艾迪药业(688488) - 2024 Q2 - 季度财报

Definitions Definitions of Common Terms This chapter defines key company abbreviations, regulatory bodies, and specialized terminology, including human-derived protein products and clinical trial phases, to facilitate report comprehension - The report defines the company's core business products, such as "human-derived protein products," as crude ulinastatin, urinastatin, and urokinase extracted from human urine, which serve as raw materials for downstream preparations and do not require drug regulatory approval[6] - The report clearly defines key new drug development stages (Phase I, II, III, IV clinical trials) and critical applications (IND, NDA), aiding in understanding the company's R&D pipeline progress[6][7] Company Profile and Key Financial Indicators Basic Company Information This chapter provides the company's basic business registration information, contact details, information disclosure channels, and stock overview, noting Jiangsu Aidi Pharmaceutical Co., Ltd. (stock code 688488) is listed on the Shanghai Stock Exchange STAR Market Basic Company Information | Item | Information | | :--- | :--- | | Company Name | Jiangsu Aidi Pharmaceutical Co., Ltd. | | Stock Abbreviation | Aidi Pharma | | Stock Code | 688488 | | Listing Exchange | Shanghai Stock Exchange STAR Market | | Legal Representative | Fu Heliang | | Registered Address | No. 69, Xingan Quan West Road, Hanjiang District, Yangzhou City | Key Accounting Data and Financial Indicators During the reporting period, the company's operating revenue decreased by 24.16% year-on-year, and net profit attributable to shareholders expanded from a loss of RMB 9.6 million in the prior period to a loss of RMB 45.43 million, primarily due to reduced human-derived protein business revenue, decreased gross profit, and increased R&D expenses, while net operating cash flow improved Key Accounting Data and Financial Indicators | Key Accounting Data | Current Period (Jan-Jun) | Prior Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue (RMB) | 181,066,750.06 | 238,740,738.87 | -24.16 | | Net Profit Attributable to Shareholders (RMB) | -45,434,583.32 | -9,599,927.19 | N/A | | Net Profit Attributable to Shareholders (Excl. Non-recurring Items) (RMB) | -53,319,938.65 | -23,443,946.11 | N/A | | Net Cash Flow from Operating Activities (RMB) | -78,361,962.97 | -119,145,674.37 | N/A | | Basic Earnings Per Share (RMB/share) | -0.11 | -0.02 | N/A | | R&D Investment as % of Operating Revenue | 26.55 | 17.45 | Increased by 9.10 percentage points | - The decrease in operating revenue was primarily due to a RMB 98.30 million reduction in human-derived crude protein business revenue, partially offset by a RMB 48.81 million increase in HIV new drug business revenue[15] - The expanded net loss attributable to shareholders was mainly due to a RMB 26.38 million year-on-year decrease in gross profit from main operations and a RMB 16.76 million year-on-year increase in R&D expenses[15] Non-recurring Gains and Losses and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to RMB 7.89 million, primarily from fair value changes and disposal gains/losses on financial assets and liabilities held by non-financial enterprises, totaling RMB 8.90 million Non-recurring Gains and Losses | Non-recurring Gain/Loss Item | Amount (RMB) | | :--- | :--- | | Disposal gains/losses on non-current assets | -75,076.73 | | Government grants | 379,000.00 | | Fair value changes and disposal gains/losses on financial assets/liabilities | 8,900,732.68 | | Other non-operating income and expenses | 3,497.35 | | Income tax impact | -1,322,797.97 | | Total | 7,885,355.33 | Management Discussion and Analysis Industry and Main Business Overview The company focuses on two core areas: anti-HIV and human-derived proteins, with two commercialized Class 1 new anti-HIV drugs, Ainuoweilin Tablets and Ainomi Tablets, achieving RMB 81.63 million in sales revenue in the first half, a 148.68% year-on-year increase, while the human-derived protein business is advancing an "API-to-formulation integration" strategy through the acquisition of Nandaya Pharmaceutical, leveraging broad market space and significant potential for domestic innovative drug substitution - The company's core business focuses on anti-HIV and human-derived proteins, enhancing core competitiveness through R&D innovation and industrial synergy[19] Key Progress in H1 2024 | Business Segment | Key Progress in H1 2024 | | :--- | :--- | | Anti-HIV New Drugs | Sales revenue approximately