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欧康维视生物-B(01477) - 2022 - 年度业绩
2023-03-30 13:10
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 本公告包含涉及風險及不確定因素的前瞻性陳述。歷史事實陳述以外的所有陳述均屬前瞻性陳 述。該等陳述涉及已知及未知的風險、不確定因素及其他因素,當中部分因素屬本公司控制範 圍以外,可能會導致實際業績、表現或成果與前瞻性陳述所明示或暗示者大相徑庭。 閣下不 應依賴前瞻性陳述作為未來事件的預測。本公司並無責任更新或修改任何前瞻性陳述(不論因 新增資料、未來事件或其他方面)。 Ocumension Therapeutics 歐康維視生物 (於開曼群島註冊成立的有限公司) (股份代號:1477) 截至2022年12月31日止年度全年業績公告 本公司董事會欣然宣佈,本集團截至2022年12月31日止年度的經審核綜合全年業 績連同截至2021年12月31日止年度的比較數字如下。本集團於報告期間的綜合財 務報表已獲審核委員會審閱及本公司核數師德勤•關黃陳方會計師行審核。 在本公告內,「我們」指本公司及本集團(如文義另有所 ...
欧康维视生物-B(01477) - 2022 - 中期财报
2022-09-20 08:47
Financial Performance - Revenue for the six months ended June 30, 2022, was RMB 54.535 million, a significant increase from RMB 20.803 million in the same period of 2021, representing a growth of 162%[8]. - Gross profit for the same period was RMB 34.304 million, compared to RMB 15.687 million in 2021, indicating a gross margin improvement[8]. - The net loss for the period was RMB (192.669) million, worsening from RMB (69.609) million in the prior year[8]. - Adjusted net loss under non-IFRS was RMB (76.850) million, an improvement from RMB (109.185) million in the previous year[9]. - The company achieved revenue of RMB 545 million, representing a 162.1% increase compared to the same period in 2021[16]. - The company recorded a significant increase in revenue from promotional services for pharmaceutical products, rising from RMB 0.5 million to RMB 8.6 million[32]. - Other income for the six months ended June 30, 2022, was RMB 15.2 million, an increase of RMB 2.6 million from RMB 12.6 million for the same period in 2021, primarily due to increased bank interest income and government subsidies[36]. - The company reported a loss of RMB 192.7 million for the six months ended June 30, 2022, an increase of RMB 123.1 million from a loss of RMB 69.6 million for the same period in 2021[45]. - The company incurred a loss attributable to owners of RMB 192,669,000 for the six months ended June 30, 2022, compared to a loss of RMB 69,609,000 in the prior year[125]. Research and Development - Total R&D expenses for the period were RMB 98.439 million, up from RMB 92.244 million in 2021[11]. - Adjusted R&D expenses, which include capitalized R&D, amounted to RMB 198.900 million, down from RMB 244.541 million in the same period last year[11]. - The company aims to provide world-class drug solutions to meet the significant demand gap in China's ophthalmic healthcare market[12]. - Seven candidate drugs are currently in Phase III clinical trials, indicating ongoing development and potential market expansion[12]. - The company plans to advance the clinical trials of its pipeline products, particularly those entering Phase III trials, in the second half of 2022[30]. - The global Phase III clinical trial for OT-101 (low-concentration atropine) has commenced in China, with participant enrollment expected to accelerate in the second half of 2022[17]. - OT-1001 (ZERVIATE®) completed its Phase III clinical trial, achieving significant results, and NDA preparation is expected to be completed in the second half of 2022[20]. - OT-502 (dexamethasone implant) is progressing with real-world studies and Phase III clinical trials, with the first participant enrollment expected in Q3 2022[21]. - OT-202 (tyrosine kinase inhibitor) completed its Phase I clinical trial enrollment and dosing, with all participants in good health, and results are anticipated in Q4 2022[22]. - OT-702 (anti-VEGF) has completed enrollment of 262 participants in its Phase III clinical trial, with completion expected by the end of 2022[23]. - OT-703 (ILUVIEN®) received IND approval for a Phase III clinical trial in China for the treatment of DME, marking the seventh new drug to enter Phase III trials in the company's pipeline[24]. Market Position and Strategy - The company has exclusive sales rights for certain products in China, enhancing its market position and product offerings[12]. - The company has commercialized over 10 products in its ophthalmic product line, covering key areas such as anti-allergy and glaucoma[27]. - The company has established exclusive promotion rights for three ophthalmic drugs in the national hospital channel, enhancing its market presence[27]. - The company aims to successfully launch and promote its core product, OT-401, in the second half of 2022[30]. - The company is actively pursuing partnerships for market expansion, particularly in the Greater China region, which includes Hong Kong and Macau[173]. - A strategic acquisition is being