先瑞达医疗(06669) - 2025 - 中期业绩

Company Information and Forward-Looking Statements This section provides company identification and outlines forward-looking statements, highlighting inherent risks and the company's non-obligation to update projections - This announcement contains forward-looking statements, involving known and unknown risks, where actual results may differ materially from expectations, and the company assumes no obligation to update them[1] - The company name is Acotec Scientific Holdings Limited, stock code: 6669[2] Financial Highlights This section presents key financial performance indicators for the six months ended June 30, 2025, demonstrating significant profit growth Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | Period-on-Period Change | | :--- | :--- | :--- | :--- | | Revenue | 351,204 | 292,339 | 20.1% | | Gross Profit | 260,501 | 217,210 | 19.9% | | Profit Before Tax | 89,493 | 39,939 | 124.1% | | Profit for the Period | 88,577 | 39,957 | 121.7% | Consolidated Financial Statements This section includes the unaudited consolidated statement of profit or loss, statement of profit or loss and other comprehensive income, and consolidated statement of financial position for the six months ended June 30, 2025, reflecting the company's financial performance and position during the reporting period Consolidated Statement of Profit or Loss For the six months ended June 30, 2025, the company's revenue increased by 20.1% to RMB 351,204 thousand, with profit for the period significantly growing by 121.7% to RMB 88,577 thousand, and basic and diluted earnings per share at RMB 0.29 Consolidated Statement of Profit or Loss (Six Months Ended June 30) | Indicator | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Revenue | 351,204 | 292,339 | | Cost of Sales | (90,703) | (75,129) | | Gross Profit | 260,501 | 217,210 | | Other Income | 26,989 | 19,335 | | Other Gains/(Losses) – Net | 3,528 | (6,053) | | Selling and Distribution Costs | (55,790) | (49,999) | | Administrative Expenses | (37,803) | (33,786) | | Research and Development Expenses | (102,390) | (100,459) | | Profit from Operations | 95,035 | 46,248 | | Finance Costs | (4,715) | (6,562) | | Share of (Losses)/Profits of Associates | (827) | 253 | | Profit Before Tax | 89,493 | 39,939 | | Income Tax (Expense)/Credit | (916) | 18 | | Profit for the Period | 88,577 | 39,957 | | Basic Earnings Per Share (RMB) | 0.29 | 0.13 | | Diluted Earnings Per Share (RMB) | 0.29 | 0.13 | - Profit for the period increased by 121.7% to RMB 88,577 thousand year-on-year[4] - Basic and diluted earnings per share were RMB 0.29, compared to RMB 0.13 in the prior period[4] Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, total comprehensive income was RMB 88,260 thousand, a significant increase from RMB 40,329 thousand in the prior year, primarily driven by the substantial rise in profit for the period, with a minor negative impact from exchange differences Consolidated Statement of Profit or Loss and Other Comprehensive Income (Six Months Ended June 30) | Indicator | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Profit for the Period | 88,577 | 39,957 | | Exchange differences on translation of financial statements of entities whose functional currency is not RMB | (317) | 372 | | Total Comprehensive Income for the Period | 88,260 | 40,329 | - Total comprehensive income for the period was RMB 88,260 thousand, representing a 118.9% year-on-year increase (from RMB 40,329 thousand to RMB 88,260 thousand)[5] Consolidated Statement of Financial Position As of June 30, 2025, the company's total assets and net assets both increased, with significant growth in intangible assets and financial assets at fair value through profit or loss within non-current assets, and substantial increases in financial assets at amortized cost and time deposits within current assets, reflecting changes in R&D investment and capital management Consolidated Statement of Financial Position (As of June 30, 2025) | Indicator | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Non-Current Assets | | | | Property, Plant and Equipment | 153,798 | 149,890 | | Right-of-Use Assets | 165,504 | 177,976 | | Intangible Assets | 76,329 | 47,489 | | Interests in Associates | 19,734 | 20,561 | | Financial Assets at Fair Value Through Profit or Loss | 49,780 | 30,804 | | Current Assets | | | | Inventories | 135,079 | 155,989 | | Trade Receivables | 188,098 | 161,099 | | Financial Assets at Amortized Cost | 229,400 | 54,621 | | Time Deposits | 109,279 | 58,181 | | Cash and Cash Equivalents | 654,696 | 751,388 | | Current Liabilities | | | | Trade and Other Payables | 125,120 | 93,392 | | Bank Borrowings | 49,000 | 10,000 | | Lease Liabilities | 28,622 | 23,654 | | Non-Current Liabilities | | | | Lease Liabilities | 158,513 | 169,262 | | Net Assets | 1,443,531 | 1,349,816 | - Intangible assets increased from RMB 47,489 thousand as of December 31, 2024, to RMB 76,329 thousand as of June 30, 2025[6] - Financial assets at amortized cost increased from RMB 54,621 thousand to RMB 229,400 thousand[6] - Bank borrowings increased from RMB 10,000 thousand to RMB 49,000 thousand[7] Notes to the Financial Statements This section elaborates on the basis of financial statement preparation, changes in accounting policies, composition of various incomes and expenses, and details of key balance sheet items, providing supplementary information for