Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[2] - The company reported a pre-tax loss of RMB 249,350,000, a reduction of 65.6% compared to a loss of RMB 725,180,000 in 2022[2] - The net loss for the year was RMB 249,350,000, down from RMB 725,180,000 in the previous year, reflecting a 65.6% improvement[3] - Basic and diluted loss per share for the year was RMB 1.25, compared to RMB 4.98 in 2022[3] - The group incurred a total loss before tax of RMB 249,350,000 for the year ended December 31, 2023, compared to a loss of RMB 725,180,000 in 2022, indicating an improvement in performance[15] - The adjusted loss for the period increased by approximately 46.6% to RMB 222,891,000 for the year ended December 31, 2023, compared to RMB 152,092,000 in 2022, primarily due to increased R&D expenses[66] Research and Development - Research and development expenses rose significantly to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[2] - The company successfully completed the Phase II clinical trial for LZ901 in China, with no serious adverse events reported[2] - The company plans to initiate a Phase III clinical trial for LZ901 in January 2024, involving approximately 26,000 participants across multiple provinces in China[2] - LZ901, a recombinant herpes zoster vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[43] - The Phase II clinical trial of LZ901 was completed in May 2023, and the company plans to submit a Biologics License Application (BLA) to the National Medical Products Administration in Q4 2024[44] - The company has decided to suspend the development of its recombinant rabies vaccine and reallocate resources to the development of a recombinant respiratory syncytial virus (RSV) vaccine[40] - The company has established an innovative protein engineering platform to support the full cycle of drug development, enhancing its capabilities in developing human vaccines and monoclonal antibodies[41] - The company has received IND approval from the FDA for LZ901 and plans to complete the Phase I clinical trial in the U.S. by Q2 2024[44] - The company has three R&D patents and six pending applications related to its core product in China, Russia, and Japan[40] - The company’s proprietary dual-specific antibody development platform, Fabite®, offers competitive advantages in treating recurrent/refractory hematological malignancies[42] - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[45] - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, began Phase I clinical trials in China in December 2019, with completion expected in the second half of 2024[46] - The company has four products in preclinical stages, including the recombinant RSV vaccine, which is being prioritized over the rabies vaccine[47] Assets and Liabilities - The company’s total assets increased to RMB 1,070,382,000 as of December 31, 2023, compared to RMB 976,056,000 in 2022[4] - The company’s equity totalled RMB 1,020,628,000, up from RMB 937,466,000 in the previous year[4] - Non-current assets (excluding financial instruments) increased to RMB 545,391,000 as of December 31, 2023, from RMB 468,853,000 as of December 31, 2022[8] - Total property, plant, and equipment increased from RMB 258,046,000 as of December 31, 2022, to RMB 422,831,000 as of December 31, 2023, reflecting a growth of approximately 64%[19] - The company’s accumulated depreciation for property, plant, and equipment increased from RMB 28,419,000 in 2022 to RMB 38,926,000 in 2023[19] - The right-of-use assets increased from RMB 62,462,000 as of December 31, 2022, to RMB 104,591,000 as of December 31, 2023, showing a growth of approximately 67%[21] - The company has a lease liability of RMB 12,216 thousand as of December 31, 2023, which is slightly higher than RMB 11,219 thousand in the previous year, reflecting an increase of approximately 8.9%[33] - The company’s total liabilities related to lease obligations over five years decreased to RMB 5,036 thousand in December 2023 from RMB 6,770 thousand in December 2022, reflecting a decline of approximately 25.7%[33] Cash Flow and Financing - Cash and cash equivalents increased significantly to RMB 257,891 thousand as of December 31, 2023, compared to RMB 68,976 thousand in the previous year, marking an increase of approximately 274%[28] - The company obtained a new bank loan of RMB 10,000,000 in March 2023, with a remaining balance of RMB 7,000,000 after partial repayment in September 2023[36] - Cash and bank balances increased by approximately RMB 196,000,000 to RMB 265,000,000 as of December 31, 2023, from RMB 69,000,000 as of December 31, 2022, mainly due to net proceeds from the global offering[68] - The company completed a public offering on May 8, 2023, raising net proceeds of approximately HKD 241.6 million, equivalent to about RMB 300.18 million[40] - The net proceeds from the global offering amounted to approximately HKD 241.6 million, with no over-allotment option exercised as of May 8, 2023[73] Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since its listing date[80] - The audit committee reviewed the consolidated financial statements for the year ended December 31, 2023, and discussed matters related to auditing and internal controls[84] - Deloitte has agreed that the figures in the preliminary announcement are consistent with the audited financial statements to be approved on March 15, 2024[85] - The board does not recommend the payment of a final dividend for the year ended December 31, 2023[86] Employee and Operational Insights - A total of 133 full-time employees were employed as of December 31, 2023, with 54.2% in R&D[76] - The production team consists of 28 members, ensuring compliance with quality control standards and regulations[50] - The internal R&D team is involved in all stages of drug development, enhancing the company's capabilities in recombinant protein design and optimization[49] - The company maintains a conservative financing and treasury policy to ensure optimal financial condition and minimal financial risk[78] - The employee incentive plan adopted on December 15, 2021, does not involve the issuance of new shares but grants rights in a partnership[79] Future Plans and Strategic Initiatives - The company plans to expand production capacity to meet growing market demand and accelerate the clinical development of its pipeline products[51] - The company aims to promote the commercialization process both domestically and internationally through strategic planning and partnerships[51] - Funding for ongoing and planned clinical trials of LZ901 in China and the US is set at HKD 97.0 million (40.2%), with HKD 32.8 million already utilized[75] - The company plans to allocate HKD 53.4 million (22.1%) for clinical development and manufacturing of K3, with HKD 38.8 million (16.1%) specifically for planned clinical trials between 2023 and 2024[75]
绿竹生物-B(02480) - 2023 - 年度业绩