Financial Performance - Total revenue for 2023 reached RMB 31.45 billion, a 1.7% increase compared to 2022[5][6] - Net profit attributable to shareholders was RMB 5.87 billion, a 3.6% decrease from 2022[5][6] - Basic profit attributable to shareholders (non-HKFRS measure) was RMB 6.28 billion, up 2.8% year-over-year[5][6] - Full-year dividend per share increased by 33.3% to 28 HK cents[5][7] - Revenue for the year reached RMB 31.45 billion, a 1.7% increase from RMB 30.937 billion in 2022, driven by growth in the pharmaceutical business[65] - Gross margin decreased by 1.4 percentage points to 70.5%, primarily due to changes in revenue structure and a decline in vitamin C product prices[65] - Net loss for the year was RMB 1.05 billion, compared to a net profit of RMB 2.91 billion in 2022, mainly due to fair value losses on financial assets of RMB 2.11 billion (2022: profit of RMB 1.01 billion) and net foreign exchange gains of RMB 1.03 billion (2022: net gain of RMB 1.18 billion)[67] - Revenue for 2023 was RMB 31,450,109 thousand, compared to RMB 30,936,904 thousand in 2022[168] - Gross profit for 2023 was RMB 22,176,686 thousand, slightly down from RMB 22,256,414 thousand in 2022[168] - Net profit for 2023 was RMB 6,072,693 thousand, compared to RMB 6,232,050 thousand in 2022[168] - Basic earnings per share for 2023 were RMB 49.47 cents, down from RMB 51.11 cents in 2022[168] - Total comprehensive income for 2023 was RMB 6,049,146 thousand, down from RMB 6,295,556 thousand in 2022[169] - The company's share of the net profit for 2023 was RMB 5,873,325 thousand, compared to RMB 6,091,390 thousand in 2022[168] - Non-controlling interests' share of the net profit for 2023 was RMB 199,368 thousand, up from RMB 140,660 thousand in 2022[168] - The company's share of the total comprehensive income for 2023 was RMB 5,849,778 thousand, compared to RMB 6,154,896 thousand in 2022[169] - Total comprehensive income for the year 2023 was RMB 6,295,556,000[172] - The company's profit for the year 2023 was RMB 6,091,390,000[172] - Dividends paid to equity holders amounted to RMB 20,475,000[172] - The company's total assets as of December 31, 2023, were RMB 35,018,012,000[172] - The company's total equity as of December 31, 2023, was RMB 33,203,208,000[172] - The company's other comprehensive income for the year 2023 was RMB 63,506,000[172] - The company's share-based payment expenses for the year 2023 were RMB 160,726,000[172] - The company's statutory reserves increased by RMB 154,187,000 in 2023[172] - The company's investment in subsidiaries and associates increased by RMB 437,141,000 in 2023[172] - The company's other reserves include a fair value adjustment of RMB 4,030,633,000 from a reverse acquisition in 2012[173] - Operating cash flow from operations decreased to RMB 4,178,815 thousand in 2023 from RMB 7,627,064 thousand in 2022, reflecting a significant decline in cash generation[174] - Pre-tax profit slightly decreased to RMB 7,389,372 thousand in 2023 from RMB 7,582,261 thousand in 2022, indicating a marginal decline in profitability[174] - Investment activities generated a net cash inflow of RMB 607,267 thousand in 2023, compared to a net cash outflow of RMB 6,795,984 thousand in 2022, showing improved investment cash flow[175] - Cash and cash equivalents increased to RMB 10,490,845 thousand at the end of 2023 from RMB 8,000,852 thousand at the beginning of the year, reflecting a strong cash position[175] - Property, plant, and equipment acquisitions decreased to RMB 1,623,688 thousand in 2023 from RMB 2,220,218 thousand in 2022, indicating reduced capital expenditure[175] - Intangible assets acquisitions decreased to RMB 265,432 thousand in 2023 from RMB 484,537 thousand in 2022, reflecting lower spending on intangible assets[175] - Dividends paid increased to RMB 2,726,253 thousand in 2023 from RMB 2,096,961 thousand in 2022, showing higher shareholder returns[175] - Government grants received increased to RMB 114,788 thousand in 2023 from RMB 41,803 thousand in 2022, indicating higher government support[175] - Inventory increased by RMB 583,746 thousand in 2023, compared to an increase of RMB 42,750 thousand in 2022, reflecting higher inventory levels[174] - Trade receivables increased by RMB 1,973,267 thousand in 2023, compared to an increase of RMB 