Revenue Growth - Revenue increased by 34.3% to RMB 716.9 million in 2023 compared to RMB 533.9 million in 2022[2] - Revenue from gene editing services increased to RMB 74,325 thousand in 2023, up from RMB 61,075 thousand in 2022, representing a growth of 21.7%[13] - Revenue from preclinical pharmacology and efficacy evaluation services rose to RMB 193,396 thousand in 2023, compared to RMB 176,069 thousand in 2022, a 9.8% increase[13] - Model animal sales revenue surged to RMB 272,805 thousand in 2023, a significant 61.1% increase from RMB 169,328 thousand in 2022[13] - Antibody development revenue grew to RMB 175,870 thousand in 2023, up from RMB 126,887 thousand in 2022, marking a 38.6% increase[13] - Total revenue from customer contracts reached RMB 716,912 thousand in 2023, a 34.3% increase from RMB 533,881 thousand in 2022[13] - Revenue from the United States increased to RMB 301,169 thousand in 2023, up from RMB 178,993 thousand in 2022, a 68.3% growth[24] - Revenue from China grew to RMB 308,610 thousand in 2023, compared to RMB 287,736 thousand in 2022, a 7.3% increase[24] - Revenue from antibody development business reached RMB 175.9 million in 2023, a 38.6% increase year-over-year, while model animal sales revenue grew by 61.1% to RMB 272.8 million[43] - Overseas revenue accounted for 57.0% of total revenue in 2023, reaching RMB 408.3 million, a 65.9% increase compared to the previous year[43] - Total revenue increased by 34.3% from RMB 533.9 million in 2022 to RMB 716.9 million in 2023, driven by growth in model animal sales and antibody development[104] - Model animal sales revenue increased to RMB 272.805 million in 2023, accounting for 38.1% of total revenue[104] - Antibody development revenue grew to RMB 175.870 million in 2023, representing 24.5% of total revenue[104] Profit and Loss - Gross profit rose by 29.2% to RMB 506.0 million in 2023 from RMB 391.8 million in 2022[2] - Pre-tax loss decreased by 36.8% to RMB 380.2 million in 2023 from RMB 601.4 million in 2022[2] - Net loss for the year reduced by 36.4% to RMB 383.0 million in 2023 from RMB 602.2 million in 2022[2] - Basic and diluted loss per share decreased by 39.2% to RMB 0.96 in 2023 from RMB 1.58 in 2022[2] - Total reportable segment gross profit for 2023 was RMB 506,351 thousand, up from RMB 392,523 thousand in 2022, a 29.0% increase[23] - The company's pre-tax loss for 2023 was RMB 380,156 thousand, compared to RMB 601,353 thousand in 2022[33] - The company's net loss narrowed by approximately 36.4% in 2023, with plans to achieve near break-even by the end of 2024 through further expansion into high-margin overseas markets and cost control[44] - Gross profit increased by 29.2% from RMB 391.8 million in 2022 to RMB 506.0 million in 2023, driven by increased revenue from model animal sales and antibody development[106] - Gross margin decreased from 73.4% in 2022 to 70.6% in 2023, primarily due to the relocation to a new laboratory in Boston, USA, which reduced the gross margin of preclinical pharmacology and antibody development[106] - The company reported a net loss of RMB 383.0 million in 2023, compared to a net loss of RMB 602.2 million in 2022[117] R&D and Innovation - R&D expenses decreased by 32.2% to RMB 474.4 million in 2023 from RMB 699.2 million in 2022[3] - R&D expenses decreased by 32.2% to RMB 474.4 million in 2023 from RMB 699.2 million in 2022, as the company concluded its large-scale R&D investment phase[43] - R&D personnel totaled 366 as of December 31, 2023, with R&D expenses of RMB 474.4 million in 2023, down from RMB 699.2 million in 2022[89] - Core product R&D expenses were RMB 65.5 million in 2023, accounting for 13.8% of total R&D expenses[89] - R&D expenses decreased by 32.2% from RMB 699.2 million in 2022 to RMB 474.4 million in 2023, mainly due to reduced employee costs, outsourcing fees, and direct material costs[112] - The company's antibody development platform, RenMice, has generated a library of 400,000 to 500,000 antibody sequences for over 1,000 targets, enabling the identification of potential therapeutic antibody molecules[44] - The company's preclinical research services, including gene editing and model animal sales, have gained recognition from both domestic and international clients, contributing to rapid revenue growth and high margins[44] - The company's strategy involves advancing a small number of promising drug molecules to the preclinical stage and then partnering with biotech and pharmaceutical companies for further development and commercialization[45] - The company has completed the development of the "Thousand Mice Ten Thousand Antibodies" project and built a large antibody sequence library by the end of Q3 2023[46] - The "Thousand Mice Ten Thousand Antibodies" project has evaluated approximately 1,000 targets and developed over 800 targets, with a library of 400,000 to 500,000 fully human antibody sequences covering more than 1,000 innovative targets[48] - The company has knocked out over 680 target genes in RenMab and over 270 target genes in RenLite as part of the "Thousand Mice Ten Thousand Antibodies" project[48] - The company plans to expand the antibody library by developing bispecific antibodies and nanobodies using RenLite and RenNano technology platforms[48] - The company's business model involves commercializing antibodies through