Revenue Increased by 63.5% Y-o-Y to RMB7,206.4 Million
Gross Profit Increased by 48.6% Y-o-Y to RMB3,413.2 Million
Net Profit Grew by 39.2% Y-o-Y to RMB2,621.2 Million
Adjusted Net Profit Rose by 60.9% to RMB2,914.9 Million
Total Backlog Reached US$18,467 Million
* * *
Non-COVID Revenue Achieved 72.6% Y-o-Y Growth
CRDMO Business Model Led Sustainable Long-Term Growth
"Follow and Win the Molecule" Strategies Drove Significant Revenue Increases
534 Total Integrated Projects, Including 59 Additions
29 Phase III Projects & 14 Commercial Manufacturing (CMO) Projects with Potential for Future Growth
Late-Phase & Commercial Manufacturing Revenue Increased by 63.5% to RMB3,151.5 Million, A Strong Growth Driver for the Future
Business Continuity Plan Implemented During Shanghai COVID Outbreak, Allowed Delivery of Projects Without Disruption
Supply Chain Optimized to Safeguard Project Execution and Timelines
Premier Quality System Re-verified, Completed 25 Global Regulatory Inspections
Drug Product CDMO Platform Established to Fuel Future Growth
Global Presence and Talent Pool Expanded to Support Business Momentum
Sufficient Capacity to Start Any Project within 4 Weeks
HONG KONG, Aug. 17, 2022 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a global leading 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 unaudited interim results for the first half of 2022 ("Reporting Period").
2022 Interim Financial Highlights
2022 Interim Business Highlights
Since the beginning of this year, the biologics industry has faced a number of challenges, such as the biotech funding slowdown, the ever-changing COVID-19 pandemic situation, and weak economic growth. However, through the successful implementation of "Follow and Win the Molecule" strategies and by leveraging its unique CRDMO business model, WuXi Biologics has managed to maintain strong growth momentum and continued to enable its global partners by accelerating and transforming the discovery, development and manufacturing of innovative biologics, benefiting patients worldwide.
Business Performance Remained Strong Despite Challenges
Despite the challenges of low biotech funding sentiment, the UVL issue and Shanghai COVID outbreak, the Group added 59 new integrated projects in the first half of 2022, with total integrated projects reaching a new record high of 534, including 204 first-in-class projects from global partners. During the Reporting Period, 5 external projects were contributed by "Win-the-Molecule" execution, including two projects in phase II and one project in phase III attributable to the Group's advanced technology, best-in-industry timeline, excellent execution track record and premium quality. In addition, more than 10 late-phase and commercial manufacturing projects are currently under negotiation. The Group's "Win-the-Molecule" strategy will further drive late- and commercial-stage revenue growth and bring additional momentum to its pipeline expansion.
Total backlog grew to US$18,467 million as of June 30, 2022, hitting a new historical high and providing high visibility of sustainable high growth. The increase was mainly driven by the expansion of the commercial manufacturing pipeline. Backlog within three years increased to US$3,049 million as of June 30, 2022, underpinning robust short-term growth.
Although the number of projects and backlog size has increased rapidly, the Group is still able to launch any new projects within four weeks because of its strong capabilities and flexible capacity.
Both Non-COVID and COVID-19 Related Businesses Performed Well
In the first half of 2022, non-COVID projects achieved robust growth with a 72.6% y-o-y increase. Underpinned by outstanding R&D capability and excellent project execution, the Group continued to gain more market share with the number of non-COVID integrated projects growing to almost 500. Non-COVID business is expected to continue its accelerated growth in both the short and long-term.
Meanwhile, COVID-19 projects made meaningful revenue contribution in the Reporting Period as the Group continues to support and enable its customers in combatting against COVID-19. The Group has formed a strategic partnership with AstraZeneca for the manufacturing of Evusheld (Tixagevimab and Cilgavimab), a long-acting antibody combination used for the pre-exposure prophylaxis of COVID-19, in China. Since the outbreak of COVID-19, the Group has delivered hundreds of millions of doses of COVID-19 vaccines and manufactured over 2,000kg of COVID-19 neutralizing antibodies, demonstrating its leading-edge technology platforms and the advantage of its disruptive disposable manufacturing processes.
Late-Phase and Commercial Manufacturing Projects Drove Significant Revenue Growth
WuXi Biologics has seen accelerated momentum for its late-stage and commercial manufacturing businesses since the banner year of 2021. By the end of the Reporting Period, the Group has accumulated 29 late-phase projects and 14 commercial manufacturing projects on its integrated enabling platform. Late-phase and commercial manufacturing revenue increased by 63.5% y-o-y to RMB3,151.5 million, accounting for 43.8% of the total revenue in the first half of 2022, which demonstrated the stickiness of biologics CRDMO model and reaped the fruition of the Group's long-term "Follow and Win the Molecule" strategies. Furthermore, over 10 late-phase and commercial manufacturing projects are currently under negotiation. Combined with the additional momentum brought by the "Win-the-Molecule" strategy, the Group expects to have more late-stage and commercial manufacturing projects in the upcoming years to drive sustainable high growth.
