Shanghai, China - MicroPort Scientific Corporation (hereafter referred to as the "Company" or “Microport®", stock code: 00853) announced on March 30 the annual results of the Company and its subsidiaries (hereafter referred to as the "Group") for the 12 months ended December 31, 2020 (hereafter referred to as the "Report Period"). In 2020, in the face of the unexpected COVID-19 pandemic, the Group maximized the allocation of its global resources and carried out its production and marketing activities in an orderly manner while actively exercising its corporate social responsibility. Although the COVID-19 pandemic has taken a heavy toll on overseas markets, the Group has managed to establish a diversified product pipeline in each business segment by accelerating the recovery of its domestic business, focusing on R&D, as well as continuously expanding the Group's business footprint, incubating new growth drivers and strengthening its overall competitiveness.
As of 31 December 2020, the Group recorded a revenue of US$648.7 million, and a gross profit margin of 67.2% (loss attributable to equity shareholders of the Group: US$191.3 million). In 2020, the Group was assessed by the capital market in terms of value. The Group and its associated companies introduced external financing approximately US$1 billion accumulatively, and recognized widely by the capital market. Through the sufficient cash brought by financing, further improve the soundness of the financial statements, and the group continues to invest in R & D, so as to burst out a steady stream of innovation vitality.
In 2020, the Group's cardiovascular devices business brought in a revenue of US$144.8 million. For the year ended 31 December 2020, the Group focused on market penetration in China, especially increased the hospital access in the county market, with the Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®") saw its hospital coverage grow by 27% year-on-year and the Firebird2™ Rapamycin-Eluting CoCr Coronary Stent System ("Firebird2®") by 14% year-on-year. In 2020, the PRC instituted centralized volume-based procurement for coronary stents, and the Group's self-developed Firebird2™ stent and the Firekingfisher® Rapamycin-Eluting CoCr Coronary Stent System ("Firekingfisher®"), which obtained its certification during the year, were both shortlisted, making the Group the only domestic company with two shortlisted products. These products also rank first in terms of intentional purchase volume, which will cement group’s coronary artery products position in the PRC market. In overseas markets, although the revenue from stents has been affected by the COVID-19), but sales in Europe continued to grow steadily. The Group strengthened its efforts to access global markets during the reporting period, with drug-eluting stents obtained 14 first registration certificates in 10 countries or regions, being launched in 30 countries and regions within the year, and the Firehawk® stent was included in the health insurance directories in 9 countries including France, Belgium and Spain, etc. the Group has officially launched the TARGET IV NA clinical study of the Firehawk® stent in the USA and completed its first subject enrollment, representing a critical milestone in the product’s overseas mainstream market expansion, laying the foundation for the approval of Firehawk® in the United States, Canada and Japan. In addition, the Group's balloon product business kept steady growth and registered a revenue of US$10.6 million globally.
At EuroPCR 2020, the Company released the latest three-year follow-up data for the TARGET All Comers (TARGET AC) clinical trial and two-year data for the Dual-Antiplatelet Therapy (DAPT) subgroup for its Firehawk® stent. The large body of medical evidence proved that Firehawk® can achieve identical clinical efficacy and safety with Xience, the first-in-class drug eluting stent with the most extensive clinical data. The over one-year target lesion revascularisation failure (TLF) rates were lower and similar in both groups, and the stent thrombosis rates in the real-world population study were lower in the Firehawk® group. Two-year data for the DAPT subgroup of the TARGET AC study showed that the TLF rate in the DAPT interrupted treatment subgroup in the Firehawk® group showed a lower trend than the Xience group. The results of the study were published online in EuroIntervention, an international medical journal. Firesorb® Bioresorbable Rapamycin Target Eluting Coronary Stent System ("Firesorb®") has also kicked off the FUTURE-III clinical trial and has completed its first subject enrollment.
In 2020, the Group's orthopedics devices business achieved global sales of US$201.6 million. The orthopedics devices business in China recorded a revenue of US$29.9 million, representing an increase of 10.1% over the previous year (excluding the impact of foreign exchange), mainly due to a surge in domestic joint implants, which grew by 93.3% (excluding the impact of foreign exchange). In addition, the orthopedic devices business raised approximately RMB580 million in the first half of 2020 and a number of well-known investors were brought in, providing the necessary financial support for new product development and market expansion and helping the orthopedic business enter a new phase of rapid development.
In 2020, the Group's cardiac rhythm management (CRM) business achieved a revenue of US$180.3 million The CRM business in China recorded a revenue of US$8.1 million, a year-on-year increase of 1.8% excluding the foreign exchange impact compared with the previous year. During the reporting period, wider recognition of Chinese pacemaker’s brand name, the Group’s pacemakers saw their sales increase by 24.7% during the year and have entered 480 hospitals by the end of 2020. During the reporting period, all R & D projects have been carried out orderly and achieved outstanding results, which is a step forward to the goal of building a global leading all-round solution for cardiac rhythm management. In addition, the CRM business raised US$75 million in July 2020, which will help accelerate the development and clinical applications of world-class CRM products, and also create more growth drivers for this business segment.
In 2020, the Group's endovascular and peripheral vascular devices business maintained excellent growth momentum and recorded a revenue of US$68.5 million, up 40.9% over the previous year (excluding the impact of foreign exchange). In particular, the Castor® Branched Aortic Stent-Graft System ("Castor®") sustained rapid growth during the year and has been applied by more than 550 hospitals in China. In the international market, the Minos® Abdominal Aortic Aneurysm and Delivery System ("Minos®") has entered the market of nine overseas countries. Castor® completed its first implantation in Poland and entered its first overseas market.
