2022 Financial Highlights

• Revenue: The Group's revenue increased to RMB15,268.7 million with an increase of 48.4% y-o-y. The increase was mainly attributable to (i) the successful execution of the Group's "Follow and Win the Molecule" strategies, contributing record number of new integrated projects and gaining more customers to achieve sustainable high growth; (ii) continued momentum of the Group's commercial manufacturing and late-stage businesses since the banner year of 2021, contributing to significant revenue growth; (iii) unique CRDMO business model, leading technology platform, best-in-industry timeline and excellent execution track record contributing to significantly higher revenue, especially in the non-COVID sector; (iv) enlarged spectrum of services offered to the biologics industry, including one-stop shop comprehensive drug product services, fast growing technology platforms such as ADC and Bispecific Antibodies, which boosted the Group's revenue stream; and (v) the utilization of existing and newly expanded capacities, as well as the successful integration of acquired businesses and facilities and (vi) the implementation of operational efficiency improvement programs, coupled with successful executions of our business continuity plan when confronted with COVID challenges, leveraging our unparalleled integrated end-to-end CRDMO platform, global footprints and robust supply chain network.
• Gross profit and gross profit margin: The Group's gross profit increased by 39.2% to RMB6,724.0 million, with a gross profit margin of 44.0%, primarily due to: (i) the strong revenue growth; (ii) the Group's deployment to fully utilize the existing manufacturing facilities and successful integration of the acquired facilities; (iii) the Group's extraordinary efforts to undertake a large number of new development projects despite of the COVID constraints; and (vi) the deployment of the WBS (WuXi Biologics Business System) as the operation DNA to drive operation efficiency improvement, offsetting the new facility ramp-up impacts.
• Net Profit & Net Profit Attributable to Owners of the Company: Net profit and net profit attributable to owners of the Company for the Reporting Period amounted to RMB4,549.9 million and RMB4,420.3 million respectively, representing a 29.7% and 30.5% increase compared to the same period last year.
• Adjusted Net Profit: Adjusted net profit for the period increased by 47.1% y-o-y to RMB5,053.9 million. Margin of adjusted net profit was 33.1%.
• Diluted earnings per share (EPS): Diluted EPS and adjusted diluted EPS were RMB1.01 and RMB1.13, up by 31.2% and 50.7% y-o-y, respectively.
• The Group has achieved positive free cash flow in 2022, another critical milestone for the Group that provides a solid foundation for its enduring growth.

