Vaccine Product Portfolio and Pipeline - AimBio has 8 commercially available vaccine products and 21 vaccine products in the pipeline, covering the top 10 global vaccine varieties[6] - AIM Vaccine has 14 clinical approvals and 21 clinical trials, with 5 Phase III trials in the final stages[9] - The company plans to submit market registration applications for 3 upgraded products in 2024: 13-valent pneumococcal conjugate vaccine, serum-free iterative rabies vaccine, and 23-valent pneumococcal vaccine[9] - AIM Vaccine is advancing 21 blockbuster vaccines, including 20-valent and 24-valent pneumococcal conjugate vaccines, and mRNA rabies vaccine[9] - The mRNA RSV vaccine and mRNA shingles vaccine are key global blockbuster products under development[9] - The company obtained 14 clinical approvals by the end of 2023 and conducted 21 clinical trials, with 5 in Phase III clinical trials[12] - The company expects 3 products to be registered and launched in 2024, with 7 products to be submitted for clinical trials[12] - The company submitted pre-approval materials for the 13-valent pneumococcal conjugate vaccine (PCV13) to the National Medical Products Administration[12] - The company completed Phase III clinical trials for the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the serum-free iterative rabies vaccine[12] - The company received clinical approval for the innovative EV71-CA16 bivalent hand, foot, and mouth disease vaccine[12] - The company's mRNA iterative rabies vaccine is the first non-COVID mRNA vaccine product accepted in China[12] - The company has commercialized 8 vaccines targeting 6 disease areas, with 21 vaccines in development for 14 disease areas, and has obtained 14 clinical approvals for 9 varieties[15] - The 13-valent pneumococcal conjugate vaccine (PCV13) has completed Phase III clinical trials and submitted a pre-application for market registration to the National Medical Products Administration[15] - The 23-valent pneumococcal polysaccharide vaccine (PPSV23) has completed Phase III clinical trials and is undergoing serum testing, with statistical unblinding imminent[15] - The serum-free iterative rabies vaccine completed Phase III clinical trials in September 2023 and is undergoing serum testing, with statistical unblinding imminent[15] - The quadrivalent meningococcal conjugate vaccine (MCV4) has completed Phase I clinical trials and initiated Phase II subject enrollment[15] - The quadrivalent meningococcal polysaccharide vaccine (MPSV4) has initiated Phase IV clinical subject enrollment[15] - The bivalent Delta-Omicron BA.5 mRNA COVID-19 vaccine has completed domestic Phase I and II clinical trials, with overseas Phase III trials in the final stages[15] - The company has submitted pre-applications for clinical trials for the 20-valent pneumococcal conjugate vaccine (PCV20), Hib conjugate vaccine, tetanus vaccine, quadrivalent MDCK cell influenza vaccine, and high-potency human diploid cell rabies vaccine[15] - The company's PCV13 vaccine completed Phase III clinical trials and submitted a pre-application for market registration, with plans to complete market application in 2024[23] - The company's PCV20 vaccine plans to submit a CTA in 2024, and PCV24 vaccine plans to submit a CTA in 2025[22] - The company's PPSV23 vaccine completed Phase III clinical trials and plans to submit a market registration application in 2024[22] - The company's MCV4 vaccine has completed Phase II clinical enrollment and plans to initiate Phase III in 2024[22] - The global PCV13 vaccine shortage is estimated at 180 million doses, and the company's PCV13 vaccine could become a major supplier upon market approval[24] - The company's PCV13 vaccine Phase III clinical trial involved 3,780 participants aged 6 weeks to 71 months[23] - The PCV13 vaccine market in China is projected to exceed RMB 20 billion by 2030, with current penetration at 25.9% compared to over 80% in the US[23] - The company's mRNA rabies vaccine is under clinical trial application review, with plans to submit a CTA for mRNA shingles vaccine in 2024[22] - The company has completed the construction of GMP workshops for pneumonia vaccines, meeting international standards, and has produced Phase III clinical samples for 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine[25] - The company plans to complete the market application for its serum-free iterative rabies vaccine by 2024, and expects to submit a clinical trial application for its high-titer human diploid cell rabies vaccine in 2024[26] - The company's mRNA rabies vaccine is the first non-COVID mRNA vaccine accepted for clinical trial application in China, showing significant advantages in reducing vaccination doses and accelerating antibody production[26] - The company has completed the construction of workshops for serum-free iterative rabies vaccine and high-titer human diploid cell rabies vaccine, with equipment debugging and validation underway[27] - The company's mRNA technology platform has been validated by over 10,000 clinical trial cases, with mRNA rabies vaccine demonstrating higher safety and efficacy compared to traditional vaccines[28] - The company is developing mRNA RSV and mRNA shingles vaccines, with clinical trial applications expected to be completed in 2024[28] - The company's MCV4 vaccine for