566,548 thousand in 2022, indicating higher credit sales[174] Business Segments - Pharmaceutical business revenue grew 4.6% to RMB 25.64 billion, accounting for 81.5% of total revenue[5] - API business revenue declined 9.7% to RMB 3.64 billion[5] - Functional food and other business revenue decreased 8.9% to RMB 2.17 billion[5] - The company's pharmaceutical business recorded revenue of RMB 25.637 billion in 2023, an increase of 4.6% year-on-year, including licensing fee income of RMB 34.7 million[14] - The respiratory system treatment area saw a significant revenue increase of 124.0% in 2023, reaching RMB 1.56 billion[15] - The anti-infective treatment area grew by 19.7% in 2023, with revenue reaching RMB 4.236 billion[15] - Sales revenue of Vitamin C products decreased by 23.7% to RMB 1.929 billion in 2023 due to weak prices, despite stable sales volume[27] - Antibiotics sales revenue increased by 13.9% to RMB 1.712 billion in 2023, driven by increased sales of products like azithromycin[28] - Functional foods and other businesses saw a sales revenue decline of 8.9% to RMB 2.172 billion in 2023, with slight growth in caffeine product sales but price drops[29] R&D and Innovation - The company has over 60 key candidate products in clinical stages, with several globally patented blockbuster products[9] - Completed 3 major product licensing deals, including an exclusive licensing agreement with US-based Corbus Pharmaceuticals for SYS6002 (Nectin-4 ADC)[10] - The company has over 2,000 R&D personnel and approximately 130 innovative drug projects in development, including over 40 large molecules, over 40 small molecules, and over 30 new formulations[12] - The company expects nearly 50 innovative drugs to be submitted for approval in the next 5 years[12] - R&D expenses reached RMB 4.83 billion in 2023, a 21.2% increase year-over-year, accounting for 18.8% of pharmaceutical business revenue[30] - The company has over 60 key drugs in clinical or application stages, with 7 submitted for market approval and 18 in registration clinical stages[30] - In 2023, 4 innovative drugs (including new indications) and 1 special formulation were approved in China, with 5 innovative drugs/special formulations under application[31] - The company's self-developed BA.5 variant mRNA vaccine (Duentai®) was approved for emergency use in China in March 2023, becoming the first mRNA vaccine in China[32] - The bivalent (XBB.1.5+BQ.1) mRNA vaccine (SYS6006.32) was approved for emergency use in China in December 2023, showing broad-spectrum cross-immunity[32] - In February 2024, Mingfule® (rhTNK-tPA) was approved for thrombolytic treatment of acute ischemic stroke, marking the first approval of its kind in China[33] - KN026 (recombinant humanized anti-HER2 bispecific antibody) received breakthrough therapy designation in November 2023 for HER2-positive gastric cancer treatment[33] - 17 innovative drugs with first indications and 24 additional indications received clinical trial approvals, including SYH2045 (PRMT5 inhibitor) for advanced malignant tumors and SYS6006.32 (bivalent COVID-19 mRNA vaccine) for COVID-19 prevention[34] - 8 generic drugs received drug registration approvals since the beginning of 2023, including the first generic drug Suvorexant Extended-Release Tablets, which was successfully included in the national medical insurance catalog in December 2023[36] - NBL-020 (TNFR2 fully humanized monoclonal antibody) received U.S. clinical trial approval in January 2023, and CPO301 (ADC) received U.S. clinical trial approval in March 2023[37] - The company successfully submitted an ANDA for Amphotericin B Liposome to the U.S. FDA in November 2023 and an NDA for Irinotecan Liposome in December 2023[38] - The Phase III clinical study of Pertuzumab Injection combined with Trastuzumab and Docetaxel for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer in China completed the first dosing in January 2023 and is currently in the enrollment phase[39] - The Phase III clinical study of Docetaxel Injection (Albumin-bound) for the treatment of locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in China completed the first site initiation in February 2024 and is currently in the enrollment phase[40] - The Phase III clinical study of Doxorubicin Hydrochloride Liposome Injection