CANSINOBIO(06185)

Search documents
康希诺生物(06185) - 2024 - 中期财报
2024-09-06 08:56
Financial Performance - Revenue for the first half of 2024 reached RMB 285,420 thousand, a significant increase of 1,253.6% compared to RMB 21,086 thousand in the same period of 2023[8]. - Operating loss improved to RMB (250,466) thousand, a reduction of 81.3% from RMB (1,342,432) thousand year-over-year[8]. - The company reported a net loss of RMB (229,666) thousand for the period, an improvement of 82.1% from RMB (1,282,024) thousand in the same period last year[8]. - Basic and diluted loss per share improved to RMB (0.91) from RMB (3.41) year-over-year, reflecting a 73.3% reduction in loss per share[8]. - Gross profit for the six months ended June 30, 2024, was approximately RMB 187.2 million, a recovery from a gross loss of RMB 776.5 million in the same period last year, attributed to reduced inventory write-downs related to COVID-19 vaccines[52]. - The company incurred a net loss of RMB 225,373 thousand for the six months ended June 30, 2024, compared to a net loss of RMB 841,429 thousand for the same period in 2023[128]. - The group reported a total other income of RMB 54,127 thousand for the six months ended June 30, 2024, a decrease of 42% compared to RMB 93,946 thousand for the same period in 2023[147]. - The group incurred a loss of RMB 272,797 thousand for the six months ended June 30, 2024, down from RMB 396,127 thousand in the same period of 2023, indicating a reduction in losses by approximately 31%[148]. Assets and Liabilities - Total assets decreased by 12.7% to RMB 8,134,571 thousand from RMB 9,318,769 thousand as of December 31, 2023[8]. - Non-current assets declined by 13.1% to RMB 3,596,135 thousand compared to RMB 4,137,941 thousand at the end of 2023[8]. - Current liabilities were reduced by 26.4% to RMB 1,907,497 thousand from RMB 2,591,844 thousand in the previous period[8]. - Total liabilities decreased to RMB 3,075,025 thousand as of June 30, 2024, down from RMB 4,031,354 thousand as of December 31, 2023, reflecting a reduction of 23.7%[127]. - The company’s borrowings as of June 30, 2024, were RMB 1,184,976 thousand, a decrease from RMB 1,394,865 thousand as of December 31, 2023[127]. - Accounts payable decreased from approximately RMB 104.0 million as of December 31, 2023, to approximately RMB 77.8 million as of June 30, 2024, in line with reduced purchase volumes[70]. - Other payables and accrued expenses decreased by 35.6% to approximately RMB 553.2 million as of June 30, 2024, from approximately RMB 858.3 million as of December 31, 2023[73]. Research and Development - The company aims to continue developing high-quality, innovative, and affordable vaccines, leveraging the expertise of its senior management team[10]. - The company is advancing multiple vaccine candidates in clinical trials, including mRNA COVID-19 vaccines and a tuberculosis booster vaccine[11]. - The company’s R&D expenses for the period were RMB 185,902,000, down from RMB 338,372,000 in 2023, indicating a reduction of about 45%[125]. - The company aims to meet the high demand for innovative vaccines in China, leveraging advanced synthetic vaccine technology and improved formulation techniques[15]. - The company has established a comprehensive commercial operation center to execute marketing strategies for its products, including MCV4 vaccines[16]. Market and Product Development - The vaccine product line targets a large and underserved global market, categorized into three types: global innovative vaccines, first-in-class vaccines in China, and preclinical candidate vaccines[11]. - The company has five commercialized products addressing over ten disease areas, with sales revenue from the meningococcal vaccines reaching approximately RMB 262.7 million, an 18.0% increase year-over-year[17]. - The company has received conditional marketing approval for the recombinant COVID-19 vaccine, Kweisha®, in China and several other countries, with emergency use authorization granted for Kweisha® Mist and the XBB.1.5 variant vaccine[19]. - The company plans to submit an age expansion application for the MCV4 vaccine for children aged 4 to 6 years in 2024, having completed subject enrollment for clinical trials[17]. - The company is actively pursuing market expansion and product development strategies to enhance its competitive position in the vaccine market[109]. Corporate Governance and Shareholder Information - The company has adopted a corporate governance code and believes it has complied with all applicable provisions during the reporting period, except for the separation of the roles of Chairman and CEO, which are held by Dr. Yu[89]. - The company does not recommend the payment of an interim dividend for the reporting period, consistent with the previous year[97]. - The Audit Committee, composed of three independent non-executive directors, has reviewed the interim financial results and found them compliant with applicable accounting standards and regulations[95]. - The company has undergone changes in its board of directors, with new appointments and resignations effective February 21, 2024, including the election of Mr. Zhang as an independent non-executive director[90]. - As of June 30, 2024, Dr. Yu holds 34,598,400 H-shares (13.98%) and 42,579,625 A-shares (17.21%), representing significant ownership stakes in the company[98]. Cash Flow and Investments - Cash used in operating activities for the six months ended June 30, 2024, was RMB 250,946 thousand, significantly improved from RMB 790,142 thousand in the prior year[130]. - The company invested RMB 5,432,000 thousand in structured deposits and financial products during the first half of 2024, compared to RMB 2,815,000 thousand in the same period of 2023[130]. - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capabilities, with RMB 718.9 million already invested[80]. - The company has not reported any significant investments, acquisitions, or disposals of subsidiaries, associates, or joint ventures during the reporting period[79]. - The company’s cash and cash equivalents, including financial assets at fair value, totaled RMB 1,548,903,000 as of June 30, 2024, compared to RMB 1,309,570,000 at the end of 2023, indicating an increase of 18.3%[180].
康希诺生物(06185) - 2024 - 中期业绩
2024-08-29 12:35
Financial Performance - For the six months ended June 30, 2024, the company reported revenue of RMB 285,420,000, a significant increase of 1,253.6% compared to RMB 21,086,000 in the same period of 2023[11]. - The operating loss for the same period was RMB (250,466,000), representing an improvement of 81.3% from a loss of RMB (1,342,432,000) in 2023[11]. - The total comprehensive loss for the period was RMB (229,666,000), a reduction of 82.1% compared to RMB (1,282,024,000) in the previous year[11]. - Basic and diluted loss per share improved to RMB (0.91) from RMB (3.41), reflecting a 73.3% decrease in loss per share[11]. - Gross profit for the six months ended June 30, 2024, was approximately RMB 187.2 million, a recovery from a gross loss of RMB 776.5 million in the same period last year, attributed to reduced inventory write-downs and improved sales of meningococcal vaccines[55]. - The company reported a net loss of RMB 230,160,000 for the six months ended June 30, 2024, compared to a net loss of RMB 1,282,171,000 in the prior year, marking a reduction of approximately 82%[128]. - The company incurred a total comprehensive expense of RMB (224,879,000) for the six months ended June 30, 2024, compared to RMB (841,282,000) for the same period in 2023, reflecting a decrease of approximately 73%[131]. Assets and Liabilities - As of June 30, 2024, total assets decreased by 12.7% to RMB 8,134,571,000 from RMB 9,318,769,000 at the end of 2023[11]. - Non-current assets decreased by 13.1% to RMB 3,596,135,000 compared to RMB 4,137,941,000 at the end of 2023[11]. - Total liabilities decreased by 23.7% to RMB 3,075,025,000 from RMB 4,031,354,000 at the end of 2023[11]. - Current liabilities saw a significant reduction of 26.4%, down to RMB 1,907,497,000 from RMB 2,591,844,000[11]. - Cash and cash equivalents as of June 30, 2024, were RMB 1,722,218,000, down from RMB 2,046,998,000 at the end of 2023, representing a decrease of about 16%[129]. - The company’s borrowings decreased to RMB 990,929,000 as of June 30, 2024, from RMB 1,065,660,000 at the end of 2023, a reduction of about 7%[130]. Research and Development - The company aims to develop and commercialize high-quality, innovative, and affordable vaccines, supported by a team of top scientists and experienced professionals in the vaccine industry[13]. - The pipeline includes various innovative vaccines, such as mRNA COVID-19 vaccines and a recombinant tuberculosis booster vaccine, indicating ongoing research and development efforts[14]. - R&D expenses decreased by 45.1% to approximately RMB 185.9 million, as the focus shifted towards non-COVID-19 areas with several candidates nearing commercialization[60]. - The company is developing a globally innovative tuberculosis booster vaccine, which has shown good safety and tolerability in Phase Ia clinical trials, enhancing immunity in BCG-vaccinated individuals[36]. - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capabilities, with