Revenue and Financial Performance - Revenue increased by 3.8% to $259.9 million in 2023 compared to $250.4 million in 2022[2] - Total revenue for 2023 was $259.855 million, compared to $250.360 million in 2022[14] - Total revenue for 2023 reached $259.855 million, up from $250.360 million in 2022[18][19] - The company's revenue increased by 3.8% YoY, from USD 250.4 million in 2022 to USD 259.9 million in 2023[69] - Total revenue increased from $250.36 million in 2022 to $259.86 million in 2023, with the U.S. contributing 70.8% ($183.79 million) and China contributing 19.0% ($49.45 million)[72] - Revenue from the top 5 customers decreased by 12.2% from $49.0 million in 2022 to $43.0 million in 2023, accounting for 16.5% of total revenue[72] - Revenue from the top 10 customers decreased by 5.4% from $63.3 million in 2022 to $59.9 million in 2023, accounting for 23.0% of total revenue[73] - North America contributed $199.065 million to revenue in 2023, while China contributed $60.790 million[18] - North American revenue grew by 1.4% YoY to USD 199.1 million, while China revenue increased by 17.5% YoY to CNY 428.9 million (USD 60.8 million)[70] - Revenue from drug discovery decreased to $33.456 million in 2023 from $46.596 million in 2022[14] - Revenue from drug development increased to $95.132 million in 2023 from $85.922 million in 2022[14] - Revenue from pharmaceutical product development decreased to $7.615 million in 2023 from $10.948 million in 2022[14] - Revenue from laboratory testing increased to $123.652 million in 2023 from $106.894 million in 2022[14] - Laboratory testing services generated the highest revenue at $123.652 million in 2023[18] - Laboratory testing services contributed the largest share of revenue at USD 123.7 million in 2023, up from USD 106.9 million in 2022[71] Profitability and Margins - Gross profit decreased by 12.1% to $78.4 million with a gross margin of 30.2% in 2023, down from 35.6% in 2022[2] - EBITDA declined by 18.2% to $57.2 million with an EBITDA margin of 22.0% in 2023, compared to 27.9% in 2022[2] - Adjusted EBITDA decreased by 13.7% to $63.2 million with an adjusted EBITDA margin of 24.3% in 2023, down from 29.3% in 2022[2] - Net profit dropped significantly by 58.7% to $10.7 million in 2023 from $25.9 million in 2022[2] - Adjusted net profit decreased by 33.7% to $24.0 million with an adjusted net profit margin of 9.2% in 2023, compared to 14.4% in 2022[2] - Basic EPS declined by 57.9% to $0.0053 in 2023 from $0.0126 in 2022[2] - Adjusted basic EPS decreased by 33.0% to $0.0118 in 2023 from $0.0176 in 2022[2] - Pre-tax profit decreased to $14.577 million in 2023 from $36.096 million in 2022[18][19] - Gross profit decreased by 12.1% from $89.2 million in 2022 to $78.4 million in 2023, with gross margin declining from 35.6% to 30.2%[75] - Net profit decreased by 58.7% from $25.9 million in 2022 to $10.7 million in 2023, with net profit margin declining from 10.3% to 4.1%[83] - Adjusted net profit decreased by 33.7% from $36.2 million in 2022 to $24.0 million in 2023, with adjusted net profit margin declining from 14.4% to 9.2%[84] - EBITDA decreased by 18.2% from $69.9 million in 2022 to $57.2 million in 2023, with EBITDA margin declining from 27.9% to 22.0%[85] - Adjusted EBITDA decreased by 13.7% from $73.2 million in 2022 to $63.2 million in 2023, with adjusted EBITDA margin declining from 29.3% to 24.3%[86] - Basic earnings per share decreased by 57.9% from $0.0126 in 2022 to $0.0053 in 2023, and diluted earnings per share decreased by 57.7% from $0.0123 in 2022 to $0.0052 in 2023[87] - Adjusted basic earnings per share decreased by 33.0% from $0.0176 in 2022 to $0.0118 in 2023, and adjusted diluted earnings per share decreased by 32.9% from $0.0173 in 2022 to $0.0116 in 2023[87] Costs and Expenses - Service costs increased to $181.461 million in 2023 from $161.166 million in 2022[18][19] - R&D expenses increased by 55.5% to $6.0 million in 2023 compared to $3.9 million in 2022[4] - R&D expenses rose to $6.038 million in 2023, compared to $3.884 million in 2022[18][19] - Service costs increased by 12.6% from $161.2 million in 2022 to $181.5 million in 2023, driven by capacity expansion in North America and China[74] - R&D expenses increased by 53.8% from $3.9 million in 2022 to $6.0 million in 2023, reflecting increased investment in new technologies and platforms[80] - Employee costs rose to $122.971 million in 2023, including $112.179 million in salaries and benefits[26] - Employee costs for the year ending December 31, 2023, were $112.2 million, compared to $102.9 million in the previous year[100] Assets and Liabilities - Total assets increased to $472.3 million in 2023 from $453.1 million in 2022[6] - Non-current assets grew to $418.803 million in 2023, up from $368.004 million in 2022[22] - Property, plant, and equipment