in local currency compared to Q2 2023. A study demonstrating the positive impact of pharmaceutical support programs on persistence with clozapine treatment was published in the Journal of Clinical Pharmacology and Therapeutics. Vascepa revenue in Canada increased 21% in local currency compared to Q2 2023. Vascepa unit demand increased by 45% compared to Q2 2023. The number of consistent prescribers2 for Vascepa increased 76% compared to Q2 2023. Finalized termination agreement with Pfizer to transition Vascepa primary care sales responsibilities back to HLS by August 31, 2024. BOARD OF DIRECTORS UPDATE Effective August 7, 2024, Laura Brege has decided to step down from the Board to focus on other endeavors. The Company is evaluating its board composition and will determine whether to fill the vacant position in due course. Norma Beauchamp, one of the Company's current Compensation and Governance Committee members, will replace Ms. Brege as Chair of that Committee. "On behalf of the Board and HLS Management, I want to thank Laura for the insights, guidance and leadership she provided during her five years on the Board. We wish her the best in all her future pursuits," said John Welborn, Chair of the Board at HLS. 2024 OUTLOOK With the release of its Q2 2024 results, the Company reiterates its 2024 guidance, which was updated following the sale of the Xenpozyme royalty interest. 2024 consolidated revenue guidance is $58.5 to $59.7 million. Comprising that number is Vascepa revenue of $17 to $18 million (C$22.5 to $24.5 million), Clozaril revenue of approximately $40 million and royalty portfolio revenue of $1.5 to $1.7 million. 2024 Adjusted EBITDA is expected to be $15.5 to $16.7 million. As communicated previously HLS expects Vascepa to make a positive contribution to Adjusted EBITDA starting in the fourth quarter, which would position the Company to enter 2025 with a growth portfolio of two profitable products, Clozaril and Vascepa. Mr. Millian added: "We look to build-on the positive momentum generated in Q2 to drive a strong second half of the year for our marketed products. With Clozaril, our regional strategies are having a positive impact, and, in Canada, we are seeing encouraging growth trends. Additionally, we expect Vascepa to benefit over the remainder of the year driven by the evolution of our go-to-market model as well as the recent public plan listings in BC and Alberta." Q2 2024 FINANCIAL REVIEW The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and six months ended June 30, 2024, are available at the Company's website and at its profile at SEDAR+. Revenue Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Product sales Canada 10,637 9,791 19,791 18,602 United States 3,462 3,179 6,104 6,391 14,099 12,970 25,895 24,993 Royalty revenue 420 3,447 1,097 6,181 14,519 16,417 26,992 31,174 Revenue for the three and six months ended June 30, 2024, decreased 12% and 13%, respectively, due to lower royalty revenues and offset, in part, by growth of the Company's marketed products. Excluding royalties, revenue for the Company's marketed products (Vascepa, and Clozaril) for the three and six months ended June 30, 2024, increased 9% and 4%, respectively, from the prior year periods. Product sales – Canada 000's of CAD Three months ended June 30, Six months ended June 30, 2024 2023 % change 2024 2023 % change Clozaril 9,131 8,665 5.4 % 16,996 17,083 (0.5) % Vascepa 5,407 4,481 20.7 % 9,878 7,996 23.5 % Other 14 — 27 — 14,552 13,146 10.7 % 26,901 25,079 7.3 % Canadian product sales of Vascepa and Clozaril in Q2 2024 increased 11% in local currency, compared to Q2 2023. Q2 2024 revenue in Canada from Vascepa and Clozaril increased 21% and 5% year-over-year, respectively, in local currency. For the six months ended June 30, 2024, Canadian product sales of Vascepa and Clozaril increased 7% in local currency, compared to the same period in 2023. For the six months ended June 30, 2024, in local currency, revenue in Canada from Vascepa and Clozaril increased 23.5% and decreased 0.5%, respectively, compared to the same period last year. Product Sales – United States In the U.S., Clozaril revenue in Q2 2024 increased 9% compared to Q2 2023. For the six months ended June 30, 2024, Clozaril revenue in the U.S. decreased 5% compared to the same period in 2023. Key demand fundamentals remain in place with the year-to-date revenue variance to the prior year period largely due to wholesalers in the U.S. ending 2023 with an unusually high level of inventory, which impacted sales in Q1 2024. Royalty revenues Royalty revenues for the three and six months ended June 30, 2024, were down 88% and 82%, respectively, compared to the prior year periods as the term for what was the largest royalty in the portfolio came to an end