RMB 718.9 million already invested[83]. Vaccine Products and Market Strategy - The vaccine product line targets a large and underserved global market, categorized into three types: global innovative vaccines, first-in-class vaccines in China, and preclinical candidate vaccines[14]. - The company has five commercialized products addressing over ten disease areas, with sales revenue from meningococcal vaccines reaching approximately RMB 262.7 million, an 18.0% increase year-over-year[20]. - The company has received conditional marketing approval for the recombinant COVID-19 vaccine, Kweisha®, in China and several overseas countries, with emergency use authorization granted for Kweisha® Mist and the XBB.1.5 variant vaccine[22]. - The company aims to meet the unmet medical needs in China with its high-quality vaccines, enhancing the overall healthcare landscape[18]. - The company has established a comprehensive commercial operation center to execute marketing strategies for Mankai Xin® domestically and internationally[19]. Shareholder and Corporate Governance - The company has adopted a corporate governance code to enhance shareholder rights and corporate value, ensuring transparency and accountability[22]. - The audit committee, consisting of three independent non-executive directors, reviewed the interim financial results and confirmed compliance with applicable accounting standards[98]. - The company has undergone changes in its board of directors, with new appointments and resignations effective February 21, 2024[93]. - The company has maintained compliance with the securities trading standards throughout the reporting period[97]. - The board believes that the current structure of having the chairman and CEO as the same individual does not affect the balance of power within the board[22]. Future Outlook and Strategic Initiatives - Future strategies include exploring global partnerships for vaccine development and considering acquisitions of promising assets related to vaccines and bioproducts to strengthen international market competitiveness[51]. - The company aims to enhance its marketing efforts and public awareness of vaccines, while also expanding its commercialization team to improve market penetration and cost management[50]. - The company plans to submit an age expansion application for the MCV4 vaccine for children aged 4 to 6 years in 2024, having completed subject enrollment for clinical trials[20]. - The company expects to obtain new drug marketing approval for PCV13i by 2025, following positive results from its Phase III clinical trial[27]. - The company has signed a funding agreement with the Bill & Melinda Gates Foundation in October 2023, securing over $2 million to support the development of the recombinant poliovirus vaccine[40].
康希诺生物(06185) - 2024 Q1 - 季度业绩
2024-04-29 13:59
Financial Performance - The company's operating revenue for the first quarter was RMB 114,282,281.78, representing a year-on-year increase of 13.65%[4] - The net profit attributable to shareholders of the listed company was a loss of RMB 170,095,866.61, with a loss of RMB 178,676,681.71 after deducting non-recurring gains and losses[4] - The net loss attributable to shareholders for Q1 2024 was ¥174,882,984.28, compared to a net loss of ¥170,199,047.09 in Q1 2023, showing a slight increase in losses[23] - The total comprehensive income attributable to the parent company for Q1 2024 was (174,560,182.55) CNY, compared to (170,165,760.27) CNY in Q1 2023, indicating a slight increase in losses[25] - Basic and diluted earnings per share for Q1 2024 were (0.69) CNY, up from (0.57) CNY in Q1 2023, reflecting improved performance[25] Cash Flow - The net cash flow from operating activities was a negative RMB 108,195,674.35, indicating a significant cash outflow[4] - The company reported a significant reduction in net cash outflow from operating activities, narrowing by 68.68% compared to the same period last year[8] - Cash flow from operating activities for Q1 2024 was (108,195,674.35) CNY, a significant improvement from (345,405,099.94) CNY in Q1 2023[27] - Cash inflow from investment activities in Q1 2024 was 2,636,256,442.11 CNY, slightly down from 2,787,235,704.28 CNY in Q1 2023[28] - Net cash flow from investment activities for Q1 2024 was 275,011,228.44 CNY, compared to (172,008,398.75) CNY in Q1 2023, indicating a positive turnaround[28] - Cash flow from financing activities in Q1 2024 was 147,374,678.75 CNY, a recovery from (10,474,806.49) CNY in Q1 2023[29] - The net increase in cash and cash equivalents for Q1 2024 was 328,808,252.94 CNY, compared to (547,374,059.15) CNY in Q1 2023, showing improved liquidity[30] - The ending balance of cash and cash equivalents for Q1 2024 was 2,374,907,374.57 CNY, down from 2,843,893,796.13 CNY in Q1 2023[30] Assets and Liabilities - Total assets at the end of the reporting period were RMB 8,568,692,147.63, down 8.05% from the end of the previous year[5] - Non-current assets totaled ¥3,544,849,827.74 as of March 31, 2024, down from ¥4,137,941,596.05 at the end of 2023, a decrease of approximately 14.3%[18] - Current liabilities decreased to ¥2,102,763,825.91 from ¥2,565,301,751.60, representing a reduction of about 18%[17] - Long-term borrowings increased to ¥1,148,909,685.31 from ¥1,065,659,776.95, reflecting an increase of approximately 7.8%[18] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 21,770[9] - The top shareholder, HKSCC NOMINEES LIMITED, holds 98,066,897 shares, representing 39.63% of the total shares[11] - Xuefeng Yu and Dongxu Qiu each hold 17,874,200 shares, accounting for 7.22% of the total shares[11] - The company has a total of 1,403,742 shares held by Sun Ge, representing 0.57% of the total shares[11] Research and Development - Research and development (R&D) expenses totaled RMB 124,328,450.39, which accounted for 108.79% of operating revenue, a decrease of 41.25 percentage points compared to the previous year[4][8] - Research and development expenses for Q1 2024 were ¥96,745,611.33, down from ¥149,765,069.58 in Q1 2023, indicating a decrease of about 35.4%[20] Legal Matters - The company is facing a lawsuit from Belcher Farmaceutica Ltda. seeking approximately BRL 167 million (about RMB 241 million) for alleged damages related to COVID-19 vaccine registration and commercialization in Brazil[14] - The company has engaged a professional legal team to address the lawsuit, believing it has a strong defense position[14] Other Financial Metrics - The weighted average return on net assets was -3.28%, a decrease of 1.19 percentage points year-on-year[4] - The company experienced an investment loss of RMB 70,511,874.94 due to the exclusion of Shanghai Pharmaceuticals CanSino Biologics from the consolidation scope[8] - The company will no longer consolidate Kangxino into its financial statements, as the agreement with Shanghai Biomedical Industry Equity Investment Fund will automatically terminate on February 2, 2024[13] - The company’s financial assets held for trading increased to RMB 1,431,702,017.93 from RMB 1,308,274,692.11, marking an increase of approximately 9.4%[15] - The company’s inventory as of March 31, 2024, was RMB 355,418,384.95, slightly up from RMB 352,847,638.45[15] - Other comprehensive income after tax for Q1 2024 was 322,801.73 CNY, a significant increase from 33,286.82 CNY in Q1 2023[24] Future Outlook - The company plans to implement new accounting standards starting January 1, 2024, which may impact future financial reporting[31]
康希诺生物(06185) - 2023 - 年度财报
2024-04-24 13:00
Financial Performance - Total revenue for 2023 was RMB 345,182 thousand, a significant decrease of 66.5% compared to RMB 1,031,041 thousand in 2022[13] - Operating loss for 2023 was RMB (2,035,182) thousand, worsening from a loss of RMB (1,368,742) thousand in the previous year[13] - Net loss for the year was RMB (1,967,433) thousand, compared to a net loss of RMB (964,757) thousand in 2022, indicating a 104.3% increase in losses[13] - Total assets decreased to RMB 9,318,769 thousand in 2023 from RMB 11,468,960 thousand in 2022, reflecting a decline of 18.8%[13] - Total equity fell to RMB 5,287,415 thousand in 2023, down from RMB 7,245,602 thousand in 2022, a decrease of 27.0%[13] - Basic and diluted loss per share for 2023 was RMB (6.01), compared to RMB (3.68) in 2022, indicating a worsening of 63.9%[13] - Revenue from the Chinese market was RMB 342.0 million in 2023, down from RMB 812.8 million in 2022, while overseas revenue was RMB 3.2 million, down from RMB 218.3 million[38] - The company reported a gross loss of approximately RMB 876.0 million for the year ended December 31, 2023, compared to a gross loss of RMB 186.6 million in 2022, mainly due to inventory and return provisions related to COVID-19 vaccines[39] Assets and Liabilities - Non-current assets increased to RMB 4,137,941 thousand in 2023, up from RMB 3,738,775 thousand in 2022, representing an increase of 10.7%[13] - Current liabilities decreased to RMB 2,591,844 thousand in 2023 from RMB 2,942,065 thousand in 2022, a reduction of 11.9%[13] - Inventory decreased significantly from approximately RMB 677.8 million as of December 31, 2022, to approximately RMB 350.7 million as of December 31, 2023, mainly due to