健友股份(603707) - 2020 Q4 - 年度财报

Definitions This chapter defines key terms, company abbreviations, partners, and regulatory bodies used in the report, providing a foundational understanding of its content - The chapter provides definitions for specialized terms, company abbreviations, partners, and regulatory bodies used throughout the report[9][10] Company Profile and Key Financial Indicators Company Basic Information This chapter outlines the company's basic business registration, contact details, disclosure channels, and stock overview, clarifying its legal entity and investor communication pathways - The company's full name is Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd., with stock abbreviation 'King-Friend' and stock code 603707, listed on the Shanghai Stock Exchange[11][15] Key Financial Data and Indicators for the Past Three Years In 2020, the company achieved robust financial growth, with operating revenue up 18.03% and net profit attributable to shareholders up 33.25%, total assets expanded by 52.02%, and profitability metrics significantly improved Key Accounting Data for the Past Three Years (Unit: CNY) | Key Accounting Data | 2020 | 2019 | YoY Change (%) | 2018 | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 2,914,880,930.50 | 2,469,669,305.11 | 18.03 | 1,700,330,667.14 | | Net Profit Attributable to Shareholders of Listed Company | 806,122,185.11 | 604,961,604.92 | 33.25 | 424,549,136.66 | | Net Profit Attributable to Shareholders of Listed Company (Excluding Non-recurring Items) | 767,277,360.29 | 587,364,048.60 | 30.63 | 411,166,740.79 | | Net Cash Flow from Operating Activities | -565,848,347.40 | -841,381,294.60 | 32.75 | 62,368,493.94 | | Asset Status | End of 2020 | End of 2019 | Period-end YoY Change (%) | End of 2018 | | Net Assets Attributable to Shareholders of Listed Company | 3,722,438,519.79 | 2,966,492,802.68 | 25.48 | 2,421,112,751.62 | | Total Assets | 7,720,360,460.30 | 5,078,419,276.66 | 52.02 | 3,402,323,291.73 | Key Financial Indicators for the Past Three Years | Key Financial Indicators | 2020 | 2019 | YoY Change (%) | 2018 | | :--- | :--- | :--- | :--- | :--- | | Basic EPS (CNY/share) | 0.86 | 0.65 | 32.31 | 0.45 | | Diluted EPS (CNY/share) | 0.87 | 0.65 | 33.85 | 0.46 | | Weighted Average ROE (%) | 24.46 | 22.52 | Increased by 1.94 percentage points | 19.12 | - In 2020, net cash flow from operating activities remained negative but improved by 32.75% compared to 2019, primarily due to decreased raw material purchases, with the negative balance mainly influenced by increased accounts receivable from expanded preparation sales and higher inventory levels[18] Quarterly Key Financial Data for 2020 The company's 2020 quarterly operating revenue and net profit attributable to shareholders remained relatively stable, though net cash flow from operating activities was negative for the first three quarters, slightly improving in Q4, reflecting full-year business expansion-driven capital pressure Quarterly Key Financial Data for 2020 (Unit: CNY) | Indicator | Q1 | Q2 | Q3 | Q4 | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 734,151,941.80 | 661,668,655.98 | 762,549,427.40 | 756,510,905.32 | | Net Profit Attributable to Shareholders of Listed Company | 204,403,725.60 | 204,071,041.01 | 204,650,846.41 | 192,996,572.09 | | Net Cash Flow from Operating Activities | -90,491,766.00 | -229,168,679.05 | -242,453,881.92 | -3,734,020.43 | Non-Recurring Gains and Losses Items and Amounts In 2020, the company's total non-recurring gains and losses amounted to CNY 38.84 million, primarily from government subsidies and investment income, a significant increase from CNY 17.60 million in 2019 Non-Recurring Gains and Losses Items (Unit: CNY) | Non-Recurring Gains and Losses Item | 2020 Amount | 2019 Amount | 2018 Amount | | :--- | :--- | :--- | :--- | | Government Subsidies | 37,967,430.46 | 12,738,908.38 | 6,882,125.08 | | Transactional Financial Assets Related Gains and Losses | 8,150,774.77 | 7,741,535.91 | 8,225,853.80 | | Total | 38,844,824.82 | 17,597,556.32 | 13,382,395.87 | Company Business Overview Main Business, Operating Model, and Industry Overview The company's core business spans R&D, production, and sales of full-range heparin products, anti-tumor, and other sterile injectables, alongside CDMO services, with rapid growth in high-end overseas preparations, particularly in the US market, establishing it as a leading Chinese injectable exporter - The company's core business strategy involves a full-industry chain layout based on heparin products, expanding into high-value sterile injectables (e.g., anti-tumor drugs) and CDMO services[26] - The company is a leading domestic injectable exporter, possessing four US FDA-certified production lines, with preparation export business