[中报]健康元(600380):健康元药业集团股份有限公司2024年半年度报告（英文版）
原标题:健康元:健康元药业集团股份有限公司2024年半年度报告（英文版） Ⅰ The Board of Directors (the “Board”), the Board of Supervisors and directors, supervisors and senior management of the Company hereby warrant the truthfulness, accuracy and completeness of the contents of the interim report (the “Report”), and that there are no false representations, misleading statements or material omissions contained in the Report, and severally and jointly accept responsibility. Ⅱ All the directors of the Company attended the Board meeting. Ⅲ The interim report of the Company is unaudited. Ⅳ Mr. Zhu Baoguo (朱保国), the person-in-charge of the Company, Mr. Qiu Qingfeng (邱庆丰), the person-in-charge of the Company's accounting work, and Ms. Guo Chenlu (郭琛璐), the person-in-charge of the accounting department (the head of the accounting department), declare that they hereby warrant the truthfulness, accuracy and completeness of the financial statements contained in the Report. Ⅴ Profit distribution plan or plan for conversion of capital reserve to share capital approved by the Board during the Reporting Period Not applicable VI Risk declaration for the forward-looking statements √Applicable □N/A The Report contains forward-looking statements which involve the future plans, development strategies, etc. of the Company, yet do not constitute substantive undertakings of the Company to investors. Investors should exercise caution prior to making investment decisions. VII Whether there is non-operating use of funds by the controlling shareholder and their related parties No VIII Whether there is a violation of the prescribed decision-making procedures to provide external guarantees No IX Whether more than half of directors cannot warrant the truthfulness, accuracy and completeness of the Report disclosed by the Company No X Significant risk warnings There is no exceptionally significant risk that will have a material impact on the production and operation of the Company during the Reporting Period. In this Report, the Company has elaborated on the risks and countermeasures that the Company may face in the course of production and operation, including industry policy risk, market risk, risk of safety and environmental protection, risk in price and supply of raw materials and R&D risk. For more information, please refer to “Potential risks” section in Chapter 3 Management Discussion and Analysis. XI Others □Applicable √N/A Table of Contents Important Notice ............................................................................................................................. 2 Financial Highlights ........................................................................................................................ 5 Chapter 1 Definitions ...................................................................................................................... 7 Chapter 2 Company Profile and Major Financial Indicators ..................................................... 9 Chapter 3 Management Discussion and Analysis ...................................................................... 13 Chapter 4 Corporate Governance ............................................................................................... 45 Chapter 5 Environmental and Corporate Social Responsibility .............................................. 48 Chapter 6 Major Events ............................................................................................................... 74 Chapter 7 Changes in Equity and Shareholders ........................................................................ 90 Chapter 8 Information on Preferred Shares .............................................................................. 95 Chapter 9 Information on Bonds ................................................................................................. 96 Chapter 10 Financial statements.................................................................................................. 97
Financial Highlights Financial Highlights Chapter 1 Definitions In this Report, unless the context otherwise requires, the following expressions shall have the following meanings:
*For identification purpose only Chapter 2 Company Profile and Major Financial Indicators I Company profile
II Contact persons and contact details
III Introduction of the Company's basic information
IV Introduction of changes in information disclosure and places for inspection
V Company Stock Profile
VI Other relevant information □Applicable √N/A VII Principal accounting data and financial indicators of the Company (I) Principal accounting data Unit: Yuan Currency: RMB
(II) Principal Financial Indicators
Description of principal accounting data and financial indicators of the Company √Applicable □N/A During the Reporting Period, the net cash flow from operating activities was RMB1,737 million, representing an approxiamate year on year increase of 38.19%, mainly due to the decrease in procurement and expenses expenditures. VIII Differences in accounting data under domestic and foreign accounting standards □Applicable √N/A IX Items and amounts of extraordinary gains and losses √Applicable □N/A Unit Yuan Currency: RMB