inventory write-offs of approximately RMB 407.5 million during the reporting period[51] - Accounts receivable decreased from approximately RMB 855.5 million as of December 31, 2022, to approximately RMB 636.9 million as of December 31, 2023, primarily due to a reduction in accounts receivable from COVID-19 vaccine product sales[53] - Accounts payable decreased significantly from approximately RMB 253.1 million as of December 31, 2022, to approximately RMB 104.0 million as of December 31, 2023, aligning with a reduction in purchase volumes[55] Market and Product Development - The company is focusing on expanding its market presence and developing new products and technologies to drive future growth[12] - The sales revenue of the quadrivalent meningococcal conjugate vaccine, Manhaixin®, reached approximately 561.7 million RMB in 2023, representing a year-on-year growth of 266.4%[14] - The company is advancing its product pipeline, with the 13-valent pneumococcal conjugate vaccine undergoing drug registration application review, and the broad-spectrum recombinant pneumococcal protein vaccine having completed Phase Ib clinical trial site work[14] - The adult vaccine market is being targeted, with the tetanus vaccine entering Phase I clinical trials and the recombinant shingles vaccine undergoing Phase I clinical trials in Canada using both intramuscular and inhalation methods[14] - The company has established international collaborations, including a framework agreement with AstraZeneca AB for contract development and manufacturing services for its mRNA vaccine project[14] Research and Development - The company has developed a pipeline of vaccines covering over 10 infectious diseases under the leadership of CEO Xuefeng Yu, who has over 30 years of experience in biotechnology research and development[68] - The company is conducting clinical trials for several innovative vaccines, including PBPV, PCV13i, and a tuberculosis booster vaccine[71] - The company has established a world-class research and development technology platform for vaccine development[71] - The company aims to enhance its product strategy and core competitiveness through the development of the infant DTcP vaccine, which serves as a domestic alternative to imported vaccines[22] Governance and Management - The company has a diverse board with members holding significant experience in finance, health, and corporate governance, enhancing its strategic oversight capabilities[75][76][78][79] - The board consists of 3 executive directors, 1 non-executive director, and 3 independent non-executive directors as of the report date[87] - The company is committed to maintaining high standards of corporate governance and compliance through its experienced management and supervisory team[84] - The independent non-executive directors confirmed their independence according to the Hong Kong Listing Rules, ensuring compliance with governance standards[179] Shareholder Engagement and Dividends - The company encourages shareholder participation in general meetings, allowing shareholders holding more than 10% of voting shares to request the board to convene an extraordinary general meeting within 10 days of the request[125] - The company has adopted a dividend distribution policy, prioritizing cash dividends while considering future operations, financial status, and other relevant factors[130] - A three-year shareholder dividend return plan (2023-2025) was approved at the annual general meeting, focusing on sustainable development and reasonable returns to shareholders[130] - The board of directors did not recommend a final dividend for the reporting period, consistent with the previous year[135] Risks and Challenges - The company faces significant financial risks, including the need for substantial additional financing to support operations and potential delays in product development due to capital acquisition challenges[143] - The company has identified risks related to the commercialization of vaccines, including competition in the vaccine market and potential regulatory approval challenges[144] - The group faces foreign exchange risk due to financial assets and liabilities denominated in currencies other than the functional currency, with a current effective contract notional amount of $60.6 million (equivalent to RMB 430.0 million) for hedging purposes[66] Employee and Compensation - The total employee benefits expenditure amounted to approximately RMB 707.8 million, an increase from RMB 667.4 million as of December 31, 2022, representing a growth of about 6.4%[180] - The company employed 1,494 employees as of December 31, 2023, a decrease from 2,291 employees as of December 31, 2022, indicating a reduction of approximately 34.8%[180] - The company has established a remuneration and assessment committee to review the remuneration policies based on operational performance and individual performance of directors and senior management[180] Future Plans and Investments - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capacity, having already invested approximately RMB 565.0 million[62] - The company plans to allocate RMB 505.1 million for the development and commercialization of the MCV vaccine and RMB 224.5 million for the DTcP vaccine research[194] - The company aims to enhance its R&D, production, testing, and storage capabilities through the strategic use of the IPO proceeds[197]
康希诺生物(06185) - 2023 - 年度业绩
2024-03-27 14:41
Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 345,182 thousand, a decrease of 66.5% compared to RMB 1,031,041 thousand in 2022[13] - The operating loss for the year was RMB (2,035,182) thousand, compared to an operating loss of RMB (1,368,742) thousand in the previous year[13] - The net loss for the year was RMB (1,967,433) thousand, an increase from a net loss of RMB (964,757) thousand in 2022[13] - Total assets as of December 31, 2023, were RMB 9,318,769 thousand, down from RMB 11,468,960 thousand in 2022[13] - Total equity decreased to RMB 5,287,415 thousand from RMB 7,245,602 thousand, representing a decline of 27.0%[13] - Basic and diluted loss per share for the year was RMB (6.01), compared to RMB (3.68) in 2022[13] - The company recorded a gross loss of approximately RMB 876.0 million for the year ended December 31, 2023, compared to a gross loss of RMB 186.6 million in 2022, mainly due to inventory and return provisions related to COVID-19 vaccines[39] - Other income increased by 25.7% to approximately RMB 197.3 million for the year ended December 31, 2023, primarily due to an increase in government subsidies[41] - Sales expenses increased from approximately RMB 266.6 million for the year ended December 31, 2022, to approximately RMB 353.4 million for the year ended December 31, 2023, primarily due to increased employee benefits and marketing expenses related to the commercialization of the Manhaixin® product[42] - Administrative expenses rose by 5.9% from approximately RMB 278.1 million for the year ended December 31, 2022, to approximately RMB 294.5 million for the year ended December 31, 2023, mainly due to an increase in employee benefits of approximately RMB 17.3 million[43] - R&D expenses decreased by 18.0% from approximately RMB 778.3 million for the year ended December 31, 2022, to approximately RMB 638.0 million for the year ended December 31, 2023, primarily due to a reduction in clinical trial and testing costs for COVID-19 vaccine products[44] Asset and Liability Management - Current assets decreased significantly to RMB 5,180,828 thousand from RMB 7,730,185 thousand, a decline of 32.7%[13] - Total liabilities were RMB 4,031,354 thousand, slightly down from RMB 4,223,358 thousand in 2022[13] - Inventory decreased significantly from approximately RMB 677.8 million as of December 31, 2022, to approximately RMB 350.7 million as of December 31, 2023, mainly due to inventory write-offs of approximately RMB 407.5 million[51] - Accounts receivable decreased from approximately RMB 855.5 million as of December 31, 2022, to approximately RMB 636.9 million as of December 31, 2023, primarily due to a reduction in accounts receivable from COVID-19 vaccine product sales[53] - Accounts payable decreased significantly from approximately RMB 253.1 million as of December 31, 2022, to approximately RMB 104.0 million as of December 31, 2023, consistent with a reduction in purchase volumes[55] - The company's bank balances and cash decreased by 39.7% from approximately RMB 3,394.8 million as of December 31, 2022, to approximately RMB 2,047.0 million as of December 31, 2023, mainly due to cash outflows from operating activities and investments[59] Research and Development Initiatives - The company is focused on expanding its product pipeline and enhancing research and development efforts to drive future growth[12] - The company is advancing its pipeline with the 13-valent pneumococcal conjugate vaccine currently undergoing drug registration application review, and the broad-spectrum recombinant pneumococcal protein vaccine has completed its Phase Ib clinical trial[14] - The adult vaccine market is being targeted with the initiation of Phase I clinical trials for the adsorbed tetanus vaccine and the recombinant shingles vaccine, which is being tested in both