复旦张江(01349) - 2021 - 中期财报

Company's Key Financial Indicators H1 2021 performance significantly recovered, with revenue up 69.36% and net profit attributable to parent up 125.20%, driven by post-pandemic market recovery Key Accounting Data and Financial Indicators H1 2021 performance significantly recovered, with revenue up 69.36% and net profit attributable to parent up 125.20%, driven by post-pandemic market recovery - During the reporting period, with the domestic epidemic under control, drug circulation and hospital patient visits significantly recovered, leading to improved drug sales and a 69.36% year-on-year increase in operating revenue, with net profit attributable to shareholders of listed companies increasing by 125.20%[6] 2021 H1 Key Accounting Data (RMB Yuan) | Key Accounting Data | This Reporting Period (Jan-Jun 2021) | Prior Year Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | 69.36 | | Net Profit Attributable to Shareholders of Listed Companies | 65,485,448 | 29,078,874 | 125.20 | | Net Profit Attributable to Shareholders of Listed Companies (Excluding Non-recurring Items) | 54,543,664 | 10,530,619 | 417.95 | | Net Cash Flow from Operating Activities | 56,033,635 | 60,819,045 | -7.87 | 2021 H1 Key Financial Indicators | Key Financial Indicators | This Reporting Period (Jan-Jun 2021) | Prior Year Period | Change | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (RMB/share) | 0.06 | 0.03 | 100.00% | | Weighted Average Return on Net Assets (%) | 3.20 | 3.19 | Increased by 0.01 percentage points | | R&D Investment as % of Operating Revenue (%) | 26.94 | 24.15 | Increased by 2.79 percentage points | - Total non-recurring gains and losses during the reporting period amounted to RMB 10,941,784, primarily from interest income of RMB 11,894,781 from structured deposits[7] Management Discussion and Analysis This section reviews the company's industry, core business, R&D progress, competitive strengths, and operational performance Industry and Main Business Overview The company specializes in biopharmaceutical R&D, production, and sales, with core revenue from three key products marketed via distribution - The Group is primarily engaged in the innovative research and development, manufacturing, and marketing of biopharmaceuticals, with main business revenue primarily derived from the sales of pharmaceutical products[9][19] - The Group's main products currently on sale include dermatological products Aila® (aminolevulinic acid hydrochloride for external use) and Fumeida® (haematoporphyrin for injection), and the anti-tumor product Libaoduo® (pegylated liposomal doxorubicin hydrochloride for injection)[16][17][18] - The Group adopts a distribution sales model, with photodynamic drugs Aila® and Fumeida® marketed by its own team, while the anti-tumor drug Libaoduo® is marketed through a CSO (Contract Sales Organization)[22] Core Technologies and R&D Progress The company leverages four core technology platforms, investing RMB 107.50 million in R&D, with significant progress in ADC and new photodynamic drug indications - The company has formed four core technology platforms: gene engineering, photodynamic, nanotechnology, and oral solid preparation technology platforms, all developed independently[23] 2021 H1 R&D Investment (RMB Yuan) | Item | Current Period | Prior Period | Change (%) | | :--- | :--- | :--- | :--- | | Total R&D Investment | 107,503,707 | 56,903,236 | 88.92 | | R&D Investment as % of Operating Revenue (%) | 26.94 | 24.15 | Increased by 2.79 percentage points | | Capitalized R&D Investment as % | 8.59 | 4.45 | Increased by 4.14 percentage points | - Significant R&D achievements during the reporting period include: - Parecoxib Sodium for Injection obtained a Drug Registration Certificate[29] - Obeticholic Acid project received a Drug Clinical Trial Approval Notice[29] - Anti-Trop2 Antibody-Drug Conjugate (FDA018 for injection) received a Drug Clinical Trial Approval Notice[29] - The number of R&D personnel increased from 99 people to 127 people, raising their proportion of total company staff from 16.02% to 18.22%[35] Core Competitiveness Analysis The company's strengths lie in R&D innovation, diverse technology platforms, market promotion, quality control, and a robust management team - The company's core competitiveness is based on an R&D orientation that addresses unmet clinical needs, with listed and pipeline projects less affected by policy changes[36] Core Technology Platforms and Pipeline Project Progress | Technology Platform | Project Name | Proposed Indication | Progress Achieved | | :--- | :--- | :--- | :--- | | Gene Engineering Technology | Anti-CD30 Antibody-Drug Conjugate | Oncology | Phase I Clinical Study | | | Anti-Trop2 Antibody-Drug Conjugate | Oncology | Phase I Clinical Study | | Photodynamic Technology | Haemoporfin | Port-wine Stains | Phase IV Clinical Study/US Registration in progress | | | Aminolevulinic Acid Hydrochloride | HPV-infected Cervical