2022 Business Highlights

• Thanks to the Group's unique CRDMO business model and the successful execution of its "Follow and Win the Molecule" strategies, a strong growth trajectory continued in 2022 despite external challenges.
• The total number of integrated projects rose to a new height of 588 with 136 new integrated projects added to the pipeline, including 127 non-COVID projects. 37 late-phase projects and 17 commercial manufacturing projects, all of which laid a solid foundation for future growth.
• The "Win-the-Molecule" strategy continued to drive additional pipeline growth, contributing 11 external projects, including 5 late-phase and commercial manufacturing projects, which will solidify both short-and long-term growth. Beginning in the second half of 2022, the Group has been in active negotiations with large pharma for more than 10 late-phase/commercial projects, and has successfully signed three projects in 2H 2022 through its "Win-the-Molecule" strategy with more potentials are expected.
• Total backlog and milestone backlog increased to US$20,571 million and US$7,032 million as of Dec 31, 2022, hitting a new record and underpinning sustained growth in both short and long-term.
• The Group and GSK entered into a license agreement on multiple novel Bi- & Multi-specific T Cell Engagers, a strong testament of the Group's research capabilities, the 'R' in the Group's CRDMO business model.
• The Group is well-positioned to continue exceptional growth due to its robust non-COVID pipeline. As of Dec 31, 2022, the number of non-COVID-19 projects grew to almost 550 with a 63% y-o-y revenue increase. The momentum will continue in the long run.
• Late-phase and commercial manufacturing revenue increased to RMB6,854.3 million, accounting for 44.9% of total revenue in 2022, demonstrating the stickiness of biologics CRDMO and reaping the fruition of the Group's "Follow and Win the Molecule" strategies.
• During the Shanghai COVID outbreak in 1H 2022 and following the relief of zero-COVID restrictions in 2H 2022, the Group minimized business disruptions through its excellent operational resilience and a well-established Business Continuity Plan. With its global capacities, multiple operational locations, and comprehensive connections across the industry's supply chains, the Group has fulfilled its commitments to customers without disruption.
• Leveraging its cutting-edge technology and manufacturing capacity, the Group is devoted to bringing COVID-19 therapeutics to global patients. The Group enabled its customers by manufacturing more than 3,000 kg COVID neutralizing antibodies, as well as hundreds of millions doses of COVID vaccine. These COVID projects have made significant contributions to the combat against the pandemic worldwide, and contributed meaningful revenue during the Reporting Period.
• The Group continued advancing its technologies to optimize the spectrum of services offered to the global biologics industry. As of Dec 31, 2022, the Group has accumulated 99 bispecific projects including 39 WuXiBody^® projects with different formats, 20 vaccine projects and 94 ADC projects on its integrated platforms. These diverse technology platforms are set to cater to the increasing demands of customers and boost the Group's sustainable growth.
• "Global Dual Sourcing within WuXi Bio" is the Group's long-standing strategy to better enable global customers and meet their growing demands. By the end of the Reporting Period, the Group's capacity had reached 262,000L, with new facilities in the U.S., Ireland and China coming online.
• The Group's total capacity is expected to increase to 580,000L by 2026 to meet strong customer demand. The Group's global network will encompass facilities in China, the U.S., Ireland, Germany and a fully integrated CRDMO base in Singapore. The Group's geographic diversity will provide more dynamic capabilities to serve its customers anywhere in the world.
• On top of its successful acquisitions in 2021, the Group made two new acquisitions in 2022 - process development and pilot-scale manufacturing facility in Suzhou from Elpiscience, and a manufacturing facility in Suzhou from Harbour BioMed. The latter will serve as WuXi Vaccines' first standalone vaccine development and GMP manufacturing site.
• The Group continues to enhance its capabilities and capacity to better enable customers, thus further diversifying its customer base by working with nearly 600 customers including all top 20 global pharmaceutical companies. The growing customer base demonstrates the strength of the Groups' unique CRDMO business model, state-of-the-art technology platforms, best-in-industry timeline and excellent execution track record.
• North America, the Group's largest market, retained its strong momentum with 62.5% growth year over year, and accounted for 55.6% of total revenue. The North America region also contributed 50% of new projects in 2022, which is a reflection of those customers' continuous trust and well-established relationships with the Group. The impact from the temporary placement of two subsidiaries on the U.S. Commerce Department's Unverified List (UVL) was minimal.
• The WuXi Biologics Business System (WBS) introduced in 2021 continues to drive operation efficiencies, offsetting the headwind from inflation and new facility ramp-up impacts.
• The Group continues to adhere to the highest quality standards, and has completed 27 regulatory inspections conducted by U.S. FDA, EU EMA, China NMPA and other regulatory agencies since 2017.
• The Group continued to build its world-class team. As of Dec 31, 2022, the Group's total staff grew to 12,373, with a biologics R&D team of 4,372 scientists. Overseas recruitment also proceeded smoothly to support the business growth and capacity increase. Talent retention measures continued to be effective, with a key talent retention rate of 95%, well above the industry average.
• The Group has incorporated Environmental, Social and Governance (ESG) as an essential part of its sustainable growth strategies. The Group's ESG performance has been widely recognized by the industry and received many prestigious awards, among which, it was named as Industry Top-rated, and APAC Regional Top-rated Company by Sustainalytics, selected as S&P Global A List with the rank of the Industry's Top 7%, designated as a Top 10 Constituent of FTSE4Good Emerging Index, etc.

2022 was a year of continued strong performance and implementation of the "Follow and Win the Molecule" strategies. With the ongoing efforts of the teams and by leveraging its unique CRDMO business model, the Group continued to navigate the challenging macro environment, delivered outstanding growth on both the topline and bottom line, and fulfilled its commitment to its customers as the enabling partner by accelerating and transforming the discovery, development and manufacturing of novel biologics, benefiting patients worldwide.