midway through Q4 2023. Following the sale of the Xenpozyme royalty interest in Q2 2024, HLS has one remaining royalty interest, which is for Obizur. Obizur is a treatment to help control bleeding in acquired "Hemophilia A" and is marketed by Takeda Pharmaceuticals. Operating Expenses Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Cost of product sales 2,303 1,777 4,077 3,221 Selling and marketing 4,561 5,325 9,087 10,132 Medical, regulatory and patient support 1,420 1,437 2,685 2,513 General and administrative 1,977 2,373 4,178 4,724 10,261 10,912 20,027 20,590 Excluding cost of product sales, operational expenses for the three and six months ended June 30, 2024, decreased 13% and 8%, respectively, compared to the prior year periods. This was due to the Company's focus on cost management while continuing to support the growth potential of its marketed products. "With the primary care sales function transition to HLS expected to be completed by the end of August, we anticipate a further reduction in operational expenses for Q4 this year and beyond," said John Hanna, CFO at HLS. "Overall, this transition is projected to save the Company around $5 million annually. Most of these savings will fall directly to our bottom line, after accounting for some modest reinvestment in expanding the Vascepa salesforce and supporting other reimbursement and retention initiatives." Cost of product sales was up for the for the three and six months ended June 30, 2024, due to higher Vascepa sales volumes. Adjusted EBITDA1 Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Net loss for the period (5,682) (9,437) (11,788) (15,229) Stock-based compensation 427 137 683 82 Amortization and depreciation 5,856 8,366 11,775 16,685 Finance and related costs, net 2,942 2,471 5,609 4,905 Other costs (income) (3,361) 3,851 (3,361) 4,064 Income tax expense 4,076 117 4,047 77 Adjusted EBITDA 4,258 5,505 6,965 10,584 Adjusted EBITDA for the three and six months ended June 30, 2024, decreased $1.2 million and $3.6 million, respectively, compared to the prior year periods. The decrease was due to the decline in royalty revenue and was offset in part by growth in the Company's marketed products. Excluding royalty revenue, Adjusted EBITDA for the three and six months ended June 30, 2024, would have been approximately $3.8 million and $5.9 million, respectively, compared to $2.1 million and $4.4 million in the prior year periods, representing increases of 86% and 33%. For Q2 2024, the direct brand contribution from Clozaril to Adjusted EBITDA was $7.6 million, while the direct brand contribution from Vascepa to Adjusted EBITDA was a loss of $1.6 million. For the 2024 year-to-date period, the direct brand contribution from Clozaril to Adjusted EBITDA was $13.7 million, while the direct brand contribution from Vascepa to Adjusted EBITDA was a loss of $3.2 million. Net Loss Net loss for the three months ended June 30, 2024, was ($5.7) million, or ($0.18) per share, compared to a net loss of ($9.4) million, or ($0.29) per share, in Q2 2023. Net loss for the six months ended June 30, 2024, was ($11.8) million, or ($0.37) per share, compared to a net loss of ($15.2) million, or ($0.47) per share, in the same period last year. Net loss improved in the year-over-year periods due primarily to lower operating expenses and lower amortization and depreciation expense as well as recording other income versus other costs in the prior year periods, which were offset, in part, by lower royalty revenue. Cash from Operations and Financial Position Cash generated from operations for the three and six months ended June 30, 2024, was $2.5 million and $3.3 million, respectively, compared to $2.7 million and $6.7 million in the prior year periods. Cash was $32.5 million at June 30, 2024 compared to $22.0 million at December 31, 2023. Cash at June 30, 2024, included $13.25 million received in the sale of the Xenpozyme royalty interest. Total borrowings under the credit agreement at June 30, 2024, was $84.9 million compared to $88.5 million at December 31, 2023. Subsequent to quarter end, HLS made a $14 million principal payment on its term loan, reducing the term loan outstanding at the time of payment to approximately $71 million. This principal payment will save the Company approximately $1.5 million annually in interest expense. Q2 2024 CONFERENCE CALL HLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q2 2024 financial results. The call will be hosted by Mr. Craig Millian, CEO, and Mr. John Hanna, Interim CFO. To view the slides that accompany management's discussion, please use the webcast link. CONFERENCE ID: 58793 DATE: Thursday, August 8, 2024 TIME: 8:30 a.m. ET WEBCAST LINK: https://app.webinar.net/Bo1rqAKyNm9 TRADITIONAL DIAL-IN NUMBER: 1-800-836-8184 or 1-289-819-1350 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/3xE2Dl5 TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 58793# 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 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" 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. 