meningococcal disease has completed Phase I clinical trials with 120 participants and has initiated Phase II trials[29] - The company is developing the world's first EV71-CA16 bivalent hand, foot, and mouth disease vaccine, which has entered the clinical stage[30] - The company utilizes five validated human vaccine platform technologies, including mRNA, genetic engineering, and combination vaccines, and is exploring AI applications in vaccine development[31] - The company's R&D team consists of three vaccine research institutions (Aimei Explorer, Aimei Lifanda, Aimei Innovator) and four vaccine production subsidiaries (Aimei Integrity, Aimei Action, Aimei Honor, Aimei Persistence), each focusing on different vaccine platform technologies such as bacterial vaccines, mRNA vaccines, and gene-engineered vaccines[32] - The company is advancing the development of 13-valent pneumococcal conjugate vaccine and quadrivalent meningococcal conjugate vaccine, both listed as high-priority pre-qualification products by WHO (2024-2026)[43] - The company's GMP workshops for iterative pneumococcal and rabies vaccine series have been completed in batches, meeting international standards, with Phase III clinical samples of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine produced in these workshops[43] Market and Sales Performance - The company's sales cover all 31 provinces, autonomous regions, and municipalities in China, reaching over 2,000 county-level CDC centers[6] - The company achieved operating revenue of approximately RMB 1,187.5 million in 2023, a decrease of 6.1% compared to 2022[13] - Revenue from Class I vaccine sales in 2023 was RMB 72.796 million, down from RMB 115.322 million in 2022[14] - Revenue from Class II vaccine sales in 2023 was RMB 1,114.672 million, slightly down from RMB 1,148.716 million in 2022[14] - The company's products cover all 31 provinces, autonomous regions, and municipalities in China, reaching over 2,000 county-level disease control centers[11] - The company's main business revenue in 2023 was RMB 1,187.5 million, a decrease of RMB 76.6 million (6.1%) compared to 2022, primarily due to a decline in sales of Class I hepatitis B vaccines and Class II rabies vaccines, partially offset by an increase in sales of Class II hepatitis B vaccines[45] - The company's gross profit in 2023 was RMB 901 million, a decrease of RMB 126.6 million (12.3%) compared to 2022, with a gross margin of 75.9%, down 5.4 percentage points from 2022, mainly due to decreased production volume and increased unit product costs[47] - The company's sales and distribution expenses in 2023 were RMB 494 million, a slight increase of RMB 0.8 million (0.2%) compared to 2022[51] - The company's other income and gains in 2023 were RMB 51.7 million, an increase of RMB 2.1 million (4.1%) compared to 2022, mainly due to increased gains from asset disposals[48] - The company recorded impairment losses on property, plant, and equipment of RMB 61.1 million in 2023, primarily due to the write-down of idle factory buildings, machinery, and other assets[54] - The company's financial asset impairment losses in 2023 were RMB 4.2 million, a decrease of RMB 23 million (84.6%) compared to 2022, mainly due to a significant reduction in bad debt provisions for accounts receivable[53] - Impairment losses on goodwill and intangible assets amounted to RMB 1,512.2 million and RMB 211.4 million respectively, primarily due to the revaluation of mRNA vaccine products and market changes[55] - The company's financing costs increased by 70.6% to RMB 43.8 million in 2023, driven by higher bank loan interest[57] - The company recorded a tax credit of RMB 320.4 million in 2023, a 57.4% increase compared to 2022, due to higher pre-tax losses[58] - The company's net loss for 2023 was RMB 1,950.2 million, a 745.6% increase from 2022, mainly due to impairment losses and increased R&D expenses[59] - Cash and cash equivalents decreased by 7.7% to RMB 736.4 million in 2023, primarily due to reduced revenue and increased R&D spending[60] - Capital expenditures decreased by 64.8% to RMB 301.6 million in 2023, as major vaccine industrialization projects were largely completed[63] - The company's total financial liabilities increased by 28.4% to RMB 1,795.6 million in 2023, driven by higher bank borrowings[64] - The capital-to-debt ratio rose to 46.2% in 2023, up 22.3 percentage points from 2022, due to increased bank loan balances[64] - The company's inventory increased by 1% to RMB 509.9 million in 2023, reflecting a slight rise in stock levels[61] - Trade receivables decreased by 4.5% to RMB 1,005.1 million in 2023, as sales revenue slightly declined[62] - The company had 1,624 employees as of December 31, 2023, compared to 1,576 employees in 2022, with total employee benefit expenses (including director remuneration) of RMB 362.4 million in 2023, down from RMB 608.0 million in 2022[68] - The company allocated HKD 38.747 million (42.30%) of IPO proceeds for the development of mRNA technology platform-related vaccines, with the full amount utilized by December 2023[71][72] - HKD 6.412 million (7.00%) of IPO proceeds were allocated for the development of pneumonia vaccine candidates (PCV13, PCV20, PPSV23), fully utilized by June 2023[71][72] - HKD 32.060 million (35.00%) of IPO proceeds were allocated