东曜药业-B(01875) - 2025 - 中期业绩

Performance Summary Financial and Operational Highlights In H1 2025, total revenue decreased by 6% to RMB 489 million, with product sales slightly down and CDMO/CMO revenue falling 32% due to project delays, leading to an 87% drop in net profit to RMB 4.06 million, while operating cash flow grew 25% to RMB 34.83 million, and core product Bevacizumab Injection made significant overseas market progress Key Financial Indicators for H1 2025 | Indicator | H1 2025 (RMB Thousands) | YoY Change | | :--- | :--- | :--- | | Revenue | 489,140 | -6% | | - Product Sales Revenue | 397,909 | -1% | | - CDMO/CMO Business Revenue | 77,301 | -32% | | Net Profit | 4,062 | -87% | | Net Cash from Operating Activities | 34,830 | +25% | - The decline in net profit is primarily attributed to delayed delivery milestones for key CDMO projects, increased depreciation and amortization from new major construction projects, and higher selling and administrative expenses for overseas market expansion and management system optimization[4] - Core product Bevacizumab Injection (Puxinting®) received marketing approval in Nigeria and Pakistan, with production facilities passing GMP inspections in Brazil, Colombia, and other countries, marking the commencement of the company's international commercial supply[5] - The company-licensed TAB014 (Bevacizumab Intravitreal Injection Solution) to Zhaoke Ophthalmology has submitted a marketing application, making it the first Bevacizumab ophthalmic formulation to be declared for marketing in China for wet age-related macular degeneration (wAMD)[6] Consolidated Financial Information Interim Condensed Consolidated Statement of Comprehensive Income For the six months ended June 30, 2025, the company reported revenue of RMB 489 million, a 6% decrease year-on-year, with operating profit significantly dropping to RMB 9.18 million from RMB 33.26 million due to stable costs and expenses amidst declining revenue, resulting in a net profit of RMB 4.06 million, down 87% year-on-year, and basic and diluted earnings per share of RMB 0.01 Summary of Interim Condensed Consolidated Statement of Comprehensive Income (For the six months ended June 30) | Item | 2025 (RMB Thousands) | 2024 (RMB Thousands) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 489,140 | 520,603 | -6.0% | | Operating Profit | 9,178 | 33,258 | -72.4% | | Profit Before Income Tax | 4,062 | 31,559 | -87.1% | | Profit for the Period | 4,062 | 31,559 | -87.1% | | Basic and Diluted Earnings Per Share (RMB) | 0.01 | 0.04 | -75.0% | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2025, total assets were RMB 1.476 billion, a slight decrease from year-end 2024, while total liabilities decreased to RMB 745 million, primarily due to lower current liabilities, and total equity slightly increased to RMB 732 million, with net current assets improving to RMB 390 million from RMB 328 million Summary of Interim Condensed Consolidated Statement of Financial Position | Item | June 30, 2025 (RMB Thousands) | December 31, 2024 (RMB Thousands) | | :--- | :--- | :--- | | Total Assets | 1,476,422 | 1,508,772 | | Non-current Assets | 729,669 | 765,495 | | Current Assets | 746,753 | 743,277 | | Total Liabilities | 744,740 | 779,117 | | Non-current Liabilities | 388,247 | 363,754 | | Current Liabilities | 356,493 | 415,363 | | Total Equity | 731,682 | 729,655 | | Net Current Assets | 390,260 | 327,914 | Notes to Financial Information The notes detail the company's accounting policies, revenue composition, and asset and liability status, showing that product sales constitute the largest portion of revenue, the vast majority of income and non-current assets are from Mainland China, total borrowings are approximately RMB 396 million with a weighted average effective interest rate of 3.33%, and no dividends were distributed this period Revenue Breakdown for H1 2025 (RMB Thousands) | Revenue Category | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Sales of Goods | 397,909 | 400,400 | | CDMO/CMO | 77,301 | 113,791 | | Commission Income | 6,144 | 5,339 | | Revenue from Licensed-out Products | 4,717 | – | | Others | 3,069 | 1,073 | | Total | 489,140 | 520,603 | - The company's operations are primarily concentrated in Mainland China, with 97.5% of total revenue in H1 2025 originating from Mainland China, and all non-current assets located there[26] - As of June 30, 2025, the company's total borrowings amounted to RMB 396 million, with approximately 90% being non-current (over one year) borrowings, and the weighted average effective interest rate for bank borrowings was 3.33%[38][40] - The Board resolved not to declare an interim dividend for the six months ended June 30, 2025[44] Management Discussion and Analysis Business Review In H1 2025, the company solidified its position as a leading domestic biopharmaceutical CDMO, particularly in the ADC field, adding 16 new projects, accumulating 169 projects, securing RMB 200 million in signed uncompleted orders with a 73% customer repurchase rate, while its self-developed core product Puxinting® (Bevacizumab) achieved significant overseas expansion with approvals in Nigeria and Pakistan, initiating international commercial supply - As a one-stop, integrated, end-to-end antibody and ADC drug CDMO service provider, the company added 16 new projects (including 14 ADC projects) in H1, accumulating a total of 169 projects[47][48] - Signed and uncompleted orders reached RMB 200 million, with a customer repurchase rate of 73% during the reporting period, and the company assisted a client in completing the world's first approved clinical dual-payload ADC project[48] - Core product Puxinting® (Bevacizumab) received marketing approval in Nigeria and