RMB 81.63 million, a 148.68% year-on-year increase | | International Business | Established cooperation with Fison Pharma in Nigeria to expand into the West African market | | Human-derived Proteins | Planning to acquire Nandaya Pharmaceutical to implement an "API-to-formulation integration" strategy | - Both of the company's core anti-HIV new drugs, Ainuoweilin Tablets and Ainomi Tablets, have been included in the "Chinese Guidelines for Diagnosis and Treatment of AIDS (2024 Edition)," with Ainomi Tablets receiving the highest A1-level recommendation, indicating high academic recognition[19][20][33] Main Business, Products, and Services The company's main business is divided into anti-HIV and human-derived protein segments, with two Class 1 new anti-HIV drugs, "Aibangde" (Ainuoweilin Tablets) and "Fubangde" (Ainomi Tablets), already commercialized and achieving significant growth, while also possessing a rich R&D pipeline including next-generation integrase inhibitor ACC017, long-acting drug ACC027, and multiple generic drugs, and advancing innovative drug AD105 and several upgraded projects in the human-derived protein field - The company has 20 ongoing R&D projects, including 8 Class 1 new drugs and 4 Class 2 new drugs, forming a tiered pipeline of marketed products and R&D candidates[19] - The core marketed products "Aibangde" (Ainuoweilin Tablets) and "Fubangde" (Ainomi Tablets) have both been included in the National Medical Insurance Catalog, accelerating commercialization, with total HIV new drug sales revenue of approximately RMB 81.63 million in the first half, a 148.68% year-on-year increase[20] - The anti-HIV R&D pipeline is comprehensive, with the next-generation integrase inhibitor ACC017 having completed Phase I single-dose escalation trials with good results, while also actively advancing the development of multiple high-end generic drugs to enrich the product portfolio[21] Industry Overview The global anti-AIDS drug market is shifting towards chronic disease management, projected to reach $58.24 billion by 2032, while domestic HIV treatment demand is rising, creating opportunities for innovative drugs, and human-derived protein products like urokinase and ulinastatin show stable demand, with urokinase facing supply shortages - The global AIDS drug market is projected to grow from $34.13 billion in 2023 to $58.24 billion by 2032, at a compound annual growth rate of 6.2%[30] - China has a large base of living HIV infected individuals, with treatment numbers continuously increasing, and the anti-HIV drug market is transitioning from national free procurement to a combination of medical insurance and out-of-pocket payments, providing vast opportunities for innovative drugs[32][33] - Demand for human-derived protein drugs remains stable, with urokinase listed as a nationally scarce drug due to raw material shortages, while market sales of ulinastatin and urinastatin are both trending upwards[36][37][38] Industry Position Analysis The company has strengthened its position in domestic HIV innovative drugs, holding two of the four approved domestic anti-AIDS innovative drugs, giving it a first-mover advantage, and in human-derived proteins, it is a leading raw material producer, aiming for "API-to-formulation integration" through the acquisition of Nandaya Pharmaceutical (the top domestic urokinase preparation market share holder) to further consolidate and enhance its competitive standing - The company possesses two of the four domestically approved innovative anti-AIDS drugs, with product advantages and commercialization achievements gradually establishing it as a leading enterprise in the domestic industry[39] - Ainomi Tablets are China's first approved Class 1 triple-combination single-pill anti-AIDS new drug with independent intellectual property rights, filling a gap in domestic innovative single-pill fixed-dose combinations and contributing to import substitution[39][40] - In the human-derived protein sector, the company is a leading crude product manufacturer, and after acquiring Nandaya Pharmaceutical, it will integrate its urokinase preparation business, which has held the top market share in domestic hospitals for consecutive years, to achieve full industry chain layout[40] Core Technologies and R&D Progress The company possesses multiple core technologies in human-derived protein and chemical drugs, continuously strengthening its technological barriers through independent R&D, with total R&D investment reaching RMB 48.08 million in the reporting