understanding the company's financial data General Information and Basis of Preparation The company was incorporated in the Cayman Islands on December 3, 2020, listed on the Hong Kong Stock Exchange on August 24, 2021, and primarily focuses on developing vascular disease treatment solutions; its interim financial report is prepared in accordance with IAS 34 and reviewed by KPMG - The company was incorporated in the Cayman Islands on December 3, 2020, and listed on the Main Board of the Hong Kong Stock Exchange on August 24, 2021[8] - The Group primarily engages in the research and development of vascular disease treatment solutions[8] - The interim financial report is prepared in accordance with International Accounting Standard 34 and has been reviewed by KPMG[9][10] Changes in Accounting Policies During this accounting period, the Group applied the amendments to IAS 21, "The Effects of Changes in Foreign Exchange Rates – Lack of Exchangeability," but these amendments had no material impact on the interim report due to the absence of relevant foreign currency transactions - The Group has applied the amendments to IAS 21, but they had no material impact on the interim report due to the absence of foreign currency non-exchangeable transactions[11] Revenue and Segment Reporting The Group's primary business is the research and development of vascular disease treatment solutions, with total revenue of RMB 351,204 thousand for the reporting period, comprising RMB 175,603 thousand from core products, RMB 172,907 thousand from venous intervention, vascular access, and other products, and RMB 2,694 thousand from service income; the company operates as a single operating segment, with most revenue derived from mainland China Revenue by Product Type | Product Type | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | – Core Products* | 175,603 | 174,634 | | – Venous Intervention, Vascular Access and Other Products | 172,907 | 117,705 | | – Service Income | 2,694 | – | | Total Revenue | 351,204 | 292,339 | Revenue by Customer Type | Customer Type | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | – Domestic Distributors | 335,855 | 276,660 | | – Domestic Hospitals | 4,315 | 3,746 | | – Overseas Customers | 11,034 | 11,933 | | Total Revenue | 351,204 | 292,339 | Revenue from External Customers (by Region) | Region | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Mainland China | 340,170 | 280,406 | | Other Countries and Regions | 11,034 | 11,933 | | Total Revenue | 351,204 | 292,339 | - The Group has only a single operating segment, and management reviews overall performance[21] Other Income For the six months ended June 30, 2025, other income increased to RMB 26,989 thousand, primarily due to a significant rise in government grants, while interest income slightly decreased Other Income (Six Months Ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Government Grants | 11,600 | 2,982 | | Interest Income | 14,110 | 15,554 | | Others | 1,279 | 799 | | Total | 26,989 | 19,335 | - Government grants increased from RMB 2,982 thousand to RMB 11,600 thousand, being the primary driver of other income growth[22] Other Net Gains/(Losses) During the reporting period, other net gains turned from a loss in the prior year to a gain of RMB 3,528 thousand, primarily driven by a significant increase in unrealized and realized net gains from financial assets at fair value through profit or loss, while net foreign exchange losses also increased Other Net Gains/(Losses) (Six Months Ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Net Foreign Exchange (Losses)/Gains | (5,539) | 285 | | Net Loss on Disposal of Property, Plant and Equipment and Termination of Lease Contracts | (22) | (6,452) | | Unrealized and Realized Net Gains from Financial Assets at Fair Value Through Profit or Loss | 9,998 | 2,476 | | Unrealized and Realized Net Losses from Foreign Currency Forward Contracts | (953) | – | | Others | 44 | (2,362) | | Total | 3,528 | (6,053) | - Unrealized and realized net gains from financial assets at fair value through profit or loss increased from RMB 2,476 thousand to RMB 9,998 thousand[24] - Net foreign exchange (losses) turned from RMB 285 thousand to (RMB 5,539) thousand[24] Profit Before Tax Profit before tax was RMB 89,493 thousand, a significant increase from RMB 39,939 thousand in the prior period, primarily due to reduced finance costs and changes in depreciation, amortization, inventory costs, and R&D expenses Finance Costs (Six Months Ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Interest Expense on Bank Borrowings | 378 | 488 | | Interest Expense on Lease Liabilities | 4,018 | 4,979 | | Others | 319 | 1,095 | | Total | 4,715 | 6,562 | Other Items (Six Months Ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Depreciation and Amortization – Property, Plant and Equipment | 12,011 | 9,168 | | Depreciation and Amortization – Right-of-Use Assets | 14,524 | 15,305 | | Depreciation and Amortization – Intangible Assets | 573 | 359 | | Cost of Inventories Recognized as Expense | 77,969 | 64,205 | | Royalty Fees | 12,734 | 10,924 | | Provision for Inventory Write-Down | 14,486 | 1,633 | | Research and Development Expenses | 102,390 | 100,459 | - Finance costs decreased from RMB 6,562 thousand to RMB 4,715 thousand, primarily due to a reduction in interest expense on lease liabilities[25] - Research and development expenses (net of capitalized