intramuscular and inhalation administration methods in Canada[14] - The company has a diverse vaccine pipeline targeting over ten disease areas, with five commercialized products and several candidates in various stages of clinical trials[16] - The innovative PBPV vaccine, which targets a broader range of pneumococcal serotypes, began Phase Ib clinical trials in March 2023[21] - The DTcP vaccine for infants officially started Phase III clinical trials in August 2023, with all participants enrolled by the report date[23] - The company is developing an Hib vaccine, which has been accepted for clinical trial application, aimed at generating effective protective antibodies against Haemophilus influenzae type b[29] - The mRNA COVID-19 vaccine is currently in clinical trials, with plans to adapt development based on emerging variants and clinical data[30] Market and Commercialization Strategies - The sales revenue of the quadrivalent meningococcal conjugate vaccine, Manhaixin®, reached approximately 561.7 million RMB in 2023, representing a year-on-year growth of 266.4%[14] - The company has established a comprehensive commercial operation center to promote and market Manhaixin® and Meinaixi® across 30 provinces in China, with ongoing clinical trials for expanding indications[17] - The company aims to leverage the market advantage of its quadrivalent meningococcal conjugate vaccine to increase market share during the current window of opportunity[15] - The company plans to enhance its commercialization efforts for the meningococcal and meningitis vaccines, focusing on professional academic promotion and public awareness of vaccination[35] Corporate Governance and Management - The company has a diverse board with members having backgrounds in finance, health, and corporate governance, which strengthens its decision-making process[75][76][78][79] - The board's composition reflects a commitment to independent oversight and strategic guidance, essential for navigating market challenges[75][76][78][79] - The company is committed to maintaining high standards of corporate governance, with experienced professionals in key roles ensuring compliance and strategic oversight[84] - The board consists of 3 executive directors, 1 non-executive director, and 3 independent non-executive directors as of the report date[87] - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix C1, except for the separation of roles between the chairman and the CEO[89] - The company has established written guidelines for employees regarding securities trading, ensuring compliance with the standard code[86] - The company has implemented a robust internal control and risk management system, which is regularly reviewed for effectiveness[99] Shareholder Engagement and Dividend Policy - The company encourages shareholder participation in general meetings, allowing shareholders holding more than 10% of voting shares to request the convening of extraordinary general meetings[125] - The company has adopted a dividend distribution policy, prioritizing cash dividends while considering future operations, financial status, and other relevant factors[130] - A three-year shareholder dividend return plan (2023-2025) was approved at the annual general meeting, focusing on sustainable development and reasonable returns for shareholders[130] - The board of directors did not recommend a final dividend for the reporting period, consistent with the previous year[135] Risks and Challenges - The company is facing significant financial risks, including the need for substantial additional financing to continue operations and the potential for major competition in the vaccine market[143] - The company has identified risks related to regulatory approvals for its vaccine candidates, which could impact commercialization efforts[144] - The company may face challenges in maintaining sufficient intellectual property protection for its vaccine candidates, which could adversely affect its business[145] Employee and Compensation Management - The company has adopted a compensation and benefits management system to provide competitive salaries and comprehensive welfare insurance for employees[180] - The total employee benefits expenditure amounted to approximately RMB 707.8 million, an increase from RMB 667.4 million as of December 31, 2022, representing a year-over-year growth of 6.4%[180] - The company employed 1,494 employees as of December 31, 2023, a decrease from 2,291 employees as of December 31, 2022, indicating a reduction of approximately 34.7%[180] Strategic Investments and Future Plans - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capacity, with approximately RMB 565.0 million already invested[62] - The company plans to allocate RMB 505.1 million for the research and commercialization of the MCV vaccine and RMB 224.5 million for the DTcP vaccine development[194] - The total amount allocated for advanced technology and vaccine-related acquisitions is RMB 420 million, with a remaining balance of RMB 332 million expected to be utilized by the end of 2024[194]
康希诺生物(06185) - 2023 Q3 - 季度业绩
2023-10-30 10:11
Financial Performance - The company's operating revenue for the third quarter was RMB 149,723,992.40, representing a 92.93% increase compared to the same period last year[4]. - The net profit attributable to shareholders for the third quarter was a loss of RMB 143,600,577.66, a decrease of 70.49% year-on-year[4]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was a loss of RMB 186,431,076.05, down 64.54% from the previous year[4]. - The overall operating revenue for the year-to-date period was RMB 175,631,799.90, reflecting a decrease of 75.17% compared to the same period last year due to a significant drop in COVID-19 vaccine sales[4]. - The company experienced a net loss attributable to shareholders of RMB 985,029,654.47 for the year-to-date period, an increase of 107.63% compared to the previous year[4]. - The net loss for the first three quarters of 2023 was ¥1,454,919,925.84, compared to a net loss of ¥488,682,218.46 in the same period of 2022, representing an increase in losses of about 197.5%[24]. Research and Development - Research and development expenses totaled RMB 140,476,879.33 for the quarter, a decrease of 38.80% compared to the same period last year[4]. - Research and development expenses decreased by 38.80% in the current reporting period, mainly due to a shift in focus away from COVID-19 vaccine-related R&D[10]. - The proportion of R&D expenses to operating income decreased by 201.94 percentage points in the current reporting period[10]. - The proportion of R&D expenses to operating income increased by 194.71 percentage points year-to-date, indicating a larger decline in operating income compared to R&D expenses[10]. Assets and Liabilities - The total assets at the end of the reporting period were RMB 9,610,642,425.30, a decrease of 19.34% from the end of the previous year[5]. - The equity attributable to shareholders at the end of the reporting period was RMB 5,770,626,650.09, down 16.94% year-on-year[5]. - As of September 30, 2023, total assets amounted to ¥9,610,642,425.30, a decrease from ¥11,468,958,286.71 as of December 31, 2022, representing a decline of approximately 16.1%[18]. - Total liabilities decreased to ¥3,812,394,223.51 from ¥4,223,356,561.52, reflecting a reduction of about 9.7%[20]. - The total equity attributable to shareholders decreased to ¥5,770,626,650.09 from ¥6,748,089,902.12, a decline of about 14.5%[21]. Earnings Per Share - The basic earnings per share for the third quarter was a loss of RMB 0.58, a decrease of 70.46% compared to the same period last year[4]. - Basic and diluted earnings per share for the first three quarters of 2023 are both (3.99) CNY, up from (1.92) CNY in the same period of 2022, reflecting improved profitability[26]. Cash Flow - The net cash flow from operating activities decreased by 46.24% year-to-date, primarily due to reduced cash payments for raw materials[9]. - Cash flow from operating activities for the first three quarters of 2023 shows a net outflow of (748,974,021.75) CNY, an improvement from a net outflow of (1,393,277,778.30) CNY in the same period of 2022[28]. - Cash inflow from investment activities for the first three quarters of 2023 is 6,640,825,701.63 CNY, down from 9,360,944,181.35 CNY in the same period of 2022[29]. - Cash flow from financing activities for the first three quarters of 2023 shows a net outflow of (131,319,499.65) CNY, compared to a net inflow of 628,604,712.22 CNY in the same period of 2022[29]. - The net increase in cash and cash equivalents for the first three quarters of 2023 is (1,040,273,125.42) CNY, with an ending balance of 2,350,994,729.85 CNY[30]. Sales Performance - The company reported a significant increase in sales revenue from its meningitis vaccine products, contributing to the rise in operating revenue for the quarter[8]. - The revenue from the combined meningococcal vaccine reached approximately 371.15 million RMB in the first three quarters of 2023, a year-on-year increase of approximately 476.47%[14]. - The total sales revenue for the group was approximately 414.39 million RMB, with a revenue reduction of approximately 238.76 million RMB due to returns[14].
