Shanghai, China, 29 March 2022 - MicroPort CardioFlow Medtech Corporation (hereafter referred to as the "MicroPort CardioFlow" or the “Group”) today announced the annual results of the Company and its subsidiaries for the 12 months ended December 31, 2021 (hereafter referred to as the "Reporting Period"). In the Reporting Period, MicroPort CardioFlow recorded revenue of RMB200.8 million, representing a year-on-year growth of 93.2%. In addition to the significant growth in revenue, the gross profit margin also improved drastically by 15.4 percentage points to 59.1%.
In 2021, the COVID-19 pandemic continued to spread around the world, but thanks to China’s effective epidemic control measures, most hospitals have basically returned to normal, and transcatheter aortic heart valve implantation (TAVI) still maintains a rapid growth trend in China. By leveraging on unique and outstanding product portfolio, and expanding Total Solutions team to broaden and deepen hospital penetration, and to strengthen the academic education among physicians and patients, MicroPort CardioFlow maintained significant growth in revenue and rapid jump in market share. Meanwhile, MicroPort CardioFlow also accelerates the development of innovative products to enhance the core competitiveness of the Company and actively explore the global market. In addition, through close communication and collaboration with global suppliers based on the concept of win-win cooperation, MicroPort CardioFlow has been reducing our purchase price while maintaining a stable supply of raw materials, which withstood the great challenges of global supply chain brought by the epidemic.
High Growth Profiting Benefits from Market Penetration of TAVI Products
MicroPort CardioFlow achieved high growth in revenue, mainly benefited from the rapid growth in sales volume of the VitaFlow® transcatheter aortic valve implantation and delivery system (VitaFlow®), as well as the rapid market penetration of the VitaFlow Liberty™ transcatheter aortic valve implantation and retrievable delivery system (VitaFlow LibertyTM), since its launching.
VitaFlow Liberty™ obtained the National Medical Products Administration (NMPA) approval for registration in August 2021, it inherits the distinctive valve design of the VitaFlow® with a breakthrough upgraded delivery system, which liberates the surgeon and also enables better surgical results for patients. As of December 31, 2021, there are 308 hospitals in China using VitaFlow® and VitaFlow Liberty™ for TAVI procedures, most of which are Class IIIA Hospitals located at tier-one and tier-two cities. Among these hospitals, we have successfully captured a leading market share in more than 180 hospitals among them.
With respect to the development of overseas markets, since the first oversea implantation in Argentina in August 2021, the Company has obtained the registration of VitaFlow Liberty™ in Argentina in December. Being the only China-developed TAVI product that commenced clinical trial in Europe, we also submitted VitaFlow Liberty™ for CE Mark registration, which marks another solid step in the international expansion of MicroPort CardioFlow. In the future, with the advancement of overseas clinical registration of products, leveraging on the global visibility of the MicroPort® brand and the oversea sales network of the MicroPort® Group, we will continue to extend our overseas business footprints and further propel our progress towards globalization to provide worldwide physicians and patients with trustworthy and universal products portfolio.
Continuous R&D Innovation Advances Product Portfolio
As for the development of new products, our in-house developed product portfolio consists of three TAVI pipeline products —third-generation self-expanding TAVI product with adjustable bending function, new generation TAVI product with unprecedented revolutionary technology of new deployment and full retrieval, and another balloon expandable TAVI product. MicroPort CardioFlow is also strategically positioned in the transcatheter mitral valve (TMV) market with five TMV products, among which, our in-house developed TMV replacement product is advancing in-human clinical trials.
To further expand our products portfolio, MicroPort CardioFlow invested in 4C Medical Technologies and Valcare Medical Ltd. and collaborates with them on TMV repair, TMV innovative replacement and transcatheter tricuspid valve pipeline products. In addition, MicroPort CardioFlow is also developing on surgical valve products and a variety of procedural accessories. Among them, 4 procedural accessories are already launched, including Alwide® Plus balloon catheter approved by NMPA in July 2021 and approved in Argentina in March 2022, and our first-generation tip-preshaped super stiff guidewire Angelguide® approved together with VitaFlow Liberty™ in August 2021. Though efficient and innovative in-house development and active and close collaboration with global partners, MicroPort CardioFlow continuously expands products portfolio to develop a more comprehensive and diversified product strategy to provide patients suffering from structural heart diseases with trustworthy and universal access to state-of-the-art total solutions.
In July 2021, by virtue of our continuous innovative R&D competence in structural heart diseases, MicroPort CardioFlow was successfully named as one of the third batch of national “Little Giant” enterprises with the features of specialisation, refinement, uniqueness and innovation. In August 2021,MicroPort CardioFlow was honored as Shanghai 1st Quality Award by Shanghai Administration for Market Regulation and Shanghai Municipal Commission of Economy and Informatization, which indicates that the product quality as well as the leading technology and industry position of the Company have been widely recognized by the society. In March 2022, VitaFlow Liberty™ won the 2022 German Red Dot Design Award: Product Design, which proves the innovation capabilities of MicroPort CardioFlow has been recognized worldwide and also establishes important milestones in our globalization development path.
With respect to production and operation, the Company rapidly expands the production capacity and advances the automated production and smart manufacturing strategies to meet the growing demand of products supply and to lay a solid foundation for cost reduction and efficiency enhancement. By far, we have two manufacturing facilities in Shanghai in compliance with the GMP standard and the new manufacturing facility in Shanghai with a total GFA of approximately 13,000 sq.m is expected to construct commence production in 2022.
Mr. Guoming Chen, the president and executive director of the Group, commented, “In 2021, MicroPort CardioFlow achieved continuous high growth in revenue and rapid increase in market share benefitting from excellent products portfolio. With years of R&D experience and technological foundation, MicroPort CardioFlow has built an integrated platform focusing on the R&D, clinical, manufacturing and commercialization of medical devices for structural heart diseases. In the future, MicroPort CardioFlow will continue to maintain the core competitiveness of products, actively expand sales and marketing network, strive forward to become the leader of total solutions for structural heart diseases.”
“The interventional treatment of structural heart diseases in China is still in rapid growth period, there is a large advancement to further expand market penetration and improve innovative technology. In the future, MicroPort CardioFlow will make greater breakthrough in market share and product innovation and provide global patients with trustworthy and universal access to state-of-the-art total solutions to treat structural heart diseases.” said Dr. Luo Qiyi, the chief technology officer of MicroPort®, the non-executive Director and chairman of the Group.
(All the revenue growth rates mentioned above are compared to the corresponding period of last year, and also adjusted to exclude the foreign exchange impact. Please refer to the 2021 Annual Results Announcement issued by the Company on March 29, 2022 for the data before excluding the foreign exchange impact.)