co-development, authorized transfers, and transfer development agreements, generating revenue from upfront payments, milestone payments, and sales royalties[48] - The company's revenue currently comes mainly from upfront payments, with milestone payments and sales royalties expected to grow significantly in the future[48] - The company's gene editing technology supports antibody discovery and model animal platforms, including the RenMice platform[79] - The company's gene editing services focus on overseas pharmaceutical clients to enhance profitability and value contribution[78] - The company's gene editing platforms include SUPCE, CRISPR/EGE, and ESC/HR, driving technological innovation[80] - The company provides customized gene editing services for rats/mice and cell lines, with final products including animal or cell line models with specific genotypes, genotyping reports, and project completion reports[81] - The company's proprietary SUPCE technology enables chromosome editing on a million-base scale, with high stability and repeatability, as demonstrated by the RenMice platform[82] - The RenMice platform has been licensed to several multinational pharmaceutical companies, including Merck Healthcare KGaA, Johnson & Johnson, Xencor, BeiGene, and Innovent Biologics, generating upfront payments, milestone payments, and sales royalties[83] - The RenMab platform, which uses RenMab mice to discover and generate fully human monoclonal antibodies, has obtained patents in China and the United States in 2023[84] - The RenLite platform generates high-affinity bispecific antibodies and bispecific ADCs, with the ability to produce bispecific ADCs targeting two tumor antigens, such as YH012 and YH013[85][86] - The RenNano platform produces fully human single-chain antibody fragments without the need for in vitro humanization, enabling high-throughput development of fully human heavy-chain antibodies[87] - The RenTCRm platform, based on RenMice, generates fully human antibodies targeting intracellular antigens, providing more candidate molecules for antibody-related drugs and CAR-T therapies[88] - GPCR platform developed based on RenMice, generating highly diverse fully human antibodies with high screening success rates[89] Clinical Trials and Drug Development - YH001 achieved an objective response rate (ORR) of 19.2% (95% CI: 6.6, 39.4) and a disease control rate (DCR) of 61.5% (95% CI: 40.6, 79.8) in a Phase I trial with 26 evaluable patients[50] - YH001 is being evaluated in a Phase I/II trial in the US for advanced or metastatic sarcoma, with 176 patients expected to be enrolled[51] - YH003 demonstrated a complete response (CR) in one patient with pancreatic cancer, who maintained CR status as of June 30, 2023[52] - YH003 Phase II MRCT enrolled 92 PDAC patients, with 47 in the first-line treatment group and 45 in the second-line and beyond treatment group[52] - YH003006 study in China enrolled 20 patients for the treatment of unresectable/metastatic mucosal melanoma, with results expected in the first half of 2024[53] - YH003005 study enrolled 15 patients for the treatment of advanced solid tumors in China and Australia[54] - YH002 Phase I trial showed a disease control rate (DCR) of 20% in 15 patients with advanced solid tumors[55] - YH002 was well-tolerated at doses up to 2.0mg/kg, with 46.7% of patients experiencing treatment-related adverse events (TEAEs)[55] - YH002 reported 3 serious adverse events (SAEs) at the 3.0mg/kg dose level, with no drug-related deaths[55] - YH002 demonstrated disease stabilization (SD) in 3 out of 15 patients based on RECIST v1.1 criteria[55] - YH002 has entered clinical trials in Mexico with promising initial clinical data showing anti-tumor activity[56] - YH004 Phase I clinical trial enrolled 17 patients with doses ranging from 0.01mg/kg to 3.0mg/kg, showing good safety and tolerability[57] - YH005 (RC118) received two orphan drug designations from the FDA for gastric and pancreatic cancer treatment[58] - YH008 secured a licensing deal with Microcore New Domain, including a RMB 40 million upfront payment and up to RMB 556 million in milestone payments[60] - YH012, a HER2/TROP2 bispecific ADC, entered an exclusive option and licensing agreement with Radiance in January 2024[61] - YH013, an EGFR/MET bispecific ADC, signed an exclusive option and licensing agreement with Doma Medical in 2023[62] - YH015, a CD40-targeting antibody, is currently in the CMC stage with potential applications in autoimmune diseases and organ transplantation[63] - YH016 and YH017, novel antibodies targeting myeloid cells and T/NK cells, have identified high-affinity candidate antibodies for further development[64] - YH001 is a recombinant humanized anti-CTLA-4 IgG1 monoclonal antibody[142] - YH002 is a recombinant humanized IgG1 antibody targeting the human OX40 receptor[142] - YH003 is a recombinant humanized agonistic anti-CD40 IgG2 monoclonal antibody[142] - YH004 is a humanized IgG1 anti-4-1BB agonist[142] - YH008 is an anti-PD-1/CD40 bispecific antibody for the treatment of solid tumors[142] - YH012 and YH013 are two bispecific ADCs developed using the RenLite platform, planned for the treatment of solid tumors[142] - YH015 is a fully human IgG1 anti-CD40 monoclonal antibody[142] - YH016 and YH017 are two novel molecules developed using the RenMice platform for