康希诺生物(06185) - 2023 - 中期财报
2023-09-15 08:30
Financial Performance - Revenue for the first half of 2023 was RMB 21,086 thousand, a decrease of 96.7% compared to RMB 629,790 thousand in the same period of 2022[7]. - Operating loss increased to RMB 1,342,432 thousand, compared to a loss of RMB 164,800 thousand in the first half of 2022, representing a 714.6% increase[7]. - Total comprehensive loss for the period was RMB 1,282,024 thousand, a significant decline from a profit of RMB 16,043 thousand in the same period last year, marking an 8,091.2% change[7]. - Basic and diluted loss per share was RMB (3.4098), compared to earnings of RMB 0.0495 per share in the first half of 2022, reflecting a 6,988.5% decrease[7]. - The company reported a net loss of RMB 841,429,000, compared to a profit of RMB 12,238,000 for the same period in 2022[109]. - The gross loss for the period was RMB (776,487) thousand, compared to a gross profit of RMB 316,173 thousand in the prior year[106]. - The company reported a loss before tax of RMB (1,283,335,000), compared to a loss of RMB (41,555,000) for the same period in 2022, indicating a significant increase in losses[143]. - The basic loss per share for the six months ended June 30, 2023, was RMB (3.41), compared to a profit of RMB 0.05 per share for the same period in 2022, reflecting a substantial decline in profitability[146]. - The company did not declare or pay any dividends for the six months ended June 30, 2023, following a total dividend payout of RMB 197,560,000 for the previous year[148]. Assets and Liabilities - Total assets decreased by 13.7% to RMB 9,897,272 thousand as of June 30, 2023, down from RMB 11,468,960 thousand at the end of 2022[8]. - Total equity decreased by 17.6% to RMB 5,969,259 thousand, compared to RMB 7,245,602 thousand at the end of 2022[8]. - The company's total liabilities decreased by 14.3% from approximately RMB 791.9 million as of December 31, 2022, to approximately RMB 678.8 million as of June 30, 2023, primarily due to a decrease in wages and benefits payable of approximately RMB 77.9 million[62]. - The company's total liabilities decreased from RMB 63,095,000 as of January 1, 2022, to RMB 56,936,000 as of June 30, 2023[160]. - The company’s total liabilities increased, with borrowings repaid amounting to RMB 1,229,022,000 during the period[110]. - The company’s total equity attributable to owners decreased to RMB 5,912,489,000 as of June 30, 2023, from RMB 6,748,090,000 at the beginning of the year[109]. Research and Development - The company has a diverse vaccine product line, including innovative vaccines targeting unmet medical needs globally[12]. - Ongoing research includes mRNA COVID-19 vaccines and tuberculosis booster vaccines, indicating a focus on advanced vaccine development[12]. - The company aims to expand its market presence with a broad portfolio of vaccines addressing over ten disease areas[12]. - The company has initiated Phase III clinical trials for the potential best-in-class PCV13i vaccine, with completion of site work in 2022 and plans to start new drug application procedures in the second half of 2023[20]. - The innovative PBPV vaccine, which targets over 90 serotypes of pneumonia, has entered Phase Ib clinical trials as of March 2023, with all subjects enrolled[21]. - The infant DTcP vaccine has officially started Phase III clinical trials in August 2023, with the first subject enrolled, aiming for new drug application procedures in 2025[22]. - The company is developing a Tdcp vaccine for adolescents and adults, which has received clinical trial approval from the National Medical Products Administration in June 2023, with Phase I trials expected to start in the second half of 2023[24]. - The company has obtained exclusive global licensing from McMaster University for the Ad5Ag85A tuberculosis vaccine, which has shown good safety and tolerance in Phase Ia trials, with plans to initiate new drug clinical trial applications in Indonesia in 2024[25]. - The recombinant shingles vaccine developed by the company has received a no-objection letter for clinical trials from Health Canada in July 2023, with both intramuscular injection and aerosol inhalation methods approved for trials[26]. - The company’s tetanus vaccine, developed using animal-free culture media, has received clinical trial approval for individuals aged 18 and above, with Phase I trials expected to start in 2023[27]. - The mRNA COVID-19 vaccine is still in clinical trials, with future development plans contingent on the tracking of variant strains and national immunization strategies[28]. Market and Sales - The revenue from the company's meningococcal vaccine products reached approximately RMB 222.6 million, up from RMB 10.6 million in the same period of 2022, driven by ongoing marketing and commercialization efforts[36]. - The company plans to continue the commercialization of its vaccines and strengthen its marketing efforts to enhance public awareness of vaccination[35]. - The company has established a comprehensive commercial operation center and aims to expand its marketing network while controlling sales expenses[35]. - The company will continue to explore global collaborations and acquisitions related to vaccines and bioproducts to enhance its international market competitiveness[35]. Cash Flow and Investments - The total cash used in operating activities was RMB 753,907,000, an improvement from RMB 1,215,901,000 in the previous year[110]. - The company invested RMB 2,815,000,000 in equity and fund investments during the period, a decrease from RMB 6,681,912,000 in the previous year[110]. - The company plans to invest approximately RMB 2,244.7 million in the CanSino Innovative Vaccine Industrial Park project to enhance manufacturing capabilities, with RMB 376.2 million already invested[68]. - The company has established foreign exchange risk hedging agreements with several commercial banks to mitigate foreign exchange risks[71]. - The company has repurchased 683,748 A-shares at a total cost of approximately RMB 150.2 million, which includes transaction costs of RMB 152,000[99]. Shareholder Information - As of June 30, 2023, Dr. Yu holds 34,598,400 H shares (13.98%) and 42,579,625 A shares (17.21%), representing approximately 26.08% and 37.10% of the respective classes of shares[83]. - The Capital Group Companies, Inc. holds 16,747,482 H shares (6.77%), accounting for approximately 12.62% of the total equity[88]. - JPMorgan Chase & Co. holds 7,335,430 H shares (2.96%) and has additional positions in 4,838,049 shares (1.96%) and 1,730,219 shares (0.70)[88]. - Qiming Corporate holds 7,516,538 H shares (3.04%), representing approximately 5.67% of the relevant class of shares[89]. Compliance and Governance - The audit committee reviewed the unaudited interim results for the six months ended June 30, 2023, and found them compliant with applicable accounting standards[80]. - The company’s independent auditor, Deloitte, conducted a review of the interim financial information in accordance with the relevant standards[81]. - The company has no other disclosures regarding the interests or short positions of directors or senior management in the company’s shares as of June 30, 2023[86]. - The company’s major shareholders, excluding directors and senior management, have disclosed their interests in the company’s shares as required by the Securities and Futures Ordinance[87]. - The company’s board consists of three independent non-executive directors overseeing financial reporting and risk management systems[80].