Robust Business Performance Continued Despite Challenges

In 2022, despite headwinds from the macro environment, and the challenges from UVL issue, COVID outbreak and biotech funding as well, the Group maintained strong business momentum thanks to its unique CRDMO business model and the successful execution of the "Follow and Win the Molecule" strategies. The Group added 136 new integrated projects, reaching one of the highest levels since its establishment, bringing the total number of integrated projects to 588. During the Reporting Period, the successful execution of the "Win-the-Molecule" strategy contributed 11 external projects, including 5 late-phase and commercial manufacturing projects, which boosted near-term revenue and brought further upside potential to the Group.

As of Dec 31, 2022, total backlog and milestone backlog grew to US$20,571 million and US$7,032 million respectively, reaching a record high and providing high visibility of sustainable growth. Backlog within three years increased to US$3,621 million, underpinning robust short-term growth.  

Despite the strong backlog and a record number of projects, the Group is still able to start any new project within four weeks, supported by its strong capabilities and sufficient capacity.

Exciting Validation of New Technology Platforms and Strong Growth Driver from New Modalities

The Group has been relentlessly enhancing its integrated enabling platform with leading-edge technologies to expedite biologics discovery, development and manufacturing. The advanced technology platforms are essential to the CRDMO business model and the spectrum of services offered to the global biologics industry.

In Jan 2023, the Group entered into an exclusive license agreement with GSK for one preclinical bi-specific T cell engaging (TCE) antibody and the option of three additional bi-/multi-specific TCE antibodies to be developed using WuXi Biologics' proprietary technology platforms. The Group will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. The Group is also eligible to receive tiered royalties on net sales. The collaboration with GSK represents an important validation of the Group's exemplary CD3 platform and WuXiBody^® platform and the 'R' in its CRDMO business model.

In addition, the Group's cutting-edge technology platforms continue to drive business growth in the fields of bispecifics, multispecifics, ADCs, fusion proteins and vaccines. By the end of the Reporting Period, the Group's bispecific antibody projects increased to 99, including 39 WuXiBody^® projects. WuXi XDC had secured 94 ADC integrated projects globally, 40 of which completed IND submission and are in various stages of clinical trials. WuXi Vaccines continued its growth momentum with 20 ongoing vaccine projects. With its proven manufacturing track record and premier-quality supply chain, WuXi Vaccines has delivered hundreds of millions of COVID-19 vaccine doses to its partners to combat the pandemic globally. These new modalities quickly become the Group's growth engines in the near future.

Non-COVID Related Business Delivered Compelling Performance

The Group remains confident that it can sustain its long-term growth trajectory post COVID with its strong growth momentum from the non-COVID sector. As of Dec 31, 2022, the number of non-COVID-19 projects grew to almost 550, the largest pipeline in the industry that will continue to boost the Group's growth in 2023 and beyond.

The Group continued to execute COVID-19 projects, and manufactured over 3,000 kg COVID neutralizing antibodies, and hundreds of millions doses of COVID vaccine to support its customers globally to combat the pandemic. In 2022, the Group has seen around RMB3.2 billion of revenue from COVID-19 related projects. By undertaking these COVID-19 projects, the Group has continued to fulfill its commitment to helping patients worldwide.

Late-Phase and Commercial Manufacturing Projects Led Future Growth

Adhering to the "Follow and Win the Molecule" strategies, the Group continued to increase the number of late-phase and commercial manufacturing projects as an important pillar of growth following the banner year of 2021. During the Reporting Period, the Group's late-phase and commercial manufacturing projects increased to 37 and 17 respectively. Late-phase and commercial manufacturing revenue increased to a total of RMB6,854.3 million, accounting for 44.9% of the overall revenue in 2022. Furthermore, during the second half of 2022, the Group has been in active negotiations for more than 10 late-phase/commercial projects with large pharma, and has signed three projects in 2H 2022 through the "Win-the-Molecule" strategy and more potential wins are expected to further expand late-phase and CMO pipeline in the near future.

Increased Capacities to Support Global Dual Sourcing Strategy

The Group continues to implement its "Global Dual Sourcing" strategy, making the Group well-positioned to serve its customers worldwide. The Group increased its manufacturing capacity to 262,000L by the end of 2022, including a 48,000L commercial manufacturing facility in Hebei, the first clinical manufacturing facility in the U.S. with designed capacity of 6,000L, and the first commercial manufacturing facility in Ireland GMP released in Q4 2022.