For the items not listed in the “Explanatory Announcement No.1 for Public Company Information Disclosures-Extraordinary Gains or Losses” that the company identifies as non-recurring gains and losses, especially those with significant amounts, as well as the extraordinary gain or loss items as illustrated in the “ Explanatory Announcement No.1 for Public Company Information Disclosures-Extraordinary Gains or Losses” which has been defined as its recurring gain or loss items, the reasons for such classification should be explained. □Applicable √N/A X Others □Applicable √N/A Chapter 3 Management Discussion and Analysis I Description of the industry in which the Company operates and principal businesses of the Company during the Reporting Period (I) Principal businesses and products of the Company The Company is primarily engaged in the R&D, production and sales of pharmaceutical products and health care products. The business scope of the Company covers chemical pharmaceuticals, biologics, chemical active pharmaceutical ingredients (APIs) and intermediates, traditional Chinese medicine (TCM), diagnostic reagents and equipment, health care products, etc. The enriched product series and mix provide larger market and growth opportunities for the Company. Main products of the Company are as follows: (II) Business model of the Company With the stable operation and rapid development over the years, the Company has become an integrated pharmaceutical group that is driven by scientific research and innovation, integrating the R&D, production, sale and service of pharmaceutical and health care products. It has complete systems of R&D, procurement, production and sale. Main business models of the Company are as follows: 1. R&D Combining independent R&D, external introduction and cooperative development, the Company has been paying attention to the cutting-edge technology and unmet clinical needs, with efforts focused on innovative drugs and high-barrier complex formulations and has established an efficient R&D innovation management model. In terms of independent innovation, the Company has a diversified and multi-dimensional R&D organization with mature R&D teams for chemical pharmaceuticals, biologics, TCM drugs, APIs, diagnostic reagents and health care products. Based on technology platform construction, the Company has built a clear product R&D pipeline centering on key areas such as respiratory, tumor immunity and psychiatry. In terms of cooperative innovation, the Company has launched technical cooperation with domestic and foreign scientific research institutions by way of commissioned development or cooperative development, and has introduced new technologies and products that meet the strategic development goal of the Company through technology transfer or license-in to implement industrial transformation, so as to reinforce and strengthen our position and strategy in the leading and emerging fields. 2. Procurement In terms of procurement, the Company pays strict attention to effectiveness, quality and cost of procurement and has established long-term and stable partnership with many suppliers. Active pharmaceutical ingredients, supplementary materials, and packaging materials were purchased and stocked up by manufacturers according to production schedules. The Company has developed strict quality standards and procurement management systems and required subordinate manufacturers to make procurements in accordance with the GMP. Meanwhile, the Company established long-term strategic partnerships with bulk material suppliers, and strengthened the management of supply quality and cost control based on strict quality standards. The Company has established an internal evaluation system and files of market prices so as to promptly acquire market information for procurement through comparisons of quality and price. 3. Production In terms of production, the Company adopts the principle of market demand-oriented approach paying attention to real market demand. Specifically, the Sales Department of the Company investigated market demands, made sales plans, and comprehensively considered factors such as the product inventory quantity and capacity of production lines of the Company so as to determine the monthly production quantities and specifications. Moreover, the purchase orders of raw materials are determined according to the production schedule and the inventory levels of raw materials. The final production plans are issued upon approval of the management of the Company and implemented by the Production Technology Department of the Company. The Company has been carrying out production in strict accordance with the GMP. The Company and its affiliates have established a sound quality management system and implemented the qualified-person system. In terms of quality control, the Company has established a strict and sound production quality assurance system, and is geared to international standards and subject to international certification while in compliance with national standards. The Company conducts annual GMP self-inspection, ISO9001 internal and external audits, and is subject to various external audits. It actively pursued the internationally advanced GMP management, and implemented whole-process quality control over supplier selection, audit, incoming material inspection, production process, product release from factory, and market tracking. The system is running well. 4. Sales (1) Drug formulation products End customers of drug formulation products (chemical pharmaceuticals, biologics, traditional Chinese medicine) of the Company are mainly hospitals, clinics, and retail pharmacies. In line with the pharmaceutical industry practice and the sales model of most peers in the industry, the Company has conducted sales of drug formulation products through drug distribution enterprises. The Company carried out selection and centralized management of