Mabwell(688062)2024-10-30 10:22Revenue and Sales Performance - Revenue for the current reporting period increased by 167.73% year-over-year, driven by a 163.22% increase in drug sales revenue to 25.05 million yuan[2][8] - Cumulative revenue from the beginning of the year to the end of the reporting period increased by 41.79%, with drug sales revenue growing 287.12% to 90.715 million yuan[2][8] - Revenue for the first three quarters of 2024 reached 141,095,928.06 RMB, a 41.8% increase compared to 99,511,384.04 RMB in the same period of 2023[21] - Cash received from sales and services in the first three quarters of 2024 was 180,722,393.45 RMB, doubling from 90,276,727.22 RMB in 2023[24] - Cash received from selling goods and providing services was 299.14 million yuan, an increase of 72.97 million yuan compared to the previous period[25] Profit and Loss - Net profit attributable to shareholders for the current reporting period was -249.11 million yuan, with a cumulative net loss of -694.09 million yuan from the beginning of the year[2] - Net loss for the first three quarters of 2024 was 696,015,164.94 RMB, a 2.9% increase from 676,619,021.82 RMB in 2023[22] - Total comprehensive loss for the first three quarters of 2024 was 697,030,853.80 RMB, a 3.8% increase from 671,829,240.37 RMB in 2023[23] - Basic and diluted earnings per share for the first three quarters of 2024 were both -1.74 RMB, compared to -1.68 RMB in 2023[23] R&D Expenses - R&D expenses for the current reporting period amounted to 158.88 million yuan, accounting for 621.42% of revenue, a decrease of 987.81 percentage points year-over-year[3][8] - Cumulative R&D expenses from the beginning of the year to the end of the reporting period were 481.01 million yuan, representing 340.91% of revenue, a decrease of 155.63 percentage points year-over-year[3][8] - R&D expenses for the first three quarters of 2024 were 481,008,266.28 RMB, a slight decrease of 2.6% compared to 494,110,768.85 RMB in 2023[21] Assets and Liabilities - Total assets at the end of the reporting period were 4.50 billion yuan, a slight increase of 0.95% compared to the end of the previous year[3] - Shareholders' equity attributable to the parent company decreased by 25.79% to 1.92 billion yuan compared to the end of the previous year[3] - The company's total liabilities as of September 30, 2024, were 2,592,617,747.89 yuan, with a significant increase in short-term borrowings to 907,717,127.46 yuan[18][19] - The company's total equity as of September 30, 2024, was 1,904,971,009.25 yuan, with a decrease in undistributed profits to -4,445,439,800.10 yuan[19][20] Non-Recurring Gains - Government subsidies contributed 5.19 million yuan to non-recurring gains for the current reporting period, with a cumulative amount of 20.14 million yuan from the beginning of the year[5][6] - Financial asset investment gains and fair value changes contributed 650,412.80 yuan to non-recurring gains for the current reporting period, with a cumulative amount of 2.50 million yuan from the beginning of the year[5][6] Product Pipeline and Clinical Trials - The company has 15 core products in clinical or market stages, including 11 innovative drugs and 4 biosimilars, covering major disease areas such as oncology, immunology, bone diseases, ophthalmology, and hematology[12] - The company's recombinant anti-Nectin-4 antibody-drug conjugate (9MW2821) received FDA Fast Track designation for treating locally advanced or metastatic Nectin-4 positive triple-negative breast cancer[13] - 9MW2821 has been approved by the NMPA to initiate Phase II clinical trials for treating triple-negative breast cancer either as a monotherapy or in combination with PD-1 inhibitors[13] - As of the report date, 9MW2821 has received 3 FDA Fast Track designations and 1 Orphan Drug designation for treating esophageal cancer, cervical cancer, and triple-negative breast cancer[13] - 9MW2821 was included in the CDE's Breakthrough Therapy list for treating locally advanced or metastatic urothelial carcinoma in August 2024[13] - The company initiated 2 Phase III pivotal registration clinical