Pakistan, with production facilities passing GMP inspections in multiple countries, initiating international commercial supply[50] CDMO Business Development and Competitive Advantages The company's CDMO business leverages its "integrated, end-to-end" antibody and ADC industrialization platform to significantly shorten R&D cycles, continuously iterating technology platforms like BDKcell® and GL-DisacLink™ ADC sugar-site conjugation technology, maintaining a quality management system compliant with Chinese, US, and European GMP standards with over 60 audits, and benefiting from flexible capacity deployment and an experienced international core team for differentiated competitive advantages - Offers "integrated, end-to-end" antibody and ADC one-stop CDMO services, capable of shortening the timeline from DNA sequence to IND submission to as fast as 11 months[56] - Continuously iterates technology platforms, including the self-developed BDKcell® cell line development platform, and co-develops GL-DisacLink™ ADC sugar-site conjugation technology with partners[57][59] - Quality system complies with international standards, having undergone over 60 GMP audits, including a zero-deficiency EU QP audit and official GMP inspections from multiple emerging market countries[60] - The CDMO core team is stable, with key executives averaging over 15 years of multinational enterprise management experience, and as of June 30, 2025, the CDMO team comprised 524 individuals, accounting for 87% of the company's total workforce[62] Marketed Products and R&D Pipeline The company is streamlining its R&D pipeline to reduce expenses and focus on its core CDMO business, with Puxinting® (Bevacizumab Injection) and Tizian® (Temozolomide Capsules) as its main commercial products; Puxinting® is a core revenue driver, generating RMB 398 million in domestic sales in H1 2025 and actively pursuing overseas registrations in 35 countries, while Tizian® continues to supply the market through national centralized procurement Status of Key R&D Pipeline | Investigational Drug | Indication | Current Stage | | :--- | :--- | :--- | | TAE020 | Acute Myeloid Leukemia | Clinical Phase I | | TAB014 | Wet Age-related Macular Degeneration | NDA | | TAC020 | Various Solid Tumors | Preclinical | - Core product Puxinting® (Bevacizumab) generated domestic sales revenue of RMB 398 million in H1 2025, has initiated marketing registration applications in 35 overseas countries, and received approvals in Nigeria and Pakistan[65] - Another marketed product, Tizian® (Temozolomide Capsules), has been included in the National Centralized Drug Procurement list and continues to supply multiple provinces after winning bids[66] Financial Position Analysis In H1 2025, the company's revenue decreased by 6% to RMB 489 million, primarily due to a 32% drop in CDMO business revenue impacted by project delivery milestones, leading to an 87% year-on-year plunge in net profit to RMB 4.06 million due to reduced revenue, increased depreciation and amortization, and higher selling and administrative expenses; R&D expenses decreased by 23% through pipeline streamlining, operating cash flow remained healthy with a 25% increase, and investing cash outflow significantly reduced as project construction neared completion Key Financial Item Changes for H1 2025 (RMB Thousands) | Item | H1 2025 | H1 2024 | Reason for Change | | :--- | :--- | :--- | :--- | | Revenue | 489,140 | 520,603 | Some CDMO projects did not reach delivery milestones | | - Product Sales Revenue | 397,909 | 400,400 | Increased market competition | | - CDMO/CMO Revenue | 77,301 | 113,791 | Significant project milestones completed in prior period | | R&D Expenses | 35,628 | 46,059 | Pipeline streamlining, resources focused on CDMO | | Selling Expenses | 277,445 | 276,482 | Increased investment in overseas market promotion | | General and Administrative Expenses | 34,725 | 32,105 | Company expansion, management system enhancement | | Net Profit | 4,062 | 31,559 | Combined impact of revenue decline and increased expenses | - Net cash inflow from operating activities was RMB 34.83 million, a 25% year-on-year increase, demonstrating effective working capital management[85] - Net cash outflow from investing activities significantly decreased to RMB 26.51 million (from RMB 68.78 million in the prior period), primarily due to the global R&D service center construction project nearing completion[85] Other Information Corporate Governance and Dividends The company's audit committee reviewed the financial statements for the period, the Board resolved not to declare an interim dividend for the six months ended June 30, 2025, and the company complied with the Corporate Governance Code and the Model Code for Securities Transactions by Directors during the reporting period - The Board resolved not to declare an interim dividend for the six months ended June 30, 2025[87] - The company confirmed compliance with the Corporate Governance Code and the Model Code for Securities Transactions by Directors of Listed Issuers as set out in the Listing Rules throughout the reporting period[88][89] Use of Proceeds from Subscription The company provided a detailed disclosure on the use of net proceeds from the 2022 subscription, with approximately RMB 20.09 million utilized in H1 2025 and approximately RMB 18.13 million remaining unutilized, which the company intends to use according to previously announced and subsequently revised proposed uses - Regarding the proceeds from the 2022 subscription, approximately RMB 18.13 million remained unutilized as of June 30, 2025[94] - The company plans to utilize the remaining net proceeds according to the disclosed purposes, as revised by reallocations in 2024 and 2025[94]