qualified drug distribution enterprises (with Drug Supply Certificate, GSP Certification, etc.) according to their distribution capability, market familiarity, financial strength, credit record, and operation scale. General sales process: After end customers place purchase orders to distribution enterprises, drug distribution enterprises will send those orders to the Company according to their inventories, distribution agreements and conditions; then, the Group will deliver products to drug distribution enterprises and do the revenue recognition. (2) APIs and intermediates Main target customers of APIs are large pharmaceutical manufacturers. The selling prices are determined based on a set of integrated factors such as costs of production, inventory levels, industry rivalry and market trend. Specific pricing method: The sales and marketing department conduct weekly or bi-weekly meetings to analyze the current market conditions, the trends and drivers of prices; the selling prices are determined based on a set of comprehensive factors such as costs of production, inventory levels, industry rivalry and market conditions; the selling prices will be effective once are reported by the managers of the sales department to our management team and get approvals. Specific sales methods of APIs include: ① Domestic market: The Company directly signs product sales contracts with large manufacturers to directly sell products to customers. Meanwhile, the Company also sells products through distributors. ② Foreign market: The Company directly sells products in the foreign market and in areas with high market and political risks, products are sold through distributors as well. At present, products of the Company are mainly exported to over 60 countries and regions in Asia, Europe, North America, and Africa. (3) Diagnostic reagents and equipment Diagnostic reagents and equipment sold by the Company both domestically manufactured and imported. Main end customers are hospitals, centers for disease control and prevention, and health departments. The Company mainly sells those products in combination with direct sales and sales through drug distribution enterprises. The Company has an experienced sales team responsible for the sales of diagnostic reagents and equipment, with provision of marketing support for some drug distribution enterprises. The Company carried out selection and centralized management of qualified drug distribution enterprises (with Drug Supply Certificate, GSP Certification, etc.) according to their distribution capability, market familiarity, financial strength, credit record, and operation scale. (4) Health care products The sales model of health care products is mainly distributor management model. Product promotion, price control, and channel carding are managed and improved with the distributor distribution channel and terminal coverage capability. At present, the Company has set up 25 provincial branches and maintained long-term partnership with distributors with better area coverage capability for stable strategic alliance and common development. The Company has cooperated with about 103 first-level/primary distributors in total, including 82 businesses in drug distribution line and approximately 30 businesses in food distribution line with more than 400,000 subordinate secondary businesses and end user businesses in drug and food distribution lines. Products are well managed and promoted through the tiered marketing channel. In addition to the traditional distribution management model, the Company realizes synergetic development through online channels. At present, the Company has set up official flagship stores on mainstream e-commerce platforms such as Tmall(天猫), Jingdong（京东）, Douyin（抖音）, Kuaishou (快手) and Pinduoduo (拼多多). (III) Analysis of industry development As a national strategic and emerging industry which concerns national economy and the people’s livelihood, pharmaceutical industry is an integral part of the national economy. According to the Development Plan of the Pharmaceutical Industry during the “14th Five-Year Plan” Period, the overall development level of the pharmaceutical industry is expected to reach a new level. In 2024, "innovative drugs" and "life sciences" were first mentioned in the Government Work Report, and were included in the category of "new quality productivity", indicating a leap forward in productivity. In July 2024, the executive meeting of the State Council approved the Implementation Plan for Full-Chain Support in Development of Innovative Drugs to provide full-chain and all-round support for development of the biomedical industry from drug research and development, drug review and approval, medical insurance and hospital coverage, to financial support. This initiative will definitely further promote innovation breakthroughs of the medical and healthcare industry, and lead toa significant leap in the development of the whole industry. Data of National Bureau of Statistics shows that in the first half of 2024, enterprises in the pharmaceutical manufacturing industry above designated scale in China have realized revenues of RMB1,235.27 billion, representing a year-on-year decrease of 0.9%; operating costs of RMB714.82 billion, representing a year-on-year increase of 0.9%; total profits of RMB180.59 billion, representing a year-on-year increase of 0.7%. (IV) Industry status of the Company Thanks to years of development, the Company has become an integrated pharmaceutical enterprise covering multiple areas including chemical pharmaceuticals, chemical APIs