Core Insights - WuXi Biologics has been recognized in the "20 Case Examples for 20 Years: Private Sector's Sustainable Development in China" report by the United Nations Global Compact, highlighting its commitment to sustainable development in the green biologics sector [1][2][3] Company Overview - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that provides end-to-end solutions for biologics, from concept to commercialization [9] - The company employs over 12,000 skilled employees across multiple countries, including China, the United States, Ireland, Germany, and Singapore [10] Sustainability Initiatives - The company integrates green technology into its operations, utilizing proprietary platforms such as WuXiBody™ for green research, WuXiUI™ for green development, and WuXiUP™ for green manufacturing [3][11] - WuXi Biologics has received numerous accolades for its sustainability efforts, including an AAA rating from MSCI ESG Ratings and inclusion in the DJSI World Index [4] ESG Commitment - The company views Environmental, Social, and Governance (ESG) responsibilities as integral to its business strategy and aims to lead in ESG within the biologics CRDMO sector [11] - An ESG committee, led by the CEO, has been established to guide the company's comprehensive ESG strategy and implementation [11] Industry Context - The UN Global Compact's report aims to showcase best practices in ESG, emphasizing the role of companies like WuXi Biologics in balancing economic growth with social responsibility and environmental protection [2][3] - The report is part of the 20th anniversary celebrations of the ESG concept, highlighting the importance of sustainable development in the private sector [2]

Core Insights - WuXi Biologics has successfully completed multiple 16,000-liter Process Performance Qualification (PPQ) runs at its Dundalk, Ireland site, achieving a 100% success rate in two runs, demonstrating the effectiveness of disposable manufacturing compared to traditional stainless reactors [1][2] - The Irish Health Products Regulatory Authority (HPRA) granted GMP approval to all three manufacturing facilities at the site, allowing WuXi Biologics to expand its services globally [3] - The Dundalk facility has been recognized for its advanced biomanufacturing capabilities and sustainability efforts, receiving the ISPE Facility of the Year Award in 2023 [4][5] Manufacturing Capabilities - The site utilizes four 4,000-liter single-use bioreactors to achieve a 16,000-liter scale, marking it as one of the largest cell culture processes using single-use technology globally [2] - WuXi Biologics has established a workforce of over 760 skilled employees at the Dundalk site since its operational start in March 2022 [4] Regulatory and Quality Achievements - The GMP authorization was granted after a comprehensive inspection in October 2024, which evaluated various aspects of the facility's operations [3] - WuXi Biologics has passed approximately 40 global regulatory inspections and received 67 license approvals to date [3] Sustainability Initiatives - The Dundalk facility holds ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001), reflecting the company's commitment to sustainability [5] - WuXi Biologics aims to become an ESG leader in the biologics CRDMO sector, integrating Environmental, Social, and Governance responsibilities into its business strategy [8][9]

Core Insights - WuXi Biologics is enhancing its drug product capabilities in Leverkusen, Germany, by adding a new sterile filling line for prefilled syringes using isolator technology [1][2] Group 1: Facility Enhancements - The new filling line will optimize the manufacturing layout for multi-product CRDMO use, capable of handling multiple syringe sizes (1 ml, 2.25 ml, and 3 ml) at a filling rate of up to 400 syringes per minute [2] - This new line will enable flexible GMP production of at least 17 million syringes annually, in addition to the existing sterile filling and freeze-drying line with an annual capacity of approximately 10 million doses [2] Group 2: Strategic Goals - Construction of the new line is set to begin recently, with the aim of achieving GMP compliance by 2026 [2] - The increased capacity is intended to meet the growing client demand for drug product services, particularly for prefilled syringes, reflecting the company's commitment to a Global Dual Sourcing strategy [3] Group 3: Company Overview - WuXi Biologics is a leading global CRDMO providing end-to-end solutions for biologics from concept to commercialization [4] - The company employs over 12,000 skilled employees across multiple countries and supports 742 integrated client projects, including 16 in commercial manufacturing as of June 30, 2024 [5] Group 4: ESG Commitment - WuXi Biologics emphasizes Environmental, Social, and Governance (ESG) responsibilities as a core part of its business strategy, aiming to become an ESG leader in the biologics CRDMO sector [6] - The company utilizes next-generation biomanufacturing technologies and clean-energy sources, with an established ESG committee led by the CEO to guide its comprehensive ESG strategy [6]

