Company code: Apt Medical Inc(688617) company abbreviation: Apt Medical Inc(688617) Apt Medical Inc(688617)
Summary of annual report 2021
Section I important tips
1 the summary of this annual report comes from the full text of the annual report. In order to fully understand the company’s operating results, financial status and future development plan, investors should go to www.sse.com com. cn. The website carefully reads the full text of the annual report. 2 major risk tips
The company has elaborated various risks and countermeasures that the company may face in the process of operation in this report. Please refer to the relevant contents in “IV. risk factors” of “section III Management Discussion and analysis” of this report. 3 the board of directors, the board of supervisors and the directors, supervisors and senior managers of the company guarantee the authenticity, accuracy and completeness of the contents of the annual report, and there are no false records, misleading statements or major omissions, and bear individual and joint legal liabilities. 4. All directors of the company attended the board meeting. 5 Lixin Certified Public Accountants (special general partnership) issued a standard unqualified audit report for the company. 6. The company is not profitable and has not yet achieved profitability when it is listed □ yes √ No 7. The profit distribution plan or the plan for the conversion of provident fund into share capital in the reporting period adopted by the resolution of the board of directors
The company plans to distribute a cash dividend of RMB 10.00 (tax included) for every 10 shares to all shareholders based on the total share capital on the registration date of dividends and dividends in 2021. The total amount of cash distributed is expected to be RMB 6667000000 (tax included), accounting for 32.07% of the net profit attributable to shareholders of Listed Companies in the consolidated statements of the company in 2021; The company does not convert the capital reserve into share capital and does not give bonus shares. The amount of cash dividends in the above profit distribution plan for 2021 is temporarily calculated based on the current total share capital of the company of 66.67 million shares, and the total amount of cash dividends actually distributed will be calculated based on the total share capital on the registration date of dividends and dividends in 2021. 8. Whether there are important matters such as special arrangements for corporate governance □ applicable √ not applicable
Section II basic information of the company
1 company profile company stock profile √ applicable □ not applicable
Company stock profile
Stock type stock exchange and sector stock abbreviation stock abbreviation before stock code change
A-share Shanghai Stock Exchange Kechuang board Apt Medical Inc(688617) Apt Medical Inc(688617) not applicable
Profile of the company’s depositary receipts □ applicable √ not applicable contact person and contact information
Contact person and contact information secretary of the board of directors (domestic representative of information disclosure) securities affairs representative
Name: Dai Zhenhua, Chen Ranran
Songpingshan community, Xili street, Nanshan District, Shenzhen office address, songpingshan community, Xili street, Nanshan District, Shenzhen 601, building B, Tongfang information port, No. 11, Langshan Road, songpingshan
Tel: 075586951506
E-mail [email protected]. [email protected].
2. Introduction to the company’s main business in the reporting period (I) main business, main products or services
1. Main business of the company
The company is a high-tech enterprise focusing on the R & D, production and sales of electrophysiological and interventional medical devices. It has formed a business layout dominated by complete coronary artery access and electrophysiological medical devices and focusing on peripheral vascular and nerve interventional medical devices. The company is one of the enterprises with complete varieties and categories of domestic electrophysiological and vascular interventional medical devices, leading scale and strong market competitiveness. It is also one of the few enterprises that can form strong competition with foreign products.
2. Main products
The listed products of the company include electrophysiology, coronary access and peripheral vascular interventional medical devices. As of December 31, 2021, the company and its subsidiaries have obtained 43 Chinese medical device registration and filing certificates, including 39 class III medical device registration certificates, 2 class II medical device registration certificates and 2 class I medical device filing certificates. The basic information of the company’s listed products is as follows:
(1) Electrophysiological products
Electrophysiological products are used in catheter ablation surgery (also known as “electrophysiological surgery”), which is divided into electrophysiological consumables and electrophysiological equipment. The purpose of electrophysiological surgery is to diagnose and treat arrhythmia. It is to puncture femoral vein, internal jugular vein or subclavian vein, deliver electrode catheter to specific parts of cardiac cavity, first check and locate the abnormal position causing tachycardia, and then conduct local radiofrequency ablation there, To achieve the interventional diagnosis and treatment technology of blocking the abnormal conduction path or origin point of cardiac electrical signal.
