Financial Performance - Revenue and gross profit increased by 114.4% and 114.3% year-over-year respectively, driven by strong demand for the company's CRDMO services[6] - Revenue for the year ended December 31, 2023, increased by 114.4% year-over-year to RMB 2,123.8 million[17] - Gross profit for the year ended December 31, 2023, increased by 114.3% year-over-year to RMB 559.6 million[17] - Revenue for the year ended December 31, 2023, increased by 114.4% year-over-year to RMB 2,123.8 million, with gross profit also rising by 114.3% to RMB 559.6 million[26] - Adjusted net profit attributable to the company's owners grew by 112.1% year-over-year to RMB 412.3 million[26] - Revenue increased by 114.4% from RMB 990.4 million in 2022 to RMB 2,123.8 million in 2023, driven by growth in global XDC outsourcing services and the company's leading position in the ADC CRDMO market[61] - Gross profit increased by 114.3% to RMB 559.6 million in 2023, with a stable gross margin of 26.3% compared to 26.4% in 2022[68] - Net profit increased by 82.1% to RMB 283.5 million in 2023, with a net profit margin of 13.4%, down from 15.7% in 2022 due to one-time listing expenses[79] - Adjusted net profit increased by 112.1% from RMB 194.4 million in 2022 to RMB 412.3 million in 2023, with the adjusted net profit margin remaining stable at 19.4%[80] - Adjusted EBITDA (non-IFRS) for 2023 was RMB 501.2 million, with an adjusted EBITDA margin of 23.6%, compared to RMB 263.5 million and 26.6% in 2022[107] Operational Highlights - The company completed its global offering and listed on the Hong Kong Stock Exchange, enhancing its global brand influence and attracting top-tier investors[6] - A new manufacturing facility in Singapore broke ground in 2023, and the Wuxi plant began operating an "integrated" manufacturing facility to expand capacity[7] - The company improved its WuXiDARx™ technology, further enriching its technology platform and maintaining its leading position in ADC development[8] - Multiple production process validation projects were successfully completed, demonstrating customer trust in the company's expertise and capabilities[8] - The company was awarded "Best Contract Development and Manufacturing Provider (CDMO)" at the 2023 World ADC Awards[12] - The IPO was recognized as the "Best IPO" by IFR Asia Award in 2023, marking the largest healthcare IPO in Hong Kong since 2021[12] - Strategic initiatives include expanding production capacity and technical collaborations to enhance market position and drive sustainable growth[13] - The company plans to continue investing in cutting-edge technologies and expanding its global operations through its fully integrated platform[13] - Total comprehensive projects increased by 52.1% from 94 in 2022 to 143 in 2023[17] - Preclinical and Phase I projects increased by 45.2% from 84 in 2022 to 122 in 2023[17] - Phase II and later-stage projects increased significantly from 10 in 2022 to 21 in 2023, with 5 PPQ projects arranged at the Wuxi base[17] - The company successfully advanced 17 projects from pre-IND to post-IND stages during the reporting period[18] - Cumulative drug discovery projects increased by 42.8% from 299 in 2022 to 427 in 2023[18] - The company helped clients submit IND applications for 15 ADC candidate drugs globally in 2023[18] - The company operates three bases in Wuxi, Changzhou, and Shanghai, providing integrated end-to-end ADC CRDMO services[33] - A new facility in Singapore is under construction and is expected to commence GMP-compliant operations in 2026, with four production lines planned[35] - XDP1 facility designed to produce 3 million doses of liquid or lyophilized bioconjugate drugs (3 million vials, one 5㎡ and one 20㎡ lyophilizer)[36] - XDP2 facility designed to produce 5 million doses of liquid or lyophilized bioconjugate drugs (5 million vials, one 5㎡ and two 20㎡ lyophilizers)[36] - XDP3 facility designed to produce 7 million doses of liquid or lyophilized bioconjugate drugs (7 million vials, two 30㎡ lyophilizers)[36] - XPLM1 facility designed for kilogram-scale production of linkers and payloads[37] - Singapore facility designed for bioconjugate API production with a capacity of up to 2,000 liters per batch for monoclonal antibody intermediates or bioconjugate APIs[38] - XDP4 facility designed to produce 8 million doses of liquid or lyophilized bioconjugate drugs (8 million vials, one 10㎡ and two 30㎡ lyophilizers, production speed of 200-300 vials per minute)[38] - WuXiDARx™ technology upgrade improves ADC drug homogeneity, process stability, and reduces development costs, enabling DAR2, DAR4, and DAR6 products[42] - Over 80 GMP audits and more than 10 EU pharmacovigilance audits completed for global clients[46] - The company's "Empower, Follow, and Win the Molecule" strategy resulted in 36 ADC candidate drugs moving from discovery to CMC development in 2023, up from 30 in 2022[51] - The company was recognized as the "Best Contract Development and Manufacturing Organization (CDMO)" at the 2023 World ADC Awards, highlighting its industry-leading capabilities[51] - The company plans to expand its global footprint and increase production capacity, with new facilities in Singapore expected to be GMP-compliant by 2026 and additional production lines in Wuxi expected to be operational by Q4 2024 and Q2 2025[57] - The company is investing in cutting-edge technologies and R&D capabilities, including the