portion) increased from RMB 100,459 thousand to RMB 102,390 thousand[25] Income Tax During the reporting period, the company recorded an income tax expense of RMB 916 thousand, compared to an income tax credit of RMB 18 thousand in the prior period, primarily due to the recognition of withholding income tax Income Tax (Six Months Ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Current Tax – Withholding Income Tax | (934) | – | | Deferred Tax – Reversal of Temporary Differences | 18 | 18 | | Total | (916) | 18 | - Income tax turned from a credit of RMB 18 thousand in the prior period to an expense of RMB 916 thousand, primarily due to withholding income tax[26] Earnings Per Share For the six months ended June 30, 2025, both basic and diluted earnings per share increased to RMB 0.29, a significant improvement from RMB 0.13 in the prior period, reflecting enhanced profitability - Basic earnings per share increased from RMB 0.13 to RMB 0.29[29] - Diluted earnings per share increased from RMB 0.13 to RMB 0.29, affected by unvested shares under the restricted share unit scheme[30][31] Property, Plant and Equipment, Right-of-Use Assets and Intangible Assets During the reporting period, the company invested RMB 16,780 thousand in property, plant and equipment and recognized additions to right-of-use assets of RMB 3,123 thousand; intangible assets significantly increased due to capitalized development costs of RMB 26,772 thousand for the BTK DCB product's clinical trials in the US - Additions to right-of-use assets amounted to RMB 3,123 thousand[32] - Purchases of property, plant and equipment amounted to RMB 16,780 thousand[33] - The increase in intangible assets primarily refers to capitalized development costs of RMB 26,772 thousand for the BTK DCB product's clinical trials in the US[34] Financial Assets at Fair Value Through Profit or Loss As of June 30, 2025, non-current financial assets at fair value through profit or loss increased to RMB 49,780 thousand, mainly due to additional contributions to unlisted units of investment funds, and new current structured deposits of RMB 2,000 thousand were added Financial Assets at Fair Value Through Profit or Loss (As of June 30, 2025) | Item | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Non-Current | | | | – Unlisted Units of Investment Funds | 37,780 | 18,804 | | – Unlisted Equity Securities | 12,000 | 12,000 | | Current | | | | – Structured Deposits | 2,000 | – | - Additional contribution of USD 1,250,000 (equivalent to RMB 8,978 thousand) to Trumed Health Innovation Fund LP[36] - New current structured deposits of RMB 2,000 thousand were added[37] Trade Receivables As of June 30, 2025, trade receivables increased to RMB 188,098 thousand, an approximate 16.8% increase from December 31, 2024, with a significant rise in receivables aged within 3 months, reflecting sales growth and changes in collection cycles Trade Receivables (As of June 30, 2025) | Item | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Trade Receivables | 188,227 | 161,228 | | Less: Loss Allowance | (129) | (129) | | Total | 188,098 | 161,099 | Ageing Analysis of Trade Receivables (As of June 30, 2025) | Ageing | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Within 3 Months | 186,828 | 115,052 | | 3 to 6 Months | 1,270 | 45,988 | | 6 to 12 Months | – | 59 | | Total | 188,098 | 161,099 | - Trade receivables within 3 months increased from RMB 115,052 thousand to RMB 186,828 thousand[39] Trade and Other Payables As of June 30, 2025, total trade and other payables increased to RMB 125,120 thousand, an approximate 33.9% increase from December 31, 2024, primarily due to increases in trade payables, accrued R&D expenses, selling and distribution expenses, salaries and bonuses, and VAT and other taxes payable Trade and Other Payables (As of June 30, 2025) | Item | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Trade Payables | 46,248 | 39,041 | | Accrued Research and Development Expenses | 850 | 327 | | Accrued Selling and Distribution Expenses | 7,215 | 3,015 | | Accrued Salaries and Bonuses | 42,194 | 36,589 | | VAT and Other Taxes Payable | 20,951 | 6,510 | | Other Payables | 6,216 | 6,203 | | Total | 125,120 | 93,392 | Ageing Analysis of Trade Payables (As of June 30, 2025) | Ageing | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Within 3 Months | 28,553 | 30,616 | | 3 to 6 Months | 7,513 | 5,345 | | 6 to 12 Months | 8,529 | 1,962 | | Over 12 Months | 1,653 | 1,118 | | Total | 46,248 | 39,041 | - VAT and other taxes payable increased from RMB 6,510 thousand to RMB 20,951 thousand[40] - Accrued salaries and bonuses increased from RMB 36,589 thousand to RMB 42,194 thousand[40] Management Discussion and Analysis This section comprehensively reviews the company's business development, product pipeline progress, R&D investment, market strategy, internationalization, and collaboration with Boston Scientific during the reporting period, outlining future directions and emphasizing the importance of technological innovation and market expansion for growth Business Review As a leading Chinese medical device technology platform company, Acotec Scientific focuses on endovascular interventional treatment solutions, leveraging its four major technology platforms; during the reporting period, the company achieved significant progress in product R&D, hospital admissions, revenue growth, and internationalization, while continuously