贝达药业(300558) - 2023 Q4 - 年度财报

Financial Performance - Revenue in 2023 increased by 3.35% to 2,456,196,486.62 yuan compared to 2022[10] - Net profit attributable to shareholders surged by 139.33% to 348,032,472.42 yuan in 2023[10] - Operating cash flow grew significantly by 198.05% to 914,227,977.50 yuan in 2023[10] - Basic earnings per share rose by 137.14% to 0.83 yuan in 2023[10] - Total assets increased by 15.64% to 9,146,908,395.53 yuan at the end of 2023[10] - Q2 2023 revenue was the highest at 782,259,420.96 yuan among all quarters[11] - Q3 2023 net profit attributable to shareholders reached 156,386,574.59 yuan, the highest quarterly figure[11] - Revenue for 2023 reached 24.56 billion yuan, a year-on-year increase of 3.35%[39] - Net profit attributable to shareholders was 348.03 million yuan, up 139.33% year-on-year[39] - Non-GAAP net profit was 262.85 million yuan, a significant increase of 768.85% year-on-year[39] - Operating cash flow surged to 914.23 million yuan, up 198.05% year-on-year[41] - Total revenue for 2023 reached 2,456,196,486.62 yuan, a year-on-year increase of 3.35%[56] - Pharmaceutical manufacturing accounted for 100% of total revenue, with drug sales contributing 98.40%[56] - Domestic sales accounted for 99.96% of total revenue, with a year-on-year increase of 3.32%[56] - Gross profit margin for pharmaceutical manufacturing was 83.53%, a decrease of 5.16% compared to the previous year[57] - Sales volume increased by 2.52% to 3,047,651 boxes, while production volume decreased by 15.71% to 3,806,830 boxes[58] - The top five customers accounted for 61.45% of total sales, with the largest customer contributing 31.62%[61] - The top five suppliers accounted for 42.23% of total procurement, with the largest supplier contributing 17.17%[62][63] - Sales expenses increased by 9.61% to RMB 853.89 million in 2023 compared to RMB 779.06 million in 2022[64] - Management expenses decreased by 42.49% to RMB 261.76 million in 2023 due to reduced equity incentive costs[64] - Financial expenses decreased by 77.45% to RMB 39.59 million in 2023 due to reduced interest expenses[64] - R&D expenses decreased by 8.54% to RMB 640.14 million in 2023 compared to RMB 699.90 million in 2022[64] - Operating cash flow increased by 198.05% to 914,227,977.50 yuan, driven by higher cash inflows from drug sales[68] - Investment cash flow net outflow increased by 13.68% to -1,505,452,905.04 yuan, mainly due to the purchase of long-term assets and equity investments[68] - Financing cash flow net inflow decreased by 35.40% to 608,193,350.56 yuan, despite a 79.00% increase in cash inflows from financing activities[68] - Net cash and cash equivalents increased by 134.12% to 20,712,054.82 yuan[68] - Non-operating income accounted for 19.12% of total profit, primarily from compensation payments[70] - Long-term loans increased by 11.56% to 1,816,000,000.00 yuan, reflecting new bank loans during the reporting period[71] - Intangible assets increased by 5.84% to 1,943,510,385.64 yuan, mainly due to the transfer of development costs for newly approved drugs[71] - Overseas assets accounted for 26.25% of the company's net assets, with Xcovery Holdings, Inc. being the largest contributor[72] - The fair value of other equity instrument investments increased by 41,845,298.27 yuan, reaching 1,006,597,002.32 yuan at the end of the period[73] - Total investment during the reporting period increased by 8.30% to 1,705,971,266.15 yuan[74] - The company invested a total of 1,116,240,904.06 yuan in significant equity investments during the reporting period, with a total investment loss of -21,721,933.08 yuan[75] - The company invested 716,490,862.42 yuan in Xcovery Holdings, Inc., holding a 98.44% stake, resulting in a loss of -19,696,491.56 yuan[75] - The company invested 249,750,000.00 yuan in Hangzhou Beicheng Venture Capital Partnership, holding a 49.95% stake, resulting in a loss of -2,025,441.52 yuan[75] - The company invested 150,000,041.64 yuan in Beijing Mabworks Biotech Co., Ltd., holding a 2.91% stake[75] - The company invested a total of 589,730,362.09 yuan in significant non-equity investments during the reporting period, with a cumulative actual investment of 1,958,290,885.25 yuan[76] - The DreamWorks Phase II project has a cumulative investment of 1,313,872,501.95 yuan, with a progress rate of 72.99%[76] - The Shengzhou Innovative Drug Industrialization Base project has a cumulative investment of 644,418,383.30 yuan, with a progress rate of 65.76%[76] - The company's securities investment in AGENUS resulted in a loss of -52,907,243.50 yuan, with an ending book value of 28,595,124.38 yuan[77] - The company invested 150,000,041.64 yuan in Beijing Mabworks Biotech Co., Ltd. through a private placement, holding 2,095,558 shares[78] - The company's total raised funds amounted to 1,001,999,913.43 yuan, with a net amount of 995,405,374.70 yuan, and a cumulative usage of 68,991.37 million yuan[79] - The company used up to 300 million yuan of idle raised funds to temporarily supplement working capital, with a usage period not exceeding 12 months, and the full amount was returned to the raised funds special account by December 9, 2023[80] - As of December 31, 2023, the