康希诺生物(06185) - 2023 - 中期业绩
2023-08-30 10:25
Financial Performance - For the six months ended June 30, 2023, the revenue was RMB 21,086 thousand, a decrease of 96.7% compared to RMB 629,790 thousand in the same period of 2022[8]. - The operating loss for the same period was RMB 1,342,432 thousand, an increase of 714.6% from RMB 164,800 thousand in the previous year[8]. - The loss before income tax was RMB 1,283,335 thousand, representing a significant increase of 2,988.3% compared to RMB 41,555 thousand in 2022[8]. - Total comprehensive loss for the period was RMB 1,282,024 thousand, a decline of 8,091.2% from a profit of RMB 16,043 thousand in the prior year[8]. - Basic and diluted loss per share was RMB (3.4098), a decrease of 6,988.5% from earnings of RMB 0.0495 per share in 2022[8]. - The company recorded a revenue of approximately RMB 21.1 million for the six months ended June 30, 2023, a significant decrease from RMB 629.8 million for the same period in 2022, primarily due to reduced demand for COVID-19 vaccine products and a provision for expected returns of RMB 237.1 million[40]. - The company reported a net loss of RMB 841,429 thousand for the six months ended June 30, 2023, compared to a net loss of RMB 1,282,024 thousand for the same period in 2022, indicating an improvement of approximately 34.4%[121]. Assets and Liabilities - As of June 30, 2023, total assets were RMB 9,897,272 thousand, down 13.7% from RMB 11,468,960 thousand at the end of 2022[10]. - Total equity decreased by 17.6% to RMB 5,969,259 thousand from RMB 7,245,602 thousand at the end of 2022[10]. - Non-current assets increased by 6.2% to RMB 3,969,248 thousand from RMB 3,738,775 thousand at the end of 2022[10]. - The company’s total liabilities decreased to RMB 3,928,013 thousand as of June 30, 2023, from RMB 4,223,358 thousand as of December 31, 2022, a decrease of approximately 7.0%[119]. - The company’s borrowings decreased to RMB 2,204,910 thousand as of June 30, 2023, from RMB 2,453,585 thousand as of December 31, 2022, a reduction of about 10.1%[119]. Research and Development - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development initiatives[11]. - The company has a broad vaccine pipeline targeting over ten disease areas, with five commercialized products currently[17]. - The company aims to address unmet medical needs globally with innovative vaccines, including mRNA COVID-19 vaccines and other candidates in clinical development[17]. - The company has initiated Phase III clinical trials for the DTcP vaccine for infants as of August 2023, with expectations to start the new drug application process in 2025[24]. - The company has launched Phase I clinical trials for the Tdcp vaccine for adolescents and adults, with approval received in June 2023, targeting populations aged 6 and above[26]. Market and Product Development - The company has received approval for the commercialization of the meningococcal vaccines Meinaixi® and Manhaixin®, with Meinaixi® being the best bivalent meningococcal vaccine in China and Manhaixin® being the first MCV4 vaccine approved in the country[17]. - The recombinant COVID-19 vaccine Kweisha® has received emergency use authorization overseas and conditional marketing approval in China as of June 30, 2023[20]. - Kweisha® has been widely administered as a booster vaccine in China since September 2022, with emergency use authorizations granted in Morocco and Indonesia[20]. - The company has established a comprehensive commercial operation center to implement marketing strategies for Manhaixin®[17]. - The company is actively expanding its marketing system and has identified key vaccination points and opinion leaders across China to promote its products, including the meningococcal vaccine[37]. Financial Position and Cash Flow - Cash and bank balances decreased by 29.6% from approximately RMB 3,394.8 million as of December 31, 2022, to approximately RMB 2,389.2 million as of June 30, 2023, attributed to reduced sales revenue and cash outflows from operating activities[69]. - Operating cash flow for the six months ended June 30, 2023, was a net outflow of RMB 753,907 thousand, an improvement from a net outflow of RMB 1,215,901 thousand in the same period of 2022[123]. - The company reported financial income of RMB 59,097 thousand for the period, down from RMB 123,245 thousand in the previous year, indicating a decrease of about 52.00%[116]. Corporate Governance - The company has adopted the corporate governance code and believes it has complied with all applicable provisions during the reporting period, except for the separation of the roles of Chairman and CEO, which are both held by Dr. Yu[80]. - The Audit Committee, consisting of three independent non-executive directors, reviewed the interim financial results for the six months ending June 30, 2023, and found them to comply with applicable accounting standards[84]. - The independent auditor, Deloitte, reviewed the interim financial information in accordance with the Hong Kong Institute of Certified Public Accountants' standards[85]. - The company will continue to review the effectiveness of its corporate governance structure, including the potential separation of the roles of Chairman and CEO[80]. Shareholder Information - As of June 30, 2023, Dr. Yu holds 34,598,400 H shares (13.98%) and 42,579,625 A shares (17.21%), representing approximately 26.08% and 37.10% of the respective classes of shares[89]. - The company did not recommend the payment of an interim dividend for the reporting period, consistent with the previous year[86]. - The company has repurchased 683,748 A-shares at a total cost of approximately RMB 150.2 million, with 277,650 shares allocated for the employee stock ownership plan as of June 30, 2023[108]. Impairment and Provisions - The group recognized an impairment loss of approximately RMB 325,401,000 for property, plant, and equipment as of June 30, 2023[142]. - The company recognized impairment losses of RMB 332,846,000 for inventory and RMB 325,401,000 for property, plant, and equipment related to COVID-19 vaccine products[127]. - The company adjusted the estimated future sales returns for sold products, resulting in a revenue adjustment of RMB 237,131,000 for the six months ended June 30, 2023[127]. Future Outlook - The company aims to enhance its capital efficiency and market competitiveness through strategic allocation of IPO proceeds[98]. - The company anticipates using the remaining unutilized proceeds based on current and future market conditions and business needs[107]. - The company plans to invest approximately RMB 2,244.7 million in the Kangsino Innovative Vaccine Industrial Park project, with funding sources including unutilized proceeds from the A-share IPO[104].
康希诺生物(06185) - 2023 Q1 - 季度业绩
2023-04-28 12:37
Financial Performance - For the first quarter ended March 31, 2023, the company reported a revenue of RMB 100,553,000, representing a decrease of 79.86% compared to the same period last year[4] - The net profit attributable to shareholders was a loss of RMB 139,547,000, reflecting a decline of 214.94% year-over-year[4] - The net profit attributable to shareholders after deducting non-recurring gains and losses was a loss of RMB 179,076,000, down 317.82% from the previous year[4] - The basic and diluted earnings per share were both RMB (0.57), a decrease of 216.33% compared to the same period last year[4] - Total revenue for Q1 2023 was RMB 100,553 thousand, a decrease of 79.9% compared to RMB 499,355 thousand in Q1 2022[16] - Net profit for Q1 2023 was a loss of RMB 170,199 thousand, compared to a profit of RMB 114,295 thousand in Q1 2022, indicating a significant decline[17] - Basic earnings per share for Q1 2023 were RMB (0.57), compared to RMB 0.49 in Q1 2022, indicating a significant decline in profitability[18] - The total comprehensive income for Q1 2023 was a loss of RMB (170,166) thousand, compared to a profit of RMB 114,295 thousand in Q1 2022, showing a significant downturn[18] Assets and Liabilities - The total assets at the end of the reporting period were RMB 11,215,389,000, a decrease of 2.21% from the end of the previous year[5] - The company's current liabilities decreased to RMB 2,620,183,000 from RMB 2,924,708,000 as of December 31, 2022, indicating improved liquidity[14] - The total liabilities as of March 31, 2023, were RMB 4,137,354 thousand, a decrease from RMB 4,223,358 thousand as of December 31, 2022, reflecting a reduction of 2.0%[15] - The total equity as of March 31, 2023, was RMB 7,078,035 thousand, down from RMB 7,245,602 thousand as of December 31, 2022, a decrease of 2.3%[15] Research and Development - Research and development expenses totaled RMB 150,871,000, representing a decrease of 5.36% year-over-year[4] - The proportion of R&D expenses to operating income was 150.04%, indicating an increase of 118.12 percentage points compared to the previous year[4] - Research and development expenses for Q1 2023 were RMB 149,765 thousand, slightly down from RMB 157,155 thousand in Q1 2022, a decrease of 4.4%[16] Cash Flow and Investments - In Q1 2023, the net cash flow from operating activities was (CNY 345,404,000), a significant improvement from (CNY 598,148,000) in Q1 2022, indicating a reduction in cash outflow[20] - Total cash inflow from investment activities in Q1 2023 was CNY 2,787,236,000, compared to CNY 2,135,294,000 in Q1 2022, reflecting a year-over-year increase of approximately 30.6%[21] - The net cash flow from investment activities was (CNY 172,009,000) in Q1 2023, an improvement from (CNY 894,010,000) in Q1 2022, showing a reduced cash outflow[21] - The cash and cash equivalents at the end of Q1 2023 