the treatment of solid tumors and immune diseases, respectively[143] - 4-1BB is a receptor expressed on activated T cells and NK cells, providing co-stimulatory signals to promote T cell proliferation, survival, and cytotoxic effects[143] Financial Position and Expenses - Cash and bank balances decreased by 33.4% to RMB 417.7 million in 2023 from RMB 626.6 million in 2022[4] - Total equity decreased by 31.3% to RMB 790.4 million in 2023 from RMB 1,150.8 million in 2022[7] - The remaining performance obligation under existing contracts as of December 31, 2023, was RMB 182,160 thousand, expected to be recognized over the next 3 years[14] - Other income and losses net amount for 2023 was RMB 42,259 thousand, compared to RMB 86,710 thousand in 2022[25] - Net fair value change of biological assets for 2023 included realized fair value negative change of RMB 59,940 thousand and unrealized fair value positive change of RMB 64,819 thousand[26] - Financial costs for 2023 increased to RMB 99,844 thousand from RMB 56,139 thousand in 2022, mainly due to higher interest on long-term payables[27] - Employee costs for 2023 decreased to RMB 404,065 thousand from RMB 419,895 thousand in 2022, with a notable increase in equity-settled share-based payment expenses[28] - Depreciation of property, plant, and equipment for 2023 was RMB 182,299 thousand, up from RMB 171,034 thousand in 2022[31] - The company enjoyed a preferential tax rate of 15% in 2023 due to its high-tech enterprise qualification[34] - Basic loss per share for 2023 was calculated based on a net loss attributable to ordinary shareholders of RMB 382,951 thousand[35] - Trade receivables as of December 31, 2023, amounted to RMB 142,205 thousand, up from RMB 107,682 thousand in 2022[38] - The aging analysis of trade receivables showed that 88.5% were within 1 year, 10% were 1-2 years, and 1.5% were 2-3 years as of December 31, 2023[39] - Trade payables and notes payable increased to RMB 175,234 thousand in 2023 from RMB 146,190 thousand in 2022, with a significant rise in payables to third parties from RMB 104,968 thousand to RMB 115,113 thousand[40] - The company's issued and fully paid ordinary shares increased to 399,398 thousand shares by the end of 2023, following the issuance of 24,468 thousand new shares in 2022[41] - Sales costs increased by 48.4% from RMB 142.1 million in 2022 to RMB 210.9 million in 2023, in line with revenue growth[105] - Other income and losses decreased by 51.3% from RMB 86.7 million in 2022 to RMB 42.3 million in 2023, mainly due to a decrease in fair value changes of financial assets and foreign exchange gains[107] - Sales and marketing expenses increased by 25.0% from RMB 50.2 million in 2022 to RMB 62.8 million in 2023, largely due to salary increases in line with revenue growth[110] - General and administrative expenses increased by 8.7% from RMB 263.4 million in 2022 to RMB 286.3 million in 2023, primarily due to increased depreciation, amortization, and rental expenses from the new Boston facility[111] - Cash and cash equivalents decreased from RMB 626.6 million in 2022 to RMB 417.7 million in 2023, primarily due to net operating losses[114] - Financial costs increased by 77.9% from RMB 56.1 million in 2022 to RMB 99.8 million in 2023, driven by higher interest on long-term payables and bank loans[116] - The asset-liability ratio increased from 1.43 in 2022 to 2.10 in 2023, reflecting higher liabilities relative to equity[118] - Total capital expenditure for the year ended December 31, 2023, was approximately RMB 79.8 million, primarily for facility and office building investments and scientific equipment purchases[120] - The company mortgaged its factory and buildings in Baiao Situ Daxing for long-term bank loans, with a net book value of RMB 239,542,000 as of December 31, 2023[121] - Net proceeds from the global offering amounted to approximately HKD 537.0 million (equivalent to RMB 436.3 million), with 70% allocated to core product clinical R&D[125][126] - As of December 31, 2023, the company had utilized HKD 480.5 million of the net proceeds, leaving HKD 56.5 million unused, which is expected to be fully utilized by December 31, 2024[126][127] - The company allocated 35% of the net proceeds (HKD 188.0 million) to YH003 R&D and 35% (HKD 188.0 million) to YH001 clinical development[126] - 15% of the net proceeds (HKD 80.6 million) was used for facility construction and equipment procurement under the "Thousand Mice, Ten Thousand Antibodies" program[126] - The company has no significant contingent liabilities or major investments as of December 31, 2023[120][121] - The company has not conducted any significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the year[122] - The company’s audit committee reviewed and confirmed compliance with accounting standards and regulations for the financial year ended December 31, 2023[128] - The board has decided not to recommend a final dividend for the year ended December 31, 2023 (2022: none)[130] - The company will suspend share transfer registration from May 23, 2024, to May 28, 2024, to determine shareholder eligibility for the annual general meeting on May 28, 2024[130] - The annual report for the year ended December 31, 2023, will be sent to shareholders and published on the Hong Kong Stock Exchange and the company
百奥赛图-B(02315) - 2023 - 年度业绩