development of WuXiDARx technology, to maintain its position at the forefront of bioconjugate research and development[59] - The company signed a Memorandum of Understanding (MOU) with IntoCell, a Korean biotech company, on January 3, 2024, for comprehensive collaboration in drug-linker technology and CRDMO services covering project discovery to commercialization[111] - On January 31, 2024, the company entered into a collaboration agreement with Multitude Therapeutics, a clinical-stage biotech company known for its ADC platform technology, and signed an MOU with HySlink Therapeutics for similar collaborations[111] - The company was included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect on March 4, 2023[111] Environmental, Social, and Governance (ESG) - The company is committed to reducing greenhouse gas emissions and improving operational efficiency to minimize environmental impact[11] - Goal to reduce Scope 1 and Scope 2 greenhouse gas emission intensity by 2030, using 2021 as the baseline year[49] - The company is committed to fulfilling social responsibilities, improving employee welfare, and promoting sustainable growth, with detailed environmental, social, and governance (ESG) policies and performance disclosed in a separate report[165] Financial Position and Capital - Total assets increased from RMB 2,496.4 million in 2022 to RMB 6,735.3 million in 2023[15] - Bank balances and cash increased significantly from RMB 334.97 million in 2022 to RMB 4,047.58 million in 2023[15] - The total backlog of orders increased by 81.9% from USD 318.0 million as of December 31, 2022, to USD 578.6 million as of December 31, 2023[26] - Property, plant, and equipment increased by 56.0% from RMB 798.6 million in 2022 to RMB 1,246.2 million in 2023, driven by expansions in Wuxi and Shanghai bases[83] - Trade and other receivables surged by 89.2% from RMB 505.6 million in 2022 to RMB 956.4 million in 2023, reflecting business growth[90] - Contract liabilities rose by 116.7% from RMB 151.5 million in 2022 to RMB 328.3 million in 2023, aligning with increased project launches[96] - Bank balances and cash increased by 1,108.2% from RMB 335.0 million in 2022 to RMB 4,047.6 million in 2023, supported by business growth and IPO proceeds[97] - Inventory decreased by 25.6% from RMB 62.9 million in 2022 to RMB 46.8 million in 2023 due to optimized inventory management[87] - Contract assets grew by 79.8% from RMB 17.3 million in 2022 to RMB 31.1 million in 2023, consistent with business expansion[91] - Trade and other payables increased by 18.4% from RMB 773.3 million in 2022 to RMB 915.4 million in 2023, driven by trade payables and equipment purchases[94] - The company had no borrowings as of December 31, 2023, compared to RMB 71.1 million in 2022, all of which were related-party loans[99] - The company issued 178,446,000 shares at HK$20.60 per share during the global offering, with an additional 19,158,500 shares issued after the full exercise of the over-allotment option[199] - The net proceeds from the global offering amounted to approximately HK$3,936.9 million, which remained unused and was deposited in the company's bank account as of December 31, 2023[199] - The planned use of the net proceeds from the global offering remained unchanged as of December 31, 2023, with details disclosed in the prospectus[199] Market and Industry Trends - The global ADC drug market is projected to grow from $7.9 billion in 2022 to $64.7 billion in 2030, with a compound annual growth rate (CAGR) of 30%, significantly higher than the 9.2% CAGR for the global biologics market excluding bioconjugates[52] - The company's revenue by region in 2023 was 40.1% from North America, 31.1% from China, 23.4% from Europe, and 5.4% from other regions[62] - Revenue from North America, China, and Europe increased significantly due to the development of the global ADC market and the company's leading position as a CRDMO service provider for ADC and other bioconjugate drugs[63] - Revenue from IND-post projects increased to RMB 1,197,065 thousand (56.4% of total revenue), up from RMB 609,352 thousand (61.5%) in 2022, driven by an increase in the number of IND-post projects with higher contract values[65] - ADC projects accounted for 88.9% of total revenue (RMB 1,888,013 thousand), while non-ADC projects contributed 11.1% (RMB 235,826 thousand)[66] - The company had 129 ADC integrated projects and 14 non-ADC integrated projects as of December 31, 2023, representing 90.2% and 9.8% of the total ongoing integrated projects, respectively[66] - The number of clients grew from 265 in 2022 to 345 in 2023, with 6 out of the top 10 global pharmaceutical companies collaborating on ADC or XDC projects, contributing approximately 24% of the company's total revenue in 2023[51] Risk Management - The company faces foreign currency risk due to transactions in currencies other than the functional currency of its entities, primarily USD, HKD, EUR, and CHF. Most revenues are denominated in USD, while raw materials and expenses are settled in RMB in China and USD abroad[102] - The company holds monetary assets and liabilities in foreign currencies, mainly USD and HKD, exposing it to foreign exchange rate fluctuations, which could impact its net profit margin[102] - The company plans to manage currency risk through close monitoring, reducing net foreign exchange exposure, and entering into forward contracts. It will