accounting for over 50% of its total preparation business[36] - The company is one of the world's major high-quality heparin API suppliers, having established long-term stable cooperative relationships with international mainstream preparation enterprises such as Pfizer and Sanofi[37][46] - 2020 performance growth was primarily driven by the commercialization of R&D achievements, explosive growth in overseas preparation sales (US subsidiary Meitheal's revenue increased by 785.53%), steady growth in domestic preparation business (25%), and high gross margins in the API business (benefiting from strategic inventory)[39][41] Core Competitiveness Analysis The company's core competitiveness lies in R&D and registration, market sales, production quality, customer resources, procurement, and integrated supply chain, boasting FDA-certified R&D, efficient global filing capabilities, a strong US sales network via Meitheal, advanced manufacturing technology, and strategic raw material procurement - R&D and Registration Advantage: The company possesses an FDA-certified R&D center, with an average of 10 ANDA approvals per year over the past three years, ranking as the top Chinese enterprise in terms of R&D approval speed in the US[42] - Market and Sales Advantage: Through the acquisition of US Meitheal, the company established localized marketing channels, directly engaging major purchasers like GPOs and IDNs, achieving rapid expansion in the US market[43] - Production and Quality Advantage: The company operates four FDA-audited sterile preparation production lines, mastering high-end technologies like fully enclosed isolation, with a production management system meeting regulatory requirements of major global pharmaceutical markets[45] - Procurement and Integration Advantage: The company employs an innovative 'centralized elution' procurement model and has built strategic crude heparin inventory since 2015, effectively mitigating raw material price fluctuation risks, with a complete heparin API to preparation industry chain layout ensuring long-term stable profitability[47] Management Discussion and Analysis of Operations Overview of Operations In 2020, the company achieved CNY 2.915 billion in operating revenue, up 18.03%, and CNY 797 million in net profit, up 31.41%, primarily driven by strong preparation business growth, which exceeded 50% of revenue, with 14 US ANDA approvals and Meitheal's revenue surging 785.53%, while effectively managing foreign exchange losses - In 2020, the company's preparation revenue share exceeded 50% for the first time, becoming the primary driver of performance growth[50] - Significant R&D achievements include 14 US FDA ANDA approvals during the reporting period, making the company the Chinese domestic manufacturer with the most US injectable ANDAs[49] - US subsidiary Meitheal's sales revenue achieved substantial growth, increasing by 785.53% compared to 2019, with operating revenue approaching USD 100 million[50] - The company's heparin and low molecular weight heparin preparations achieved a rapid market share of 20% in the US within just one year of launch, with sales performance nearing 30 million units[50] - Despite significant fluctuations in USD and EUR exchange rates, the company, through precise capital operations, limited full-year exchange losses to CNY 1.66 million, significantly below the industry average for comparable foreign trade revenue[51] Analysis of Main Business In 2020, the company's main business revenue reached CNY 2.911 billion, up 18%, with preparation business revenue surging 93.48% to 50.63% of total, surpassing raw materials, while standard heparin raw material gross margin significantly increased by 14.39 percentage points to 56.14% despite a 14.42% revenue decline, and foreign market gross margin improved due to economies of scale Main Business by Product (Unit: CNY) | By Product | Operating Revenue | Operating Cost | Gross Margin (%) | Operating Revenue YoY Change (%) | Operating Cost YoY Change (%) | Gross Margin YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Standard Heparin API | 1,304,154,037.51 | 572,029,524.10 | 56.14 | -14.42 | -35.56 | Increased by 14.39 percentage points | | Preparations | 1,474,123,032.87 | 532,317,590.05 | 63.89 | 93.48 | 154.38 | Decreased by 8.65 percentage points | | CDMO and Others | 133,050,494.92 | 89,861,343.47 | 32.46 | -26.70 | -14.91 | Decreased by 9.36 percentage points | Main Business by Region (Unit: CNY) | By Region | Operating Revenue | Operating Cost | Gross Margin (%) | Operating Revenue YoY Change (%) | Operating Cost YoY Change (%) | Gross Margin YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Domestic | 971,026,990.25 | 305,757,452.62 | 68.51 | 39.07 | 90.03 | Decreased by 10.97 percentage points | | International | 1,940,300,575.05 | 888,451,004.99 | 54.21 | 9.53 | -14.85 | Increased by 31.91 percentage points | Production and Sales Volume Analysis | Main Product | Unit | Production Volume | Sales Volume | Production Volume YoY Change (%) | Sales Volume YoY Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | Standard Heparin API | 100 million units | 40,044.93 | 22,980.88 | -5.93 | -44.77 | | Preparations | 10,000 units | 6,872.98 | 5,982.68 | 101.53 | 114.09 | Analysis of Assets and Liabilities As of year-end 2020, total assets reached CNY 7.72 billion, up 52.02%, driven by a 36.15% increase in inventory, a 1393.39% surge in transactional financial assets, and a 101.37% rise in accounts receivable due to sales growth, with short-term borrowings up 55.84% to support business expansion, indicating a rapid growth phase Major Balance Sheet Items Change Analysis (Unit: CNY) | Item Name | Current Period-end Amount | Previous Period-end Amount | Change Ratio (%) | Main Reason | | :--- | :--- | :--- | :--- | :--- | | Transactional Financial Assets | 845,794,154.61 | 56,635,833.33 | 1,393.39 | Due to purchase of redeemable demand wealth management products | | Accounts Receivable | 783,312,186.00 | 388,990,075.28 | 101.37 | Due to sales growth | | Inventory | 4,457,423,902.01 | 3,273,856,779.15 | 36.15 | Due to increased raw material prices and higher inventory for overseas business expansion | | Short-term Borrowings | 2,132,430,038.42 | 1,368,366,370.23 | 55.84 | Due to increased short-term bank borrowings | Analysis of Industry Operating Information This chapter analyzes the pharmaceutical industry's policy environment, market conditions for key products, and R&D progress, highlighting national medical insurance negotiations and centralized drug procurement as key trends impacting industry profits and market structure, while the company's R&D investment grew 15.84% to CNY 221 million in 2020, with 56 ongoing projects and 14 US ANDA approvals, demonstrating strong R&D and registration capabilities - Industry Trend: National medical insurance catalog negotiations and centralized drug procurement continue to advance, with price reduction as the main theme, accelerating industry innovation and market consolidation, benefiting leading enterprises[75] Key Products Approved for Listing During the Reporting Period | Product Name | Application Country | Approval Date | | :--- | :--- | :--- | | Doxercalciferol Injection | USA | 2020年2月7日 | | Heparin Sodium Injection | USA | 2020年2月24日 | | Bortezomib for Injection | USA | 2020年3月22日 | | Dalteparin Sodium Injection | China | 2020年5月26日 | | Busulfan Injection | USA | 2020年10月23日 | | Gemcitabine Hydrochloride Injection | USA | 2020年12月12日 | | Cisatracurium Besilate Injection | China | 2020年12月22日 | R&D Investment (Unit: CNY) | Item | Amount | | :--- | :--- | | Expensed R&D Investment for Current Period | 187,532,206.16 | | Capitalized R&D Investment for Current Period | 33,916,295.47 | | Total R&D Investment | 221,448,501.63 | | Total R&D Investment as % of Operating Revenue | 7.60 | | Number of R&D Personnel | 306 | | Proportion of Capitalized R&D Investment (%) | 15.32 | Discussion and Analysis of Future Development The company anticipates continued growth in global heparin and anti-tumor markets, aiming to become a top-tier international biopharmaceutical enterprise by consolidating heparin leadership, diversifying product lines, and achieving vertical integration, with strategic plans including synchronized US-China R&D, strengthening raw material market position, building robust domestic sales, achieving overseas preparation sales breakthroughs via Meitheal, and ensuring successful fundraising project implementation, while acknowledging risks like policy changes, quality control, raw material prices, and market shifts - Development Strategy: Aspiring to be a 'first-class international biopharmaceutical enterprise,' consolidating heparin product advantages, expanding other pharmaceutical product lines, and achieving product diversification and vertical production integration[109] - Operating Plan: - R&D: Adhere to synchronized US-China R&D and dual-filing strategies, increase R&D investment, and establish an efficient R&D pace - Marketing: Build a strong marketing team, embrace centralized procurement policies, and leverage internet platforms to expand domestic market coverage - Overseas: Rely on US subsidiary Meitheal to achieve new breakthroughs in overseas preparation sales - Capacity: Advance convertible bond fundraising projects, construct high-end preparation production lines, and enhance high-end manufacturing capabilities[111][112] - Key Risks: The company faces industry policy risks (e.g., centralized procurement, medical insurance cost control), product quality control