三叶草生物-B(02197) - 2024 - 中期财报

Company and Financial Overview Corporate Information Provides basic corporate information, including board composition, registered offices, auditors, and listing details - The company is incorporated in the Cayman Islands, headquartered in Shanghai, with its principal place of business in Hong Kong[2] - The company's stock code is 2197, listed on the Hong Kong Stock Exchange on November 5, 2021, with Ernst & Young as the auditor[3] Financial Highlights The company shifted from a profit to a loss, primarily due to the absence of significant one-off income and reduced expenses across all categories Key Financial Data for H1 2024 (vs. H1 2023) | Metric | Six Months Ended June 30, 2024 (RMB'000) | Six Months Ended June 30, 2023 (RMB'000) | Change | | :--- | :--- | :--- | :--- | | Revenue | (10,100) | 257 | Turned to negative revenue | | Other Income and Gains | 67,148 | 2,510,809 | -97.3% | | R&D Expenses | (98,297) | (385,603) | -74.5% | | Administrative Expenses | (42,075) | (109,468) | -61.6% | | Period (Loss)/Profit | (95,123) | 650,624 | Shifted from profit to loss | | Adjusted Period (Loss)/Profit | (87,259) | 674,468 | Shifted from profit to loss | - Cash and bank balances decreased from RMB 1.096 billion at the end of 2023 to RMB 830 million at the end of the reporting period, mainly due to daily operations and repayment of bank loans[4][5] - R&D expenses decreased significantly by 75% (approximately RMB 287 million) year-over-year, as R&D activities for the COVID-19 vaccine SCB-2019 were completed and operations were streamlined[6] - Other expenses decreased by 99.8% year-over-year, primarily because a RMB 1.237 billion inventory provision for the COVID-19 vaccine was recorded in the prior-year period, with no such expense this period[6][29] Management Discussion and Analysis Business Summary and Outlook The company is focusing on its respiratory vaccine portfolio, prioritizing the development of its RSV candidate while ensuring financial sustainability through operational efficiency - The company's core strategy is to build a leading global respiratory vaccine portfolio using its validated Trimer-Tag technology platform[21] - The company will prioritize resources for the development of its proprietary bivalent PreF RSV vaccine candidate, SCB-1019, with full Phase I results expected by the end of 2024[21] - The company will continue measures to ensure financial sustainability, including improving operational efficiency and maintaining robust cash flow management[21] Product Pipeline and Business Review Details the progress of the product pipeline, highlighting positive RSV candidate data, commercial readiness of the influenza vaccine, and exploration of other opportunities RSV Vaccine Candidate (SCB-1019) The bivalent RSV candidate SCB-1019 demonstrated encouraging immunogenicity and safety in its Phase I trial, showing competitive potential - SCB-1019 is a bivalent RSV vaccine candidate developed using the Trimer-Tag platform, with its Phase I clinical trial initiated in Australia[14] Preliminary Immunogenicity Data for SCB-1019 in Older Adults (28 Days Post-Vaccination) | Antibody Type | SCB-1019 Group GMT (IU/mL) | Placebo Group GMT (IU/mL) | | :--- | :--- | :--- | | RSV-A Neutralizing Antibody | Up to 7,906 | 1,078 | | RSV-B Neutralizing Antibody | Up to 46,674 | 12,185 | - SCB-1019 was well-tolerated, with adverse events generally mild and comparable to the placebo group, indicating a potential safety differentiation advantage[16] AdimFlu-S (Quadrivalent Influenza Vaccine) The company holds exclusive distribution rights for AdimFlu-S in mainland China and completed batch release ahead of the flu season - The company completed the batch release for AdimFlu-S at the end of July 2024, significantly earlier than the mid-September 2023 release, helping to capture sales opportunities for the autumn/winter season[11][16] SCB-219M (CIT Treatment) The company is actively exploring business development opportunities for SCB-219M, a treatment for chemotherapy-induced thrombocytopenia, following positive Phase I data - The company is actively seeking business development opportunities for SCB-219M and may initiate a Phase Ib clinical trial before the end of 2024[17] COVID-19 Vaccine The company is prudently assessing market opportunities for its COVID-19 vaccine after the market in mainland China transitioned to a private-pay model - The COVID-19 vaccine market in mainland China transitioned to a private-pay model on July 15, 2024, and the company is evaluating its impact on future commercialization[18] R&D, Manufacturing, and Other Developments The company maintains an internal R&D team and a GMP-compliant manufacturing facility, while continuing to streamline operations for efficiency - As of June 30, 2024, the company's internal R&D team consisted of 124 employees[18] - The company's proprietary manufacturing facility in Changxing, Zhejiang has obtained a Drug Manufacturing License (DML) for vaccines, supporting future product development including the RSV candidate[19] - The company continues to streamline its organization and scrutinize expenditures to address macroeconomic challenges and improve operational efficiency[20] Financial Review Provides an in-depth analysis of financial performance, including negative revenue from sales returns, a sharp drop in other income, and significantly lower operating expenses Revenue Analysis The company recorded negative revenue of approximately RMB 10.1 million due to higher-than-expected sales returns