In 2020, the neurovascular devices business recorded a revenue of $32.9 million, representing a 17.5% growth over the previous year (excluding the impact of foreign exchange). The Tubridge® vascular reconstruction device expanded its clinical applications, the Numen® Coil Embolization System, the Bridge® Rapamycin Target Eluting Vertebral Artery Stent System and the U-track® Intracranial Support Catheter System, all of which obtained certification during the year, have also contributed to the segment’s growth momentum and laid a solid foundation for a comprehensive solution for cerebral stroke. The Group has obtained six registration certificates in four overseas countries during 2020, accelerated its global business expansion.
In 2020, the Group's heart valve business recorded a revenue of US$15.2 million, representing a year-on-year growth of 383.4% (excluding the impact of foreign exchange). In the two years since its launch, the VitaFlow® Valve System has given excellent clinical performance and has been well received by industry experts. During the year, the Group has also applied to the National Medical Products Administration ("NMPA") for the registration of the VitaFlow® II Transcatheter Aortic Valve and Retrieval System ("VitaFlow® II"), the second-generation TAVI product. During 2020, VitaFlow® obtained registration certificates in Argentina and Thailand respectively. At the same time, VitaFlow® II has commenced clinical trial in Europe, becoming the only made-in-China TAVI product to do so. In addition, MicroPort CardioFlow Medtech Corporation was successfully listed on the Main Board of the Hong Kong Stock Exchange on 4 February 2021 (stock code: 02160), becoming the second listed subsidiary of the Group. The listing will provide financial support for its market expansion, capacity expansion and continuous R&D of its product lines.
In surgical robot field, the Group’s products under development and products of international cooperation have complete coverage of the five major "golden tracks" of lumpectomy, orthopedics, vascular intervention, natural cavity and robot for percutaneous intervention in the surgery robot business. The Skywalker™ Orthopedic Robot completed its 100th surgery in multi-centre clinical trials before launch in January 2021, and became China’s first surgery robot completing total knee replacement in multi-centre clinical trials before launch. Moreover, the Group's Toumai® Laparoscopic Surgical Robot also completed registration for clinical testing in January 2021, becoming the first self-developed laparoscopic surgical robot to complete registration for multi-centre clinical trials in the field of urology. During reporting period, the Group tapped into the fields of surgery robots by investing in Robocath (a French vascular interventional robotics company), NDR (a Singaporean percutaneous puncture robot company) and Biobot (a Singaporean prostate puncture robot company).
In 2020, the Group obtained registration certificates for 30 of its products from the NMPA. For the cardiovascular devices business, the Firekingfisher® Rapamycin-Eluting CoCr Coronary Stent System, a delivery system upgrade based on Firebird2®, obtained certification during the year. For the orthopedics devices business’s joint segment, the made-in-China Goral® Total Hip Arthroplasty System and the Bipolar Easy® Partial Hip Replacement System obtained registration certificates and entered the market during the year, marking the completion of the Chinese orthopedic devices business's initial joint replacement product line. In the endovascular devices business, the self-developed Reewarm® PTX Drug Balloon Dilation Catheter obtained NMPA registration certificate and entered the market. In the neurovascular devices business, the Bridge® Rapamycin Target Eluting Vertebral Artery Stent System, the Numen® Coil Embolization System and the U-track® Intracranial Support Catheter System were all launched in China. In terms of Green Path, two products of the Group were granted the Green Path status in 2020, they are the Tigertriever® clot retriever (“Tigertriever®”) of Rapid Medical, which is invested by the Group, and the Group’s self-developed Skywalker™.
Overseas, the Group has 4 products obtained FDA approval and 14 products obtained CE certification. For the orthopedics devices business, the Profemur® cementless monolithic HA-coated collared Gladiator® femoral hip stem and Profemur® cemented monolithic collared Gladiator® femoral hip stem were approved by the FDA in the US. The Procotyl® P Acetabular Cup System and the new-generation Evolution® NitrX™ Medial Pivot Knee for patients with allergies to certain metallic ions all obtained the EU CE certification, adding to our existing product portfolio. In the CRM business, the new-generation Alizea™, Borea™ and Celea™ pacemakers equipped with Bluetooth and SmartView Connect™ wireless remote monitor, have all submitted registration applications in Europe, the U.S. and Japan in 2020 and obtained CE certification approval in January 2021, speeding up the process of commercialization. The Astral-4LV clinical trial for the Axone™ pacing lead used in cardiac resynchronization therapy (CRT) was officially launched during the year and the first implantation has been completed, making the Axone™ pacing lead a major breakthrough in the application of cardiac resynchronization therapy for heart failure patients. In addition, the Reewarm® PTX Drug Balloon Dilation Catheter and Hercules® Aneurysm and Delivery Systems have obtained the EU CE certification, further strengthening our endovascular product lines in overseas markets.
”Dr. Zhaohua Chang, Chairman and CEO of MicroPort®, said, "the COVID-19 pandemic in 2020 has been a tremendous shock and test for the entire world, especially for the healthcare industry, but it has also presented to us the opportunities and prospects for growth, and we are acutely aware of the important mission we have been entrusted with. With our concerted efforts to fight against the pandemic and overcome the difficulties, the performance of all regions around the world has started to recover. In the 'post-COVID era' where pandemic prevention and control becomes normal, MicroPort®, as a leading innovative high-end medical device conglomerate, will fulfill its mission and social responsibility by actively developing diversified product lines and integrated solutions through continuous innovation, and deepening its localization-based global operation strategy to bring the Group's medical solutions to more countries and regions for the benefit of patients worldwide."