Shanghai, China, 31 March 2022 - MicroPort Scientific Corporation (hereafter referred to as “MicroPort®” or the “Group”) today announced the annual results of the Company and its subsidiaries for the twelve months ended December 31, 2021 (hereafter referred to as the "Reporting Period").
The Group recorded revenue of US$778.6 million in 2021, representing an increase of 15.0% as compared to 2020. Particularly, the revenue in South America, EMEA (Europe, Middle East and Africa) and North America recorded growth of 29.9%, 16.8% and 6.7% as compared to last year, respectively. Benefited from rapid market penetration and new product launches, the Heart Valve Business, the Neurovascular Devices Business and the Endovascular and Peripheral Vascular Devices Business continued to maintain rapid growth with revenue growth of 93.2%, 72.5% and 45.6%, respectively.
Cardiovascular Business Becomes Top 2 Globally & Orthopedics and CRM Business Achieves Steady Growth
In Cardiovascular Devices Business, the global sales volume of the Group’s coronary stents amounted to 1.22 million units, representing an increase of 132.0% as compared to last year, with market share ranking the world’s top two and Chinese top one in terms of sales volume.
In the overseas markets, the segment recorded an increase in revenue of 34.5% as compared to last year. In particular, the revenue in the EMEA and South America recorded year-on-year growth of 136.3% and 17.8%, respectively. In the Indian market, the Group has successfully launched Firehawk IN™ as its first locally manufactured coronary stent in overseas market, and realized the first batch of commercial sales. In the United States, the Group established headquarters for the Americas and commenced the construction of Southern California Innovation Center and Intelligent Manufacturing Base.
After obtaining the registration certificate from the National Medical Products Administration (NMPA) for our medical digital subtraction angiography (DSA) system, a jointly developed China-made product with Siemens Medical, the Group strategically acquired the controlling interest of Suzhou Argus Medical Technology Corp., Ltd, and shall take advantage of the existing mature sales channels, services and clinical resources to promote the application of its OCT products and imaging technology in the global market.
As for the Orthopedics Devices Business, despite the challenges brought by the complicated development of COVID-19, the international business still achieved a year-on-year revenue growth of 11.8%, and loss reduced sharply by 57.3%. Our revenue in the United States, EMEA and Japan increased by 27.6%, 6.7% and 6.7% as compared to last year. In the PRC market, the Group’s hip and knee joint products won the bids in the national volume-based procurement (VBP). Our trauma products won the bids in the VBP of a twelve-provincial league, achieving a great breakthrough in the expansion of sales channels. During the Reporting Period, the revenue of spine and trauma business recorded a significant increase of 47.4% as compared to last year.
During the Reporting Period, the CRM Business recorded a revenue of US$220.4 million, representing an increase of 18.8% as compared to last year, among which the international (non-China) CRM Business realized an increase of 17.2% in revenue. Particularly, the Group has achieved a substantial year-on-year revenue growth of 127.2% in Japan, a high-margin market with direct-sales model, and a year-on-year revenue growth of 13.3% in EMEA. During the Reporting Period, the CRM Business in the PRC recorded a revenue of US$13.6 million, representing an increase of 53.7% as compared to last year. Our made-in-China pacemakers have completed over 10,000 implantations accumulatively, further strengthening its leading position with the largest market share among all the domestic players.
Established Business Segments Experiences Rapid Growth
The Endovascular and Peripheral Vascular Devices Business achieved a revenue of US$106.0 million during the Reporting Period, representing an increase of 45.6% as compared to last year. In overseas market, the Endovascular and Peripheral Vascular Devices Business achieved a substantial year-on-year revenue increase of over 100%. Our international business has covered 18 overseas markets with the expansion to European, South African and other Asia-Pacific countries and regions.
The Neurovascular Devices Business also recorded a substantial increase of 72.5% in revenue, amounting to US$59.1 million, representing an increase of 72.5% as compared to last year, which continue to maintain good profitability. As to the overseas market, the self-developed NUMEN® Coil Embolisation System of the Group was approved by the Ministry of Food and Drug Safety (MFDS) in South Korea and the United States Food and Drug Administration (FDA) respectively after obtaining the CE Marking. Multiple clinical implantations for NUMEN® Coil Embolisation System were successfully completed in Chile, marking the overseas commercialisation for this business segment.