strengthening clinical promotion and talent acquisition - The company leverages four major technology platforms: drug-coating, radiofrequency ablation, polymer materials, and aspiration, to provide endovascular interventional treatment solutions[42] - During the reporting period, three products underwent clinical trials, four submitted registration applications, six received marketing approval, two patents were registered, and four new patent applications were filed[43] - Both DCB products and venous intervention products achieved admission to over 2,500 hospitals[43] - Revenue was approximately RMB 351.2 million, representing a year-on-year increase of approximately 20.1%[43] - Six products received marketing approval, including DCB for peripheral, coronary, and vertebral arteries[44] - International business accelerated, with ATK DCB and BTK DCB expected to launch in multiple countries in 2025, and a framework agreement signed with Boston Scientific Group plc[46] - As of June 30, 2025, the total number of employees was 645, with 141 in the R&D team, and continuous recruitment of technical personnel in biomedical engineering and other fields[51] Products and Pipeline The company boasts a comprehensive and diversified product pipeline, encompassing over 30 commercialized and in-development products across four major therapeutic areas: vascular surgery, cardiology, nephrology, and neurology; during the reporting period, multiple new products received registration approval, further enriching the product portfolio and expanding market coverage - The product portfolio covers vascular surgery, cardiology, nephrology, and neurology, with over 30 products in total[47][53] - The vertebral artery paclitaxel-coated balloon dilatation catheter (AcoArt Verbena®) received NMPA approval, with clinical trial results showing significantly superior target lesion restenosis rates compared to the control group[48] - AcoArt Litos® received FDA IDE approval, and clinical trial centers in the US and Europe have been initiated with patient enrollment underway[48] Core Products Core products AcoArt Orchid® & Dhalia® (for SFA/PPA) and AcoArt Tulip® & Litos® (for BTK) are the company's main revenue drivers; AcoArt Orchid® & Dhalia® is China's first peripheral DCB product, AcoArt Tulip® & Litos® received FDA "Breakthrough Device" designation, and both products are actively promoted in overseas markets with BSC collaboration for distribution - AcoArt Orchid® & Dhalia® is the first peripheral DCB product launched in China, approved by the NMPA in 2016[56] - AcoArt Tulip® & Litos® received FDA "Breakthrough Device" designation in 2019 and NMPA marketing approval in December 2020[58] - Both core products are expected to launch in the UK, Belgium, Ireland, Norway, Denmark, Hungary, Colombia, and Singapore in 2025, and will be sold by BSC in overseas markets[56][58] Devices for Vascular Surgery Beyond core products, the company has 15 commercialized products and 1 in-development product in vascular surgery, including PTA balloons, aspiration systems, and radiofrequency ablation systems; multiple products have received NMPA and international regulatory approvals, with new product clinical trials and registrations continuously advancing - Possesses 15 commercialized products and 1 in-development product, such as AcoArt Iris® & Jasmin®, AcoStream®, and AcoArt Cedar®[61] - Peripheral support catheter (Vericor®) has received approval from NMPA, Brazil ANVISA, FDA, and Japan's MHLW[63] - Products such as pressure control connecting tube, peripheral scoring balloon dilatation catheter (E-Peridge®), embolectomy device for peripheral thrombus aspiration catheter, and peripheral high-pressure balloon dilatation catheter (Armoni-HP®) received NMPA or Beijing Medical Products Administration approval in 2025[63][64] - Lower limb sirolimus DCB is undergoing clinical trials, with NMPA approval expected in 2026[65] Devices for Cardiology The company has 9 commercialized products and 1 in-development product in cardiology, including various PTCA balloons, microcatheters, and valvuloplasty balloon dilatation catheters; clinical trial results for both paclitaxel-eluting coronary balloon dilatation catheter (AcoArt Camellia®) and sirolimus-coated coronary balloon dilatation catheter (AcoArt Canna®) have shown good efficacy and safety - Possesses 9 commercialized products and 1 in-development product, such as semi-compliant PTCA balloon (Yan), coronary CTO recanalization balloon (RT-Zero®), and coronary microcatheter (Vericor-S2®)[66] - Clinical trials for the paclitaxel-eluting coronary balloon dilatation catheter (AcoArt Camellia®) showed a significantly lower in-segment diameter stenosis rate at 9 months post-procedure compared to the control group[68] - Clinical trials for the sirolimus-coated coronary balloon dilatation catheter (AcoArt Canna®) showed no statistically significant difference in target lesion branch vessel diameter stenosis rate at 9 months post-procedure compared to the control group[69] - The coronary IVL system is an in-development product, with NMPA approval expected in 2027[69] Devices for Nephrology The company has 2 commercialized products in nephrology, namely the paclitaxel-coated high-pressure balloon (ACOART AVENS®) and AV scoring balloon (Peridge®), used for treating arteriovenous fistula stenosis in hemodialysis patients, both of which have received NMPA approval - The