considered to strengthen the company's position in the ophthalmic market[175]. Financial Position and Cash Flow - The cash and cash equivalents as of June 30, 2022, amounted to RMB 1.575 billion[16]. - As of June 30, 2022, total assets amounted to RMB 3,267.5 million, down from RMB 3,331.1 million as of December 31, 2021[50]. - Cash and cash equivalents increased to RMB 1,572.3 million as of June 30, 2022, compared to RMB 1,125.2 million at the end of 2021[51]. - The company had no borrowings as of June 30, 2022, maintaining a net cash position[52]. - The company reported a net increase in cash and cash equivalents of RMB 433,088 thousand, compared to RMB 235,391 thousand in the same period last year[106]. - The company generated net cash from investing activities of RMB 495,807 thousand, a significant increase from RMB (308,573) thousand in the prior year[106]. - The company reported a total of 667,792,020 ordinary shares outstanding as of June 30, 2022, an increase from 666,743,175 shares at the end of 2021[145]. Employee Compensation and Incentives - Total employee compensation costs for the six months ended June 30, 2022, were RMB 193.7 million, significantly higher than RMB 131.1 million in the same period of 2021[57]. - The company has implemented various employee incentive plans, including ESOP and RSU programs[58]. - The company aims to attract, motivate, and retain qualified employees through the ESOP and RSU plans[69][72]. - The total expense recognized for stock options granted by the company during the six months ended June 30, 2022, was RMB 1,609,000, down from RMB 54,316,000 for the same period in 2021[153]. - The total expense recognized for RSUs granted during the six months ended June 30, 2022, was RMB 8,330,000, compared to RMB 21,059,000 for the same period in 2021[156]. Compliance and Governance - The independent auditor, Deloitte, reviewed the interim financial statements for the six months ended June 30, 2022, confirming compliance with applicable accounting standards[95]. - The company has adopted a written code of conduct for directors regarding securities trading, confirming compliance for the six months ended June 30, 2022[85]. - The company has fully complied with the listing rules regarding independent non-executive directors after the appointment of Mr. Zhang Zhenyu on April 8, 2022[84]. - The management emphasized a commitment to corporate governance and compliance with international financial reporting standards[174].
欧康维视生物-B(01477) - 2021 - 年度财报
2022-04-26 09:41
Drug Development and Innovation - In 2021, Ocumension Therapeutics submitted its first core innovative drug OT-401 for new drug approval to NMPA, expected to be approved in 2022[5]. - The company advanced two more innovative drugs, OT-101 and OT-502, into Phase III clinical trials, bringing the total to six drugs in this stage, leading the ophthalmic sector in China[5]. - OT-101 is the first Chinese innovative drug to receive FDA approval for clinical use in children, highlighting the company's leadership in pediatric ophthalmic treatments[5]. - The company initiated its first human study for OT-202, a new mechanism compound, marking a significant milestone in its innovative drug development[5]. - The company has a pipeline of 20 drug assets, with six candidates currently in Phase III clinical trials, addressing major front and back eye diseases[12]. - The company aims to provide comprehensive treatment solutions for retinal diseases, addressing the growing patient population affected by diabetic retinopathy[5]. - The company is exploring real-world studies to accelerate drug registration, which will significantly impact future drug approvals and commercialization efforts[15]. - OT-401 became the first drug in Chinese pharmaceutical history to be approved for market based solely on real-world data, with its NDA accepted by NMPA in April 2021[15]. - The company plans to register as the marketing authorization holder for the acquired product OQIN, which includes all drug registration certificates and related data[14]. - The company is advancing the clinical trial recruitment process for OT-702, with all patient enrollment expected to be completed by the end of 2022[19]. Financial Performance - In 2021, Ocumension generated approximately RMB 90 million in revenue despite challenges from centralized procurement and pandemic impacts, marking its first full fiscal year of commercialization[6]. - The company achieved revenue of RMB 56,146,000 in 2021, a significant increase from RMB 13,096,000 in 2020, representing a growth