also adopt hedge accounting for derivatives to mitigate the impact of exchange rate fluctuations on the income statement[102] - The company faces risks such as potential declines in customer spending, increased competition, and challenges in developing new technologies, which could adversely affect its business[164] Corporate Governance and Leadership - Under the leadership of Dr. Li Jincai, the company completed over 40 ADC/bioconjugate drug IND submissions in China, the US, and Europe between 2021 and 2022[113] - Dr. Li Jincai was appointed as CEO in June 2023, bringing over 20 years of experience in biologics process development and cGMP production[113] - Mr. Zhang Jingwei, appointed as COO in April 2023, has over 25 years of experience in the biotech industry and is responsible for managing the company's supply chain and operational support[113] - Mr. Xi Xiaojie, appointed as CFO in May 2023, brings over 18 years of financial industry experience in the US and China, overseeing the company's financial management and strategic development[114] - Dr. Chen Zhisheng, appointed as Chairman in May 2021, has over 20 years of experience in the biotech industry and provides strategic guidance to the company[117] - Dr. Zhou Weichang, with over 30 years of experience in the biotech industry, was appointed as a non-executive director in June 2023, providing guidance on corporate strategy and governance[117] - Dr. Zhu Meiying, appointed as CTO in July 2023, has over 28 years of experience in drug development and leads the early discovery of new drugs, drug-linkers, and novel conjugation technologies[123] - The company's board of directors includes executive and non-executive members, with Dr. Li Jincai serving as CEO[127] - Each executive and non-executive director has a three-year service contract starting from November 17, 2023[130] - The company has received annual confirmations from independent non-executive directors regarding their independence[135] - The company has a non-compete agreement with WuXi Biologics, which has been complied with as of December 31, 2023[136] - No directors or their associates were engaged in any business directly or indirectly competing with the company as of December 31, 2023[139] - The company provided indemnity provisions for its directors and senior officers, with appropriate insurance coverage in place[192] Shareholding and Equity - WuXi Biologics holds approximately 50.10% of the company's issued share capital as of December 31, 2023[145] - WuXi AppTec indirectly holds 98.23% of Shanghai HeQuan, which in turn controls approximately 33.40% of the company's issued share capital[145] - As of December 31, 2023, Dr. Li Jincai held 32,455,840 shares, representing approximately 2.71% of the company's issued share capital[167] - Mr. Zhang Jingwei held 3,254,016 shares, representing approximately 0.27% of the company's issued share capital[167] - Mr. Xi Xiaojie held 10,000,000 shares, representing approximately 0.84% of the company's issued share capital[167] - Dr. Chen Zhisheng held 3,242 shares directly and 415,636 shares through a discretionary trust, representing approximately 0.03% of the company's issued share capital[167] - Dr. Li Jincai held 1,672,653 shares in Lanming Biotech, representing approximately 0.04% of the equity[169] - WuXi Biologics holds 600,000,000 shares, representing approximately 50.10% of the company's issued shares[170] - WuXi Biologics' restricted share reward plan and global partner share reward plan have granted restricted share unit rights[170][171] - Chen Zhisheng holds shares through a trust, with his spouse and children as beneficiaries[171] - Weimin Jiang holds 3,000 shares in WuXi Biologics, with his spouse Shi Ming having an interest[171] - The total issued shares of WuXi Biologics as of December 31, 2023, were 4,257,500,616[171] - WuXi AppTec holds 400,000,000 shares, representing 33.40% of the company's issued shares[175] - The 2021 Pre-IPO Share Option Plan allows for the issuance of up to 100,000,000 shares, representing 8.49% of the expanded share capital[180] - The 2023 Pre-IPO Share Option Plan allows for the issuance of up to 40,000,000 shares, representing 3.39% of the expanded share capital[180] - The total number of unexercised share options as of December 31, 2023, was 77,023,246, with 18,517,841 options granted during the reporting period[181] - The company adopted the 2023 Pre-IPO Share Option Plan on March 22, 2023, with options vesting over a 10-year period[184] - The potential number of shares to be issued under the Pre-IPO Share Option Plan during the reporting period was 116,941,546, representing approximately 11.43% of the weighted average number of issued shares[185] Customer and Supplier Relationships - The company's sales to its top five customers accounted for 38.7% of total revenue in 2023, up from 34.1% in 2022, with the largest single customer contributing 13.7% of total revenue, compared to 8.9% in 2022[187] - The top five suppliers accounted for 73.2% of total procurement in 2023, up from 71.8% in 2022, with the largest single supplier contributing 51.8% of total procurement, compared to 39.9% in 2022[188] - The company had no significant disputes with employees, suppliers, or customers during the reporting period[189] Contracts and Agreements - The total amount payable by the company under the Antibody Master Service Agreement for 2023,
药明合联(02268) - 2023 - 年度财报