Wuxi PharmaTech (Cayman), Inc.

The manufacturing and regulatory process of biopharmaceuticals is highly complex and costly to implement, which can be challenging for big pharma companies and startups to take on themselves. Outsourcing the task to CDMOs allows these companies to spend less of their own time and resources at the cost of surrendering full control of the process. A growing number of clinical trials involving advanced therapies is increasing demand for CDMOs, with many technologies gaining traction such as CAR-T cell therapies and gene therapies. As a result, the global CDMO market for advanced therapies was valued ​ at $5.6 billion last year and is projected to soar to $18.8 billion by 2030. However, there are also challenges with the use of CDMOs. One example is evolving industry regulations that make it vital to stay up to date with the latest requirements. Another is the shifting political landscape, such as the U.S.’s movements toward passing the BIOSECURE act ​, which is aimed to clamp down ​ on the use of CDMOs based in China. Here are five of the key CDMOs leading the market, with sprawling facilities around the world and a wide array of services to offer for clients developing advanced therapies. Catalent (Novo Holdings) Headquarters: Somerset, New Jersey, US ​ Founded: 2007 ​ Catalent was set up ​ when Blackstone acquired the pharmaceutical and services assets from Cardinal Health and rebranded them under their current name. Catalent handles the production and supply of therapeutic products across the range of small molecules and biologics. In terms of advanced therapies, the firm has expertise in the production of induced pluripotent stem cells (iPSCs) and viral vectors for gene therapies. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The company went public in 2014, raising around $822 million in an initial public offering on the New York Stock Exchange. In 2023, Catalent raked in ​ almost $4.3 billion in revenue, of which biologics accounted for $1.9 billion. Catalent was acquired by the investment company Novo Holdings, the investment arm of the Novo Nordisk Foundation, earlier this year ​. Novo Holdings forked out $16.5 billion for the CDMO, a 16.5% premium on Catalent’s closing price in February 2024. The move was prompted by a need to boost the production of Wegovy, Novo Nordisk’s lucrative drug for weight loss. Catalent also expanded its clinical supply facility in Germany as part of a $25 million project earlier this year. Lonza ​ Headquarters: Basel, Switzerland ​ Founded: 1897 ​ Nestled in the Swiss Alps, Lonza was set up by a group of Swiss financiers as a company that produced electrochemical products from hydroelectric power on the river Lonza. After World War 1, the firm began to produce more complex chemicals for use in industry and agriculture, and in the 1990s, the company branched into biotechnology with the acquisition of Celltech Biologics. Lonza helps its clients to take advanced therapies from late phase drug discovery and drug substance to commercial supply and drug product. For example, it offers services based on the microbial production of vaccines and recombinant proteins and the manufacturing of antibody-drug conjugates (ADCs) and different types of antibodies. It also helps users to navigate the complexities of cell and gene therapies including T-cell therapies and iPSCs. Lonza’s sales hit CHF 6.7 billion ​ ($7.6 billion) last year, of which its biologics division accounted for CHF 3.7 billion ($4.2 billion). In the same year, Lonza showed the drive to reinforce its expertise in the development of ADCs with the acquisition of the Dutch player Synaffix ​ for up to $175 million. In an expansion effort of its manufacturing capacity, Lonza acquired ​ a large-scale biologics manufacturing facility from Roche for $1.2 billion earlier this year. Thermo Fisher Scientific Headquarters: Waltham, Massachusetts, US ​ Founded: 1956 ​ Thermo Fisher Scientific is a heavyweight