balance of idle raised funds used to temporarily supplement working capital was 260 million yuan[80] - The new drug R&D and R&D equipment upgrade project had a total investment commitment of 742 million yuan, with 58.83% (436.51 million yuan) invested by the end of the reporting period[81] - The supplementary working capital project had a total investment commitment of 260 million yuan, with 100% (253.41 million yuan) invested by the end of the reporting period[81] - The CM082 combined with JS001 for mucosal melanoma treatment clinical phase III project was suspended due to insufficient clinical advantages and inability to gain commercial competitive advantage in the current market environment[81] - The company used 176.58 million yuan of raised funds to replace pre-invested self-raised funds in the fundraising projects and paid issuance costs[81] - As of December 31, 2023, the unused raised funds were stored in the company's raised funds special account, with a balance of 260 million yuan temporarily supplementing working capital[82] - BPI-16350 project received RMB 127.5057 million in funding for Phase III clinical trials targeting HR-positive/HER2-negative advanced breast cancer[83][84] - The investment progress for BPI-16350 reached 62.90% with RMB 80.2009 million cumulatively invested by the end of the reporting period[83] - Hydrochloric acid ensartinib capsule project received RMB 60 million for Phase III clinical trials targeting ALK-positive NSCLC postoperative adjuvant treatment[83][84] - The investment progress for hydrochloric acid ensartinib capsule project reached 21.49% with RMB 12.8927 million cumulatively invested by the end of the reporting period[83] - X-396 project funding was reduced as it completed Phase III clinical trials and received approval for market launch[84] - CM082 combined with JS001 project funding was reduced due to insufficient clinical advantages and lack of commercial competitiveness[84] - MIL60 project funding was reduced as it completed Phase III clinical trials and received approval for market launch[84] - Total adjusted funding for new drug R&D projects amounted to RMB 187.5057 million[83] - Xcovery Holdings, Inc., a subsidiary, reported a net loss of RMB 199.3499 million[85] Product Portfolio and R&D - The company's main products include "Kemena" (Icotinib Hydrochloride Tablets), "Beimena" (Ensartinib), "Beianting" (Bevacizumab Injection), "Saimena" (Befotertinib Mesylate Capsules), and "Fumena" (Vorolanib Tablets)[4] - The company's Beijing and Hangzhou R&D centers are subsidiaries focused on new drug development[4] - The company's main business is the development and production of anti-tumor drugs, including small molecule and large molecule drugs[4] - The company's products are mainly used for the treatment of non-small cell lung cancer (NSCLC) and other cancers[4] - The company has successfully commercialized five new drugs, including Kaimeina, Beimeina, and Saimeina, which have become new revenue growth drivers[22] - The company has established a strong position in the lung cancer treatment field, with Kaimeina being the first domestically developed small molecule lung cancer targeted drug in China[21] - The company has also achieved a breakthrough in the kidney cancer treatment field with the launch of Fumeina, the first domestically developed anti-angiogenic drug in China[21] - The company's R&D pipeline focuses on unmet clinical needs in the field of malignant tumor treatment, particularly lung cancer[21] - The company's strategy includes academic promotion and real-world research to meet the treatment needs of experts and patients[21] - The company aims to build differentiated product advantages and promote more products to achieve successful commercialization[21] - Kemena (Icotinib) achieved a median DFS of 47.0 months vs. 22.1 months in the chemotherapy group for II-IIIA stage NSCLC patients with EGFR mutations[25] - Kemena reduced the risk of disease recurrence by 77% in completely resected IB stage NSCLC patients compared to the observation group[25] - Kemena's 3-year DFS rate was 63.9% vs. 32.5% in the chemotherapy group for II-IIIA stage NSCLC patients[25] - Bemnax (Ensartinib) showed a median PFS of 41.5 months in the overall population and 47.1 months in the non-brain metastasis population for ALK-positive NSCLC[24] - Bemnax's new drug application for first-line treatment of ALK-positive NSCLC was accepted by the US FDA[24] - Saimena (Furmonertinib) achieved a median PFS of 22.1 months in first-line treatment and 16.6 months in second-line treatment for EGFR-mutated NSCLC[24] - Saimena's median OS in second-line treatment reached 31.5 months, with an ORR of 92.3% in patients with baseline brain metastases[24] - Fumena (Fruquintinib) combined with everolimus achieved a median PFS of 10 months and a median OS of 30.4 months in advanced RCC patients[24] - Kemena has been involved in over 100 clinical studies and published 259 SCI papers with a total impact factor of 1,086.97[25] - Kemena was included in the National Reimbursement Drug List (NRDL) for all its approved indications[25] - Envonalkib (Bemena) has achieved a median PFS of 41.5 months in the Asian population, with a 4-year