and intermediates, traditional Chinese medicine, diagnostic reagents and equipment as well as health care products. Chemical drug foemulation products are the largest revenue generator of the Company, among which drugs for gastroenterology and gonadotropic hormones are traditional competitive products of the Company, with key products securing a long-term position in national drug formulation market segment, and respiratory and psychiatry products have been the strategic focus of the Company, with key products maintaining a strong sales growth momentum. During the Reporting Period, the Company, leveraging its robust R&D and production capabilities and steady marketing presence, the Company ranked Top 10 in “2023 Annual Ranking of Top 100 Chinese Chemical Drug Enterprises”, and top 50 in “China's comprehensive strength in drug R&D in 2024”. (V) Performance drivers in the Reporting Period In the first half of 2024, the biopharmaceutical industry faced many changes and challenges due to the complex and severe external international environment, the sluggish economic recovery and the endless geopolitical conflicts. Under such environment, the Company always adhered to the mission of “For the health, For the future” and the vision to “Diligently make high-quality and innovative drugs”, and focused on the stable operation and layout of the main pharmaceutical business. During the Reporting Period, the Company's chemical pharmaceuticals segment grew steadily in areas such as gonadotropic hormones and psychiatry, while the field of respiratory recorded a decline in revenue due to the impact of centralized procurement; the revenue of the APIs and intermediates segment declined slightly, and its gross profit margin gradually increased as the Company empowered drug production with intelligent manufacturing technology; in terms of the health care products segment, the Company continued to upgrade the market strategy of interpenetration and coordination between online and offline channels, and have established a user-centric digital marketing system, leading to rapid growth in sales performance. Meanwhile, the Company continued to increase its R&D expenditures. While strengthening its independent R&D capabilities, the Company had introduced multiple innovative medicine projects through external introductions and co-development, continuously reinforced its leading position in respiratory, anti- infective and psychiatric areas, and gradually expanded its pipelines in areas such as analgesic to consolidate the foundation for its overall innovation and transformation. II Analysis of core competitive strengths during the Reporting Period 1. Leading integrated pharmaceutical company under continuous innovation and development in China The Company is primarily engaged in the R&D, production and sale of pharmaceutical products and health care products. The business scope of the Company covers chemical pharmaceuticals, biologics, chemical APIs and intermediates, TCM drugs, diagnostic reagents and equipment, as well as health care products, allowing the Company to establish competitive advantages across various therapeutic areas such as respiratory, anti-infection, assisted reproduction, gastroenterology, psychiatry, and tumor immunity. 1) Innovative R&D drives growth: The Company has developed and launched a number of innovative medicine products and high-barrier complex formulation products, strengthening the Group’s product portfolio and drug candidates in the pipeline. 2) The Company has first-tier commercialization ability, and its sales network covers all provinces in China and over 80 overseas countries and regions in the world. The Company emphasizes scientific promotion and evidence-based marketing. By building a professional marketing team, the Company has established a comprehensive marketing system, and market education and brand building have been deeply strengthened through digital marketing. Leveraging our comprehensive sales channels, broad market coverage, leading digital marketing and brand awareness, the Company is able to sell the products at scale in an efficient manner. 3) Cross-industry and multi-specialist innovative R&D and coordinated development: On one hand, the Company actively adapts to the changes in the pharmaceutical market and constantly adjusts its product strategy and R&D direction according to policies and clinical needs. This will realize the continuous iteration and upgrade of the main products. On the other hand, the Company fully utilizes external scientific research and commercial resources, such as strategic collaboration with Chinese Academy of Sciences, Tencent Quantum Lab and other scientific research institutes and innovative companies and invests in cutting-edge biotechnology companies to expand the Company’s product portfolio and R&D pipeline, thus realizing the Company’s sustainable development. 2. Strong R&D capabilities, diversified product portfolio and leading commercialization capabilities Focusing on innovative drugs and high-barrier complex formulation, the Company has formed diversified product portfolio. With the huge clinical demand and high product quality, it has established market competitive advantages in many pharmaceutical segments. The Company’s chemical pharmaceuticals cover gastroenterology, assisted reproduction, anti-infection, respiratory, psychiatry, tumor and other fields, among which alimentary tract proton pump inhibitor (PPI) drugs, gonadorelin hormone drugs, and inhalation formulation for respiratory diseases have an advantageous market position. Relying on APIs production, the Company’s core products, together with our chemical APIs and intermediates, form an integrated and stable pharmaceutical industrial chain of “APIs-formulations vertical integration”. Meanwhile, the Company actively develops overseas markets, and our products are marketed and distributed worldwide, facilitating strategic cooperation with many internationally renowned pharmaceutical companies. In addition, the Company also has a number of TCM drugs and in vitro diagnostic reagent products and has accumulated resources and extensive brand influence in healthcare products for many years. 