The Heart Valve Business recorded a year-on-year growth of 93.2% in revenue, with a substantial rise of 15 percentage points in gross profit margin to 59.1%. The VitaFlow® Transcatheter Aortic Valve System completed the first overseas commercial implantation in Argentina. The second generation TAVI product VitaFlow Liberty™ was approved for launching to the market in the PRC and Argentina, and submitted for CE Marking in the European Union, creating new momentum for the growth of this business segment.
Regarding the Surgical Robot Business segment, one of the flagship products, Toumai® Laparoscopic Surgical Robot, was approved for marketing, being the first four-arm laparoscopic robot approved for marketing developed by a Chinese company. Another flagship product, the Honghu Orthopedic Surgical Robot has submitted the registration application to the NMPA and FDA respectively. In addition, the jointly-developed R-ONE™ Panvascular Surgical Robot and the Mona Lisa Percutaneous Surgical Robot have both entered the registrational clinical trial stage.
During the Reporting Period, the Surgical Devices Business recorded a revenue growth of 11.6% as compared to last year. The self-developed VitaSprings™ Spiral Diversion Integrated Membrane Oxygenator was admitted in the Innovative Medical Device Special Review and Approval Procedure (Green Path) of the NMPA.
Emerging Business Segments Spring Up
While its established business segments are showing rapid growth, MicroPort® is also actively exploring emerging business fields such as the non-vascular intervention, endocrinology, rehabilitation treatment, sports medicine, assisted reproduction, in vitro diagnostics (IVD), skin and body management, otolaryngology, ophthalmology and stomatology as well as disinfection and sterilisation.
In the field of non-vascular intervention, the single-use flexible ureteropelvic electronic endoscopic catheter of MicroPort® was approved in early 2022, marking the strategic breakthrough in the field of endoscopic solutions. Meanwhile, another self-developed product, prostatic lift system, was newly admitted in the NMPA Green Path.
Besides, in the field of endocrinology, the first chemotherapy injection pump, AutoEx®, was approved for marketing by the NMPA in early 2022.
For rehabilitation treatment, MicroPort® actively deploys the fields of musculoskeletal rehabilitation, cardiopulmonary rehabilitation and neurological rehabilitation, owning a total of six approved products, multiple commercialised product lines and over 100 technical patents. During the Reporting Period, the TherMotion® Cryo-Thermo Compression Device obtained the registration certificate, being its first active device approved for marketing.
As for sports medicine, Archimedes®, the world’s first long-term implantable balloon rotator cuff system self-developed by an associated company, successfully performed the clinical implantation surgeries and commenced clinical trials in seven large sports medicine centers in the PRC.
In the field of assisted reproduction, the associated company’s self-developed Orkid® Intrauterine Insemination Catheter and two Daylily® ovum aspiration needles were approved for commercialisation in the PRC, and the Daylily® Embryo Transfer Catheter and the Lotus™ Ovum Aspiration Needle were approved for commercialistion in Thailand.
In the field of IVD, the self-developed real-time PCR test of MicroPort®, SARS-CoV-2 Nucleic Acid Test Kit received the CE Marking.
Research and Development Gains Fruitful Results
Since the beginning of 2021 to date, MicroPort® and associated companies have 22 products obtaining the registration certificates from the NMPA, and 5 products admitted in the Green Path and the Group had a total of 26 products being approved to enter the Green Path, ranking the first in the medical device industry for seven consecutive years. As for the overseas market, the Group also obtained the registration certificates from the United States FDA for 7 products and the CE Markings for 15 products.
In the future, MicroPort® aims to solve the medical difficulties in clinical practice through the breakthrough of advanced technology by leveraging on the efficiency and synergies from group operation, and is committed to building a complete business portfolio from disease prevention and diagnosis to treatment and rehabilitation, which covers the entire life cycle of human beings.
(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 31, 2022 for the data before excluding the foreign exchange impact.)