for its influenza vaccine, AdimFlu-S - The company recorded negative revenue of RMB 10.1 million during the period due to sales returns of the quadrivalent influenza vaccine AdimFlu-S[23] - Sales returns were higher than anticipated because an expected influenza outbreak in spring 2024 did not materialize, leading to lower-than-expected market demand[23][124] Expense Analysis All major expense categories decreased significantly year-over-year, reflecting cost control measures such as team optimization and strategic R&D prioritization Year-over-Year Change in Expenses | Expense Item | H1 2024 (RMB'000) | H1 2023 (RMB'000) | YoY Change | | :--- | :--- | :--- | :--- | | Selling and Distribution Expenses | 6,684 | 22,511 | -70.3% | | Administrative Expenses | 42,075 | 109,468 | -61.6% | | R&D Expenses | 98,297 | 385,603 | -74.5% | | Other Expenses | 2,540 | 1,330,909 | -99.8% | - The decrease in administrative expenses was mainly attributable to lower salaries and benefits from organizational streamlining, as well as reduced consulting and depreciation fees[26] - The reduction in R&D expenses was primarily due to the completion of activities related to the COVID-19 vaccine SCB-2019 and the company's strategic focus on its respiratory vaccine portfolio[27] Liquidity and Capital Management The company maintains a net cash position with sufficient liquidity to sustain operations, despite a decrease in cash reserves and net current liabilities - As of June 30, 2024, the Group's cash and bank balances stood at RMB 829.8 million[35] - As of June 30, 2024, the Group was in a net cash position, making the gearing ratio not applicable[36] - As of June 30, 2024, the Group had RMB 347.2 million in time deposits pledged for bank credit facilities[36] Other Information Shareholding Structure and Directors' Interests Discloses the shareholdings of directors, chief executives, and substantial shareholders, with executive directors Dr. Peng Liang and Mr. Guo Liang as controlling shareholders - Executive directors Dr. Peng Liang and Mr. Guo Liang are deemed to have a joint interest in each other's shares due to a concert party deed[40][41] - Substantial shareholders (holding over 5%) include JNRY (7.03%), AUT-XXI (5.12%), Shanghai Tianhe (5.40%), and Ms. Shibi Wang (indirectly holding 6.98% through controlled corporations)[42][43] Share Incentive Schemes The company operates Pre-IPO, RSU, and Post-IPO share incentive schemes to reward directors, employees, and consultants for their contributions - As of June 30, 2024, 1,852,817 share options under the Pre-IPO Share Option Scheme remained outstanding[60] - As of June 30, 2024, 15,557,014 unvested Restricted Share Units (RSUs) were outstanding under the RSU Scheme[72][74] - As of June 30, 2024, 35,401,791 share options under the Post-IPO Share Option Scheme remained outstanding[90][91] Use of Proceeds Details the utilization of net proceeds from the Global Offering and Placing, with funds primarily allocated to R&D and commercialization of the respiratory vaccine portfolio Use of Net Proceeds from the Global Offering (as of June 30, 2024) | Use of Proceeds (Post-reallocation) | Re-allocated Amount (RMB million) | Utilized Amount (RMB million) | Unutilized Amount (RMB million) | Expected Full Utilization Date | | :--- | :--- | :--- | :--- | :--- | | Development of RSV candidate SCB-1019 | 228.4 | 130.1 | 98.3 | Before June 2025 | | R&D for other pipeline candidates | 93.4 | 40.9 | 52.5 | Before June 2025 | | R&D for COVID-19 vaccine | 51.9 | 51.9 | 0 | Completed | | Working capital and other | 41.5 | 41.5 | 0 | Completed | - Net proceeds from the Placing amounted to approximately RMB 449 million, of which RMB 416.6 million (92.8%) had been used as of June 30, 2024, with the remainder expected to be used by December 2024[101][102] Interim Condensed Consolidated Financial Statements and Notes Key Financial Statements Presents the unaudited interim consolidated statements, showing a net loss for the period and a net liability position on the balance sheet Core Financial Statement Data (as of June 30, 2024) | Statement Item | Amount (RMB'000) | | :--- | :--- | | Income Statement (H1 2024) | | | Loss for the period | (95,123) | | Basic loss per share | (0.08) yuan | | Statement of Financial Position (Period-end) | | | Total Assets | 1,797,271 | | Total Liabilities | 2,630,046 | | Total Equity (Deficit) | (832,775) | | Cash and cash equivalents | 458,774 | | Cash Flow Statement (H1 2024) | | | Net cash flow from operating activities | (157,926) | | Net cash flow from investing activities | (9,011) | | Net cash flow from financing activities | (111,887) | Summary of Notes to Financial Statements Provides detailed explanations for key financial data, including the basis of preparation, contract liabilities, and related party transactions - Despite recording net liabilities of RMB 833 million as of June 30, 2024, the directors believe the company can operate as a going concern, considering non-cash-flow-generating contract liabilities and available financing[118] - Contract liabilities of RMB 1.589 billion primarily consist of an advance payment from GAVI for the SCB-2019 vaccine, for which GAVI has not yet exercised its purchase option[152] - The non-current portion of trade payables, approximately RMB 508 million, is owed to Dynavax for the purchase of CpG 1018 adjuvant, with a settlement period exceeding 12 months[151] - During the period, the company incurred office rental and utility expenses of RMB 2.847 million with related party Chengdu Tianhe[170]