indication for AcoArt Orchid® & Dhalia® has been expanded to treat AVF stenosis[70] - The paclitaxel-coated high-pressure balloon (ACOART AVENS®) received NMPA approval in April 2023[71] - The AV scoring balloon (Peridge®) received NMPA approval in January 2024[72] Devices for Neurology The company has 2 commercialized products in neurology, the intracranial PTA balloon (NEO-Skater®) and the vertebral artery paclitaxel-coated balloon dilatation catheter (AcoArt Verbena®), used for treating intracranial vascular stenosis and vertebral artery ostial stenosis, with clinical trial results for AcoArt Verbena® showing significant efficacy - The intracranial PTA balloon (NEO-Skater®) received NMPA approval in December 2022[76] - The vertebral artery paclitaxel-coated balloon dilatation catheter (AcoArt Verbena®) received NMPA approval in May 2025, with clinical trials showing significantly lower target lesion restenosis rates compared to the control group[76] Research and Development The company boasts a strong in-house R&D team primarily employing a self-development model, holding 66 registered patents and 30 pending patent applications; during the reporting period, the R&D team expanded its technical personnel in biomedical engineering and other fields, further strengthening its talent pool - Possesses a strong in-house R&D team, primarily employing a self-development model[75] - As of June 30, 2025, holds 66 registered patents and 30 pending patent applications[75] - During the reporting period, the R&D team expanded its technical personnel in biomedical engineering, mechanical engineering, materials science and engineering, and mechatronics engineering[77] Production The company operates production facilities in Beijing and Shenzhen, with total building areas of approximately 30,800 square meters and 8,126 square meters respectively, primarily for manufacturing balloon catheter products, active devices, and in-development products - Leased a new facility in Beijing for the research, development, testing, and production of medical devices[78] - As of June 30, 2025, the Beijing production facility has a total building area of approximately 30,800 square meters, and Shenzhen approximately 8,126 square meters[78] Sales and Marketing The company primarily sells its core products and venous intervention, vascular access, and other products in China through its internal sales team, hospital collaborations, and independent distributor network; during the reporting period, core product revenue was approximately RMB 175.6 million (0.6% year-on-year increase), and venous intervention, vascular access, and other product revenue was approximately RMB 172.9 million (46.9% year-on-year increase), with most revenue originating from China - Core product revenue was approximately RMB 175.6 million, representing a year-on-year increase of approximately 0.6%[79] - Venous intervention, vascular access, and other product revenue was approximately RMB 172.9 million, representing a year-on-year increase of approximately 46.9%[79] - Most revenue originates from China, with anticipated increases in overseas market sales[79] - Employs a strategic marketing model through academic marketing, establishing research and clinical collaborations, training relationships, and KOL networks with hospitals[80] Intellectual Property As of June 30, 2025, the company holds 66 registered patents, 180 registered trademarks, and 30 pending patent applications and 15 pending trademark applications, establishing a comprehensive intellectual property portfolio to protect its technology and know-how - As of June 30, 2025, holds 66 registered patents and 180 registered trademarks[81] - Possesses 30 pending patent applications and 15 pending trademark applications[81] Continuing Connected Transactions The company has entered into a master cooperation agreement and a master service agreement with its controlling shareholder, Boston Scientific Group plc (BSG), covering product commercialization, manufacturing services, and product development; agreements have been established for product distribution in overseas and mainland China markets, as well as R&D collaboration, with BSG holding commercialization rights for jointly developed products - Signed a master cooperation agreement and a master service agreement with controlling shareholder BSG, governing product commercialization, manufacturing services, and product development collaboration[82] - Distribution agreements have been established for peripheral DCB products in overseas markets and various products in Hong Kong, Taiwan, and mainland China markets[83] - Entered into R&D service agreements with BSG, where the Group is responsible for R&D and regulatory approvals, and BSC holds commercialization rights[83] Future Outlook and Strategy The company aims to become a global leader in interventional solutions for vascular diseases, planning to achieve long-term growth by expanding product offerings, increasing investment in technological innovation, diversifying marketing strategies, and accelerating internationalization; it will continue to promote DCB training and patient education, and expand the coverage of venous interventional products in lower-tier city hospitals - The goal is to become a global leader providing a full suite of interventional solutions for vascular diseases[84] - Plans to increase investment in technological innovation, enhance R&D