3. Making breakthroughs in the key R&D and industrialization technologies of complex formulation The technology platform, which has been developed over the years in the field of innovative medicines and high-barrier complex formulation, enables the Company to address the complex process problems in the R&D and production of relevant drugs. Guided by clinical value, the Company develops R&D projects with high short-term certainty and cutting-edge technologies with long-term growth potential (such as AI-driven drug molecular design, proteolysis targeted chimeric (PROTAC), synthetic biology, gene-editing, cellular treatment, etc.). All in all, the Company’s R&D system covers through-cycle of drug development and production. Based on the mature R&D platform of innovative drugs and high-barrier complex formulations, the Company has designed extensive pipeline in fields with significant clinical demand such as respiratory, gastroenterology, assisted reproduction, psychiatry, and tumor. In recent years, the company has continuously enhanced and strengthened its BD efforts, adhering to our dual-drive strategy of innovative medicines and high-barrier complex formulations. While focusing on independent innovation, we also continued to deepen cooperation in the development and licensing introduction of core varieties, aligning with global advantageous resources and cutting-edge technologies. This strategic initiative strengthens the company's commercialization and integration capabilities, accelerating the pace of the company's transformation into an innovative pharmaceutical enterprise. 4. Stable management and R&D team with expertise, long-term vision and commitment to social responsibility The Company has a stable, visionary and experienced, results-oriented management team and an outstanding talent team. Outstanding leaders are the key to the Company’s rapid development. The founder of the Company has over 30 years of expertise in the pharmaceutical industry as well as a global vision and a strategic mindset. With a deep industry insight, the founder has led us develop platform technologies centered on high-barrier complex formulations, which has established leading position of the Group with sustainable development in the broader healthcare industry. The senior management team of the Company has over 20 years of industry experience on average, with an average of more than 10 years of service in the Company, and has a thorough understanding of market demand, industry development and growth opportunities. Each key R&D field of the Company is led by industry-leading scientists and accompanied by an efficient R&D management team. In addition, the Company has upheld the core value of “Putting People First, Valuing Workmanship and Quality, Pursuing Innovation and Truth, Promoting Cooperation and Sharing” and laid emphasis on talent team training to build a diversified reserve of talents with global vision, advanced knowledge, strong implementation capability and sense of self-reliance. conscientiously to jointly contribute to the sustainable development of the enterprise through teamwork and collaboration. III Discussion and analysis of business conditions 1. Main business conditions during the Reporting Period During the Reporting Period, the Company realized revenues of RMB8,235 million, representing a year-on-year decrease of approximately 5.56%; a net profit attributable to shareholders of the listed company of RMB776 million, representing a year-on-year decrease of approximately 4.78%, and a net profit attributable to shareholders of the listed company after deducting the extraordinary gains or loss of RMB762 million, representing a year-on-year decrease of approximately 2.54%. Business development of various segments of the Company is as follows: (1) Livzon Group (excluding Livzon MAB) As at the End of the Reporting Period, the Company directly and indirectly held 45.22% equity interest in Livzon Group (000513.SZ, 01513.HK). During the Reporting Period, Livzon Group (excluding Livzon MAB) realized revenues of RMB6,256 million, representing a year-on-year decrease of approximately 6.32%; and realized a net profit of approximately RMB579 million attributable to shareholders of the Company. During the Reporting Period, the formulation drug sector of Livzon Group was affected by multiple factors such as price reduction in medical insurance and centralized rectification of the pharmaceutical industry, resulting in a slight decline. The sales of its products in the key therapeutic areas are as follows: Gonadotropic hormones products realized revenues of RMB1,549 million, representing a year-on-year increase of approximately 12.51%; Gastroenterology products realized revenues of RMB1,301 million, representing a year-on-year decrease of approximately 19.96%; and psychiatry products realized revenues of RMB297 million, representing a year-on-year increase of approximately 6.68%. （未完）  |