risks, raw material (crude heparin) price increase risks, and risks from changes in the heparin preparation market landscape[114][115][116] Significant Matters Profit Distribution and Dividends The company's 2020 profit distribution plan proposes a cash dividend of CNY 1.5 (tax inclusive) and 3 bonus shares per 10 shares, continuing its three-year trend of cash dividends and capital increases, with 2020 cash dividends representing 17.38% of net profit attributable to shareholders, compared to 35.63% in 2019 - 2020 Profit Distribution Plan: A cash dividend of CNY 1.5 (tax inclusive) and 3 bonus shares per 10 shares[5] Dividend Distribution Plans for the Past Three Years | Dividend Year | Bonus Shares per 10 Shares (shares) | Cash Dividend per 10 Shares (CNY) (tax incl.) | Capitalized Shares per 10 Shares (shares) | Cash Dividend Amount (CNY 10,000) | Ratio to Net Profit Attributable to Shareholders (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | 2020 | 3 | 1.5 | 0 | 14,012.41 | 17.38 | | 2019 | 0 | 3 | 3 | 21,557.45 | 35.63 | | 2018 | 0 | 1.5 | 3 | 8,290.09 | 19.53 | Equity Incentive Plan During the reporting period, the company implemented its 2020 Restricted Stock Incentive Plan and completed partial unlocking of the 2018 plan, while also repurchasing and canceling some granted restricted shares due to employee departures or unmet performance targets - Disclosed the 'King-Friend 2020 Restricted Stock Incentive Plan (Draft),' proposing to grant no more than 227,000 shares[129] - Completed the second unlocking of the initial grant and the first unlocking of the reserved portion of the 2018 Restricted Stock Incentive Plan, totaling 881,762 shares listed for circulation[129] Guarantees During the reporting period, all external guarantees were for subsidiaries, with a total year-end guarantee balance of CNY 321 million, representing 8.58% of the company's net assets, primarily supporting the operations and development of Hong Kong King-Friend, Meitheal, and Nanjing Jianzhi Ziming Total Company Guarantees | Item | Amount (CNY) | | :--- | :--- | | Total Guarantees to Subsidiaries During Reporting Period | 509,529,441.00 | | Total Guarantees to Subsidiaries at Period-end | 321,286,076.00 | | Total Guarantees as % of Company Net Assets (%) | 8.58 | Convertible Corporate Bonds In 2020, the company successfully issued two convertible corporate bonds: 'King-Friend Convertible Bond' (CNY 503 million) and 'KF20 Convertible Bond' (CNY 780 million), with 'King-Friend Convertible Bond' listed in May 2020 and experiencing minor conversions, while its conversion price was adjusted due to equity incentives and profit distribution - On April 23, 2020, publicly issued 'King-Friend Convertible Bond' with a total amount of CNY 503 million, code 113579[155] - On December 17, 2020, publicly issued 'KF20 Convertible Bond' with a total amount of CNY 780 million, code 113614[157] - The conversion price of 'King-Friend Convertible Bond' was adjusted from an initial CNY 54.97/share to CNY 42.05/share due to the implementation of equity incentives and 2019 equity distribution[162] Share Changes and Shareholder Information Common Share Capital Changes During the reporting period, the company's total share capital increased from 718.47 million shares to 934.16 million shares, primarily due to the 2019 profit distribution plan (3 bonus shares per 10 shares), 2020 restricted stock grants, repurchase and cancellation of some restricted shares, and minor convertible bond conversions - The company's total share capital increased from 718.47 million shares at the beginning of the period to 934.16 million shares at the end of the period[165] - The primary reason for the increase in share capital was the transfer of 3 bonus shares per 10 shares from capital reserves to all shareholders, totaling 216 million shares[166] Shareholders and Actual Controllers As of year-end 2020, the company had 19,017 shareholders, with the top three being Xie Juhua (27.85%), Jiangsu Coastal Development Group Co., Ltd. (21.80%), and TANG YONGQUN (20.26%), with Xie Juhua and TANG YONGQUN, mother and son, acting in concert as the actual controllers Top Ten Shareholders' Holdings | Shareholder Name | Shares Held at Period-end | Proportion (%) | | :--- | :--- | :--- | | Xie Juhua | 260,167,427 | 27.85 | | Jiangsu Coastal Development Group Co., Ltd. | 203,647,922 | 21.80 | | TANG YONGQUN | 189,281,212 | 20.26 | | Huang Xiwei | 41,807,229 | 4.48 | | Fullgoal Optimized Flexible Allocation Mixed Fund (LOF) | 19,190,346 | 2.05 | - The company's actual controllers are Xie Juhua, TANG YONGQUN (Tang Yongqun), and Ding Ying, with Xie Juhua and TANG YONGQUN being mother and son, having signed a concerted action agreement[175][179][182] Directors, Supervisors, Senior Management, and