period, a 15.40% year-on-year increase, raising the proportion of revenue to 26.55%, and its rich R&D pipeline covers anti-HIV, human-derived protein, and anti-tumor fields, with several projects achieving phased results, while the R&D team continues to grow to 89 personnel R&D Investment Indicators | R&D Investment Indicator | Current Period | Prior Period | Change (%) | | :--- | :--- | :--- | :--- | | Total R&D Investment (RMB) | 48,077,192.69 | 41,661,651.90 | 15.40 | | Total R&D Investment as % of Operating Revenue | 26.55 | 17.45 | Increased by 9.10 percentage points | | Capitalized R&D Investment as % of Total R&D Investment | 10.23 | 28.61 | Decreased by 18.38 percentage points | - As of the end of the reporting period, the company had cumulatively submitted 82 patent applications and obtained 37 authorized patents, including 20 invention patents, continuously improving its intellectual property protection system[47] - The company has 20 R&D projects, including the anti-HIV integrase inhibitor ACC017 which has completed Phase I single-dose escalation trials, and the anti-HIV fixed-dose combination ACC008 (for treated patients) which has submitted and received acceptance for a new indication marketing application[51] Core Competitiveness Analysis The company's core competitiveness stems from its deep expertise in HIV with two approved Class 1 new drugs and a robust R&D pipeline, integrated "R&D-production" and "API-to-formulation" advantages in both anti-HIV and human-derived protein sectors, a strategic commercialization model, and a strong R&D platform with a talented team - The company's two anti-HIV Class 1 new drugs (Ainuoweilin Tablets, Ainomi Tablets) were successively approved for marketing within two years and included in the "Chinese Guidelines for Diagnosis and Treatment of AIDS," with product advantages and brand effects gradually emerging[56] - The company possesses integrated "API-to-formulation" and "R&D-production" operational advantages in both anti-HIV and human-derived protein core business areas, which contributes to cost control, quality assurance, and R&D innovation[56][57] - The company has established a "medical-led, market-driven, sales-executed" marketing strategy and an innovative self-operated plus distributor marketing model, while actively expanding into overseas markets to advance commercialization[57] Discussion and Analysis of Operations In the first half of 2024, the company achieved operating revenue of RMB 181 million and a net loss attributable to shareholders of RMB 45.43 million, yet core businesses made positive strides: HIV innovative drug commercialization advanced with sales revenue up 148.68% year-on-year; R&D pipeline progressed smoothly, with ACC017 Phase I clinical results being favorable and an invention patent granted; two core products were included in the latest national treatment guidelines, solidifying academic standing; and the proposed acquisition of Nandaya Pharmaceutical will substantially promote human-derived protein business integration, creating a second growth curve - During the reporting period, total HIV new drug sales revenue reached RMB 81.63 million, a 148.68% year-on-year increase, indicating initial effectiveness of the commercialization operating system[60] - The Phase I clinical study of the investigational integrase inhibitor ACC017 has completed single-dose escalation trials, showing good safety and drug exposure levels, and has been granted a national invention patent[62] - The company plans to deepen its human-derived protein business layout through the acquisition of Nandaya Pharmaceutical, building an integrated industry chain from raw materials to formulations, and establishing the company's second growth curve[59][67] Risk Factors The company faces risks including sustained losses from declining human-derived protein business and increased R&D, core competency risks like R&D failure and talent loss, operational risks from project delays and commercialization challenges, industry risks from raw material fluctuations, and acquisition-related risks such as centralized drug procurement and increased financial leverage - Risk of Sustained Losses: Net profit attributable to shareholders was RMB -45.43 million in H1 2024; continued decline in human-derived protein business, lower-than-expected HIV new drug sales, or increased R&D investment could lead to sustained or expanded losses[68] - New Drug R&D and Commercialization Risks: Investigational innovative drugs have long R&D cycles and