Diseases | Phase II Clinical Study | | | Aminolevulinic Acid Hydrochloride | Acne | Phase II Clinical Study | | Nanotechnology | Doxorubicin Hydrochloride Liposome | Oncology | Domestic Consistency Evaluation and US Registration in progress | | Oral Solid Preparation | JAK1 Inhibitor | Rheumatoid Arthritis | Phase I Clinical Study | | | Obeticholic Acid | Hepatobiliary Diseases | Confirmatory Clinical Study | - The company adheres to academic promotion as its primary marketing strategy and has established an online service system for doctor academic exchange and doctor-patient interaction using new media platforms like WeChat official accounts[39] Discussion and Analysis of Operating Performance Operating revenue rebounded to RMB 399 million, up 69.36% YoY, with core products contributing 99.6% of sales - During the reporting period, the company achieved operating revenue of RMB 399 million, a year-on-year increase of 69.36%[42] - The three core products, Aila® (for condyloma acuminata), Libaoduo® (for oncology), and Fumeida® (for port-wine stains), contributed 99.6% to pharmaceutical product sales revenue[42] Risk Factors Key risks include long R&D cycles, product concentration, competition, policy changes, and potential loss of core technical personnel - New drug R&D involves long cycles, high costs, and significant uncertainty, and failure to successfully develop or obtain approval for pipeline products would result in losses on prior investments[43] - The company's product portfolio is relatively concentrated, with Aila®, Libaoduo®, and Fumeida® accounting for a large proportion of total revenue, exposing it to competitive pressures and drug price reduction risks[44][45] - The stability of core technical personnel is crucial for the company, and their loss could adversely affect its core competitiveness and sustained profitability[46] Key Operating Performance H1 2021 saw full operational recovery, 69.36% revenue growth, increased expenses, and significant investment in Shanghai Handu - Looking ahead, the company will continue to focus R&D resources on ADC drugs, photodynamic drugs, small molecule targeted drugs (such as JAK1 inhibitors), and nanomedicines, and plans to venture into neurological slow-release drugs and explore gene therapy[50][51][52] Financial Statement Item Variation Analysis (RMB Yuan) | Item | Current Period | Prior Year Period | Change (%) | Main Reason | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | 69.36 | Sales rebound after pandemic control | | Selling Expenses | 184,117,626 | 117,516,961 | 56.67 | Increased with sales growth | | R&D Expenses | 98,267,565 | 54,373,006 | 80.73 | Increased R&D project investment | | Net Cash Flow from Investing Activities | -295,770,820 | -32,205,077 | 818.40 | Payment for capital injection and equity acquisition in Shanghai Handu | | Net Cash Flow from Financing Activities | -38,726,106 | 923,837,507 | -104.19 | Prior period included bank loans and A-share issuance proceeds | - During the reporting period, the company invested RMB 266 million to increase capital and acquire a total of 39.5663% equity in Shanghai Handu, leading to a 428.13% increase in long-term equity investments[62][63] Corporate Governance This section details the company's shareholder meetings, equity incentive plans, and overall governance structure Shareholder Meeting Information The company held its 2020 AGM and A/H Share Class Meetings, approving the annual report, profit distribution, and H-share repurchase - The company held a general meeting of shareholders on May 27, 2021, approving various proposals including the "Company's 2021 Restricted Share Incentive Plan (Draft)" and a general mandate to the Board of Directors to repurchase H shares[70][72] Equity Incentive Plan The company adopted a 2021 restricted share incentive plan, granting 32.77 million shares to 258 grantees at RMB 8.90 per share - The company adopted the 2021 Restricted Share Incentive Plan, proposing to grant 38 million shares, accounting for approximately 3.64% of the total share capital[75] - On July 22, 2021, the company initially granted 32.77 million restricted shares to 258 grantees at a grant price of RMB 8.90 per share[75][76] Environmental and Social Responsibility The company prioritizes environmental protection through strict waste treatment, energy-saving measures, and social contributions Environmental Information The company maintains strict environmental management, ensuring compliant waste treatment and promoting energy efficiency, with no reported violations - The company strictly processes wastewater, exhaust gas, and waste generated during production in accordance with national and local standards, and engages qualified entities for regular monitoring, with no related violations reported during the period[79] - The company formulated the "Energy and Resource Management Procedure" and implemented energy-saving and emission reduction measures through energy performance