Financial Performance - In 2023, the company's annual sales revenue reached 246 million, an increase of 55.0% compared to the previous year[8]. - The company's revenue for the fiscal year ended December 31, 2023, was RMB 246,367,000, an increase of 55% compared to RMB 158,957,000 in 2022[12]. - Gross profit for 2023 was RMB 144,365,000, representing a gross margin of approximately 58.5%[12]. - The net loss for the year was RMB 379,787,000, a slight improvement from a net loss of RMB 402,643,000 in 2022[13]. - The company recorded a total comprehensive income of RMB 27.5 million for the year ended December 31, 2023, compared to a total comprehensive expense of RMB 580.0 million for the previous year[40]. - Cash and bank balances as of December 31, 2023, were approximately RMB 1,053.8 million[41]. - The company reported other income of RMB 23,203,000 in 2023, down from RMB 35,654,000 in 2022[12]. - The financial cost for the year was RMB 1,325,000, a decrease from RMB 1,793,000 in 2022, indicating a reduction of approximately 26.1%[12]. - The company recorded short-term loans of RMB 120.0 million as of December 31, 2023, compared to none as of December 31, 2022, with fixed interest rates of 3.0% and 3.1%[64]. - The company has not declared or paid any dividends on ordinary or preferred shares, and any future dividend payments will depend on various factors including profitability and capital needs[185]. Research and Development - The company successfully completed the NDA submission for ZERVIATE® (OT-1001), which is expected to be approved soon for treating allergic conjunctivitis in children[7]. - The company completed patient enrollment for three Phase III clinical trials for OT-101, OT-702, and DEXYCU® (OT-502), achieving significant milestones for future registration submissions[7]. - The company is set to announce results for the Phase II clinical trial of OT-202 in Q1 2024, continuing its leadership in ophthalmic research and development[7]. - The company has a comprehensive ophthalmic product line with 25 drug assets, including five products in Phase III clinical trials, addressing major anterior and posterior eye diseases[15]. - OT-1001 (ZERVIATE®) for allergic conjunctivitis has received NDA acceptance from the National Medical Products Administration and is included in the priority review and approval process, expected to be approved soon[21]. - OT-101 (0.01% atropine sulfate eye drops) has completed patient enrollment of 678 in a global Phase III clinical trial[19]. - OT-502 (DEXYCU®) has completed real-world studies with 263 patients and is expected to submit NDA this year after completing enrollment of 300 patients in Phase III trials[26][27]. - OT-702 (a biosimilar to Aflibercept) has successfully completed patient enrollment for Phase III clinical trials and is expected to submit NDA this year[23][24]. - The company plans to initiate Phase III clinical trials for OT-202 in 2023[30]. - The company aims to continue advancing its Phase III clinical trials throughout the year[20]. Market Expansion and Product Development - The company expanded its market presence by obtaining approval for ILUVIEN® (OT-703) in Hong Kong, marking its first listing outside mainland China[7]. - The company established a national academic network for the launch of its product, Yushiying®, which successfully entered the new national medical insurance drug list, setting the stage for rapid sales growth in 2024[8]. - Sales of ophthalmic products rose by 88.1% to RMB 204.7 million, up from RMB 108.8 million in the previous year[43]. - The new drug Yushiying (fluocinolone acetonide intravitreal implant) has been included in the latest National Medical Insurance Drug List, effective January 1, 2024, significantly reducing patient payment burdens[36]. - The company aims to adapt to market changes and continue rapid development, focusing on creating value for shareholders in its sixth year of operation[10]. - The company plans to expand its market presence in Southeast Asia, targeting a 30% increase in market share by 2025[100]. - A strategic acquisition is in progress, aimed at enhancing the company's technological capabilities and product offerings[100]. - The company has invested HKD 200 million in R&D for new technologies, representing a 20% increase in R&D spending compared to last year[100]. Workforce and Management - The workforce increased from 398 employees at the end of 2022 to 444 employees by December 31, 2023, reflecting business expansion[10]. - The total employee compensation cost for the year ended December 31, 2023, was RMB 314.6 million, down from RMB 382.1 million in 2022[75]. - The management team has been strengthened with the appointment of a new CFO, who has extensive experience in investment banking and financial management[98]. - Liu Hongying appointed as Chief Manufacturing Officer in January 2023, overseeing the construction and operation of the Suzhou factory and production of real estate products[101]. - Shen Bo appointed as Chief Medical Officer starting January 2024, leading the group's clinical research and development efforts[101]. Corporate Governance and Compliance - The company has adopted a corporate governance code and believes it has fully complied with its provisions for the year ending December 31, 2023[109]. - The board consists of at least three independent non-executive directors, with one possessing appropriate professional qualifications in accounting or related financial management knowledge[116]. - The company has established three board committees: Audit Committee, Remuneration Committee, and Nomination Committee to oversee specific matters[112]. - The company has implemented measures to promote gender diversity at all levels, including management[125]. - The board's composition is deemed reasonable, with diverse experiences and skills that maintain high operational standards[119]. - The company has established effective mechanisms to support an independent board and independent viewpoints[126]. - The company has implemented a compliance window for employees to report compliance inquiries and issues anonymously[169]. - The board of directors confirmed that the risk management and internal control systems were effective and sufficient to protect stakeholders' interests as of December 31, 2023[170]. Strategic Vision and Future Outlook - The company is a Chinese ophthalmic pharmaceutical platform focused on identifying, developing, and commercializing innovative ophthalmic therapies to meet the significant demand gap in China's eye care market[194]. - The company’s vision is to provide world-class drug solutions to address the substantial unmet needs in Chinese ophthalmic healthcare[194]. - The company aims to improve operational efficiency, targeting a 10% reduction in operational costs by the end of the fiscal year[100]. - The company anticipates NDA approval for OT-1001 within the year and aims to advance clinical progress for self-developed products like OT-101 and OT-202[39]. - The company is committed to social responsibility, employee welfare, and environmental protection, aiming for sustainable growth through resource and emission management[197].
欧康维视生物-B(01477) - 2023 - 年度财报