业聚医疗(06929) - 2025 - 中期财报

Company Information This section provides essential details about OrbusNeich Medical Group Holdings Limited, including its board members, committees, registered office, and auditor Company Basic Information This section provides basic information about OrbusNeich Medical Group Holdings Limited, including its board members, audit committee, remuneration committee, nomination committee, authorized representatives, company secretary, registered office, company headquarters, principal place of business in Hong Kong, share registrar, legal advisers, auditor, principal bankers, stock code, and company website - Board members include Executive Directors Mr. Qian Yongxun, Ms. Liu Guizhen, Mr. Chen Yongcheng; Non-executive Directors Mr. Liang Dingxin, Dr. Zhou Yi, Mr. Zhou Jingzhong (resigned); Independent Non-executive Directors Mr. Chen Yeqiang, Mr. Lou Jiaqiang, Dr. Tan Lifen[8] - The company's registered office is in the Cayman Islands, with its headquarters and principal place of business in Hong Kong located in Hong Kong Science Park[8] - The auditor is PricewaterhouseCoopers, stock code is 6929, and the company website is https://orbusneich.com/[10](index=10&type=chunk) Financial Highlights This section summarizes the Group's financial performance, highlighting revenue growth, profit for the period, and key profitability ratios Operating Results and Profitability For the six months ended June 30, 2025, the company's revenue increased by 5.9% year-on-year to USD 83,550 thousand, but gross margin decreased by 3.8 percentage points to 66.9%; profit for the period attributable to owners of the company grew by 5.1% to USD 19,785 thousand, with basic earnings per share at 2.40 US cents For the six months ended June 30, Operating Results and Profitability | Metric | 2025 (USD thousands) | 2024 (USD thousands) | Change (%) | Change (percentage points) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 83,550 | 78,910 | 5.9% | - | | Cost of Sales | (27,653) | (23,134) | 19.5% | - | | Gross Profit | 55,897 | 55,776 | 0.2% | - | | Profit Before Income Tax | 20,775 | 21,285 | -2.4% | - | | Profit for the Period Attributable to Owners of the Company | 19,785 | 18,828 | 5.1% | - | | Basic EPS (US cents) | 2.40 | 2.28 | 5.3% | - | | Diluted EPS (US cents) | 2.40 | 2.28 | 5.3% | - | | Gross Margin | 66.9% | 70.7% | - | -3.8% | | Net Margin | 23.7% | 23.9% | - | -0.2% | Management Discussion and Analysis This section provides a comprehensive review of the Group's business operations, financial performance, strategic outlook, and capital management for the reporting period Business Review OrbusNeich Medical is a global medical device company specializing in PCI and PTA interventional devices, headquartered in Hong Kong, with products sold in over 70 countries and regions worldwide; in H1 2025, despite macroeconomic and geopolitical challenges, the company's revenue grew by 5.9%, driven by strong growth in Asia Pacific and EMEA markets, partially offset by declines in Japan and China, while actively expanding its direct sales model and investing in product development and manufacturing facilities - OrbusNeich Medical specializes in PCI and PTA interventional devices, with products sold in over 70 countries and regions globally, and is actively expanding into the structural heart disease field[14] - In H1 2025, the Group's revenue reached USD 83.6 million, a year-on-year increase of 5.9%, with proprietary product sales growing by 8.6% year-on-year[15] - Profit attributable to owners of the Company was USD 19.8 million, a year-on-year increase of 5.1%; the Board declared a special dividend of HK 15 cents per ordinary share to celebrate the Group's 25th anniversary[16] Performance by Geographical Market The Asia Pacific and Europe, Middle East & Africa markets showed strong performance, with revenue growth of 14.0% and 17.0% respectively; the US market also saw significant growth of 20.0% despite tariff impacts, while Japan and Mainland China experienced revenue declines of 14.8% and 5.1% due to sales strategy adjustments and volume-based procurement For the six months ended June 30, Revenue Performance by Geographical Market | Region | 2025 (USD thousands) | 2024 (USD thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Asia