increased by 8.4% from $115.0 million in 2022 to $124.7 million in 2023, driven by R&D and manufacturing capacity expansion[89] - Goodwill increased by 23.3% from $149.2 million in 2022 to $183.9 million in 2023, primarily due to the acquisition of Nucro-Technics[90] - Trade and other receivables and prepayments increased by 6.4% from $57.6 million in 2022 to $61.3 million in 2023, reflecting business growth[91] - Unbilled revenue increased by 6.2% from $17.7 million in 2022 to $18.8 million in 2023, driven by business growth[92] - Bank balances and cash decreased from $87.4 million in 2022 to $53.2 million in 2023, due to payments for property, plant, and equipment and subsidiary acquisitions[93] - Total bank borrowings increased from $48.9 million in 2022 to $81.4 million in 2023, with $56.4 million in USD and $25.0 million in RMB[96] - The asset-liability ratio increased from 8.2% in 2022 to 26.2% in 2023, driven by significant financing activities to support business expansion[99] Restructuring and Strategic Initiatives - The company restructured in 2023 to form two main divisions: Global Drug Discovery and Development Services and Global Laboratory Services[13] - The company restructured its global operations into two main divisions: Global Drug Discovery and Development Services and Global Laboratory Services to enhance efficiency and consistency[47] - The restructuring aims to provide standardized top-tier services, improve market competitiveness, and optimize resource allocation across North America and China[47] - The company expanded its presence in Canada through the acquisition of Nucro-Technics Inc. in August 2023, establishing strategic bases in both Toronto and Vancouver[48] - The company plans to focus on high-growth areas such as pathology and genotoxicity, leveraging its dual operations in North America and China[69] - Future strategies include exploring business opportunities in Japan, South Korea, Europe, and South America to expand its global client base[69] - Fangda launched new global drug discovery and development services, unifying operations in chemistry, biology, ADME/PK, and pharmacology across the US and Canada[53] - Fangda established a centralized global laboratory services system, covering logistics, lab testing, and biomarker services to ensure efficient service delivery[53] - Fangda completed the acquisition of Nucro-Technics, a Canadian contract research organization, expanding its presence in Toronto and Vancouver, Canada[54] - Fangda operates 11 laboratories and production facilities in China, totaling 810,000 square feet, enhancing its diversified service platform[55] - Fangda's Suzhou safety evaluation center, spanning 215,000 square feet, received GLP certification from China's NMPA in June 2023[55] - Fangda developed a BSEP research platform using human liver cells and implemented a high-throughput PAMPA screening platform to improve compound membrane permeability assessment[56] - Fangda expanded its pharmacodynamics services to include over 50 new enzymatic test targets and established more than 30 cell lines, including GPCRs and ion channels[56] - Fangda's Suzhou clinical sample production facility, covering 89,000 square feet, began partial operations, enabling the production of various dosage forms for clinical trials[56] - Fangda's Wuhan drug development center Phase 1 commenced operations in May 2023, featuring 50 advanced drug chemistry labs and 4 process R&D labs[57] Tax and Regulatory Environment - The effective weighted average tax rate for 2023 was 25.77%, up from 24.95% in 2022[28] - BRI Biopharmaceutical Research, Inc. is subject to a flat tax rate of 27%[29] - Nucro Technics, Inc. is subject to an effective corporate tax rate of 26.5%[29] - Fangda Pharmaceutical Technology (Shanghai) Co., Ltd. enjoys a preferential tax rate of 15% from 2023 onwards for another three years[29] - Fangda Pharmaceutical Technology (Suzhou) Co., Ltd. enjoys a preferential tax rate of 15% from 2021 onwards for three years[30] - Heya Pharmaceutical Technology (Shanghai) Co., Ltd. enjoys a preferential tax rate of 15% from 2022 onwards for three years[31] - Wuhan Heyan Biopharmaceutical Technology Co., Ltd. enjoys a preferential tax rate of 15% from 2023 onwards for another three years[31] - The company's operations are influenced by the 2017 Tax Cuts and Jobs Act, which introduced significant changes to U.S. corporate tax policies[112] Employee and Human Resources - The company has a total of 1,759 employees, with 851 in North America and 908 in China. 