Core Insights - WuXi Biologics has launched the WuXia™ RidGS platform, a high-yield glutamine synthetase-knockout CHO expression system that utilizes ZFN technology for targeted gene knockout [1][2] - The new platform achieves an average clonal expression level exceeding 6 g/L for monoclonal antibodies and maintains cell line stability for various therapeutic modalities [2][3] - The WuXia™ platform has generated over 900 cell lines for clinical and commercial manufacturing, demonstrating its acceptance by regulatory agencies worldwide [4] Company Overview - WuXi Biologics is a leading global CRDMO providing end-to-end solutions for the discovery, development, and manufacturing of biologics [5] - The company employs over 12,000 skilled employees across multiple countries, supporting 742 integrated client projects as of June 30, 2024 [6] - WuXi Biologics emphasizes its commitment to ESG responsibilities, aiming to become a leader in sustainability within the biologics CRDMO sector [7]

Core Insights - WuXi Biologics has received a Platinum Award from The Asset ESG Corporate Awards for the fourth consecutive year, highlighting its commitment to sustainable practices and innovation through green technology [1][2][3] ESG Recognition - The Asset evaluates companies on various ESG metrics, and WuXi Biologics is the only healthcare company recognized in this year's awards [2] - The company has achieved an "AAA" rating from MSCI ESG Ratings and has been awarded the Platinum Medal by EcoVadis, among other recognitions [4] Leadership and Commitment - Dr. Chris Chen, CEO of WuXi Biologics, emphasized the award as a motivation to continue advancing sustainability efforts in the biologics CRDMO industry [3] - WuXi Biologics aligns its initiatives with the United Nations Sustainable Development Goals and is a signatory to the UN Global Compact and the Science Based Targets initiative [3][7] Operational Overview - WuXi Biologics employs over 12,000 skilled workers across multiple countries and supports 742 integrated client projects, including 16 in commercial manufacturing as of June 30, 2024 [6] - The company aims to be an ESG leader in the biologics CRDMO sector, utilizing next-generation biomanufacturing technologies and clean energy sources [7]

Core Insights - WuXi Biologics has been included in the Hang Seng ESG 50 Index, marking it as the only pharmaceutical company selected this year [1] - The Hang Seng ESG 50 Index, launched in 2020, aims to highlight the top 50 ESG leaders with high market capitalization in Hong Kong [2] - WuXi Biologics received an "A" rating in the 2024 HKQAA Sustainability Ratings, placing it in the top 10% among industry peers [3] Company Achievements - The CEO of WuXi Biologics expressed satisfaction with the inclusion in the Hang Seng ESG 50 Index, emphasizing the company's commitment to enhancing ESG capabilities [4] - WuXi Biologics is a signatory to the United Nations Global Compact and the Science Based Targets initiative (SBTi), demonstrating its commitment to sustainable development [4] - The company has received multiple recognitions from ESG rating agencies, including an "AAA" rating from MSCI ESG Ratings and a Platinum Medal from EcoVadis [5] Operational Overview - WuXi Biologics operates as a leading global Contract Research, Development and Manufacturing Organization (CRDMO), providing end-to-end solutions for biologics [6] - The company employs over 12,000 skilled workers across various countries and supports 742 integrated client projects as of June 30, 2024 [7] - WuXi Biologics integrates ESG responsibilities into its business strategy, utilizing next-generation biomanufacturing technologies and clean energy sources [8]