Positive Progress Made Regarding the U.S. Department of Commerce's Unverified List
WuXi Biologics has made positive progress and effectively addressed the concerns of global customers since its Wuxi and Shanghai subsidiaries were added to the Unverified List (UVL) by the U.S. Department of Commerce in February 2022.
The onsite inspection for WuXi Biologics Co., Ltd., located in Wuxi city, has been successfully completed by the U.S. Bureau of Industry and Security (BIS), in coordination with China's Ministry of Commerce (MOFCOM), which is an important step towards the removal of the subsidiary from the UVL. As a global company, WuXi Biologics has always been operating with stringent compliance standards. The Group is working closely with the appropriate U.S. and Chinese government agencies to schedule the onsite inspection for its Shanghai subsidiary and to facilitate the removal of the two subsidiaries from the UVL.
This development has not posed any material impact to the Group's business operations or cause any disruption to its supply chain. Since the two facilities were added to the list, the Group has continued to see strong demand from global customers, especially in the U.S. and EU, and signed two manufacturing contracts valued over US$100 million with two multi-national pharmaceutical companies. Thanks to its "Dual-Source, Dual-Factory" supply chain strategy, the Group was able to maintain normal procurement from global vendors and ensure sufficient stock to support project delivery.
Outstanding Execution during Shanghai COVID Outbreak Demonstrated Strong Operational Resilience
At the very beginning of the Shanghai COVID outbreak, WuXi Biologics effectively implemented its Business Continuity Plan. More than 600 employees voluntarily stayed at the Shanghai sites to ensure the progress of projects. By virtue of the employees' dedication and the Group's diversified operational locations and comprehensive connections across the industry's supply chains, key projects were delivered with a 100% success rate despite limited staff and there was no disruption to the customers. The Group's strong supply chain management played a critical role in avoiding material supply shortages and sustaining normal logistics to support business operation and safeguard project deliveries. In response to regional contingencies, the Group demonstrated excellent operational resilience, great flexibility and unwavering commitment, winning broad appreciation and recognition from customers worldwide.
Accelerated Growth Seen within New Businesses
In the first half of 2022, the Group saw accelerated growth within new businesses, including bispecifics, multispecifics, ADCs, fusion proteins and vaccines. By the end of the Reporting Period, the Group's bispecific antibody projects had increased to 84, including relevant projects based on the WuXiBody™ platform, which have delivered strong growth for and will continue contributing to the Group's businesses. Moreover, WuXi Vaccines has signed 16 vaccine contracts, including viral vector vaccines, virus-like particles (VLP) vaccines, recombinant protein vaccines and mRNA vaccines. With its strong manufacturing track record and premier-quality supply chain, WuXi Vaccines has delivered hundreds of millions of COVID-19 vaccine doses for its partners to help combat the COVID-19 pandemic in over 180 countries.
WuXi XDC is well-positioned to provide industry-leading, one-stop CRDMO offerings to customers to discover, develop and manufacture bioconjugates. As of June 30, 2022, WuXi XDC has already secured 76 integrated projects from customers worldwide, with two projects at late-phase. The Group remains positive regarding the growth outlook for the new modalities, which are set to become the Group's next rapid growth engines.
Enabling Both Biotech and Big Pharma
During the Reporting Period, the Group further enlarged and diversified its customer base by providing services to 434 customers including all top 20 global pharmaceutical companies. Recognizing the Group's capabilities and capacity to provide high-quality, efficient and more cost-effective CRDMO services, big pharmaceutical companies are increasingly utilizing the Group's services. Additionally, small and medium-sized biotech companies continue to rely on the Group's platforms to accelerate the development of their innovative biologics. The Group will continue to build its capabilities and capacities to meet growing industry demand, from biotech start-ups to big pharmaceutical companies.
End-to-End Drug Product Services Generate New Growth
Over the course of a decade's worth of continual investment and development, the Group has built up and expanded its world-class DP development and manufacturing capacity and capabilities to replicate its success in DS development and manufacturing. With state-of-art facilities and cutting-edge technologies, including integrated high throughput and automation instruments, pioneering lyophilization technologies, and advanced process development capabilities, the Group's comprehensive DP capacity and capabilities enlarged the spectrum of services offered to the biologics industry, boosting the Group's revenue stream.