for the construction of new production facilities, with HKD 13.210 million utilized and HKD 18.850 million remaining as of December 31, 2023[71] - The company plans to complete the utilization of the remaining HKD 18.850 million for the Ningbo mRNA vaccine production facility by December 31, 2024[71] - HKD 4.590 million (5.00%) of IPO proceeds were allocated for sales and marketing activities, fully utilized by January 2023[71][72] - The company proposed the issuance of up to 242,212,519 non-listed RMB ordinary shares to qualified investors and existing shareholders, pending regulatory approval[73] - The company's total IPO proceeds amounted to HKD 91.610 million, with HKD 72.760 million utilized and HKD 18.850 million remaining as of December 31, 2023[71] - The company issued 9,714,000 H shares at HKD 16.16 per share on October 6, 2022, and partially exercised the over-allotment option for 1,348,600 H shares at the same price on October 28, 2022, raising net proceeds of approximately HKD 91.61 million[97] - As of December 31, 2023, the company's share capital consisted of 718,888,888 domestic shares (59.36%) and 492,173,711 H shares (40.64%)[98] - The company had no distributable reserves as of December 31, 2023[99] - The company's dividend policy considers factors such as financial performance, cash flow, business conditions, future operations, capital requirements, and shareholder interests[99] - The company leased approximately 1,979 square meters of office space in Shanghai from its controlling shareholder and executive director, Mr. Zhou Yan, with an annual rent of RMB 9,540,000 for the first year, increasing by RMB 0.5 per square meter for the second and third years[102] - The company confirmed that its controlling shareholder, Mr. Zhou Yan, had no competing interests outside the company's business as of December 31, 2023[103] - No directors or their associates were engaged in any business competing with the company during the reporting period[104] - Zhou Yan holds 210,135,235 domestic shares, representing 29.23% of the domestic share class and 17.35% of the total shares[109] - Zhou Yan also holds 23,254,765 H-shares, representing 4.72% of the H-share class and 1.92% of the total shares[109] - Zhou Jie holds 40,000,000 domestic shares, representing 5.56% of the domestic share class and 3.30% of the total shares[109] - Zhou Xin holds 40,000,000 domestic shares, representing 5.56% of the domestic share class and 3.30% of the total shares[109] - Jia Shaojun holds 25,000,000 domestic shares, representing 3.48% of the domestic share class and 2.06% of the total shares[109] - Wang Aijun holds 25,000,000 domestic shares, representing 3.48% of the domestic share class and 2.06% of the total shares[109] - Wang Aijun also holds 25,000,000 H-shares, representing 5.08% of the H-share class and 2.06% of the total shares[109] - Jia Shaojun holds 10,310,000 H-shares, representing 2.09% of the H-share class and 0.85% of the total shares[109] - The company has a total of 1,211,062,599 shares issued, including 718,888,888 domestic shares and 492,173,711 H-shares[110] - Tibet Chizhi Heart Enterprise Management Co., Ltd. holds 200,000,000 domestic shares, representing 27.82% of the domestic share category and 16.51% of the total shares[113] - Yang Aihua holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Shanghai Xunjing Enterprise Management Center holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Tibet Yingfeng Industrial Co., Ltd. holds 44,300,000 domestic shares and 55,700,000 H-shares, representing 6.16% and 11.32% of the respective share categories, and 3.66% and 4.60% of the total shares[113] - Ningbo Beilun State-owned Capital Operation Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[113] - Ningbo Economic & Technological Development Zone Holding Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[113] - Ningbo Bonded Zone Holding Co., Ltd. holds 54,051,428 H-shares, representing 10.98% of the H-share category and 4.46% of the total shares[114] - Chang Wei and Zhang Kuo each hold 40,000,000 H-shares through controlled entities, representing 8.13% of the H-share category and 3.30% of the total shares[114] - Qingdao Chunteng Venture Capital Partnership holds 40,000,000 H-shares, representing 8.13% of the H-share category and 3.30% of the total shares[115] - China Merchants Bank Co., Ltd. and its affiliates hold 29,031,000 H-shares, representing 5.90% of the H-share category and 2.40% of the total shares[115] - Zhaoshang Bank holds 83.20% equity in Zhaoshang International Financial Co., Ltd through its wholly-owned subsidiary Zhaoshang International Financial Holdings Co., Ltd[117] - Zhaoshang International Capital Management (Shenzhen) Co., Ltd manages two partnerships holding 13,834,800 H shares and 15,196,200 H shares respectively[117] - Lhasa Meihua, a wholly-owned subsidiary of Meihua Biological Technology Group, directly holds 25,000,000 H shares[117] - Zhuhai Hengqin Ruifan Technology Partnership holds 32.2% equity in Aimei Lifanda[118] - Zhuhai Hengqin Qijing Technology Partnership holds 11.0% equity in Aimei Lifanda[118] - Zhuhai Ruijin Technology Partnership holds 6.6% equity in Aimei Lifanda[118] - The maximum number of shares that can be issued under the Pre-IPO Employee Share Incentive Plan is
艾美疫苗(06660) - 2023 - 年度财报