Pacific | 27,311 | 23,955 | 14.0% | | Europe, Middle East & Africa | 22,429 | 19,170 | 17.0% | | Japan | 16,114 | 18,908 | -14.8% | | Mainland China | 9,652 | 10,176 | -5.1% | | United States | 8,044 | 6,701 | 20.0% | | Total | 83,550 | 78,910 | 5.9% | - Revenue in the Asia Pacific region significantly increased by 14.0%, primarily due to strong growth in the Indonesian market and widespread adoption of Scoreflex TRIO in Singapore and Malaysia[17] - Revenue in Europe, Middle East, and Africa (EMEA) significantly rose by 17.0%, mainly driven by increased sales of proprietary balloon products in direct sales markets (e.g., Germany, France, Spain) and distribution markets (e.g., UK, Slovakia, Czech Republic)[18] - Revenue in Japan decreased by 14.8% year-on-year, primarily due to adjusted sales strategy, shifting focus away from lower-priced coronary balloon products, leading to a decline in sales volume[19] - Revenue in Mainland China decreased by 5.1% year-on-year, mainly due to a decline in average selling prices caused by the volume-based procurement program, despite an increase in sales volume of conventional balloon products[20] - Revenue in the US market significantly increased by 20.0%, primarily due to a notable rise in sales volume of conventional and scoring coronary balloons, and peripheral balloons (including high-value Scoreflex NC balloons)[21] Operations Summary The company's strategy focuses on enhancing brand value through a direct sales model and extensive distributor network covering over 70 countries and regions globally; in H1 2025, the company acquired a Taiwanese distributor, transitioning the Taiwan market to a direct sales model and increasing its direct sales team to 13; the company continues to invest in R&D, holding over 250 granted patents, with several new products receiving regulatory approvals or entering clinical trials; global manufacturing facilities include a new Hangzhou facility expected to be operational by 2027, significantly boosting production capacity - The company covers over 70 countries and regions through its direct sales team and distributor network; in H1 2025, it acquired a Taiwanese distributor, transitioning the Taiwan market to a direct sales model, increasing the direct sales team to 13[23] - As of June 30, 2025, the Group had 286 sales and marketing personnel (December 31, 2024: 266), with direct sales and distributor sales contributing 57.7% and 42.3% of total revenue, respectively[23] - The Group holds over 250 granted patents and published patent applications in major global jurisdictions, with several products having obtained CE Mark, PMDA, or FDA approvals[27][28] - The company has manufacturing facilities in multiple global locations, including Shenzhen (China), Hoofddorp (Netherlands), and Weil am Rhein (Germany); the largest R&D and manufacturing facility in Hangzhou is expected to be operational by 2027, increasing annual production capacity by approximately 2.4 million units[29] Third-Party Product Collaboration OrbusNeich Medical expanded its exclusive distribution agreement with Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ("Mindray Medical") to include intravascular ultrasound (IVUS) products, extending the collaboration from Hong Kong and Macau to direct sales markets such as Singapore, Malaysia, France, Germany, Spain, and Switzerland, and covering six additional distribution markets in Europe - The exclusive distribution agreement with Kaili Medical has been expanded to direct sales markets including Singapore, Malaysia, France, Germany, Spain, and Switzerland, and covers six additional distribution markets in Europe for its IVUS products[26] Joint Ventures The joint venture OrbusNeich P&F focuses on developing innovative structural heart products, with TricValve's clinical trials in Mainland China progressing well, expanding to 21 participating institutions and achieving its first commercial application in July; the joint venture also boasts a pipeline of structural heart interventional devices - Joint venture OrbusNeich P&F focuses on innovative structural heart products; TricValve's clinical trials in Mainland China have expanded to 21 participating institutions and achieved its first commercial application in Mainland China in July 2025[30](index=30&type