capabilities, and expand product offerings to include ancillary devices[84] - Will continue to increase core product sales, implement DCB training programs, and conduct patient education activities[85] - Will expand the coverage of venous interventional products in lower-tier city hospitals and provide comprehensive training for physicians[85] - The framework agreement with BSG will facilitate global sales expansion and penetration rate improvement[85] Financial Review This section provides a detailed analysis of the reporting period's financial indicators, including revenue, costs, profits, expenses, capital management, and liquidity, revealing the drivers and trends of the company's financial performance Revenue During the reporting period, revenue was approximately RMB 351.2 million, a 20.1% year-on-year increase, primarily driven by increased sales of venous intervention, vascular access, and other products, which grew by 46.9% to RMB 172.9 million, accounting for 49.2% of total revenue; core products remained the main revenue source, but their proportion decreased - Total revenue was approximately RMB 351.2 million, representing a year-on-year increase of 20.1%[88] - Sales revenue from venous intervention, vascular access, and other products increased by 46.9% to RMB 172.9 million, accounting for 49.2% of total revenue (compared to 40.3% in the prior period)[88] Revenue Details (Six Months Ended June 30) | Revenue Category | 2025 (RMB '000) | % of Total | 2024 (RMB '000) | % of Total | | :--- | :--- | :--- | :--- | :--- | | Core Products | 175,603 | 50.0% | 174,634 | 59.7% | | Venous Intervention, Vascular Access and Other Products | 172,907 | 49.2% | 117,705 | 40.3% | | Service Income | 2,694 | 0.8% | – | – | | Total | 351,204 | 100.0% | 292,339 | 100.0% | Cost of Sales Cost of sales was approximately RMB 90.7 million, a 20.7% year-on-year increase, consistent with the overall sales revenue growth - Cost of sales was approximately RMB 90.7 million, representing a year-on-year increase of 20.7%, consistent with sales revenue growth[90] Gross Profit Gross profit was approximately RMB 260.5 million, a 19.9% year-on-year increase, primarily driven by increased sales revenue, with the gross profit margin remaining stable at approximately 74.2% - Gross profit was approximately RMB 260.5 million, representing a year-on-year increase of 19.9%[91] - Gross profit margin was approximately 74.2%, similar to 74.3% in the prior period[91] Other Income Other income was approximately RMB 27.0 million, a 39.6% year-on-year increase, primarily due to increased government grants - Other income was approximately RMB 27.0 million, representing a year-on-year increase of 39.6%, primarily due to increased government grants[92] Other Gains/(Losses) – Net Other net gains turned from a loss of RMB 6.1 million in the prior period to a gain of RMB 3.5 million, primarily attributable to increased net gains from financial assets at fair value through profit or loss - Other net gains turned from a loss of RMB 6.1 million in the prior period to a gain of RMB 3.5 million[93] - Primarily attributable to increased net gains from financial assets at fair value through profit or loss[93] Selling and Distribution Costs Selling and distribution costs were approximately RMB 55.8 million, an 11.6% year-on-year increase, primarily due to increased market investment to address intensifying competition - Selling and distribution costs were approximately RMB 55.8 million, representing an 11.6% year-on-year increase, primarily due to increased market investment[94] Research and Development Expenses R&D costs were approximately RMB 102.4 million, a 1.9% year-on-year increase, primarily due to higher employee costs from increased share-based payments and greater consumption of materials for R&D projects; capitalized development costs for the BTK DCB product's clinical trials in the US amounted to RMB 26.8 million - Research and development costs were approximately RMB 102.4 million, representing a year-on-year increase of 1.9%[95] - The increase was primarily due to higher employee costs from increased share-based payments and greater consumption of materials[95] - Capitalized development costs for the BTK DCB product's clinical trials in the US amounted to RMB 26.8 million[95] R&D Expense Composition (Six Months Ended June 30) | Item | 2025 (RMB '000) | % of Total | 2024 (RMB '000) | % of Total | | :--- | :--- | :--- | :--- | :--- | | Employee Benefit Expenses | 42,707 | 41.7% | 41,544 | 41.4% | | Third-Party Contracting and Consulting Expenses | 24,155 | 23.6% | 28,688 | 28.6% | | Depreciation and Amortization | 6,294 | 6.1% | 6,391 | 6.4% | | Consumables | 26,781 | 26.2% | 20,594 | 20.5% | | Others | 2,453 | 2.4% | 3,242 | 3.1% | | Total | 102,390 | 100.0% | 100,459 | 100.0% | Administrative Expenses Administrative expenses were approximately RMB 37.8 million, an 11.9% year-on-year increase, primarily due to consulting fees for renewing the framework agreement with BSG - Administrative expenses were approximately RMB 37.8 million, representing an 11.9% year-on-year increase, primarily due to consulting fees for renewing the framework agreement with BSG[98] Finance Costs Finance costs were approximately RMB 4.7 million, a 28.1% year-on-year decrease, primarily due to reduced interest expense on lease liabilities - Finance costs were approximately RMB 4.7 million, representing a 