of approximately 329%[8]. - Gross profit for 2021 was RMB 36,935,000, compared to RMB 11,372,000 in 2020, indicating a substantial increase of about 225%[8]. - The company reported a net loss attributable to shareholders of RMB 259,992,000 in 2021, a decrease from a loss of RMB 2,264,866,000 in 2020, reflecting an improvement of approximately 88%[8]. - The company reported other income of RMB 27,589,000 in 2021, an increase from RMB 19,271,000 in 2020, representing a growth of approximately 43%[8]. - The company recorded an adjusted net loss of RMB 187.0 million for the year ended December 31, 2021, a decrease of RMB 89.7 million compared to RMB 276.7 million for the year ended December 31, 2020, primarily due to increased gross profit from ophthalmic product sales[27]. - The company achieved total hospital terminal sales revenue of approximately RMB 90 million from six commercialized products, representing a growth of 466.53% compared to the year ended December 31, 2020[22]. Research and Development - Adjusted R&D expenses increased by 27.9% year-on-year to RMB 454.7 million, primarily due to an increase in the number of pipeline products and clinical trial activities[14]. - Total R&D expenses for the year ended December 31, 2021, amounted to RMB 169.1 million, while capitalized R&D expenses were RMB 285.7 million[38]. - The company established a research institute in Suzhou to enhance its preclinical research and development capabilities[16]. - The majority of R&D expenses were paid to contract research organizations and clinical trial centers, indicating a reliance on outsourced services[193]. Corporate Governance - The company has adopted a corporate governance code and believes it has fully complied with it for the year ending December 31, 2021[69]. - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors as of the report date[72]. - The company has established three board committees: Audit Committee, Remuneration Committee, and Nomination Committee to oversee specific matters[70]. - The company is committed to maintaining high levels of corporate governance to protect shareholder interests and enhance corporate value[69]. - The board has established measurable goals to continuously monitor and evaluate the company's culture[70]. Employee and Management - The company has a total of 244 employees, with 41.4% in business functions, 20.1% in R&D, 28.3% in manufacturing, and 10.2% in management and administration[55]. - Employee compensation includes salaries, bonuses, employee provident fund contributions, stock-based payments, and social security contributions, reviewed regularly based on performance and market levels[55]. - The company has implemented ESOP, RSU plans, and stock option plans to incentivize employees[55]. - The CEO, Ye Liu, has over 21 years of experience in the pharmaceutical industry and has been with the company since August 2018[56]. - The company is focused on employee training and development to ensure compliance with policies and procedures[55]. Market Expansion and Strategy - The company aims to broaden its product line to become a comprehensive solution provider for ophthalmic diseases[26]. - The company plans to enhance its production capacity to meet future commercialization needs, ensuring a robust supply chain for its products[7]. - The company is planning to expand its market presence in Southeast Asia, targeting a 10% market share within the next two years[62]. - The company has established strategic partnerships with three leading healthcare institutions to enhance service delivery[64]. Risks and Challenges - The company faces risks related to the successful completion of clinical trials and obtaining regulatory approvals for its drug candidates[112]. - The company relies on third parties for the supply of drug candidates or raw materials, which could impact its business if those parties fail to deliver sufficient quantities or quality[112]. - The company may need to raise additional funds to meet operational cash needs, which may not be available on acceptable terms[112]. Shareholder and Financial Management - The company has not declared or paid any dividends on ordinary or preferred shares, and it plans to retain all available funds for research and development of drug candidates in the foreseeable future[106]. - The company has a shareholder communication policy to facilitate effective communication with shareholders and potential investors[101]. - The company held two shareholder meetings during the year ending December 31, 2021, to enhance investor relations[101].