心泰医疗(02291) - 2025 - 中期业绩

Financial Highlights During the reporting period, the company achieved significant growth in revenue, gross profit, R&D expenses, and net profit attributable to parent company shareholders, but the board does not recommend an interim dividend Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | June 30, 2025 (RMB million) | June 30, 2024 (RMB million) | Year-over-year growth rate (%) | | :--- | :--- | :--- | :--- | | Revenue | 329.7 | 249.1 | 32.4 | | Gross Profit | 284.3 | 226.7 | 25.4 | | R&D Expenses | 25.4 | 21.7 | 17.0 | | Net Profit Attributable to Parent Company Shareholders | 182.0 | 140.2 | 29.8 | - The Board does not recommend an interim dividend for the six months ended June 30, 2025 (for the six months ended June 30, 2024: nil)[5] Management Discussion and Analysis During the reporting period, the company maintained strong business momentum with stable revenue growth, continuous innovation in cardiovascular interventional devices, particularly in biodegradable technology and structural heart disease treatment, and active expansion in domestic and international markets Business Review The company specializes in R&D, production, and commercialization of cardiovascular interventional devices, offering a broad product portfolio including congenital heart disease occluders, PFO and LAA occluders, heart valves, mechanical circulatory support, and access products, with many innovative products successfully commercialized or in clinical stages Overall Operating Performance During the reporting period, the company achieved double-digit growth in revenue and net profit, significantly increased operating cash flow, and maintained steady growth in total assets Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | June 30, 2025 (RMB million) | June 30, 2024 (RMB million) | Year-over-year growth rate (%) | | :--- | :--- | :--- | :--- | | Revenue | 329.7 | 249.1 | 32.4 | | Net Profit Attributable to Parent Company Shareholders | 182.0 | 140.2 | 29.8 | | Net Cash Generated from Operating Activities | 166.8 | 103.5 | 61.2 | | Total Assets (end of period) | 2,279.1 | 2,083.0 (beginning of reporting period) | 9.4 | | Net Assets (end of period) | 1,973.2 | 1,997.0 (beginning of reporting period) | -1.2 | Congenital Heart Disease Occluder Products The company maintains a leading position in congenital heart disease occluders, with third-generation oxide film and fourth-generation biodegradable occluder series successfully commercialized, becoming a cornerstone of business growth and embodying the "intervention without implant" philosophy - As of the date of this announcement, the Company has a total of 30 listed occluders, heart valve and accessory products, 4 products under registration review and preparation, and 28 pipeline products including occluders, heart valve and surgical accessories, and mechanical circulatory support at various R&D stages[6] - The fourth-generation MemoSorb® biodegradable atrial septal defect occluder product obtained the medical device registration certificate from the NMPA in August 2024 and has been rapidly commercialized[11] - Adhering to the technical concept of "intervention without implant," the Group will continue to promote the R&D and promotion of biodegradable materials[11] PFO and LAA Occluder Products First-generation cardiogenic stroke prevention products have been commercialized, with third-generation MemoSorb® biodegradable PFO occluders achieving over RMB 200 million in sales since launch, second-generation oxide film PFO occluders entering the registration application stage, and biodegradable LAA occluders entering multi-center clinical trials - The third-generation MemoSorb® biodegradable PFO occluder was approved for market in September 2023, with cumulative sales exceeding RMB 200 million as of June 30, 2025[12] - The second-generation oxide film PFO occluder has completed clinical follow-up and entered the registration application stage, with NMPA registration submission expected in Q3 2025[12] - The Bio-Lefort® biodegradable LAA occluder pipeline product has officially entered the multi-center clinical trial enrollment phase[12] Aortic and Peripheral Occluder Devices The company is strategically developing biodegradable aortic occluders and aortic embolization occluders in the aortic and peripheral fields, with both global innovative products having entered clinical trial stages, poised to address international challenges and offering promising market prospects - Both biodegradable aortic occluders and aortic embolization occluders have completed type testing and animal experiments, entering the clinical trial stage[13] - Currently, no targeted therapeutic devices for aortic dissection rupture and post-aortic aneurysm repair type II endoleak have been commercialized, making both of the Group's products global innovations[13] Heart Valve Pipeline Products The ScienCrown® transcatheter aortic valve system was commercialized in early 2025, entering over 70 clinical centers in China, and the company is actively developing new products for aortic regurgitation, mitral valve repair, and replacement - The ScienCrown® transcatheter aortic valve system was officially commercialized in early 2025, having entered over 70 clinical centers in China for implantation[14] - A transcatheter aortic valve system for patients with isolated aortic regurgitation is currently under development, having completed animal experiments and type testing, with clinical trials planned for late 2025[14][15] - The transapical mitral valve clip system is undergoing its second phase of clinical trials, with registration application to the NMPA expected to be postponed until 2026[15] Mechanical Circulatory Support Products The company has entered the mechanical circulatory support (MCS) device field, with a product line covering short-term and long-term ventricular assist systems, and multiple products in preclinical or type testing stages, aiming to become a core participant in this domain - The Company has entered the mechanical circulatory support (MCS) device field, with these devices designed to provide temporary or long-term support for patients requiring cardiac assistance[16] - The transcatheter left ventricular assist system for left ventricular support is in the preclinical type testing stage, with batch animal experiments already initiated[16] - The Company is one of the earliest pioneers in the domestic MCS field and is confident in becoming one of the most core and valuable participants in this area[16] Access Products The company boasts a rich pipeline of access products, with RF-Lance® radiofrequency puncture devices and needles approved for market, biodegradable LAA occluder delivery systems launched, and multiple valve surgery accessories (such as aortic valve balloon dilation catheters) approved or in clinical/registration stages - The RF-Lance® radiofrequency puncture device and RF-Lance® disposable radiofrequency atrial septal puncture needle were approved for market