high uncertainties, posing risks of not meeting expectations; marketed innovative drugs are in early commercialization, potentially facing risks of underperforming market promotion[69][72] - Risks Related to Significant Asset Acquisition: Post-acquisition of Nandaya Pharmaceutical, the company faces risks of centralized procurement for its main product, urokinase for injection, increased financial leverage, and potential impacts on cooperation with other crude product customers[75][76][77] Key Operating Performance During the reporting period, the company's total operating revenue was RMB 181 million, down 24.16% year-on-year, with net loss attributable to shareholders expanding to RMB -45.43 million, primarily due to decreased gross profit and increased R&D expenses, while financial expenses rose, trading financial assets decreased, and non-current liabilities due within one year increased Key Operating Performance | Item | Current Period (RMB) | Prior Period (RMB) | Change (%) | Primary Reason | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 181,066,750.06 | 238,740,738.87 | -24.16 | Decrease in human-derived crude protein business revenue | | R&D Expenses | 46,499,361.18 | 29,743,921.63 | 56.33 | Increased investment in new product development | | Financial Expenses | 6,586,159.21 | 4,118,360.25 | 59.92 | Increase in bank loan interest expenses | | Trading Financial Assets | 115,290,637.12 | 215,749,408.73 | -46.56 | Redemption of wealth management products upon maturity | | Non-current Liabilities Due Within One Year | 172,947,007.58 | 83,851,402.02 | 106.25 | Reclassification of new long-term borrowings due within one year | - The company's loss increased compared to the prior period, primarily due to a RMB 26.38 million decrease in gross profit from main operations and a RMB 16.76 million increase in R&D expenses during the reporting period[79] Corporate Governance Corporate Governance Status During the reporting period, the company held two shareholder meetings, approving key proposals including the annual report and equity incentives, with no changes in directors, supervisors, senior management, or core technical personnel, no profit distribution or capital reserve capitalization plans, and continued progress on restricted stock incentive plans - During the reporting period, the company convened the first extraordinary general meeting of shareholders in 2024 and the 2023 annual general meeting of shareholders, approving proposals including routine related-party transactions, the annual report, and profit distribution plans[90] - The company's directors, supervisors, senior management, and core technical personnel (6 individuals) remained unchanged during the reporting period[91] - The company's board of directors resolved that there would be no profit distribution or capital reserve capitalization plan for the current reporting period[3][92] Environmental and Social Responsibility Environmental Information The company invested RMB 0.915 million in environmental protection during the reporting period, disclosing that all four of its plants met emission standards for wastewater, exhaust gas, noise, and hazardous waste, while also implementing emergency response plans, self-monitoring, and various measures to enhance environmental performance - During the reporting period, the company's environmental protection investment amounted to RMB 0.915 million[97] - The company disclosed detailed pollutant discharge information for its four main plants (Ganquan, Liuzhuang, Wuqiao, Chahe), including wastewater, exhaust gas, noise, and hazardous waste, with all monitoring results indicating compliance with discharge standards[97][101][104][108] - The company has prepared and filed "Emergency Response Plans for Environmental Incidents" for each plant and formulated and implemented "Self-Monitoring Programs" in accordance with pollutant discharge permit requirements[115][116] Significant Matters Fulfillment of Commitments During and continuing through the reporting period, the company's actual controller, shareholders, related parties, and the company itself strictly fulfilled all commitments, including those related to major asset restructuring, initial public offering, and equity incentives, with no instances of failure to perform in a timely manner - The company and relevant parties made commitments regarding information authenticity, confidentiality, and measures to compensate for immediate returns concerning the major asset restructuring (acquisition of Nandaya