Employees Holdings and Remuneration of Directors, Supervisors, and Senior Management During the reporting period, the company's core management maintained stable shareholdings, with changes primarily from the annual profit distribution plan; Chairman Tang Yongqun's total pre-tax remuneration was CNY 1.5 million, and Director and Deputy General Manager Huang Xiwei's was CNY 1.11 million, supported by a performance-linked compensation and assessment mechanism Core Management Remuneration (Unit: CNY 10,000) | Name | Position | Total Pre-tax Remuneration from Company During Reporting Period | | :--- | :--- | :--- | | Tang Yongqun | Chairman, General Manager | 150 | | Huang Xiwei | Director, Deputy General Manager, CFO, Board Secretary | 111 | | Wu Guiping | Deputy General Manager | 36.25 | Employee Information As of the reporting period end, the company and its main subsidiaries had 953 employees, with technical and production personnel comprising 38.6% and 37.7% respectively, and over 56% holding bachelor's degrees or higher, reflecting the company's emphasis on high-caliber talent Employee Professional Composition | Professional Category | Number of People | | :--- | :--- | | Production Personnel | 359 | | Sales Personnel | 64 | | Technical Personnel | 368 | | Financial Personnel | 23 | | Administrative Personnel | 139 | | Total | 953 | Employee Education Level | Education Level Category | Number of People | | :--- | :--- | | PhD | 10 | | Master's | 74 | | Bachelor's | 454 | | Associate Degree | 262 | | Below Associate Degree | 153 | | Total | 953 | Corporate Governance Overview of Corporate Governance During the reporting period, the company strictly adhered to laws and regulations like the Company Law and Securities Law, continuously improving its corporate governance structure, establishing and effectively implementing standardized systems for shareholders, board of directors, supervisory board, information disclosure, and investor relations, ensuring compliant and transparent operations while safeguarding all shareholders' interests - The company's governance structure is sound, operating strictly in accordance with relevant laws and regulations, ensuring the standardized operation of the general meeting of shareholders, board of directors, and supervisory board, and fulfilling information disclosure obligations truthfully, accurately, completely, and timely[199][200] Financial Report Audit Report Zhongtianyun Certified Public Accountants (Special General Partnership) audited the company's 2020 financial statements, issuing a standard unqualified audit opinion, affirming that the financial statements fairly represent the company's financial position and operating results in all material respects, with 'revenue recognition' identified as a key audit matter due to its significance and rapid growth - The auditing firm is Zhongtianyun Certified Public Accountants (Special General Partnership), which issued a standard unqualified audit opinion[209][210] - The key audit matter is 'revenue recognition,' for which auditors performed procedures including internal control testing, analytical procedures, contract examination, cut-off testing, and confirmations[212][213][214] Financial Statements This chapter includes the company's 2020 consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity, detailing the financial position at period-end, full-year operating results, and cash flow Notes to Financial Statements Notes to the financial statements provide detailed explanations of financial statement items, including the company's basic information, basis of preparation, significant accounting policies and estimates, and specific notes on major consolidated financial statement items, indicating the company adopted new revenue standards from January 1, 2020, and disclosing related party transactions, share-based payments, and financial instrument risks - The company adopted the Ministry of Finance's revised 'Accounting Standard for Business Enterprises No. 14 – Revenue' starting January 1, 2020[323] - The company's revenue recognition principles are: domestic sales are recognized upon customer receipt, and export sales are recognized upon obtaining customs declaration forms[314] - The company faces primary financial risks including market risk (foreign exchange risk, interest rate risk), credit risk, and liquidity risk, and has implemented corresponding management and monitoring measures[487][488] Reference Documents Catalog - Reference documents include original financial statements bearing the signatures and seals of the legal representative, chief financial officer, and head of accounting, as well as the original audit report bearing the seal of the accounting firm and signatures and seals of certified public accountants[539]