Share Issuance and Ownership - The company has issued a total of 1,294,002,733 shares as of June 30, 2023[4][20] - Longpan Fund III holds a beneficial ownership of 35,152,768 shares, representing 2.72% of the total shares[7] - The beneficial ownership of certain individuals is 82,022 shares, representing 0.006% of the total shares[2] - The company's share capital as of June 30, 2023, was RMB 836 thousand, with 1,294,002,733 ordinary shares issued[143] Share Option and Restricted Share Unit Plans - The maximum number of shares that can be granted under the Pre-IPO Share Option Plan is 25,947,096 shares[18] - The Pre-IPO Share Option Plan is effective from the adoption date until the day before the listing date[19] - The company has issued restricted share units and share options to directors under the Restricted Share Unit Plan and Post-IPO Share Option Plan[3][4] - The company granted 4,988,000 restricted share units to 105 employees at zero cost under the Restricted Share Unit Plan[48] - As of June 30, 2023, 5,013,534 restricted share units had vested and 3,429,004 had lapsed under the Restricted Share Unit Plan[48] - The company had 20,256,959 unvested restricted share units under the Restricted Share Unit Plan as of June 30, 2023[48] - The company granted 5,013,534 restricted share units during the six months ended June 30, 2023, resulting in a transfer of RMB 20,197 thousand from the share-based compensation reserve to share premium[144] - The company issued 18,850,500 stock options during the six months ended June 30, 2023, with a weighted average exercise price of USD 0.2322 per option[149] - The company had 55,625,659 outstanding stock options as of June 30, 2023, with a weighted average exercise price of USD 0.4787 per option[149] - The total number of shares available for issuance under the post-IPO share option plan is 115,751,136, representing approximately 8.94% of the total issued shares as of the latest practicable date[192] - The exercise price of restricted share units is zero[188] - The company's restricted share units vest in two schedules: 25% on the first anniversary of the grantee's employment start date or on December 1, 2023, with the remaining vesting monthly over the next three years[186] Corporate Governance - The company has established an audit committee composed of three independent non-executive directors[14] - The company continues to regularly review and monitor corporate governance practices to ensure compliance with the Corporate Governance Code[12] - The company has adopted a policy on "inside information" to fulfill its responsibilities under the Securities and Futures Ordinance and Listing Rules[8] - The company has disclosed changes in director information since April 20, 2023, in accordance with Listing Rule 13.51B (1)[9] Financial Performance and Expenses - The company achieved a turnaround from a loss of RMB 1,136.1 million in the first half of 2022 to a profit of RMB 650.6 million in the first half of 2023, primarily due to CEPI funding recognized as other income and a 50% reduction in R&D and administrative expenses[76] - Administrative expenses decreased significantly by RMB 115.8 million, or 51%, from RMB 225.3 million in the first half of 2022 to RMB 109.5 million in the first half of 2023, primarily due to workforce reductions and cost-saving measures[75] - R&D expenses decreased from RMB 855.3 million in the first half of 2022 to RMB 385.6 million in the first half of 2023, reflecting a reduction in research and development activities[72] - Other expenses increased significantly from RMB 65.1 million in the first half of 2022 to RMB 1,330.9 million in the first half of 2023, primarily due to inventory provisions[72] - Cash and bank balances decreased to RMB 1,522,872 thousand as of June 30, 2023, compared to RMB 1,856,513 thousand as of December 31, 2022[82] - Other income and gains increased significantly to RMB 2,510.8 million for the six months ended June 30, 2023, primarily due to RMB 2,494.1 million received from CEPI[84] - Other expenses increased to RMB 1,330.9 million for the six months ended June 30, 2023, mainly due to a provision for inventory (mostly raw materials) of RMB 1,236.7 million[86] - Adjusted profit for the period was RMB 674,468 thousand for the six months ended June 30, 2023, compared to a loss of RMB 1,072,218 thousand for the same period in 2022[88] - The company reported a net profit of RMB 650,624 thousand for the six months ended June 30, 2023, compared to a net loss of RMB 1,136,085 thousand in the same period last year[138] - The company's total comprehensive income for the six months ended June 30, 2023, was RMB 671,837 thousand, compared to a total comprehensive loss of RMB 1,103,133 thousand in the same period last year[139] - The company's adjusted net profit for the six months ended June 30, 2023, was RMB 674,468 thousand, compared to an adjusted net loss of RMB 1,072,218 thousand in the same period last year[139] - The company's deferred revenue balance as of June 30, 2023, was RMB 117,826 thousand, including RMB 53,221 thousand in cash funding from CEPI and RMB 64,605 thousand for certain vials donated by CEPI in previous years[140] - The company's revenue from SCB-2019 (CpG 1018/Aluminum Adjuvant) since its commercial launch in China in February 2023 was RMB 0.3 million as of June 30, 2023[171] - Other income and gains increased by RMB 2,499.0 million to RMB 2,510.8 million for the six months ended June 30, 2023, primarily due to the recognition of RMB 2,494.1 million in funding from CEPI[172] - Sales and distribution expenses related to the launch of commercial sales activities were RMB 22.5 million for the six months ended June 30, 2023[173] - The company's other expenses increased by RMB 1,265.8 million to RMB 1,330.9 million for the six months ended June 30, 2023, mainly due to a provision for inventory (mostly raw materials) of RMB 1,236.7 million[176] - The company's financial costs increased by RMB 9.5 million to RMB 11.7 million for the six months ended June 30, 2023, mainly due to increased interest expenses on bank loans[177] - The company provides adjusted profit/loss as supplementary information, which is not required by IFRS but is considered useful for shareholders and potential investors[178] Employee Compensation and Benefits - Restricted stock units