Since 2018, the Group's DP business has seen accelerated growth in its number of customers and projects, covering hundreds of biologics products, including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), fusion proteins, antibody conjugation drugs (ADCs), enzymes and other modalities. By the end of 2022, the Group expects to operate 11 GMP-compliant DP facilities in China, the United States and Germany, with an annual capacity of more than 100 million doses of vials and pre-filled syringes. DP services will become a new pillar of growth for the Group's business and further solidify its leading position in the global biologics CRDMO industry.
Acquisitions Successfully Integrated
WuXi Biologics completed three acquisitions in 1H 2021 to further enhance its capacity - a DS facility in Wuppertal, Germany from Bayer; DS and DP facilities in Hangzhou, China from Pfizer China; and CMAB, a full-service CDMO company in China. These facilities have been completely integrated into the Group's global network with fully upgraded capacity and capabilities, showcasing the Group's strong M&A and integration capabilities to create synergies. In just one year, revenue and project numbers at WuXi Biologics Suzhou (former CMAB) have increased by more than 200% and 300% respectively, and its international customer base has expanded exponentially.
Global Footprint Extended
WuXi Biologics continues to implement its "Global Dual Sourcing" strategy and advances its global manufacturing capacity plan as scheduled. In order to better serve the surging demand from global customers, WuXi Biologics intends to build parallel capabilities established from DNA to BLA and provide fully integrated services from process development to DS and DP manufacturing in the U.S. and Europe in 2022. The MFG18 facility located in Cranbury, New Jersey, U.S., and the MFG6 and MFG7 facilities located in Dundalk, Ireland, are expected to be GMP operational in 2H 2022, with partial capacity already reserved by a number of customers. Together with the MFG8 facility located in Hebei, China, which is scheduled to commence operations in 2H 2022, the Group's total planned manufacturing capacity will reach 262,000L by the end of this year.
Furthermore, the Group plans to build a cutting-edge, fully integrated CRDMO center in Singapore, encompassing a research and development service center and large-scale DS and DP manufacturing facilities. The new site will add 120,000L biomanufacturing capacity to the Group's global network, bringing the total planned manufacturing capacity to over 580,000L by 2026. The new addition in Singapore will provide the global biologics industry with a more robust supply chain and reinforce the Group's "Global Dual Sourcing" strategy, which ensures that customer projects can be fulfilled at multiple facilities around the world.
Expand Talent Pool to Support Robust Business Growth
WuXi Biologics values talent development and has established an extensive recruiting, training and compensation program, allowing it to attract and retain top talents worldwide. As of June 30, 2022, the Group's total staff had increased to 10,593, with a sizable biologics R&D team of 3,414 scientists. The Group's recruitment outside of China proceeded well and attracted over 960 global employees on board. The number of total employees is expected to exceed 13,000 by the end of 2022 to support strong business growth. Talent retention continued to be successful, with a key talent retention rate of 97.8%, well above industry average.
Innovative Technology Platforms Enhanced to Underpin Future Success
WuXi Biologics continued to enhance innovative biologics generation capabilities and optimize several existing proprietary technology platforms, including the WuXia™ cell line development platform, WuXiBody™ bispecific antibody platform, SDArBodY™ multispecific antibody platform, WuXiUP™ continuous manufacturing platform and mRNA vaccine platform. In the meantime, the new modalities, including bispecifics, ADCs, fusion proteins and vaccines, have advanced rapidly through various project phases, laying a solid foundation for royalty and milestone revenue potential. Differentiated technology in advanced modalities is expected to usher in robust and consistent growth for the Group in the foreseeable future.
Global Standards Met by Premier Quality System
WuXi Biologics believes that its long-established and proven quality system is a significant competitive advantage. With its world-class quality system, the Group has completed 25 regulatory inspections conducted by U.S. FDA, EU EMA, China NMPA and other national regulatory agencies since 2017, distinguishing the Group as the first and only biologics company certified by these regulatory agencies for commercial manufacturing in China. 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 An Essential Component of Business Strategy
WuXi Biologics' ESG strategy has been expanded and is defined as "enhancing governance, enabling customers, giving back to society and greening business". To actively address climate change, the Group has set mid-to-long term greenhouse gas (GHG) emissions reduction and water consumption targets, including reducing its ratio of Scope 1 and Scope 2 GHG emissions intensity by 50% by 2030 (compared to its 2020 outputs), and reducing water consumption intensity by 18% by 2025 (compared to 2019). Even with its capacity tripled in 2021, the Group achieved expected progress in accordance with its proposed medium and long-term environmental goals. Additionally, the Group has formed a WiSTEM (Women in STEM) committee consisting of female employees from across the company. The committee aims to foster a healthy business environment through greater diversity, equity, and inclusion (DE&I).