supplier ​ of lab equipment such as analytical instruments in addition to consumables. The company launched an initial public offering all the way back in 1967 and listed on the New York Stock Exchange in 1980, with a current market capitalization of $212 billion. In an effort to push into the CDMO space, Thermo Fisher Scientific acquired Patheon for $7.2 billion in 2017, nabbing the latter’s network of manufacturing facilities, which are largely in the US and Europe. At the time, Patheon had earned a neat $1.9 billion in revenue and was shuffled into the larger firm’s Laboratory Products and Services segment. Patheon has experience in the development of a wide range of advanced therapies, with services available for the production of viral vectors as well as cell therapies based on T cells, IPSCs, natural killer cells and more. The firm also offers help with the development of therapies based on messenger RNA (mRNA). Thermo Fisher Scientific’s revenue from 2023 ​ was $42.9 billion, with its Laboratory Products and Services segment accounting for roughly half of the total. Thermo Fisher Scientific also acquired the Swedish proteomics company Olink for $3.1 billion last year to help biopharmaceutical clients to examine diseases at the protein level. Rentschler Biopharma ​ Headquarters: Laupheim, Germany ​ Founded: 1927 ​ Rentschler Biopharma is a family-owned business that has its roots in a pharmacy that was opened in Laupheim in 1872. The company occupies a niche in rare orphan diseases ​ and focuses on offering services for the development and manufacturing of biopharmaceuticals for these conditions. For example, the firm is currently manufacturing eight approved products including bispecific antibodies and recombinant enzymes. Last year, Rentschler provided support with the manufacturing and regulatory development of four newly approved biopharmaceuticals in the US – roughly a quarter of the 17 biopharmaceuticals approved that year. Being family owned gives the CDMO strategic flexibility at the same time as a long-term outlook, among other advantages, said the CEO in 2020 ​. The company is also working with the UK organizations the Cell and Gene Therapy Catapult and Refeyn to deploy automated analytical technology and make the manufacturing of viral vectors more efficient than traditional methods. The CDMO recently completed ​ an expansion of its production site in Milford, Massachusetts, U.S., with a new production line opening operations, representing the biggest investment in the 150-year history of the company. WuXi Advanced Therapies (WuXi AppTec) ​ Headquarters: Shanghai, China ​ Founded: 2000 ​ WuXi Advanced Therapies is a CDMO arm of WuXi AppTec. The larger company originated as the drug development service provider and gradually expanded its offerings over the years, with the acquisition of AppTec Laboratory Services leading to the new name of WuXi Apptec. WuXi Advanced Therapies, also known as WuXi ATU, focuses on the development of advanced therapies such as cell and gene therapies with clients, with expertise in testing and manufacturing to speed up the path of new medicines to the market. For example, the team has cell banking tools to ensure that a client’s cells will pass regulatory standards, and analytical experts that deploy molecular biology, microscopy, flow cytometry-based tests and more to speed up the product development process. In 2021, WuXi AppTec acquired the UK CDMO Oxgene to absorb its gene therapy services into those of WuXi Advanced Therapies. In particular, WuXi was attracted by Oxgene’s viral vector technology which is designed to manufacture cell and gene therapies more simply and cheaply than current methods. Last year, WuXi AppTec reported ​ an overall revenue of RMB 40.3 billion ($5.5 billion) – a 2.5% increase from 2022. Revenue from its CDMO grew to RMB 1.31 billion ($180 million), though its profit margin declined due to the under-utilization of capacity, according to the company.