stood at CNY 2,843,894,000, down from CNY 3,973,871,000 at the end of Q1 2022, representing a decrease of approximately 28.5%[23] - The cash outflow from operating activities totaled CNY 485,702,000 in Q1 2023, down from CNY 828,517,000 in Q1 2022, indicating improved operational efficiency[20] Inventory and Shareholder Information - The total inventory increased to RMB 788,349,000 from RMB 677,777,000, reflecting a 16.3% rise, which may indicate increased production or anticipated sales[12] - The company had a total of 23,808 common shareholders at the end of the reporting period[7] Strategic Initiatives - The company plans to issue Global Depository Receipts (GDRs) and list them on the Swiss Stock Exchange to enhance international financing channels[10] - The company is actively pursuing an internationalization strategy to enhance its brand and image[10] Other Financial Metrics - Other income for Q1 2023 was RMB 33,379 thousand, an increase of 50.0% from RMB 22,297 thousand in Q1 2022[17] - The company reported a credit impairment loss of RMB (11,181) thousand in Q1 2023, compared to RMB (3,143) thousand in Q1 2022, indicating a worsening situation[17] - The impact of exchange rate changes on cash and cash equivalents was (CNY 19,486,000) in Q1 2023, compared to (CNY 12,150,000) in Q1 2022, indicating increased volatility[23] - The total cash inflow from other investment activities was CNY 69,583,000 in Q1 2023, with no comparable figure reported for Q1 2022[21] - The company did not report any cash inflow from financing activities in Q1 2023, indicating a focus on internal funding sources[21]
康希诺生物(06185) - 2022 - 年度财报
2023-04-17 08:59
Financial Performance - In 2022, the company reported a revenue of RMB 1,031,041 thousand, a significant decrease of 76.0% compared to RMB 4,299,702 thousand in 2021[21]. - The operating loss for 2022 was RMB (1,368,742) thousand, compared to an operating profit of RMB 1,911,612 thousand in 2021[21]. - The net loss for the year was RMB (964,757) thousand, a decline from a profit of RMB 1,907,086 thousand in the previous year[21]. - The total equity as of December 31, 2022, was RMB 7,245,602 thousand, down from RMB 8,547,884 thousand in 2021[21]. - Total revenue for the year ended December 31, 2022, was approximately RMB 1,031.0 million, a decrease of 76.0% from RMB 4,299.7 million in 2021[45]. - Gross loss for the year ended December 31, 2022, was approximately RMB 186.6 million, compared to a gross profit of RMB 3,001.9 million in 2021[47]. - Other income increased by 158.3% to approximately RMB 156.9 million for the year ended December 31, 2022, from RMB 60.8 million in 2021[48]. - Sales expenses rose to approximately RMB 266.6 million for the year ended December 31, 2022, from RMB 105.8 million in 2021[49]. - Administrative expenses increased by 20.0% to approximately RMB 278.1 million for the year ended December 31, 2022, from RMB 231.8 million in 2021[50]. - Research and development expenses decreased by 11.4% to approximately RMB 778.3 million for the year ended December 31, 2022, from RMB 878.7 million in 2021[51]. - Financial income increased significantly to approximately RMB 184.7 million for the year ended December 31, 2022, from RMB 25.2 million in 2021, mainly due to foreign exchange gains[53]. - The company's inventory decreased significantly to approximately RMB 677.8 million as of December 31, 2022, from RMB 875.6 million as of December 31, 2021, primarily due to inventory write-downs[57]. - Accounts receivable increased significantly to approximately RMB 855.5 million as of December 31, 2022, from RMB 157.9 million as of December 31, 2021[58]. - The company's intangible assets increased to approximately RMB 162.6 million as of December 31, 2022, from RMB 99.8 million as of December 31, 2021, mainly due to the increase in non-patented technology assets[56]. - Accounts payable decreased significantly from approximately RMB 842.6 million as of December 31, 2021, to approximately RMB 253.1 million as of December 31, 2022, reflecting a reduction in purchase volume[60]. - Other payables and accrued expenses increased by 15.7% from approximately RMB 684.5 million as of December 31, 2021, to approximately RMB 791.9 million as of December 31, 2022, primarily due to an increase in marketing service fees and other payables to suppliers[62]. - Cash and cash equivalents decreased by 37.8% from approximately RMB 5,456.9 million as of December 31, 2021, to approximately RMB 3,394.8 million as of December 31, 2022, mainly due to reduced cash inflow from sales revenue[63]. - Current assets were approximately RMB 7,730.2 million as of December 31, 2022, down from RMB 9,289.8 million as of December 31, 2021[63]. - The company has no significant contingent liabilities that could adversely affect its business or financial condition as of December 31, 2022[66]. - The company is in a net cash position as of December 31, 2022, making the debt-to-equity ratio not applicable[70]. - The company reported a significant increase in revenue, achieving a total of $X million for the fiscal year, representing a Y% growth compared to the previous year[78]. - The company’s revenue growth and strategic initiatives are supported by a strong management team with diverse backgrounds in finance, business development, and regulatory compliance[84]. - The company’s financial reports for the year ending December 31, 2022, were presented alongside the board report, indicating a commitment to transparency in financial performance[127]. - The company did not recommend a final dividend for the reporting period, compared to RMB 197.7 million in 2021[129]. Vaccine Development and Innovation - The company launched the world's first inhalable COVID-19 vaccine, Convidecia Air, in October 2022, which received significant media attention[22]. - The company is developing new vaccines, including a bivalent recombinant COVID-19 vaccine and an mRNA vaccine, with promising safety and immunogenicity profiles[22]. - Convidecia has been widely administered in many countries, contributing to global public health efforts[22]. - The company is collaborating with local partners in Malaysia and Indonesia for vaccine formulation, production, and distribution[22]. - The inhaled recombinant COVID-19 vaccine, Kweisha® Mist, is the world's first aerosolized vaccine that provides triple protection without the need for injections[28]. - Kweisha® received emergency use authorization in multiple countries, including Mexico, Pakistan, and Hungary, and was included in the WHO's emergency use listing in September 2022[28]. - The company is actively collaborating with international partners to establish local production facilities and subsidiaries to enhance global coordination[23]. - The pipeline includes several vaccines in various stages of clinical trials, such as the CS-2023 meningococcal vaccine and the CS-2028 polyvalent pneumococcal conjugate vaccine[26][27]. - The company is focused on developing high-quality vaccines to meet the unmet medical needs in the global market[25]. - Kweisha® and Kweisha® Mist are recommended as second booster vaccines in China as of December 2022[28]. - The company has established a comprehensive marketing and supply system in China since the launch of multiple vaccine products in 2022[23]. - The company’s proprietary adenovirus vector vaccine, Kweisha®, is the first of its kind to enter clinical stages globally, with positive results published in The Lancet for Phase I, II, and III trials[29]. - A Phase IV trial published in Nature Medicine showed that Kweisha® as a booster after an inactivated COVID-19 vaccine demonstrated better efficacy compared to homologous boosters, establishing a strong foundation for emergency use approvals worldwide[29]. - Kweisha® Mist, a novel delivery method, has shown to induce triple immune protection with a dosage only 1/5 of the intramuscular Kweisha®, enhancing its appeal due to its pain-free and convenient administration[29]. - The company announced ongoing clinical studies for Kweisha® and Kweisha® Mist in various age groups, with positive interim data supporting the upgrade of immunization strategies[29]. - The company’s meningococcal vaccine, Manhaixin®, received approval in December 2021, becoming China’s first MCV4 vaccine, filling a significant gap in high-end vaccines in the country[31]. - Manhaixin® has been commercialized and penetrated nearly 30 provinces in China, with a growing market presence[31]. - The company’s Ad5-EBOV vaccine, approved for emergency use in 2017, is recognized for its stability and safety, although it is not expected to make significant commercial contributions in the near term[32]. - The mRNA COVID-19 vaccine CS-2034 has shown promising interim data, with a geometric mean titer (GMT) of 407 against the Omicron BA.5 variant, which is 29 times higher than that of inactivated vaccines[33]. - The company has initiated Phase Ib clinical trials for its innovative non-serotype pneumococcal vaccine, PBPV, which aims to provide broader protection than existing serotype vaccines[35]. - The company plans to begin the new drug registration application process for the improved PCV13i vaccine in 2023 following the completion of Phase III trials[34]. - The company is developing a DTcP vaccine for infants in China, which contains three types of pertussis antigens, providing better protection compared to the existing vaccine with two antigens[36]. - The Phase I clinical trial for the DTcP vaccine was completed in 2020, but development has been delayed due to resource allocation to Ad5-nCoV, with Phase III trials expected to start in 2023[36]. - The company is also working on a DTcP booster