2CONSISTENT PRESCRIBER A consistent prescriber is a physician that has prescribed Vascepa in at least 4 of the past 5 weeks. 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 13, 2024, and Management's Discussion and Analysis dated August 7, 2024, 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, 2024 December 31, 2023 ASSETS Current Cash 32,515 21,952 Accounts receivable 9,115 10,608 Inventories 8,796 9,534 Income taxes recoverable 95 86 Other current assets 2,338 1,915 Total current assets 52,859 44,095 Property, plant and equipment 701 965 Intangible assets 136,387 162,344 Deferred tax asset 777 1,037 Other non-current assets 598 619 Total assets 191,322 209,060 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 12,317 14,107 Provisions 7,054 5,424 Debt and other liabilities 6,591 6,876 Income taxes payable 158 281 Total current liabilities 26,120 26,688 Debt and other liabilities 78,514 84,233 Deferred tax liability 3,982 442 Total liabilities 108,616 111,363 Shareholders' equity Share capital 260,595 262,127 Contributed surplus 14,598 13,865 Accumulated other comprehensive loss (6,174) (2,838) Deficit (186,313) (175,457) Total shareholders' equity 82,706 97,697 Total liabilities and shareholders' equity 191,322 209,060 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, 2024 2023 2024 2023 Revenue 14,519 16,417 26,992 31,174 Expenses Cost of product sales 2,303 1,777 4,077 3,221 Selling and marketing 4,561 5,325 9,087 10,132 Medical, regulatory and patient support 1,420 1,437 2,685 2,513 General and administrative 1,977 2,373 4,178 4,724 Stock-based compensation 427 137 683 82 Amortization and depreciation 5,856 8,366 11,775 16,685 Finance and related costs, net 2,942 2,471 5,609 4,905 Other costs (income) (3,361) 3,851 (3,361) 4,064 Loss before income taxes (1,606) (9,320) (7,741) (15,152) Income tax expense 4,076 117 4,047 77 Net loss for the period (5,682) (9,437) (11,788) (15,229) Net loss per share: Basic and diluted $(0.18) $(0.29) $(0.37) $(0.47) 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, 2024 2023 2024 2023 Net loss for the period (5,682) (9,437) (11,788) (15,229) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment (963) 2,297 (3,336) 2,390 Comprehensive loss for the period (6,645) (7,140) (15,124) (12,839) 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, 2023 262,127 13,865 (2,838) (175,457) 97,697 Shares repurchased (1,532) — — 932 (600) 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, June 30, 2024 260,595 14,598 (6,174) (186,313) 82,706 Balance, December 31, 2022 265,206 13,821 (5,260) (148,449) 125,318 Stock options exercised 178 (44) — — 134 Shares repurchased (623) — — 254 (369) Share purchase obligation — (305) — — (305) Stock option expense — 679 — — 679 Net loss for the period — — — (15,229) (15,229) Dividends declared — — — (1,182) (1,182) Unrealized foreign currency translation adjustment — — 2,390 — 2,390 Balance, June 30, 2023 264,761 14,151 (2,870) (164,606) 111,436 HLS THERAPEUTICS INC. CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 OPERATING ACTIVITIES Net loss for the period (5,682) (9,437) (11,788) (15,229) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 427 137 683 82 Amortization and depreciation 5,856 8,366 11,775 16,685 Gain on royalty sale (3,381) — (3,381) — Impairment charge — 2,352 — 2,352 Accreted interest 277 190 559 381 Fair value adjustment on financial assets and liabilities 318 570 505 1,121 Deferred income taxes 3,861 (85) 3,800 (262) Net change in non-cash working capital balances related to operations 843 575 1,144 1,558 Cash provided by operating activities 2,519 2,668 3,297 6,688 INVESTING ACTIVITIES Proceeds from royalty sale 13,250 — 13,250 — Additions to property, plant and equipment — (27) (2) (27) Additions to intangible assets — (108) — (108) Cash provided by (used in) investing activities 13,250 (135) 13,248 (135) FINANCING ACTIVITIES Stock options exercised — — — 134 Shares repurchased (317) (185) (600) (369) Dividends paid — (1,216) — (2,398) Repayment of borrowing under credit agreement (1,493) (1,389) (3,568) (3,510) Debt costs (658) — (1,191) — Lease payments (112) (158) (255) (319) Cash used in financing activities (2,580) (2,948) (5,614) (6,462) Net increase (decrease) in cash during the period 13,189 (415) 10,931 91 Foreign exchange on cash (117) 133 (368) 118 Cash, beginning of period 19,443 21,214 21,952 20,723 Cash, end of period 32,515 20,932 32,515 20,932 SOURCE HLS Therapeutics Inc.