for platinum-based therapy-failed recurrent or metastatic nasopharyngeal carcinoma in China completed the first patient dosing in March 2023 and is currently in the enrollment phase[41] - The Phase II/III clinical study of CM310 Injection (IL-4Rα antibody) for the treatment of moderate to severe asthma in China was initiated in March 2023, with the first dosing completed in April 2023 and currently in the enrollment phase[42] - The Phase III clinical study of SYHX2011 (Paclitaxel for Injection (Albumin-bound) II) for the treatment of advanced breast cancer in China completed the first dosing in April 2023 and completed enrollment in March 2024[43] - The Phase III clinical study of Semaglutide Injection for the treatment of type 2 diabetes in China was initiated in February 2024 and is currently in the enrollment phase[45] - JMT101 achieved the preset endpoint in a Phase II clinical study for treating non-small cell lung cancer with EGFR exon 20 insertion mutations in China in January 2024[47] - Mingfule (recombinant TNK tissue-type plasminogen activator) demonstrated non-inferior efficacy to alteplase in the TRACE-2 Phase III clinical trial for acute ischemic stroke, with results published in The Lancet (IF: 202.731) in February 2023[48] - JMT101 combined with osimertinib showed promising efficacy and manageable safety in EGFR exon 20 insertion mutation non-small cell lung cancer patients, with Phase II results presented at the 2024 ELCC in March 2024[49] - The first-generation COVID-19 mRNA vaccine demonstrated good protective efficacy, immunogenicity, and safety, with clinical results published in multiple international journals from November 2023 to February 2024[50] - Ouyuexin (desvenlafaxine succinate sustained-release tablets) showed non-inferior efficacy to duloxetine in treating depression, with Phase III results published in the Journal of Affective Disorders in February 2023[51] - TG103 (GLP-1 receptor agonist) demonstrated safety and tolerability in a Phase Ia study in healthy Chinese subjects, with results published in the European Journal of Pharmaceutical Science in April 2023[52] - SYSA1801 (CLDN18.2 ADC) exhibited promising anti-tumor efficacy, particularly in gastric cancer, with Phase I results presented at the 2023 ASCO Annual Meeting in June 2023[53] - ALMB-0168 (Cx43 hemichannel antibody agonist) showed favorable efficacy trends and tolerability in metastatic or unresectable osteosarcoma patients, with Phase I data presented at the 2023 ASCO Annual Meeting in June 2023[54] - SYS6002 (anti-Nectin4 monoclonal antibody-drug conjugate) demonstrated clear efficacy signals in advanced solid tumors, including cervical and urothelial cancers, with Phase I results presented at the 2024 ASCO-GU in January 2024[55] - SYHA1813 (VEGFR/CSF1R inhibitor) showed good objective response and tolerability in recurrent meningioma patients, with Phase I results presented at the 2023 ESMO Congress in October 2023[56] Market Expansion and Partnerships - Established international headquarters in Singapore and expanded market presence in Europe, US, Japan, Korea, and Belt and Road countries[10] - The company signed a strategic cooperation agreement with Pfizer for the localized production of the COVID-19 oral antiviral treatment Paxlovid in China[63] - The company entered into an exclusive licensing agreement with Corbus Pharmaceuticals for the development and commercialization of SYS6002 (Nectin-4 ADC) in multiple regions, with potential payments up to $690 million[64] Corporate Governance and Compliance - The company maintained a robust corporate governance framework, complying with the Hong Kong Stock Exchange's Corporate Governance Code throughout 2023[75] - The company held 4 board meetings in 2023, with attendance rates for executive directors ranging from 75% to 100%[78] - The company has 23,480 employees as of December 31, 2023, with a gender ratio of 0.93 (11,308 females to 12,172 males)[80] - The Remuneration Committee granted 50,000,000 share options to executive directors in 2023 as part of incentive and reward measures[81] - The Audit Committee held 4 meetings in 2023, focusing on financial reporting, risk management, and internal control systems[84] - The company's board consists of 14 male members and 1 female member, reflecting ongoing efforts