Funds will empower Adcentrx to progress its pipeline of novel antibody-drug conjugates into clinical development SAN DIEGO and SHANGHAI, April 24, 2023 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a biotechnology company dedicated to revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, announces the closing of a $38 million Series A+ financing. The round was led by Eight Roads Ventures, with participation from F-Prime Capital, ABio-X, Delta Capital, Trinity Innovation Fund, and other strategic investors. Life Venture Partners and Lighthouse Capital acted as Adcentrx's financial advisors. Adcentrx intends to use the proceeds from the financing to advance its proprietary ADC therapeutic pipeline into the clinic. Continue Reading ADCs are a class of therapies that combine the target specificity of antibodies with the potency of conventional chemotherapy drugs. This class has revolutionized the treatment landscape in oncology with the potential to positively impact other serious diseases. Adcentrx differentiates itself by leveraging its team's industry-leading experience in ADC drug development as well as deep expertise in chemistry and biology. The team has pioneered the development of an ADC technology toolbox addressing key components of protein conjugate design to solve challenges that arose in previous generations of ADCs. Adcentrx implements this optimized approach to fuel the development of a robust pipeline of first-in-class and best-in-class therapies. The company's lead candidate, ADRX-0706, is anticipated to enter a first-in-human Phase 1 clinical trial in the second half of 2023. Adcentrx is developing additional candidates in parallel with the goal of advancing at least one into the clinic each year. Funds will empower Adcentrx to progress its pipeline of novel antibody-drug conjugates into clinical development. Tweet this "We are thrilled to have Eight Roads and our investors supporting our mission to bring innovative treatments to patients," said Hui Li, Ph.D., Founder and CEO of Adcentrx. "Over the last two years, we have made significant progress advancing our emerging therapeutic pipeline that implements our proprietary and differentiated technology platform. This new round of funding from our investors will enable Adcentrx to quickly advance our safer and more efficacious conjugate therapies for patients in need. This year will be pivotal for Adcentrx, when we transition from the discovery stage into a clinical stage company." "ADCs as a therapeutic modality have flourished in recent years with a transformative inflow of active investment and strategic transactions. Adcentrx has demonstrated good potential of developing differentiated ADCs for unmet medical needs" commented Tao Huang, Ph.D., Principal of Eight Roads Ventures. "We are very excited to lead this round of financing to empower Adcentrx to accelerate its work in bringing new hope to patients in need." "Through its innovative work in the ADC field, Adcentrx exemplifies the type of company that ABio-X was designed to support as a global platform for developing the next generation healthcare companies. We are pleased to join together with other quality investors in this financing round and look forward to continuing our support of Adcentrx through the platform and board representation," added Jeff Jonas, President and CEO of ABio-X. "Adcentrx has made significant progress in building its preclinical pipeline and platform technology since our initial investment," said Meng Jiang, Head, Venture Capital at CBC Group. "Together with our ABio-X colleagues, we are pleased to reaffirm our commitment to support the company's continued growth and development." "As an innovation company with a global vision, Adcentrx leverages its technology platform to address the challenges of ADC drug development," commented Lei Hong, Executive Director of Lighthouse Capital. "It is a privilege to participate in this round of financing that attracted investment from renowned funds and industry players, indicating the company's growing prominence within the industry. We look forward to Adcentrx's continued progress of advancing its novel ADCs into the clinic." For more information about Adcentrx and its innovative ADC technology, please visit . About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. By combining the targeting precision of biologics and the disease fighting power of small molecule payloads, Adcentrx strives to develop next-generation targeted therapies for improving patient treatment options. About Eight Roads Ventures Eight Roads Ventures is a global proprietary investment firm backed by Fidelity, managing over $11 billion of assets across China, India, Europe, Israel, Japan and the U.S. Our 50-year history of investing includes partnerships with over 300 healthcare and technology companies globally. Some of Eight Roads Ventures' global investments include Alibaba, Beam Therapeutics, Pony.ai, Innovent Biologics, Insilico Medicine, Hibob, Medbanks, Semma Therapeutics and WuXi PharmaTech. About F-Prime F-Prime Capital is a global venture capital firm investing in healthcare and technology. For the past 50 years, its independent venture