Furthermore, a comprehensive CRDMO center in Shanghai has commenced operation. The Group has also announced a plan for a Singapore CRDMO base that will encompass an R&D service center and large-scale DS & DP manufacturing facilities. The new site will add 120,000L biomanufacturing capacity to WuXi Biologics' global network by 2026, bringing the total planned manufacturing capacity to 580,000L.

The Group's comprehensive DP capacity and capabilities enlarged the spectrum of services offered to the biologics industry. By the end of 2022, the Group had established a global manufacturing network with 9 drug product facilities for vial and PFS in China and Germany, and is now one of the global leaders in drug product CDMO services.

Well Established Partnerships with Both Biotech and Big Pharma

During the Reporting Period, the Group extended partnerships with almost 600 global customers including all top 20 global pharmaceutical companies. The enlarged customer base further demonstrates the effectiveness of the Group's unique CRDMO business model, leading technology platform, best-in-industry timeline, premier quality system and excellent execution track record. A diversified customer base and well-established partnerships with both biotech and big pharma ensured stable revenue distribution and broad growth opportunities. The Group has formed strong partnerships with big pharma over the years, establishing in-depth cooperation and long-term trusted relationships. Additionally, the Group continues to enable small and medium-sized biotech companies to expedite the development of their novel biologics.

Successful Delisting from Unverified List within Ten Months

During the Reporting Period, the Group's WuXi Biologics Co., Ltd. and WuXi Biologics (Shanghai) Co., Ltd. subsidiaries were successfully removed from the U.S. Commerce Department's Unverified List ("UVL") following the completion of on-site end-use checks conducted by that government agency. The removal from the UVL reinforced the Group's commitment to operating with the highest standard of compliance and in accordance with relevant laws and regulations.

As a global company, the Group has always been adhered to the most stringent compliance standards. During the Reporting Period, there were no material impacts to the Group's business operations and no disruptions to its supply chain. The Group effectively addressed inquiries from global customers, and these responses were well received. In North America, the Group achieved 62.5% growth, contributed 55.6% of total revenue and 50% newly-added projects in 2022. Thanks to its "Dual-Source, Dual-Factory" supply chain strategy, the Group maintained regular and reliable procurement from global vendors and ensure sufficient stock to deliver hundreds of projects on time.

Safeguarding Project Deliveries through Outstanding Execution and Strong Supply Chain Management While Confronting COVID Challenges

When facing the Shanghai COVID outbreak in 1H 2022 as well as circumstances following the relief of zero-COVID restrictions in 2H 2022, the Group managed to maintain business operations with minimal disruptions and ensured project delivery by successfully implementing its Business Continuity Plan, bolstered by remarkable contributions and untiring dedication from its employees. Over 600 employees voluntarily stayed at the Shanghai sites in 1H 2022 to ensure the progress of projects while the remaining staff in diversified locations also supported the project delivery. In addition, the optimized supply chain also safeguarded the Group's project execution and timeline, resulting in all key projects being delivered with a 100% success rate. The joint efforts made by the Group's employees were recognized by global customers for responding rapidly and delivering their projects on schedule.

Talent Pool Growth

The Group values workforce development and places a strong emphasis on human resources strategy to attract, train and retain talents worldwide. As of Dec 31, 2022, the Group's total staff increased to 12,373, with a world-class R&D team of 4,372 scientists. The Group's recruitment efforts across its geographic regions supported the Group's enhanced capacity and capabilities. The growing talent base enables the Group to sustain strong business momentum and the project delivery timeline. Talent retention continued to be successful, with a key talent retention rate of over 95%, well above the industry average.

World-Class Quality System Underpins WuXi Biologics Future Growth

The Group remains committed to meeting the highest quality standards. With its world-class quality system, the Group has completed 27 regulatory inspections since 2017 that were conducted by U.S. FDA, EU EMA, China NMPA and other regulatory agencies, distinguishing the Group as the first and only biologics company certified by these regulatory agencies for commercial manufacturing in China. The Group's 14 GMP-certified manufacturing facilities, including its first GMP-certified manufacturing facilities in Germany and Ireland, demonstrate the Group's adherence to the world's most stringent quality standards. The Group believes that these certifications will help manifest its world-class quality system that meets global quality standards and thereby benefit patients globally with biologics of better quality.

