Shenzhen, March 30, 2022/PRNewswire/ -- On March 30, 2022, a leading minimally invasive cardiovascular and peripheral vascular interventional medical device company -- Xianjian Technology Co., Ltd. (hereinafter referred to as the “Company”) and its subsidiaries (hereinafter referred to as the “Group”) announced the audited comprehensive results for the year ended December 31, 2021 (the “Reporting Period”).
Business performance is growing rapidly, and two-wheel drive is steady and far-reaching
In 2021, under the guidance of “innovation” and “international” two-wheel drive development strategies, Xianjian Technology continued to promote high-quality development, further expanded its international layout, and recorded steady and rapid growth in business performance. During the reporting period, revenue was about RMB 925.3 million, up about 44.1% and about 38.3% respectively from the same period in 2020 and the same period in 2019; achieved gross profit of about RMB 747.5 million, an increase of about 45.7% over the same period last year, and gross margin increased by about 0.9% to about 80.8% over the same period last year. During the period, operating profit increased by about 24.3% year on year to about RMB 328.7 million; net profit attributable to the company's owners increased by about 35.4% year on year to about RMB 292.5 million. Basic earnings per share were around RMB 6.8, an increase of about 36.0% over the same period last year.
Excluding non-recurring items, that is, “other gains and losses arising from financial assets that include profit and loss at fair value” and “share-based payment expenses”, the Group's operating profit during the reporting period was approximately RMB 360.3 million, an increase of about 55.5% over the previous year. Meanwhile, net profit attributable to the company's owners after deduction was approximately RMB 324.0 million, an increase of about 76.8% over the previous year.
Domestic business continues to rise, and overseas markets have regained stability, moderation and improvement
In 2021, we will continue to cultivate the Chinese market, and mainland China will still be our biggest market. Benefiting from the resumption of economic activity in mainland China under the effective control of the epidemic and the continuous increase in the company's product penetration rate, domestic sales increased by about 43.6% over the same period last year, accounting for about 83.6% of the Group's total revenue.
Although the epidemic situation in most overseas markets is still unstable, the Group's sales from overseas markets increased by about 46.4% over the same period last year, thanks to long-term accumulated channel resources and innovative advantages, and effective implementation of marketing strategies.
During the reporting period, the Group joined hands with the world with innovative products, continuously integrated and developed, and continued to expand the international influence of its brands and innovative products. The Group's sales network has covered more than 100 countries and regions around the world and achieved further breakthroughs in the North American market: three innovative products -- the LamBRE™ left ventricular ear blocker system, the IBS Titan™ absorbable drug eluting peripheral stent system, and the IBS Angel™ iron-based absorbable stent system were approved for “sympathetic use” by the US Food and Drug Administration.
The development of the three major business segments is moving forward steadily
1) Structured Heart Disease Business -- Revenue is growing rapidly and differentiated sales are very effective
The Group's structural heart disease business mainly includes third-generation congenital heart disease blockers and left atrial ear blockers. During the reporting period, the Group's structured heart disease business sales revenue increased by about 60.4% over the same period last year to about RMB 331.1 million.
Xianjian Technology is committed to adapting to local conditions in the global market and promoting and selling third-generation congenital heart disease blocker products according to local treatment needs and economic levels. After years of hard work, the differentiated market strategy has further highlighted its advantages. During the reporting period, sales of the third-generation congenital heart disease blocker products HeartR™, Cera™, and CeraFlex™ increased by about 29.6%, 88.2%, and 16.6%, respectively.
The LamBRE™ left ventricular ear blocker system is the only domestic brand that has both the EU CE and the Chinese NMPA marketing license so far. During the reporting period, the Group actively promoted the entry and penetration of this product into the global market, and sales increased by about 83.8% over the same period last year.
2) Peripheral vascular disease business -- China leads market share and maintains steady revenue growth
The Group's main products in the peripheral vascular disease business include thoracic aortic venous stents, abdominal aortic venous stents, iliac artery bifurcation stents, and venous venous filters. During the reporting period, the Group's peripheral vascular disease business recorded sales revenue of approximately RMB548.5 million yuanThis is an increase of about 33.4% over the same period last year. Among them, sales of aortic laminating stents increased by about 38.2% year on year, and sales revenue of venous venous filters increased by about 15.8% over the same period last year.
3) Pacing Electrophysiology Business -- Using Imports to Replace Dongfeng, Development Continues to Accelerate
The core product of the Group's pacing electrophysiology business is the HeartTone™ Xintong series of implantable pacemakers. Cooperating with top international technology and taking advantage of China's import substitution from Dongfeng, the business's development accelerated further during the reporting period, recording sales revenue of around RMB45.7 million yuanThis is an increase of about 85.8% over the same period last year. During the reporting period, the company and Medtronic completed a series of supplementary agreements to further expand the strategic cooperation of the “Xintong” domestic pacemaker project. The two sides aim to cooperate on nuclear magnetic compatible (MRI compatible) pacemaking systems in China, leading domestic pacemakers into a new era of MRI compatible pacemaking.
