贝达药业(300558) - 2025 Q1 - 季度财报

Financial Performance - The company's revenue for Q1 2025 reached ¥917,554,506.92, representing a 24.71% increase compared to ¥735,775,468.80 in the same period last year[6] - Net profit attributable to shareholders was ¥100,089,181.47, a slight increase of 1.99% from ¥98,140,741.56 year-on-year[6] - The net profit after deducting non-recurring gains and losses surged by 83.59% to ¥164,430,292.77 from ¥89,562,834.38 in the previous year[6] - The net cash flow from operating activities improved by 20.35%, amounting to ¥297,535,688.01 compared to ¥247,235,603.12 in the prior year[6] - The company's basic earnings per share increased by 4.35% to ¥0.24 from ¥0.23 in the same period last year[6] - Total operating revenue for the current period reached ¥917,554,506.92, an increase of 24.7% compared to ¥735,775,468.80 in the previous period[25] - Net profit for the current period was ¥95,463,516.48, a slight increase from ¥93,790,802.53 in the previous period, representing a growth of 1.8%[26] - The company reported a net cash flow from operating activities of ¥297,535,688.01, an increase of 20.3% compared to ¥247,235,603.12 in the previous period[28] - Basic and diluted earnings per share were both ¥0.24, up from ¥0.23 in the previous period[26] Assets and Liabilities - Total assets at the end of the reporting period were ¥9,125,518,301.96, down 2.31% from ¥9,341,677,723.81 at the end of the previous year[6] - The total current assets as of March 31, 2025, amounted to CNY 1,301,717,893.56, an increase from CNY 1,224,330,599.97 at the beginning of the period[22] - The total liabilities as of March 31, 2025, were CNY 3,494,218,702.83, down from CNY 3,675,567,489.25 at the beginning of the period[23] - The total assets decreased to CNY 9,125,518,301.96 from CNY 9,341,677,723.81[24] - The total owner's equity as of March 31, 2025, was CNY 5,631,299,599.13, a decrease from CNY 5,666,110,234.56[24] Operating Costs and Expenses - Operating costs increased by 33.65% to ¥171,801,799.66, primarily driven by higher sales volumes of pharmaceuticals[9] - Total operating costs increased to ¥730,520,724.15, up 14% from ¥641,561,760.14 in the previous period[25] - Research and development expenses decreased to ¥113,293,329.82, down 26% from ¥152,750,433.40 in the previous period[25] - The company incurred financial expenses of ¥20,838,891.73, which is an increase of 109.5% compared to ¥9,947,530.44 in the previous period[25] Clinical Developments - The company received FDA approval for its drug, Beimingna (恩沙替尼胶囊), in December 2024, and it was recommended in the NCCN guidelines for NSCLC in January 2025[16] - Xcovery Holdings, Inc. submitted a marketing application to the European Medicines Agency for Beimingna, aiming to provide new treatment options for ALK-positive NSCLC patients[16] - The company’s oral small molecule HIF-2α inhibitor, BPI-452080, has received approval for clinical trials targeting tumors related to von Hippel-Lindau syndrome[16] - DURAVYU™, developed in collaboration with EyePoint Pharmaceuticals, showed significant efficacy in a Phase II trial for diabetic macular edema, with a +7.1 letter improvement in best-corrected visual acuity[17] - In the DURAVYU™ trial, 73% of patients did not require supplemental treatment, compared to 50% in the control group[17] - The company is advancing its clinical trials for DURAVYU™ in both diabetic macular edema and wet age-related macular degeneration[17] - The objective response rate (ORR) for the new MET inhibitor, Bemcentinib, reached 53.3% in patients with advanced NSCLC carrying MET exon 14 skipping mutations[19] - The disease control rate (DCR) for Bemcentinib was reported at 86.7%, with a median progression-free survival (PFS) of 6.0 months and a median duration of response (DoR) of 7.9 months[19] - In patients with ctDNA clearance after 4 weeks, the ORR was 80%, and the median PFS extended to 9.5 months, significantly better than the non-clearance group, which had a median PFS of 2.2 months[19] Non-Recurring Items - The company recorded a total of ¥64,341,111.30 in non-recurring losses, mainly due to fair value changes in financial assets and liabilities[7] - The company recorded a total comprehensive income of -¥42,417,477.67, a significant decline from ¥241,283,970.75 in the previous period[26] Cash and Cash Equivalents - Cash and cash equivalents increased to CNY 548,136,702.10 from CNY 471,682,855.12[22] - Cash and cash equivalents at the end of the period totaled ¥548,136,702.10, a slight decrease from ¥554,020,499.69 at the end of the previous period[28]