ESG as a Long-term Business Strategy

The Group believes that a good environmental, social and governance (ESG) strategy will drive long-term success and endeavors to maintain high ESG standard. As a means to address climate change, the Group has reinforced its commitment to sustainability by pledging to achieve net-zero emissions from overall operations by 2050 and, reduce waste intensity by 10% by 2027. To achieve these goals, the Group has adopted solar-power system and electric vehicles, as well as energy-saving initiatives across its global sites, etc. The Group has also launched more CSR initiatives to benefit employees, partners, patients and local communities.

The Group's broad ESG efforts have been widely recognized by multiple leading ESG rating agencies and institutional investors. It was named as Industry Top-rated and APAC Regional Top-rated Company by Sustainalytics, selected by S&P Global A List with the rank of Industry Top 7%, designated as a Top 10 Constituent of FTSE4Good Emerging Index, obtained an A Rating from the MSCI ESG Index, received "Leadership Award" from CDP, and Bronze Medal from EcoVadis with Recognition by Top Pharma companies, etc.

Management Comment

Dr. Chris Chen, CEO of WuXi Biologics, said, "Continuing the successful implementation of our 'Follow and Win the Molecule' strategies and leveraging our unique CRDMO business model ensured we were able to deliver outstanding results in 2022. We have made notable progress toward our robust pipeline, indicating sustained business momentum and great upside potential. Non-COVID projects continue to be a main driving force for our solid growth thanks to our robust non-COVID-19 pipeline. I remain confident that having one of the largest biologics pipelines in our industry will fuel future growth for the Group. At the same time, the excellent execution of COVID-19 projects demonstrates our strong capabilities to expedite the R&D timeline and proven track record to undertake mass production with our leading single-use technology, allowing the Group to win more trust from global customers. The extended partnership with GSK for multiple bispecific & multi-specific TCE antibodies further validates our CRDMO business model and cutting-edge technology platforms. I am also excited by the backlog growth and revenue contribution from the late-phase and commercial manufacturing projects which are set to be another growth engine for the Group. The potential blockbusters in our later stages and the potential brought by our 'Win-the-Molecule' strategy ensures the Group to sustain long-term growth and fulfill its commitment to benefiting patients worldwide."

Dr. Chris Chen added, "I am very pleased with our solid financial position as the Group's free cash flow became positive in 2022, allowing us to focus on long-term strategy and support capacity increases with our own operating cash inflow going forward. In response to the growing demand from our global customers and unmet needs from the industry, we continue to build parallel capacities and capabilities across our global network, and expand our CRDMO footprint by acquisitions as well. We will bring our total manufacturing capacity to 580,000L by 2026, with 60% in China and 40% in North America, EU and Singapore, the geographic diversity will reinforce our 'Global Dual Sourcing' strategy. Confronted with external challenges, we demonstrated strong execution and operational resilience to ensure business continuity and delivered hundreds of projects on time through our robust supply chain. With our diversified operation locations, industry-leading timeline and proven track record, our business fundamentals remain strong, especially in the North America market, which generated 62.5% y-o-y growth and accounted for 55.6% of total revenue. I am also impressed by the solid growth from EU market with over 150% non-COVID revenue growth, indicating the robust momentum post COVID. In addition, we launched WBS and built the foundation for our digital transformation. These initiatives have helped us make considerable progress in efficiency enhancement and process optimization, which better realizes value for our partners and the Group. I am also proud of our over 12,300 staff for their dedication, and impressed by ESG best practice, which have been the cornerstone of the Group's sustainable development. Looking ahead, we will continue to strive for better operational efficiency, broaden our capabilities and capacity to enable our partners, support patients worldwide, and deliver more growth opportunities to our shareholders."

Dr. Ge Li, Chairman of WuXi Biologics, concluded, "2022 was another successful year for WuXi Biologics and despite external challenges, we have made a series of significant accomplishments supported by our CRDMO business model. I am confident that our leading technology platform, best-in-industry timeline, excellent execution track record, premier quality system and solid financial strength will make the Group well-positioned to deliver exceptional value for our partners and shareholders going forward. And we remain committed to bringing life-saving therapeutics to patients and realizing our vision that 'every drug can be made and every disease can be treated'."