management and the renovation of water production equipment for waste heat utilization[82] - During the reporting period, the company donated RMB 100,000 to the Gongshan Education Foundation in Nanjiang County, Bazhong City, Sichuan Province, to establish scholarships and grants supporting rural education revitalization[83] Significant Matters This section covers the fulfillment of commitments made during the A-share IPO and the progress of raised funds utilization Fulfillment of Commitments The company and major shareholders strictly fulfilled all A-share IPO commitments, including share lock-up and avoiding competition - Major shareholders including Shanghai Pharma, Xinqi Phase II, Yang Zongmeng, and Chairman Wang Haibo all committed to a 36 months lock-up period from the date of A-share listing[84][85] - Major shareholders such as Shanghai Pharma committed to avoiding horizontal competition, regulating related-party transactions, and made prudent arrangements for share reductions after the lock-up period expires[89][90][93] Progress of Raised Funds Utilization As of June 30, 2021, RMB 393 million of A-share raised funds were used for key projects, with RMB 96 million over-raised funds for working capital Utilization of Raised Funds (As of June 30, 2021, RMB 10,000) | Planned Project | Budgeted Amount | Amount Used | Remaining Amount | | :--- | :--- | :--- | :--- | | Haemoporfin US Registration Project | 23,000.00 | 2,032.02 | 20,967.98 | | Biopharmaceutical Innovation R&D and Sustainable Development Project | 24,000.00 | 9,827.46 | 14,172.54 | | Acquisition of Minority Equity in Taizhou Fudan-Zhangjiang Project | 18,000.00 | 17,839.30 | 160.70 | | Over-raised Funds | – | 9,600.00 | 22,832.39 | | Total | 65,000.00 | 39,298.78 | 60,155.90 | Share Changes and Shareholder Information This section details changes in share capital and provides an overview of the company's shareholder structure Share Capital Changes Total share capital remained stable, but 167,577,060 restricted shares became tradable, altering the proportion of restricted vs. unrestricted shares - On June 21, 2021, a portion of the company's initially issued restricted shares, totaling 167,577,060 shares, became tradable after a 12 months lock-up period[130] - After the reporting period, the company implemented an H-share repurchase, cumulatively repurchasing 1,469,000 shares, which, if cancelled, would slightly reduce total share capital and positively impact EPS and net assets per share[130] Shareholder Information As of the reporting period end, the company had 21,885 shareholders, with HKSCC NOMINEES LIMITED, Shanghai Pharma, and Xinqi Phase II as top holders - As of the end of the reporting period, the company had a total of 21,885 ordinary shareholders, comprising 21,736 A-share holders and 149 H-share holders[132] Top Five Shareholders' Holdings (As of June 30, 2021) | Shareholder Name | Number of Shares Held at Period End | Proportion (%) | | :--- | :--- | :--- | | HKSCC NOMINEES LIMITED | 241,867,900 | 23.19 | | Shanghai Pharma Group Co., Ltd. | 210,142,560 | 20.15 | | Xinqi Phase II Venture Capital Enterprise | 156,892,912 | 15.04 | | Yang Zongmeng | 80,000,000 | 7.67 | | Wang Haibo | 57,886,430 | 5.55 | Financial Statements This section presents the company's consolidated balance sheet, income statement, and cash flow statement Consolidated Balance Sheet As of June 30, 2021, total assets were RMB 2.479 billion, with a slight decrease from year-end, while equity attributable to parent company shareholders increased Consolidated Balance Sheet Key Items (RMB Yuan) | Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Total Assets | 2,479,272,106 | 2,500,701,037 | | Total Liabilities | 453,915,407 | 492,211,194 | | Total Equity Attributable to Parent Company Shareholders | 2,028,213,577 | 2,010,930,752 | Consolidated Income Statement H1 2021 saw RMB 399 million in operating revenue, up 69.36% YoY, leading to a 125.20% increase in net profit attributable to parent company shareholders Consolidated Income Statement Key Items (RMB Yuan) | Item | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | | Operating Profit | 68,518,791 | 27,703,448 | | Total Profit | 66,786,868 | 27,996,722 | | Net Profit | 65,069,479 | 29,364,848 | | Net Profit Attributable to Parent Company Shareholders | 65,485,448 | 29,078,874 | Consolidated Cash Flow Statement H1 2021 operating cash flow was RMB 56.03 million, with significant investing cash outflow due to equity investments Consolidated Cash Flow Statement Key Items (RMB Yuan) | Item | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net Cash Flow from Operating Activities | 56,033,635 | 60,819,045 | | Net Cash Flow Used in Investing Activities | (295,770,820) | (32,205,077) | | Net Cash Flow (Used in)/Generated from Financing Activities | (38,726,106) | 923,837,507 | | Net (Decrease)/Increase in Cash | (278,495,510) | 952,502,846 | | Cash Balance at Period End | 1,118,394,682 | 1,529,302,256 |