28.1% year-on-year decrease, primarily due to reduced interest expense on lease liabilities[99] Income Tax During the reporting period, income tax expense was approximately RMB 916 thousand, compared to an income tax credit of RMB 18 thousand in the prior period - Income tax expense was approximately RMB 916 thousand, compared to an income tax credit of RMB 18 thousand in the prior period[100] Capital Management The company's capital management objective is to maintain stability and growth, safeguard normal operations, and maximize shareholder value, achieved by regularly reviewing the capital structure and making timely adjustments, potentially raising capital through bank loans or equity issuance - Capital management objectives are to maintain stability and growth, safeguard normal operations, and maximize shareholder value[101] - Capital may be raised through bank loans or equity issuance[101] Liquidity and Financial Resources As of June 30, 2025, total available financial resources were approximately RMB 999.7 million, an increase of 15.7% from December 31, 2024, primarily attributable to cash generated from operating and financing activities; the company adopts a conservative treasury policy and expects to generate more operating cash flow through product sales and new product launches - Total available financial resources were approximately RMB 999.7 million, representing a 15.7% increase from December 31, 2024[102] - The increase is primarily attributable to cash generated from operating and financing activities[102] - Adopts a conservative treasury policy, with cash primarily denominated in USD, HKD, and RMB[102] Borrowings and Gearing Ratio As of June 30, 2025, total borrowings increased to RMB 49.0 million, and the gearing ratio rose from 23.2% to 26.6%, primarily due to increased bank borrowings - Total borrowings increased to RMB 49.0 million (December 31, 2024: RMB 10.0 million)[103] - The gearing ratio increased from 23.2% to 26.6%, primarily due to increased bank borrowings[103] Net Current Assets As of June 30, 2025, net current assets were approximately RMB 1,128.0 million, an increase of 4.9% from December 31, 2024 - Net current assets were approximately RMB 1,128.0 million, representing a 4.9% increase from December 31, 2024[104] Foreign Exchange Risk The company faces transactional exchange rate risk, with some bank balances, receivables, and payables denominated in foreign currencies; to mitigate this risk, the company entered into foreign exchange forward contracts with a carrying amount of RMB 0.8 million at the end of the reporting period - The company faces transactional exchange rate risk, with some bank balances, receivables, and payables denominated in foreign currencies[105] - As of June 30, 2025, foreign exchange forward contracts with a carrying amount of RMB 0.8 million were entered into, not for hedging purposes[105] Material Investments, Significant Acquisitions and Disposals As of June 30, 2025, the company held no material investments and had no significant acquisitions or disposals of subsidiaries, associates, or joint ventures - As of June 30, 2025, no material investments were held, nor were there any significant acquisitions or disposals[106] Capital Expenditure Total capital expenditure for the reporting period was approximately RMB 37.6 million, primarily for the purchase of plant and equipment and the development of intangible assets - Total capital expenditure was approximately RMB 37.6 million, used for purchasing plant and equipment and developing intangible assets[107] Pledge of Assets As of June 30, 2025, none of the company's assets were pledged - As of June 30, 2025, none of the company's assets were pledged[108] Contingent Liabilities As of June 30, 2025, the company had no contingent liabilities - As of June 30, 2025, the company had no contingent liabilities[109] Employees and Remuneration Policy As of June 30, 2025, the company had 645 employees, predominantly based in China, offering competitive remuneration, incentive programs, and continuous education and training to attract and retain talent - As of June 30, 2025, there were 645 employees, mostly based in China[110] - Offers competitive remuneration, project and equity incentive plans, and invests in continuous education and training[110] Future Investment Plans and Expected Funding The company will continue to expand in China and global markets, drive product development, and grow through organic development, mergers, and acquisitions; it will utilize various financing channels, including internal funds and bank loans, to support capital expenditures, with sufficient bank credit lines currently available - Will continue to expand in China and global markets, drive product development, and grow through organic development, mergers, and acquisitions[111] - Will utilize various financing channels, including internal funds and bank loans, to support capital expenditures, with sufficient bank credit lines currently available[111] Events After the Reporting Period No significant events requiring additional disclosure or adjustment occurred after the reporting period - No significant events requiring additional disclosure or adjustment occurred after the reporting period[112] Use of Net Proceeds from Listing The net proceeds from the global offering, approximately RMB 1,294.0 million, have been utilized as disclosed in the prospectus, primarily for core