Revenue Increased by 48.4% Y-o-Y to RMB15,268.7 Million
Gross Profit Increased by 39.2% Y-o-Y to RMB6,724.0 Million
Adjusted Net Profit Rose by 47.1% to RMB5,053.9 Million
Non-COVID Revenue Achieved 63% Y-o-Y Growth, Strong Momentum Continues into 2023 and Beyond
"R" in CRDMO Business Model Accelerated to Extend Partnerships with Pharma Clients
Positive Free Cash Flow to Support Sustainable Growth
Total Backlog Surged to US$20,571 Million
* * *
CRDMO Business Model Enabled Sustainable Long-Term Growth
"Follow and Win the Molecule" Strategies Delivered Significant Revenue Increases
136 New Integrated Projects Added, One of the Highest Increases in Company History
588 Total Integrated Projects, including 17 Commercial Manufacturing Projects and 37 Late-phase Projects with Potential for Future Growth
"Win-the-Molecule" Strategy Contributed 11 External Projects and Accelerated Growth
Late-phase & Commercial Manufacturing Revenue Increased to RMB6,854.3 Million, Accounting for 44.9% of Total Revenue
Global Presence and Talent Pool Expanded to Support Business Momentum
Growth Trend Maintained in Diverse Geographic Markets, Especially in North America
Premier Quality System Re-verified, Completed 27 Global Regulatory Inspections
Optimized Supply Chain to Safeguard Project Execution and Timelines
WBS (WuXi Biologics Business System) Deployed to Improve Efficiencies and Lean Processes
Sufficient Capacity to Start Any Project within 4 Weeks
HONG KONG, March 22, 2023 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, is pleased to announce its audited annual results for the year ended 31 December 2022 ("Reporting Period").
2022 Financial Highlights
2022 Business Highlights
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'."
Key Financial Ratios |
|||
(For the Twelve Months Ended Dec 31) |
|||
Key Financial Ratio |
2022 |
2021 |
Change |
Revenue (In RMB million) |
15,268.7 |
10,290.1 |
48.4 % |
Gross Profit (In RMB million) |
6,724.0 |
4,828.9 |
39.2 % |
Margin (%) |
44.0 % |
46.9 % |
|
Net Profit (In RMB million) |
4,549.9 |
3,508.6 |
29.7 % |
Margin (%) |
29.8 % |
34.1 % |
|
Net Profit Attributable to Owners of the |
4,420.3 |
3,388.5 |
30.5 % |
Margin (%) |
29.0 % |
32.9 % |
|
Adjusted Net Profit (In RMB million) |
5,053.9 |
3,435.9 |
47.1 % |
Margin (%) |
33.1 % |
33.4 % |
|
EBITDA (In RMB million) |
6,353.4 |
4,662.3 |
36.3 % |
Margin (%) |
41.6 % |
45.3 % |
|
Adjusted EBITDA (In RMB million) |
6,857.4 |
4,589.6 |
49.4 % |
Margin (%) |
44.9 % |
44.6 % |
|
Adjusted Diluted EPS (In RMB) |
1.13 |
0.75 |
50.7 % |
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of Dec 31, 2022, WuXi Biologics is supporting 588 integrated client projects, including 17 in commercial manufacturing.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
Forward-Looking Statements
This announcement may contain certain "forward-looking statements" that are not historical facts, but instead are predictions about future events based on our expectations as well as assumptions made by and information currently available to our management. Although we believe that our predictions are reasonable, future events are inherently uncertain and our forward-looking statements may turn out to be incorrect. Our forward-looking statements are subject to risks relating to, among other things, the ability of our service offerings to compete effectively, our ability to meet timelines for the expansion of our service offerings, and our ability to protect our clients' intellectual property. Our forward-looking statements in this announcement speak only as of the date on which they are made, and we assume no obligation to update any forward-looking statements except as required by applicable law or listing rules. Accordingly, you are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section.
Non-IFRS Measures
To supplement the Group's condensed consolidated financial statements which are presented in accordance with the IFRS, the Company has provided adjusted net profit, adjusted net profit margin, adjusted EBITDA, adjusted EBITDA margin and adjusted basic and diluted earnings per share as additional financial measures, which are not required by, or presented in accordance with, the IFRS.
The Company believes that the adjusted financial measures are useful for understanding and assessing underlying business performance and operating trends, and that the Company's management and investors may benefit from referring to these adjusted financial measures in assessing the Group's financial performance by eliminating the impact of certain unusual, non-recurring, non-cash and/or non-operating items that the Group does not consider indicative of the performance of the Group's core business. These non-IFRS financial measures, as the management of the Group believes, is widely accepted and adopted in the industry in which the Group is operating in. However, the presentation of these non-IFRS financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with the IFRS. Shareholders of the Company and potential investors should not view the adjusted results on a stand-alone basis or as a substitute for results under IFRS. And these non-IFRS financial measures may not be comparable to similarly-titled measures represented by other companies.
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