granted to Wu Jing totaled 2,123,254 units as of January 1, 2023, with 303,324 units traded during the reporting period[29] - Wu Peng held 1,213,303 restricted stock units as of January 1, 2023, with 173,320 units traded during the reporting period[29] - Ralf Leo Clemens had 485,331 restricted stock units as of April 18, 2021, with 103,932 units traded from January 15, 2023, to June 15, 2023[29] - Short-term employee benefits totaled RMB 26,711 thousand for the six months ended June 30, 2023[54] - Share-based compensation expenses were RMB 17,882 thousand for the six months ended June 30, 2023[54] - Post-employment benefits amounted to RMB 3,162 thousand for the six months ended June 30, 2023[54] - Total remuneration paid to key management personnel was RMB 47,755 thousand for the six months ended June 30, 2023[54] - The fair value of share options granted to directors and employees under the Post-IPO Share Option Scheme was RMB 16,275,000 for the six months ended June 30, 2023[158] - The company recognized share-based compensation expenses of RMB 15,125,000 for the six months ended June 30, 2023[158] - As of June 30, 2023, the company had unexercised share options with exercise prices ranging from HKD 0.001 to HKD 7.300 and exercise periods from 2022 to 2033[156] - As of December 31, 2022, the company had 23,711,497 unvested restricted share units under the Restricted Share Unit Plan[160] - The weighted average closing price of shares before the vesting date of restricted share units during the reporting period was HKD 1.99[187] Fair Value Measurements - The fair value of financial assets measured at fair value through profit or loss was RMB 14,452 thousand as of June 30, 2023[37] - No significant transfers between Level 1 and Level 2 fair value measurements occurred during the period[39] - The fair value of financial assets measured at fair value through profit or loss was RMB 14,452 thousand[58] - The fair value of financial assets measured at fair value through profit or loss was RMB 13,929 thousand[58] Vaccine Development and Commercialization - The company completed registration applications for its COVID-19 vaccine in one Southeast Asian country and one Latin American country in the first half of 2023[95] - The company plans to disclose more preclinical data and development plans for its RSV PreF vaccine in the second half of 2023[96] - The company announced an exclusive agreement with Adimmune Corporation to distribute AdimFlu-S (QIS) in mainland China, the only imported quadrivalent seasonal influenza vaccine approved for individuals aged three and above[89][103] - The company has completed initial internal commercial capability building to support the commercialization of AdimFlu-S (QIS) and partnered with Keyuan Trading to maximize its access and commercial success[90] - The company's Trimer-Tag technology platform is the only one globally that uses a human-derived trimerization tag to produce recombinant covalent trimerized fusion proteins[98] - The company is focusing on building a leading respiratory vaccine portfolio, including seasonal influenza, COVID-19, RSV, and PCV vaccines[102] - AdimFlu-S (QIS) is expected to be commercially launched in mainland China in the second half of 2023, with production starting in Q1 2023 and importation planned for Q3 2023[104] - The company aims to be among the first in China to enter human clinical trials for the RSV PreF vaccine, with more preclinical data and development plans to be disclosed in the second half of 2023[105] - SCB-1019, an RSV candidate vaccine, is being developed without oil-in-water emulsion adjuvants, potentially offering industry-leading safety and tolerability, including for infant populations[107] - The company completed COVID-19 vaccine registration applications in one Southeast Asian country and one Latin American country in the first half of 2023, with regulatory reviews ongoing[108] - SCB-219M, a candidate vaccine for XBB variant, is expected to release interim Phase 1 clinical trial data in Q4 2023[109] - The company anticipates at least one additional vaccine licensing deal in 2023 to expand its mid-to-late stage pipeline, focusing on PCV and pediatric vaccines[110] - The company’s COVID-19 vaccine has been launched in 28 provinces in China, covering over 95% of the population, demonstrating strong commercialization and market access capabilities[118] - The company’s proprietary production base in Zhejiang Changxing has established commercial-scale production capabilities for COVID-19 vaccines and passed multiple GMP inspections[132] - The company's COVID-19 vaccine has been launched in 28 provinces in China, covering over 95% of the population[182] - The company is developing a new generation of COVID-19 vaccines targeting the XBB.1.5 variant, with development expected to be completed in the second half of 2023[183] - The RSV vaccine candidate utilizes the Trimer-Tag platform, positioning the company as a leading RSV vaccine developer in China and globally[179] - SCB-1019 will be commercially produced at the Changxing facility, which has passed multiple GMP reviews and obtained a vaccine production license from the Chinese National Medical Products Administration[181] - The company is transitioning into a commercial-stage biopharmaceutical company, focusing on expanding its product and vaccine candidate portfolio for long-term sustainable development[185] Operational Expenses and Leasing - Office leasing and utility expenses in Chengdu Tianhe amounted to RMB 1,977 thousand for the six months ended June 30, 2023[51] - The company's lease liability with Chengdu Tianhe was RMB 5,984,000 as of June 30, 2023[165] Financial Statements and Reporting - The board of directors approved the issuance of the interim condensed consolidated financial information on August 22, 2023[41] - Cash and bank balances decreased by RMB 333.6 million to RMB 1,522.9 million as of June 30, 2023, primarily due to commercial capacity expansion and ongoing R&D activities[113] - R&D expenses decreased by 55% to RMB 385.6 million in the first half of 2023, as activities related to SCB-2019 (CpG 1018/aluminum adjuvant) were largely completed[115] - The company's total equity as of June 30, 2023, was RMB 8,589,440 thousand, including RMB 8,588,636 thousand in share premium[144]
三叶草生物-B(02197) - 2023 - 中期财报