心通医疗(02160) - 2025 - 中期业绩

Company Overview Financial Summary and Performance Highlights MicroPort CardioFlow Medtech reported H1 2025 unaudited interim results, with revenue up 2.7% to RMB 229.1 million and net loss significantly narrowed to RMB 2.2 million, driven by global commercialization and operational efficiency Financial Summary for the Six Months Ended June 30, 2025 | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 229,103 RMB thousand | 223,138 RMB thousand | +2.7% | | Gross Profit | 160,922 RMB thousand | 158,224 RMB thousand | +1.7% | | Profit/(Loss) from Operations | 3,817 RMB thousand | (28,480) RMB thousand | 扭虧為盈 | | Loss for the Period | (2,197) RMB thousand | (57,753) RMB thousand | 虧損大幅收窄 | | Loss per Share (RMB cents) | (0.09) RMB cents | (2.40) RMB cents | 虧損大幅收窄 | - Overseas revenue rapidly grew by 235.3%, primarily driven by the global commercialization of VitaFlow Liberty® and Alwide® Plus[5] - AnchorMan® Left Atrial Appendage Occluder System and delivery system steadily advanced commercialization in China, with new revenue contributions from Europe[5] - Net loss significantly reduced, primarily due to revenue and gross profit growth, improved operational efficiency, and gain on deemed disposal of equity interest after associate 4C Medical's Series D financing[5] Operating Review and Business Development Industry Overview In H1 2025, China's structural heart disease sector saw TAVI and LAAO procedure growth amid innovation, but faces challenges from competition and centralized procurement - New TAVI products launched, with academic exchanges, patient education, and procedure promotion jointly boosting efforts, driving steady growth in surgical penetration and industry scale[6] - Left atrial appendage occlusion achieved breakthroughs in technological innovation and domestic substitution, leveraging the 'catheter ablation + left atrial appendage occlusion' one-stop surgery promotion, leading to rapid growth in surgical volume[6] - The industry faces challenges from intensified competition leading to price adjustments and centralized volume-based procurement policies[6] Product Pipeline The company has 7 approved products in TAVI and LAAO, with various TAVI, TMV, TTV, LAAO, and VSR products in development, holding exclusive China commercialization rights for 4C Medical's TMV/TTV - As of the announcement date, the company's self-developed product portfolio includes 7 approved products: VitaFlow®, VitaFlow Liberty®, VitaFlow Liberty® Flex, Alwide® Plus, AccuSniperTM, AnchorMan® Left Atrial Appendage Occluder System, and AnchorMan® Left Atrial Appendage Delivery System[11] - The company collaborates with 4C Medical to develop TMV and TTV products, holding exclusive commercialization rights for these products in China[11] Approved Products The company has multiple TAVI products (VitaFlow®, VitaFlow Liberty®, VitaFlow Liberty® Flex) and accessory products (Alwide® Plus), plus the AnchorMan® LAAO system, with NMPA/CE certifications and global commercialization - VitaFlow Liberty® newly obtained registration approvals in Kazakhstan, Latvia, Sweden, Ecuador, and Brazil, accumulating approvals in 22 countries/regions[9] - AnchorMan® Left Atrial Appendage Occluder System obtained CE approval, becoming the only left atrial appendage occluder system to date with both CE-MDR and NMPA dual certifications[9] - Alwide® Plus obtained CE mark in August 2025, accumulating registration approvals in 14 countries or regions[9] VitaFlow® VitaFlow®, the company's first-gen TAVI product, approved by NMPA in 2019, shows excellent 5-year and 8-year safety and efficacy, outperforming other Chinese TAVI products - VitaFlow® was approved by NMPA in July 2019 and commercialized in China in August[14] - 5-year follow-up results released in July 2022 showed 18.2% all-cause mortality and 2.1% severe stroke event incidence[14] - 8-year follow-up results released in 2024 showed 39.1% all-cause mortality and 20.6% cardiac mortality, outperforming other TAVI products in China[14] VitaFlow Liberty® VitaFlow Liberty®, the second-gen TAVI product, features a unique retrievable delivery system, won design awards, and is NMPA/CE approved, registered in 20 overseas countries - VitaFlow Liberty® is a second-generation TAVI product with a retrievable delivery system, allowing up to three retrievals to improve surgical success rates[16] - The product won the German Red Dot Product Design Award and the Italian A'Design Award[16] - Approved by NMPA in August 2021, CE certified in April 2024, and registered in 20 overseas countries/regions[16] VitaFlow Liberty® Flex VitaFlow Liberty® Flex, the third-gen TAVI product, NMPA approved in Dec 2024, is the world's only true coaxial steerable self-expanding aortic valve delivery system, offering precise solutions for complex cases - VitaFlow Liberty® Flex was approved by NMPA in December 2024, becoming the world's only 'true' coaxial steerable self-expanding aortic valve delivery system[17] - Features 3D spatial steering function and Capsule segment steerability, ensuring coaxial valve release and stable, precise implantation[17] - Excellent early exploratory clinical implantation results, with significant improvement in 30-day follow-up indicators, and widespread acclaim for real-world clinical performance[17] Alwide® Plus Alwide® Plus, the second-gen cardiac valve balloon dilatation catheter, compatible with three generations of TAVI products, offers ultra-low compliance and high puncture resistance for safer procedures - Alwide® Plus is a second-generation cardiac valve balloon dilatation catheter, compatible with the company's three generations of TAVI products[18] - Key features include ultra-low compliance, high burst pressure, rapid inflation/deflation, and excellent puncture resistance[18] - Approved by NMPA in August 2021, obtained CE mark in August 2025, and subsequently received registration approvals in 12 overseas countries or regions[18] AnchorMan® Left Atrial Appendage Occluder System AnchorMan® LAAO System is an interventional solution for non-valvular AF stroke prevention, featuring a semi-closed structure for stable anchoring, reduced tissue damage, and improved sealing - AnchorMan® Left Atrial Appendage Occluder System and delivery system is an interventional medical solution for stroke prevention in non-valvular atrial fibrillation[19] - Features 12 '3D folding' units at the tail forming a semi-closed structure with the mesh, addressing the clinical pain point of traditional plug-type occluder sheaths deeply entering the left atrial appendage[19] - The device's distal end is rounded and soft, reducing left atrial appendage tissue damage; the dense nitinol mesh design enhances sealing effect, and offers both push and pull release methods[19] Products Under Development The company is advancing innovative products including fourth-gen TAVI, AR, MR, TR, next-gen LAAO, and the world's first VSR product for post-MI VSP, aiming to expand its portfolio and market leadership - VitaFlow Liberty® Pro is the fourth-generation product in the VitaFlow series, aiming to enhance safety and efficacy, and offer better options in terms of low profile, durability, and hemodynamics[20] - VitaFlow® SELFValveTM is a TMVR product for MR patients, with dozens of human implantations and up to two-year postoperative follow-ups completed, and human application and validation are being advanced in multiple centers[23] - VitaManTM is the world's first and only ventricular septal reconstruction product designed for post-myocardial infarction ventricular septal perforation, aiming to fill market gaps and enhance brand influence[27] VitaFlow Liberty® Pro VitaFlow Liberty® Pro, the fourth-gen VitaFlow product, is in R&D, aiming for enhanced safety, efficacy, low profile, durability, and hemodynamics - VitaFlow Liberty® Pro is the VitaFlow series fourth-generation product, currently in the R&D and design phase[20] - The product will continue technical features such as steerability and strong support, and continuously strive for improvements in safety