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].
康希诺生物(06185) - 2022 - 年度财报