The company’s electrophysiological products include electrophysiological electrode catheter, controllable radiofrequency ablation electrode catheter, three-dimensional cardiac electrophysiological mapping system and other electrophysiological products. Both electrophysiological electrode catheter and controllable radiofrequency ablation catheter are the first domestic products with registration certificate in China, and are recognized as national key new products by the Ministry of science and technology It is recognized as an independent innovative product of Shenzhen by Shenzhen Science, industry, trade and Information Technology Commission. Controllable radiofrequency ablation catheter was recognized as a high-tech product by the Department of science and technology of Guangdong Province. The company’s floating temporary pacing electrode catheter was approved for listing in May 2020, becoming the first domestic product with registration certificate in this category in China.
In January 2021, the company obtained the Chinese registration certificate of three-dimensional cardiac electrophysiological mapping system and magnetic positioning cold saline perfusion radiofrequency ablation electrode catheter at the same time. The company’s three-dimensional cardiac electrophysiological mapping system not only adopts the international advanced magnetoelectric fusion positioning method in system positioning technology, but also has the high integration characteristics of three machines in one. It innovatively integrates the three-dimensional mapping system, multi-channel recorder and stimulator into an integrated platform, which greatly improves the operation efficiency, The development of cardiac electrophysiological mapping system has been pushed to a new height. (2) Coronary access products
The medical devices used in coronary intervention mainly include coronary stent products and coronary access products. The company has built a complete coronary access product line, which is mainly used for PCI. PCI refers to the treatment method of dredging the narrow or even occluded coronary lumen through cardiac catheterization technology, so as to improve the blood perfusion of myocardium, including four important steps: radial / femoral artery puncture, coronary angiography, pathway establishment and stent implantation. The company’s coronary pathway product line can meet the clinical needs of the first three important steps of PCI.
The following figure shows the specific application of the company’s products in PCI:
The company’s coronary artery access products mainly include guide wire, microcatheter, balloon, angiography guide wire and catheter, among which the coronary artery guide extension catheter and thin-walled sheath (vascular sheath group) are domestic exclusive products, and the microcatheter (coronary artery application) and adjustable valve catheter sheath (catheter sheath group) are the first domestic similar products with registration certificate in China. In addition, the anchored balloon dilatation catheter is the first Innovation Medical Management Co.Ltd(002173) instrument in China that uses balloon anchoring for catheter exchange, which is used for interventional treatment of coronary artery stenosis caused by coronary atherosclerosis and other diseases.
(3) Peripheral vascular interventional products
Stenosis, occlusion or tumor like dilation disease. The working principle of peripheral vascular interventional products is similar to that of coronary artery access products. The bending shape and length of products are slightly different because they are used for blood vessels in different body parts.
Through the successful industrialization of coronary access products, the company has established a mature and complete industrialization platform of vascular interventional devices, and officially launched peripheral vascular interventional products in 2019. The company’s peripheral intervention is mainly divided into two directions: tumor embolization therapy and peripheral vascular therapy. Its products mainly include microcatheter, microcatheter, catheter sheath group, contrast catheter, contrast wire, guide catheter, lower limb working guide wire, snare device, guide sheath, etc. among them, the peripheral adjustable valve catheter sheath (catheter sheath group) is the only domestic product approved for listing in China. (4) OEM business
Since the establishment of the company, in order to broaden the sales source, the company has made full use of its own R & D advantages and the core production process of interventional medical devices, undertaken OEM business in China and abroad, and provided services such as batch processing, product customization and entrusted project development. The products mainly include all kinds of vascular / non vascular delivery systems, catheters, guide wires and nitinol products. （2） Main business model
1. Procurement mode
The production or R & D Department of the company puts forward the demand plan, and the procurement department formulates the corresponding procurement plan according to the inventory situation. The purchasing department selects the corresponding suppliers to place orders and sign the purchase contract according to the purchase application form.
2. Production mode
The company’s production mode is a market-oriented and customer demand-based production mode, which is divided into self-made production and OEM. The company has three production bases, among which Hunan eput is responsible for the production of coronary artery access products and peripheral vascular intervention products, huitai Guanlan branch is responsible for the production of electrophysiological consumables, and Shanghai Hongtong is responsible for the production of electrophysiological equipment.
For products with fixed demand in the market, the marketing department shall organize relevant departments to hold a contract review meeting at the end of each month to determine the production plan of the next month according to the prediction of market sales, combined with the inventory of the corresponding warehouse, the production capacity of the workshop and the production situation of the previous month. For OEM products processed for customers, the marketing department first evaluates the development value of the company’s internal capacity and customized products according to the drawings, specifications, quality requirements and inspection standards provided by customers. After that, the R & D, production and other relevant departments will evaluate the feasibility of product design and process. After passing the internal evaluation, the company will sign contracts and delivery specifications with customers and formulate corresponding production plans.