Core Insights - WuXi Biologics has successfully scaled up its proprietary WuXiUI™ platform to 2,000L drug substance GMP manufacturing, achieving a 4-fold productivity improvement compared to traditional methods [1][3] - The utilization of WuXiUI™ and MagniCHO™ cell culture media has led to significant reductions in overall drug substance manufacturing costs [1][2] - The platform demonstrates consistent performance from small scales to large-scale production, confirming its maturity and robustness in biologics production [1][3] Manufacturing Efficiency - The enhanced downstream technology platform has doubled purification processing capacity while maintaining similar impurity removal, resulting in a 50% reduction in downstream processing time and a final drug substance yield of 70% [2] - WuXiUI™ has enabled a 30-50% reduction in the utilization of materials and consumables, leading to decreased waste generation [2][3] - The integration of Raman Process Analytical Technology (PAT) into the manufacturing process has improved operational efficiency and provided real-time automated process control [4] Market Position and Strategy - The WuXiUI™ platform, launched in 2023, enhances productivity for various CHO and other mammalian cell lines, addressing the growing demand for therapeutic proteins and antibodies with lower costs [3] - The company aims to provide clients with more affordable, high-quality biologics, thereby benefiting patients globally [5] - WuXi Biologics supports 742 integrated client projects, including 16 in commercial manufacturing, showcasing its extensive operational capabilities [6] Commitment to Sustainability - WuXi Biologics emphasizes Environmental, Social, and Governance (ESG) responsibilities as a core part of its business strategy, aiming to become a leader in ESG within the biologics CRDMO sector [7] - The company utilizes next-generation biomanufacturing technologies and clean-energy sources to enhance its sustainability efforts [7]

WuXi Biologics (Cayman) Inc. (OTCPK:WXXWY) Q2 2024 Earnings Conference Call August 22, 2024 8:30 AM ET Company Participants Lina Fan - Senior Vice President, Head of Investor Relations Chris Chen - Chief Executive Officer Ming Tu - Chief Financial Officer, Executive Vice President Ziyi Chen - China Healthcare Analyst, Goldman Sachs Conference Call Participants Chen Chen - UBS Samuel Isaly - Exome Asset Management Jingyi Li - Harding Loevner Ziyi Chen Great. Good morning and good evening, global investors. T ...

| --- | --- | --- | |-------|--------------------------------------------------------------------------------------------------|-------| | | Global Premier CRDMO: | | | | Enabling Global Partners and Delivering Sustainable Growth August 2024 2024 Interim Results | | | | | | | | | | | | Stock Code: 2269.HK | | Forward-Looking Statements This presentation may contain certain "forward-looking statements" which are not historical facts, but instead are predictions about future events based on our beliefs as wel ...

Core Viewpoint - WuXi Biologics reported a modest revenue increase of 1.0% YoY, with significant growth in non-COVID related revenue, indicating resilience and strategic execution in a challenging macroeconomic environment [1][2][4]. Financial Highlights - Revenue for the first half of 2024 was RMB 8,574.2 million, reflecting a 1.0% increase YoY [2][5]. - Non-COVID revenue grew by 7.7% YoY, with late-phase and commercial manufacturing revenue increasing by 11.7% [2][6]. - Gross profit was RMB 3,350.0 million, with a gross profit margin of 39.1%, down from 41.9% in the previous year [5][6]. - EBITDA was RMB 2,805.9 million, with an EBITDA margin of 32.7%, compared to 38.0% in 1H 2023 [6]. - Net profit attributable to owners of the company was RMB 1,499.1 million, representing a YoY decline of 33.9% [5][6]. Business Highlights - The company added 61 new integrated projects in 1H 2024, a significant increase from 46 in the same period last year, indicating strong client engagement [2][3]. - Total integrated projects reached 742, one of the largest portfolios of complex biologics, including various advanced therapeutic platforms [3][7]. - The backlog remained stable at US$20.1 billion, providing visibility for future revenue opportunities [3][4]. Technology and Innovation - WuXi Biologics utilizes advanced proprietary technology platforms, including WuXiBody™, TCE platform, and WuXiUP™, which have been recognized for their effectiveness in drug development [3][4]. - The company has achieved a 100% success rate in passing pre-approval inspections from EMA and FDA, underscoring its commitment to quality [3][4]. Management and Strategy - The management team emphasizes the importance of a unified quality system and a strong talent pool, with over 4,200 scientists contributing to the company's success [4][8]. - The company is committed to enhancing its R&D and manufacturing efficiencies while expanding its global presence [4][8]. ESG Commitment - WuXi Biologics integrates Environmental, Social, and Governance (ESG) responsibilities into its business strategy, aiming to be a leader in sustainability within the CRDMO sector [8].