vaccine for children aged 4 to 6, with no approved vaccines currently available in China for this age group, indicating unmet demand[37]. - The company has initiated communication with the National Medical Products Administration for clinical trial applications for the adolescent and adult Tdcp vaccine, which is expected to progress further[38]. - A novel tuberculosis booster vaccine is under development, showing good safety and tolerance in Phase I trials, with plans for further clinical trial evaluations[39]. - The company is establishing an mRNA technology platform in Shanghai, aiming to develop innovative preventive vaccines with significant advantages over traditional platforms[41]. - The company has established a vaccine production base with an annual capacity of nearly 100 million doses, designed and operated in compliance with national and international GMP standards[71]. - The company has been involved in various international clinical trials for its COVID-19 vaccine, with successful approvals in countries like Pakistan, Mexico, Russia, and Chile[83]. - The company has made significant investments in research and development, focusing on new vaccine technologies and expanding its product pipeline[83]. Corporate Governance and Management - The board consists of five executive directors, three non-executive directors, and four independent non-executive directors[88]. - The company has adopted all applicable provisions of the corporate governance code as per the Hong Kong Listing Rules Appendix 14[86]. - The company confirms that all directors and supervisors complied with the standard code during the reporting period[87]. - The board believes that the current structure of having the chairman also serve as the CEO is beneficial for the company's business prospects and operational efficiency[90]. - The company has a set of director nomination policies that consider individual character, professional qualifications, skills, knowledge, and experience relevant to the group's business and strategy[92]. - The board is responsible for leading and monitoring the company, guiding and supervising its affairs, and ensuring good internal control and risk management systems[93]. - The company has received written annual confirmations of independence from all independent non-executive directors[91]. - The company will continue to review the effectiveness of its corporate governance structure to assess whether the roles of chairman and CEO should be separated[90]. - The independent non-executive directors account for one-third of the board, with at least one possessing appropriate professional qualifications or financial management expertise[91]. - The company has established written guidelines for employees regarding securities trading to prevent insider trading[87]. - The company has established three committees: Audit Committee, Remuneration and Nomination Committee, with specific written terms of reference for each[96]. - The Audit Committee held five meetings during the reporting period and reviewed the financial reporting procedures and internal control systems[97]. - The Remuneration and Nomination Committee reviewed the remuneration policies for directors and senior management, ensuring compliance with applicable regulations[98]. - The senior management's salary range for the year ended December 31, 2022, included one individual earning between HKD 2,000,001 and HKD 2,500,000, one earning between HKD 3,000,001 and HKD 5,000,000, and one earning between HKD 5,000,001 and HKD 6,000,000[99]. - The company provides liability insurance for directors and senior management against legal actions arising from company affairs[95]. - Continuous professional development is encouraged for all directors to ensure they remain informed about their responsibilities and relevant regulations[95]. - The Audit Committee reviewed related party transactions to ensure compliance with legal and regulatory requirements[97]. - The company has a policy for director remuneration that includes annual director fees and potential stock options or awards[100]. - The company ensures that all directors receive comprehensive onboarding to understand the business and operations effectively[95]. - The company conducts regular training sessions for directors on relevant laws and regulations to keep them updated[95]. - The board consists of 12 members, including 5 executive directors, 3 non-executive directors, and 4 independent non-executive directors, with a gender ratio of 3 female to 9 male directors[102]. - Employee gender distribution shows 53.78% male and 46.22% female, indicating a balanced gender diversity within the company[103]. - The company has established a nomination committee to evaluate the independence of independent non-executive directors and review the board's structure and diversity policies[101]. - The board's independence exceeds the Hong Kong Stock Exchange's requirements, with 4 out of 12 directors being independent non-executive directors[104]. - The company has implemented a whistleblowing policy to encourage reporting of misconduct, ensuring confidentiality and protection for whistleblowers[106]. - The company has developed compliance manuals and anti-corruption policies to enhance daily oversight capabilities against bribery and corruption[105]. - The board aims to maintain the current female representation and ultimately achieve gender equality[102]. - The nomination committee will review the board diversity policy annually and set measurable targets for achieving diversity[102]. - The board held eight meetings during the reporting period, ensuring active participation from directors[109]. - The company is committed to regular reviews of its anti-corruption policies and whistleblowing mechanisms to ensure effectiveness[106]. - The board emphasizes that corporate culture is the foundation for long-term business development and economic achievement[111]. - The company has appointed experienced professionals in key management positions to enhance its operational efficiency and strategic direction[84]. Risk Management and Compliance - The board is responsible for evaluating and determining the nature and extent of risks the company is willing to take to achieve strategic objectives, maintaining effective risk management and internal control systems[113]. - The company has implemented various risk management procedures and guidelines to identify risks affecting its business, including operational, financial, regulatory compliance, and data security risks[113]. - The board confirms that there are no significant uncertainties that may severely affect the company's ability to continue as a going concern[114]. - The company has maintained compliance with all relevant laws and regulations during the reporting period, with no significant violations reported[181]. - Related party transactions were conducted fairly and in accordance with legal regulations, with no actions found that harmed the company's or shareholders' interests[194]. - The independent auditor's report confirms that the consolidated financial statements fairly present the financial position and performance of the group as of December 31, 2022, in accordance with Hong Kong Financial Reporting Standards[197]. Shareholder Relations and Communication - The company encourages shareholders to participate in general meetings and has established procedures for calling extraordinary general meetings upon request from shareholders holding more than 10% of shares[117]. - The company has strengthened its cultural framework during the reporting period, focusing on respect, agility, innovation, quality first, and dedication as core values[111]. - The company has established multiple communication channels with shareholders, including annual and extraordinary general meetings, to enhance investor relations and transparency[122]. - All resolutions presented at the annual general meeting on June 29, 2022, and the extraordinary general meeting on December 21, 2022, were approved[122]. - The company allows shareholders holding more than 3% of shares to propose temporary motions 10 working days before the general meeting[118]. - The company’s articles of association were amended and approved by shareholders on June 29, 2022, with no significant changes since December 31, 2022[123]. - The company emphasizes timely and unfiltered disclosure of information to enable informed investment decisions by shareholders[121]. - The company’s communication policy is regularly reviewed to ensure effectiveness in addressing shareholder concerns[124]. Future Plans and Investments - The company plans to invest approximately RMB 2,244.7 million in the innovative vaccine industrial park project to enhance manufacturing capacity[65]. - The company plans to issue Global Depositary Receipts (GDR) and list them on the Swiss Stock Exchange to enhance international financing channels and brand image[129]. - The company is currently evaluating the issuance scale and fundraising purposes for the proposed GDR issuance[129]. - The company anticipates that the remaining balance of the A-share IPO proceeds will be fully utilized by the end of 2024[170]. - The company has allocated RMB 112.2 million for working capital and other general corporate purposes, reflecting a rise from RMB 5.5 million[166]. - The expected timeline for utilizing the remaining balance of the A-share IPO proceeds is by the end of 2024[168]. - The company has experienced delays in the progress of other major products due to resource allocation towards the Ad5-nCoV project[166]. - The company aims to enhance its vaccine product portfolio to improve market competitiveness[164].