Pharmaceutical), all of which are being fulfilled[121][122] - Commitments related to the initial public offering, such as share lock-up, resolution of horizontal competition, and standardization of related-party transactions, remain valid and are strictly adhered to[123][124] Explanation of Proceeds Utilization Progress The company's IPO net proceeds were RMB 764 million, with RMB 584 million cumulatively invested by the end of the reporting period (76.49% progress), primarily in clinical and R&D projects, while the "Ulinastatin New Indication Research Project" was extended to June 2025 due to development difficulty, and the API production R&D project concluded, with RMB 33.33 million in remaining funds permanently supplementing working capital Proceeds Utilization Summary | Item | Amount (RMB) | | :--- | :--- | | Net Proceeds from Fundraising | 764,073,045.39 | | Cumulative Investment as of Reporting Period End | 584,428,675.75 | | Cumulative Investment Progress (%) | 76.49 | - The "Ulinastatin New Indication Research Project" implementation progress is behind schedule due to stricter review standards and significant development difficulty, with its planned usable date extended to June 30, 2025[138][140] - The "API Production R&D and Supporting Facilities Project" has been completed, and the remaining proceeds of RMB 33.33 million were permanently transferred to working capital in March 2023[139][140] Share Changes and Shareholder Information Shareholder Information As of the end of the reporting period, the company had 9,481 common shareholders, with a stable top ten shareholder structure where controlling shareholder Guangzhou Weimei Investment Co., Ltd. and its concerted parties held a relatively high combined stake, and Chairman Fu Heliang increased his holdings by 200,000 shares during the period - As of the end of the reporting period, the company had a total of 9,481 common shareholders[146] Top Shareholders | Shareholder Name | Shares Held at Period End | Proportion (%) | | :--- | :--- | :--- | | Guangzhou Weimei Investment Co., Ltd. | 94,500,000 | 22.46 | | Weimei Investment (Hong Kong) Co., Ltd. | 77,693,400 | 18.46 | | AEGLE TECH LIMITED | 16,200,000 | 3.85 | | Fu Hexiang | 13,179,944 | 3.13 | - During the reporting period, the company's Chairman Fu Heliang purchased 200,000 shares of the company's stock as per the share increase plan[149] Financial Report Financial Statements This chapter presents the unaudited consolidated and parent company balance sheets, income statements, cash flow statements, and statements of changes in owners' equity, comprehensively reflecting the company's financial position at the end of the reporting period, as well as its operating results and cash flows during the period - As of the end of the reporting period, the company's total assets were RMB 1.669 billion, a 4.47% decrease from the end of the prior year; net assets attributable to shareholders were RMB 1.084 billion, a 3.70% decrease from the end of the prior year[13][151][153] - During the reporting period, the company achieved operating revenue of RMB 181 million, a 24.16% year-on-year decrease; net profit attributable to shareholders was RMB -45.43 million, compared to RMB -9.6 million in the prior period, indicating an expanded loss[13][158][160] - Net cash flow from operating activities was RMB -78.36 million, an improvement from RMB -119 million in the prior period, primarily due to reduced payments for materials and increased receipts from sales[13][15][163] Notes to Financial Statements This chapter details the basis of financial statement preparation, compliance with accounting standards, and significant accounting policies and estimates, including financial instruments, inventories, revenue recognition, and R&D capitalization, while also providing detailed notes and analysis for major consolidated financial statement items and disclosing related party transactions, share-based payments, and contingent liabilities - The company's financial statements are prepared on a going concern basis, with an operating cycle of 12 months[181][186] - Regarding R&D expenditures, the company defines the stage from new drug projects entering Phase III clinical trials to obtaining production approval as the development stage, where expenditures meeting criteria are capitalized[230][231] - The notes provide detailed disclosure of accounts receivable aging and impairment provisions, with an ending balance of RMB 221 million and an impairment provision of RMB 17.96 million[272][273]