product development, R&D of other products, expanding production capacity, and product portfolio, with the Board finding no material changes to the planned use - Net proceeds from the global offering were approximately RMB 1,294.0 million[113] Use of Net Proceeds from Global Offering (As of June 30, 2025) | Intended Use of Proceeds as per Prospectus | Percentage of Total (%) | Net Proceeds from IPO (RMB '000) | Amount Utilized for Six Months Ended June 30, 2025 (RMB '000) | Amount Utilized as of June 30, 2025 (RMB '000) | Unutilized Amount as of June 30, 2025 (RMB '000) | Expected Timeline for Utilizing Unutilized Amount | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Development and Commercialization of Our Core Products | 32 | 414,067 | 57,156 | 395,087 | 18,980 | 2027 | | Research and Development and Commercialization of Our Remaining 24 Products | 23 | 297,611 | – | 297,611 | – | 2024 | | Expanding Production Capacity and Strengthening Manufacturing Capabilities | 7 | 90,577 | – | 90,577 | – | 2024 | | Expanding Our Product Portfolio through In-house R&D, Collaborations, Mergers, etc. | 24 | 310,550 | 38,092 | 239,518 | 71,032 | 2027 | | Working Capital and Other General Corporate Purposes | 8 | 103,517 | 5,925 | 103,517 | – | 2025 | | Repayment of Loans | 6 | 77,638 | – | 77,638 | – | Not Applicable | | Total | 100 | 1,293,960 | 101,173 | 1,203,948 | 90,012 | | - The Board is not aware of any material changes to the planned use of net proceeds[114] Interim Dividend The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025[115] Corporate Governance and Other Information This section outlines the company's corporate governance practices, including the arrangement of Chairman and CEO responsibilities, compliance with the Model Code for securities transactions by directors, audit committee review work, and publication information for interim results Corporate Governance The company is committed to maintaining high standards of corporate governance and complies with the Corporate Governance Code; while the Chairman and CEO roles are held by the same person, the Board believes this structure does not undermine the balance of power due to sufficient checks and balances and an experienced Board; the company currently has no dividend policy and will review it periodically in the future - The company complies with the Corporate Governance Code, but the roles of Chairman and Chief Executive Officer are held by the same person (Ms. Li Jing)[116] - The Board believes this structure does not undermine the balance of power due to independent non-executive directors and an experienced Board[117] - The company currently has no dividend policy and expects to retain future earnings for business operations and expansion[117] Model Code for Securities Transactions The company has adopted the Model Code as its code of conduct for directors' securities transactions, and all directors have confirmed compliance during the reporting period; employees with unpublished inside information are also subject to this code - The company has adopted the Model Code as its code of conduct for directors' securities transactions, and all directors have confirmed compliance[118] - Employees with unpublished inside information are also subject to the Model Code[119] Purchase, Sale or Redemption of Listed Securities During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities or sold any treasury shares, and as of June 30, 2025, the company held no treasury shares - During the reporting period, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities or sold any treasury shares[120] - As of June 30, 2025, the company held no treasury shares[120] Audit Committee The Audit Committee, in conjunction with the Board, has reviewed the accounting standards and practices adopted by the Group, as well as the interim results for the reporting period - The Audit Committee, in conjunction with the Board, has reviewed the accounting standards and practices adopted by the Group, as well as the interim results for the reporting period[121] Independent Review by Auditor The interim financial report for the six months ended June 30, 2025, is unaudited but has undergone an independent review by KPMG in accordance with Hong Kong Standard on Review Engagements 2410, resulting in a review report without modification - The interim financial report is unaudited but has undergone an independent review by KPMG in accordance with Hong Kong Standard on Review Engagements 2410[122] - The review report is without modification[122] Publication of Interim Results and Interim Report This interim results announcement has been published on the HKEX and company websites, and the 2025 interim report containing all required information will be dispatched to shareholders and published in due course - This interim results announcement has been published on the HKEX website (www.hkexnews.hk) and the **company website (www.acotec.cn)**[123](index=123&type=chunk) - The 2025 interim report will be dispatched to shareholders and published in due course[123] Definitions and Technical Terms This section provides definitions for key terms and technical vocabulary used in the interim results announcement, ensuring readers' accurate understanding of the report content - This section provides definitions for key terms and technical vocabulary used in the report, such as BSC Group, DCB, LEAD, etc[124][125][126][127][128]