3. Sales model
The company’s domestic sales are dominated by distribution mode, supplemented by direct sales and distribution mode, and the distribution mode is implemented in individual regions. The company’s overseas sales are sold through the distribution mode.
(1) Distribution mode
Under the distribution mode, the company’s dealers implement buyout sales, that is, after the company sells products to the dealers, the ownership and risk of goods will be transferred to the dealers.
(2) Direct selling mode
Under the direct selling mode, the company directly sells the products to the hospital and authorizes the third-party agent service provider to carry out sales related services, such as logistics service in the hospital, technical follow-up service, payment follow-up, etc. In the direct selling mode, the settlement period between the company and the hospital is longer than that in the distribution mode.
(3) Distribution mode
Under the distribution mode, the company sends the products to the “distribution platform” enterprise designated by the terminal hospital, and then the distribution platform enterprise distributes the company’s products to the terminal hospital. At the same time, the company still authorizes third-party agent service providers to provide product sales services, hospital technology follow-up and payment follow-up services. （3） Industry 1 Development stage, basic characteristics and main technical threshold of the industry
The company’s products are electrophysiological and vascular interventional medical devices. According to the industry classification guidelines for listed companies (revised in 2012) of China Securities Regulatory Commission, the company belongs to the “special equipment manufacturing industry” in the manufacturing industry (classification code C35); According to the industrial classification of national economy (GB / t47542017), the company belongs to the “manufacturing of medical instruments and devices” (classification code c358) in the “special equipment manufacturing industry” (classification code C35); According to the classification of strategic emerging industries (2018) (Order No. 23 of the National Bureau of Statistics), the company belongs to “4.2.2 biomedical materials and equipment manufacturing” in “4.2 biomedical engineering industry”.
With the natural growth of global population, the improvement of population aging and the economic growth of developing countries, the global medical device market will continue to grow in the long run. In March 2021, the fourteenth five year plan for national economic and social development of the people’s Republic of China and the outline of long-term objectives for 2035 were released, which clearly proposed to improve the rapid review and approval mechanism for innovative drugs, vaccines and medical devices, and accelerate the review of drugs and medical devices for the treatment of clinical urgent needs and rare diseases. According to the relevant research report of frost Sullivan (June 2020 Edition), it is expected that by 2023, the market scale of medical devices will reach 1061.9 billion yuan, with an annual compound growth rate of 15.0%, and the overall market will maintain a good trend of rapid growth. With the increasing attention of the state to the development of the medical industry, the continuous introduction of favorable policies such as encouraging innovation and accelerating approval, the increase of people’s medical and health expenditure and the enhancement of health awareness will drive the further development of the medical device market.
Medical devices can be divided into four categories: high-value medical consumables, low-value medical consumables, medical equipment and IVD (in vitro diagnosis). According to different uses, the market of high-value medical consumables can be divided into orthopedic implantation, vascular intervention and implantation, electrophysiology and pacemaker, non vascular intervention and so on. Vascular interventional devices mainly include cardiovascular interventional devices, cerebrovascular interventional devices and peripheral vascular interventional devices. Among them, the market scale of cardiovascular interventional devices is the largest.
Since 2014, the state has issued a series of policies to support the development of domestic medical devices, including the selection of excellent domestic medical devices, the release of new regulations on the supervision of medical devices and the launch of Innovation Medical Management Co.Ltd(002173) device special approval procedures, which not only strengthened the support for domestic medical devices, but also promoted the R & D and innovation of Chinese medical devices. In the context of policy support, the overall import substitution process of medical devices has been gradually accelerated. Because interventional therapy technology was first introduced from abroad and started late in China, coupled with high technical barriers to interventional therapy devices, most products are still in the pattern of foreign monopoly. At present, only coronary stents (vascular implantation) products with relatively mature technology have basically completed import substitution, and there is still a large space for import substitution for other products. In addition, with the establishment of a series of innovative organizations such as the Chinese cardiovascular doctor Innovation Club established by the engineering research center of the Ministry of education of vascular interventional therapy technology and devices, and the emergence of Chinese independent innovation enterprises, clinicians, research institutions and production enterprises will be connected. The strategy of industry university research combination will also accelerate the independent R & D products to the market, which is expected to gradually follow