OS rate of 75.7% in the baseline non-brain metastasis group[27] - Envonalkib (Bemena) demonstrated a median PFS of 23.9 months in patients with baseline brain metastasis[27] - Envonalkib (Bemena) showed a median OS of 42.8 months in patients with advanced crizotinib-resistant NSCLC[27] - Envonalkib (Bemena) has published 64 articles with a total impact factor of nearly 400 points[27] - Envonalkib (Bemena) has completed enrollment for Phase II-IIIB in postoperative adjuvant therapy trials in China[26] - Envonalkib (Bemena) has submitted a new drug application for first-line treatment to the US FDA in March 2024[26] - Bevacizumab (Beianting) demonstrated an ORR of 48.6% at 12 weeks, equivalent to Avastin[28] - Bevacizumab (Beianting) has published 3 SCI papers with a total impact factor of 24.23 points[29] - BPI-D0316 (Saimeina) is a novel third-generation EGFR-TKI with independent intellectual property rights[30] - Saimena (Befotertinib) achieved a median PFS of 22.1 months in the IBIO-103 study, significantly higher than the 13.8 months in the Icotinib group[31] - Saimena's median PFS for patients with baseline brain metastasis was 19.4 months, compared to 13.7 months in the Icotinib group[31] - Saimena has been included in the National Reimbursement Drug List and has published 5 SCI papers with a total impact factor of 116.66[31] - Fumena (Vorolanib) combined with Everolimus showed a median PFS of 10.0 months, significantly better than the 6.4 months in the Everolimus monotherapy group[33] - Fumena combined with Everolimus achieved an ORR of 24.8%, significantly higher than the 8.3% in the Everolimus monotherapy group[33] - Fumena has published 17 SCI papers with a total impact factor of 74.06 and has been presented at international conferences[33] - EYP-1901, a sustained-release formulation of Vorolanib, reduced injection frequency by 89% and 85% in the 2mg and 3mg dose groups, respectively[33] - 65% and 64% of patients in the EYP-1901 2mg and 3mg dose groups did not require anti-VEGF rescue therapy for six months[33] - The company has established a leading domestic R&D system with centers in Beijing and Hangzhou, focusing on unmet clinical needs[35] - The company adheres to GMP standards throughout the entire production process, ensuring stable product quality[37] - R&D investment in 2023 was 1.00 billion yuan, accounting for 40.80% of revenue[41] - Kaimeina (凯美纳) extended its product lifecycle with stable sales, supported by strong clinical data[40] - Beimeina (贝美纳) saw rapid sales growth after being included in the National Reimbursement Drug List (NRDL) in 2023[40] - New products Saimeina (赛美纳) and Fumeina (伏美纳) were approved and included in the NRDL, contributing to revenue growth[40] - The company has 5 marketed products, with 4 included in the NRDL, diversifying revenue sources[48] - Strategic collaborations with companies like TianGuangShi and EYPT enriched the R&D pipeline[45] - R&D investment in 2023 reached RMB 10,020.505 million, accounting for 40.80% of total revenue, driving pipeline growth and achieving milestones[49] - 5 products are now on the market, with 4 included in the National Reimbursement Drug List (NRDL)[49] - BPI-16350 Phase III clinical study completed patient enrollment in April 2023, showing a confirmed ORR of 60.5% with good safety[49] - 10 drug candidates/indications received clinical trial approvals in 2023, including TEAD inhibitor BPI-460372 approved for clinical studies in both China and the US[49] - CFT8919 exclusive rights in China secured with a $10 million upfront payment, and$25 million invested in C4T for 5,567,928 shares[51] - RMB 21 million invested in Hangzhou Guoshun Jianheng Venture Capital Partnership, with the company contributing RMB 4 million (19.05%)[51] - Production of all batches in 2023 achieved a 100% qualification rate, ensuring stable supply for commercial and clinical use[52] - BPI-442096, BPI-371153, BPI-361175, BPI-452080, BPI-460372, and BPI-21668 clinical trial drug supplies were delivered as planned[53] - Ensartinib (ALK inhibitor) NDA for NSCLC treatment accepted by the US FDA, currently under review[54] - Caimena and Baimena maintained in the NRDL, while Samena and Fumena were newly included in 2023[54] - The company's main products include Icotinib Hydrochloride Tablets, Ensartinib Hydrochloride Capsules, Befotertinib Mesylate Capsules, and Vorolanib Tablets, all of which are protected by patents until at least 2027[55] - The company has multiple R&D projects in Phase III clinical trials, including BPI-16350 and BPI-D0316, which are expected to contribute to future revenue growth[65] - The company decided to suspend the development of BPI-43487 and BPI-421286 due to insufficient clinical advantages[66] Corporate Governance and Shareholder Information - The company's profit distribution plan for 2023 is to distribute a cash dividend of 1.7 yuan per 10 shares (tax included) based on 418,485,885 shares[3] - The company's registered address was changed to No. 355 Xingzhong Road, Economic and Technological Development Zone, Linping District, Hangzhou, Zhejiang Province on December 12, 2023[6] - The company's stock code is 300558, and its legal representative is Ding Lieming[6] -