Consolidate R&D strength Innovation drives development
Xianjian Technology is driven by R&D and innovation as its core driving force. It received the honorary title of a specialized, special and new “Little Giant” enterprise from the Small and Medium Enterprises Bureau of the Ministry of Industry and Information Technology during the reporting period, and was ranked among the top 100 innovative enterprises in Shenzhen. In 2021, the company continued to consolidate its R&D capabilities and continue to promote the research and clinical process of innovative products. The total investment in R&D reached about RMB212.5 millionYuan, accounting for about 23.0% of revenue.
A number of innovative products have been approved for listing
In January 2021, Xianjian Technology pioneered the exclusive G-iliac™ iliac iliac artery bifurcation stent system and the Silverflow™ iliac internal ventricular stent system approved for listing by China's NMPA, filling the gap in reconstructing the internal iliac artery in China and bringing safe and effective treatment methods to the vast majority of patients with abdominal aortic aneurysms combined with iliac aneurysms or common iliac aneurysms.
In April 2021, the LANavi™ segmented bending control guidance system was approved for listing in China. This innovative product is the world's first commercialized left-ventricular segmented dual-adjustable bending guidance system, providing a personalized delivery solution for our left ventricular occlusion. By achieving precise navigation and coaxial blocking during surgery, clinicians' operation is greatly facilitated.
In May 2021, the Xuper™ aortic intra-operative laminal stent system obtained EU CE marketing approval. It is the world's first commercialized multi-branch interstitial stent system, providing a new solution for hybrid surgical treatment of Stanford type A aortic dissection.
In June 2021, IBS Angel™ Iron-based Absorbable Stent System (“IBS Angel™”), the world's only absorbable stent suitable for children, was registered and approved by the Malaysian Medical Devices Authority.
In September 2021, Laxible™, a next-generation left ventricular ear blocker, was approved for marketing in China. It has optimized design and technology based on the unique advantages of first-generation products, further improving safety and effectiveness.
In November 2021, Yuranos™, a next-generation abdominal aortic stent system, was approved for launch in China. The upgraded product design has been optimized so that it can be applied to more complex and challenging tumor anatomy forms in clinical practice.
In addition, the Group's OKCurve™ adjustable bending conveyor system, Freepath™ guidance system and iCable™ pusher also received approval for listing in China during the reporting period.
Innovative research has achieved breakthrough development
During the reporting period, the Group continued to optimize resources to promote the commercialization process of innovative products. Research and clinical development of a number of innovative products were achieved:
- IBS Angel™ has initiated clinical enrollment registration in China during the reporting period and has successfully implanted more than 10 cases;
- The Cinnamon™ Pulmonary Resilience Ring System completed clinical trial enrollment in Europe. Preliminary clinical results were safe and effective, and the one-year follow-up phase has already been completed. Meanwhile, the registered clinical trial of this product in China is being prepared;
- The G-Branch™ thoraco-abdominal aortic laminating stent system has completed the enrollment of all FIM clinical (feasibility clinical) patients. The mid-term follow-up results are excellent. Currently, clinical enrollment of products registered in China is progressing steadily;
- The IBS™ absorbable drug-eluting coronary stent system has obtained implied approval for confirmatory clinical trials in China. The results of a two-year follow-up of the FIM clinical trial initially showed that IBS™ coronary stents have good medium-term safety and efficacy in simple primary coronary disease.
Furthermore, the world's first aortic ventricular stent system (chimney stent solution) independently developed by the Group for “chimney technology” and the country's first G-Branch™ thoracic aortic aortic stent system for total endovenous repair of thoracic and abdominal aortic aneurysms were approved for entry into the national “Special Examination Procedure for Innovative Medical Devices” during the reporting period. So far, the Group has approved a total of 14 products to enter the “green channel” of national innovation, which will greatly optimize the listing and registration path of products in China.
Intellectual property is protected, and the first patent capital shows strength
Intellectual property is an important intangible asset of the Group and an internal driving force for the Group to continuously improve its core competitiveness in the global medical device market. Through continuous intellectual property innovation, application, protection and management, Xianjian Technology has developed leading technological innovation capabilities, a forward-looking patent layout, and a perfect intellectual property protection system. As of December 31, 2021, the Group has submitted a total of 1,529 patent applications, of which 584 patents have been approved. During the reporting period, the Group's invention patent “left ventricular ear blocker” won the 22nd China Patent Gold Award. Among the highest awards in China's intellectual property field, it created the “first gold” invention patent in history in the field of minimally invasive cardiovascular interventional medical devices. At the same time, the Group also received the 8th Guangdong Patent Silver Award for two other patents.
Looking to the future,Mr. Xie Yuehui, Chairman of the Board and CEO of Xianjian Technology, said:
“2021 is a year in which Xianjian Technology achieved breakthrough development. Despite the challenging external environment, we have achieved impressive results in performance growth, R&D innovation, etc. Looking ahead to 2022, we will continue to maintain good momentum, continue to promote the steady and rapid development of our existing business in the global market based on independent innovation and international two-wheel drive development strategies, continuously enhance the global competitiveness of our products, actively seize new development opportunities, further deepen the global layout, and achieve continuous high-quality growth in the company's value.”