to improve diversity[79] - The Nomination Committee held 1 meeting in 2023 to review board structure and composition, and assess independence of non-executive directors[83] - The company has adopted a board diversity policy considering factors such as gender, age, cultural background, and professional experience[79] - The Audit Committee reviewed quarterly, semi-annual, and annual financial statements and provided recommendations to the board[84] - The Remuneration Committee held 2 meetings in 2023 to review and recommend compensation policies for directors and senior management[81] - The company encourages continuous professional development for all directors to maintain knowledge of regulatory requirements and good governance practices[86] - The company's external auditor, Deloitte Touche Tohmatsu, received a total fee of RMB 7.493 million for audit and non-audit services in 2023, with RMB 6.882 million for audit and assurance services and RMB 611,000 for tax advisory and compliance services[97] - The company's internal audit function conducted an annual review of the effectiveness of the risk management and internal control systems in 2023, covering all major financial, operational, and compliance controls[91] - The Board of Directors confirmed that the company's risk management and internal control systems were effective and adequate as of December 31, 2023, with no significant concerns identified[92] - The company has adopted an anti-corruption policy and a whistleblowing policy to regulate employee conduct and provide guidance for reporting suspected or actual misconduct[93] - The company's internal control system is designed to promote effective and efficient operations, ensure proper accounting records, comply with applicable laws, and protect company assets[91] - The company's risk management framework ensures that risks across different business units are effectively controlled within the company's risk appetite[90] - The company's external auditor will rotate the engagement partner in 2028, as the current partner has been in charge since 2021[97] - The company has implemented a mechanism for the Board to seek independent legal, financial, or professional advice when necessary, with costs borne by the company[88] - The company's internal audit function reviewed the adequacy of resources, qualifications, experience, training programs, and budgets for accounting, internal audit, and financial reporting functions in 2023[91] - The company's Board of Directors is responsible for overseeing the company's corporate governance policies, including shareholder communication, board diversity, and the independent opinion mechanism[95] - The company's management attended approximately 300 one-on-one and group meetings with investors in 2023 to enhance corporate transparency and understanding of the group's business model and latest development strategies[99] - The company has established a shareholder communication policy to ensure timely, transparent, accurate, and open communication with shareholders, which has been reviewed and deemed effective by the board[100] - Shareholders holding at least 5% of the total voting rights can request the convening of a general meeting, and the board must convene the meeting within 21 days of receiving the request[101] - Shareholders holding at least 2.5% of the total voting rights or at least 50 shareholders can request the circulation of resolutions at the annual general meeting[102] - The company's board of directors has reviewed and approved the annual report and audited consolidated financial statements for the year ended December 31, 2023[104] - The company faces risks related to the drug approval process, including delays or failures in preclinical studies or clinical trials, which could impact the actual time to market for development products[106] - The company's sales and profitability depend on the success of its products in China's drug bidding and centralized procurement processes, with potential impacts on market share and profitability if products fail to win bids[107] - The company must comply with Chinese environmental and safety regulations, with potential penalties, criminal sanctions, or facility closures for violations[108] - The company's products may be removed from
石药集团(01093) - 2023 - 年度财报