In the first quarter of 2022, WuXi Biologics was recognized as the Industry Top-Rated Company in 2022 and was assessed as Low Risk and ranked top in the industry by Sustainalytics, a global provider of ESG-related research, ratings and data. WuXi Biologics has also been selected as a constituent of FTSE4Good Index Series. This is the second year in a row that the Group has received both of these recognitions. Looking forward, the Group will continue to focus on delivering on its ESG commitments and ensuring that sustainability remains a priority across its business operations today and in the future.
Management Comment
Dr. Chris Chen, CEO of WuXi Biologics, said, "We achieved solid growth in the first half of 2022, despite a less favorable investment environment for biotech, the UVL issue, and the Shanghai COVID-19 outbreak. Our CRDMO business model and 'Follow and Win the Molecule' strategies continued to bring excellent results. 59 new integrated projects were added to our pipeline and total integrated project number reached 534, indicating a continuation of our strong growth momentum and expanded market share. Non-COVID revenue increased by 72.6% y-o-y and non-COVID projects grew to almost 500. COVID-19 projects demonstrate the power of our technology platforms and our strong project execution capabilities. Leveraging the improved operational efficiency achieved through the execution of COVID-19 projects, our visibility in the R&D and commercial manufacturing is further enhanced, which allows us to win more trust from global customers and drives the increase of project pipeline and backlog. Supported by active business development activities and improved global presence, the North America market registered a robust 78.0% y-o-y growth and the momentum is expected to continue as overseas customers become increasingly interested in our new facilities and seek more opportunities for collaboration. We are also pleased that the China market resumed an exciting 54.4% y-o-y growth thanks to our strong R&D capabilities and the continued trust of our customers. Moreover, the accelerated growth in new modalities and the end-to-end Drug Product CDMO platform are expected to fuel the future growth. We currently have over 10,000 employees – which will increase to 13,000 by the end of this year – and I am so proud of the contributions they have made supporting all aspects of our business. I am especially impressed by the dedication and perseverance our team has demonstrated during the COVID-19 outbreak in Shanghai to ensure business continuity and project delivery."
Dr. Chris Chen added, "Our revenue and adjusted net profit grew 63.5% and 60.9% y-o-y respectively as a result of the combined efforts of all our employees and support from our partners globally. Confronted with external challenges, we demonstrated strong execution and operational resilience to ensure business continuity and fulfill our commitment to customers. The successful integration of three acquisitions closed in 2021 and their recent revenue contributions also showcased 'WuXi Bio Speed' and 'WuXi Bio Execution'. As a trusted partner to global healthcare companies, we will build a new comprehensive CRDMO center in Singapore to enable the global biologics industry with a more robust supply chain and further reinforce our 'Global Dual Sourcing' strategy. Looking ahead, we will continue to strive for better operational efficiency, enhance our capabilities and expand our capacities to capture the exciting opportunities in the biologics industry. Combining these efforts with ESG initiatives as a cornerstone of our global business development rooted in our mission and vision, we will continue to enable our customers and partners to benefit patients worldwide."
Dr. Ge Li, Chairman of WuXi Biologics, concluded, "The success of our unique CRDMO business model lays a solid foundation for sustainable long-term growth for our company and customers worldwide. Both the fundamentals of our business and its future outlook remain very strong, and we will continue to improve operational efficiency and invest in R&D service capabilities and capacities, particularly in new modalities and manufacturing. We are confident that these investments will better enable our customers worldwide to bring innovative medicines to patients in need – realizing our vision that 'every drug can be made and every disease can be treated.'"
Key Financial Ratios
(For the Six Months Ended June 30)
Key Financial Ratio |
1H 2022 |
1H 2021 |
Change |
Revenue (In RMB million) |
7,206.4 |
4,406.8 |
63.5 % |
Gross Profit (In RMB million) |
3,413.2 |
2,296.8 |
48.6 % |
Gross Profit Margin (%) |
47.4 % |
52.1 % |
|
Net Profit (In RMB million) |
2,621.2 |
1,882.8 |
39.2 % |
Net Profit Margin (%) |
36.4 % |
42.7 % |
|
Net Profit Attributable to Owners of the |
2,535.1 |
1,842.1 |
37.6 % |
Margin (%) |
35.2 % |
41.8 % |
|
Adjusted Net Profit (In RMB million) |
2,914.9 |
1,812.1 |
60.9 % |
Adjusted Net Profit Margin (%) |
40.4 % |
41.1 % |
|
EBITDA (In RMB million) |
3,392.7 |
2,387.1 |
42.1 % |
EBITDA Margin (%) |
47.1 % |
54.2 % |
|
Adjusted EBITDA (In RMB million) |
3,686.4 |
2,316.4 |
59.1 % |
Adjusted EBITDA Margin (%) |
51.2 % |
52.6 % |
|
Adjusted Diluted EPS (In RMB) |
0.65 |
0.40 |
62.5 % |
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 10,000 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 June 30, 2022, WuXi Biologics is supporting 534 integrated client projects, including 14 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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