studies for 9MW2821 during the reporting period, targeting cervical cancer and first-line treatment of urothelial carcinoma in combination with PD-1 monoclonal antibody[13] - The company's recombinant human vascular endothelial growth factor receptor-antibody fusion protein (9MW0813) completed Phase III clinical trial head-to-head comparison with the original drug Eylea® in August 2024, with data locked ahead of schedule. The research data is expected to be obtained by the end of 2024, and the market application is planned to be submitted in 2025, potentially becoming one of the top three Eylea® biosimilars in China[14] Marketed Products and Sales - As of the reporting period, the company has three marketed products: Mailishu®, Maijian®, and Junmaikang®. Mailishu® achieved sales revenue of 235.624 million yuan in Q3 2024, with access to 1,336 hospitals and coverage in 2,632 pharmacies[15] - Maijian® achieved sales revenue of 14.876 million yuan in Q3 2024, with access to 42 hospitals and coverage in 653 pharmacies[15] - Junmaikang® has been approved for marketing since March 2022, with access to 270 hospitals and coverage in 1,370 pharmacies[15] - The company signed commercialization agreements for Mailishu® and Maijian® with pharmaceutical companies in Brazil and Jordan in August and September 2024, respectively. For Junmaikang®, agreements were signed with companies in Jordan and Peru in September 2024, covering dozens of overseas markets with a cumulative milestone amount of 14.285 million USD[16] Shareholder Information - The company's largest shareholder, Langrun (Shenzhen) Equity Investment Fund, holds 140,560,000 shares, representing 35.18% of the total shares[9] - The second-largest shareholder, Ningbo Meishan Bonded Port Area Zhongjun Jianlong Investment Partnership, holds 20,000,000 shares, accounting for 5.01% of the total shares[9] - The third-largest shareholder, Liu Datao, holds 15,100,000 shares, representing 3.78% of the total shares[9] - The company's top 10 shareholders include several institutional investors such as China Merchants Bank, China Construction Bank, and China Minsheng Bank, holding shares through various funds[10] Cash Flow - Net cash flow from operating activities was -668.22 million yuan, a decrease of 105.76 million yuan compared to the previous period[25] - Net cash flow from investing activities was -203.17 million yuan, an improvement of 248.53 million yuan compared to the previous period[25] - Net cash flow from financing activities was 827.13 million yuan, an increase of 498.64 million yuan compared to the previous period[26] - Cash paid for goods and services was 21.92 million yuan, a decrease of 35.85 million yuan compared to the previous period[25] - Cash paid to employees was 365.18 million yuan, an increase of 54.74 million yuan compared to the previous period[25] - Cash received from investments was 322.06 million yuan, an increase of 41.22 million yuan compared to the previous period[25] - Cash paid for investments was 290.91 million yuan, an increase of 20.18 million yuan compared to the previous period[25] - Cash received from borrowings was 2.24 billion yuan, an increase of 1.81 billion yuan compared to the previous period[26] - Net increase in cash and cash equivalents was -45.19 million yuan, an improvement of 635.00 million yuan compared to the previous period[26] Operating Costs and Expenses - Operating costs for the first three quarters of 2024 were 844,467,620.30 RMB, up 8.9% from 775,388,223.53 RMB in 2023[21] - Sales expenses for the first three quarters of 2024 were 168,466,717.93 RMB, a 4.5% increase from 161,278,252.49 RMB in 2023[21] - Management expenses for the first three quarters of 2024 were 158,902,611.01 RMB, up 10.2% from 144,203,638.77 RMB in 2023[21] - Financial expenses for the first three quarters of 2024 were 22,740,778.95 RMB, compared to a financial income of 26,622,479.36 RMB in 2023[21] Monetary Funds and Financial Position - As of September 30, 2024, the company's monetary funds amounted to 1,564,341,685.47 yuan, with total assets of 4,497,588,757.14 yuan[17][18][19][20]