81% of employees hold a bachelor's degree or higher, and 540 employees have advanced degrees (master's or higher)[100] - The company has established a comprehensive training system for employees, including onboarding and ongoing training, with a focus on technical skills, management development, and compliance[100] - The company has adopted various equity incentive plans, including the Pre-IPO Share Incentive Plan, 2018 Share Incentive Plan, and 2021 Share Incentive Plan, to reward eligible participants[100] Acquisitions and Investments - The company acquired Nucro-Technics Inc. for approximately CAD 70 million (HKD 410.4 million) in August 2023, enhancing its capabilities in drug metabolism, pharmacokinetics, and preclinical safety[67] - Frontage Labs completed the acquisition of Accelera's bioanalytical and drug metabolism business for EUR 6.835 million, effective January 1, 2024[67] - The company utilized the entire net proceeds of $193.2 million from its IPO for planned purposes, including capacity expansion (20%), potential acquisitions (40%), and working capital (10%)[102] - The company repurchased 15,848,000 shares in 2023 for a total consideration of HK$33,009,920, reflecting confidence in its business outlook[105] Regulatory Compliance and Quality Assurance - The company's quality assurance team ensures compliance with protocols, SOPs, and regulatory codes, safeguarding subject safety and data integrity[61] - The company's facilities in the US and Canada have undergone inspections by FDA, DEA, CNSC, PHAC, CLIA/CAP, DOH, AAALAC, and USDA without any significant adverse findings[62] - The company's facilities in China have been inspected by NMPA without any significant adverse findings[62] - The company has implemented SOPs and high-quality animal care programs to ensure humane treatment of animals in compliance with relevant laws and regulations[63] - The company has not received any non-compliance reports from USDA and FDA regarding animal welfare during the reporting period[63] - The company's Chicago facility successfully completed AAALAC accreditation, USDA inspections, and FDA inspections, receiving positive feedback[52] Market and Customer Engagement - The company's global business development team strategically operates in the US, China, and Canada, focusing on expanding services across all stages of drug development[64] - The marketing team drives customer engagement through digital marketing, conferences, and high-profile publications, aiming to increase demand for the company's service portfolio[65] - Frontage Labs received multiple awards in 2023, including recognition as a top 20 CRO enterprise in China at the 2023 Healthcare Industry High-Quality Development Conference[66] Financial Reporting and Governance - The company's Annual General Meeting (AGM) will be held on May 28, 2024, with share transfer registration suspended from May 23 to May 28, 2024[104] - The company's Audit and Risk Management Committee reviewed and approved the audited financial statements, confirming compliance with applicable accounting standards[109] - The company's auditor, BDO Limited, compared the preliminary financial data with the audited financial statements and found them to be consistent[110] - Frontage Labs' 2023 annual report and performance announcement were published on the HKEX website and the company's official website[111] - The company's board of directors includes executive and non-executive directors, with Dr. Li Song serving as an executive director[119] Operational and Service Capabilities - The company has successfully managed multi-center BE studies, providing comprehensive support including protocol development, project supervision, clinical and medical monitoring, data management, statistical analysis, pharmacokinetic evaluation, and timely report submission[58] - The company has secured multiple integrated service contracts covering drug chemistry, API development, pharmacodynamics, drug metabolism and pharmacokinetics, safety and toxicology, CMC formulation development, and bioanalysis[58] - The company has established 12 facilities in North America and 11 facilities in China as of December 31, 2023[60] - The company's service portfolio covers drug discovery to late-stage approval, including lead compound quantification, formulation development, GLP toxicology studies, and commercial product release[114] - Frontage Labs has subsidiaries in Shanghai and Suzhou, established in 2005 and 2014 respectively, focusing on pharmaceutical technology[115] - The company's major shareholders include Hangzhou Tigermed and Hong Kong Tigermed, both listed on the Shenzhen and Hong Kong stock exchanges[115] - Frontage Labs adopted the 2021 Share Award Plan, granting 22,950,500 shares to selected participants[112] - The company operates under the International Financial Reporting Standards (IFRS) and is listed on the Hong Kong Stock Exchange[115] - Frontage Labs' subsidiaries include BRI Biopharmaceutical Research, Inc., registered in Canada in 2003[112] - The company's shares are denominated in USD with a par value of $0.00001 per share[118]
方达控股(01521) - 2023 - 年度业绩