capital group has had the privilege of backing great entrepreneurs building groundbreaking companies. About ABio-X ABio-X was founded in 2021 by CBC Group, Asia's largest healthcare-dedicated asset management firm headquartered in Singapore. ABio-X operates with a mission to incubate next-generation companies that bring transformative medicines and solutions to the global market. About Delta Capital Founded in 2010, Delta Capital is a leading early-growth and growth equity investment fund platform in China. Delta's investment strategy focuses on early growth equity investments in Technology (semiconductor value chain, AI, biotech) and Consumer Services sectors. The firm has a stable and highly experienced team of over fifteen professionals who are experts in their respective fields. With its expertise in early growth equity investment and a focus on high-growth companies, Delta Capital is a prominent player in China's venture capital market. About Trinity Innovation Fund Trinity Innovation Fund (TIF) is dedicated to investing in biomedical innovations. TIF's limited partners include renowned biopharmaceutical companies and investment institutions. As an investor, TIF helps passionate scientists and entrepreneurs develop ground-breaking scientific research into successful corporate ventures. Partnering with scientists and entrepreneurs, TIF aims to transform innovations into cures for humanity. About Lighthouse Capital Lighthouse Capital, the most active new generation boutique investment bank in China. Founded in 2014, the firm is a fast-growing boutique investment bank serving enterprises with a global vision, committed to facilitating industrial upgrading and development through capital services and ecological empowerment. Lighthouse's services include private equity financing, mergers and acquisitions, asset management, securities underwriting, and industrial development advisory. Media Contact: [email protected] SOURCE Adcentrx Therapeutics

Revenue Up 71.8% Year-Over-Year to RMB39,355 Million Net Profit Attributable to Owners of the Company Up 72.9% Year-Over-Year to RMB8,814 Million Diluted Earnings Per Share (EPS) Up 63.0% Year-Over-Year to RMB2.82 Adjusted Non-IFRS Net Profit Attributable to Owners of the Company Up 83.2% Year-Over-Year to RMB9,399 Million Adjusted Non-IFRS Diluted EPS Up 81.7% Year-Over-Year to RMB3.18 [1] Operating Cash Flow Up 133.6% Year-Over-Year to RMB10,230 Million, and Free Cash Flow Turned Positive Company to Pay Cash Dividend of RMB2,644 Million, 30% of 2022 Net Profit SHANGHAI, March 20, 2023 /PRNewswire/ -- WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries to advance discoveries and deliver groundbreaking treatments to patients, is pleased to announce its annual results for the year ending December 31, 2022 ("Reporting Period"). This release provides a summary of the results and is not intended to be a comprehensive report. For additional information, please refer to the 2022 Annual Report and other relevant announcements published on the websites of the Shanghai Stock Exchange () and the Stock Exchange of Hong Kong (), and the designated media for dissemination of the relevant information. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares. All financial information disclosed in this press release is prepared based on International Financial Reporting Standards (IFRS), in currency of RMB. The 2022 Annual Report of the Company has been audited. 2022 Financial Highlights In 2022, we achieved record revenue growth in a very challenging operating environment. Revenue grew 71.8% year-over-year to RMB39,355 million. This is primarily attributable to the Company's continuing strong execution of our unique Contract Research, Development and Manufacturing Organization (CRDMO) business model to achieve synergy and strong growth: WuXi Chemistry revenue grew 104.8% to RMB28,850 million and adjusted non-IFRS gross profit grew 106.6% to RMB11,882 million, with a gross profit margin of 41.2%. WuXi Testing revenue grew 26.4% to RMB5,719 million and adjusted non-IFRS gross profit grew 37.3% to RMB2,101 million, with a gross profit margin of 36.7%. WuXi Biology revenue grew 24.7% to RMB2,475 million and adjusted non-IFRS gross profit grew 22.5% to RMB1,013 million, with a gross profit margin of 40.9%. WuXi ATU revenue grew 27.4% to RMB1,308 million and adjusted non-IFRS gross profit was RMB(77) million, with a gross profit margin of -5.9% WuXi DDSU revenue declined 22.5% to RMB970 million and adjusted non-IFRS gross profit declined 48.7% to RMB293 million, with a gross profit margin of 30.2%. Unit: RMB million IFRS gross profit increased 75.5% year-over-year to RMB14,507 million. Gross profit margin was 36.9%.[2] Adjusted non-IFRS gross profit increased 75.0% year-over-year to RMB15,228 million. Adjusted non-IFRS gross margin was 38.7%. Net profit attributable to owners of the Company increased 72.9% year-over-year to RMB8,814 million. Adjusted non-IFRS net profit attributable to owners of the Company increased 83.2% year-over-year to RMB9,399 million. Diluted EPS increased 63.0% year-over-year to RMB2.82, while adjusted diluted non-IFRS EPS increased by 81.7% year-over-year to RMB3.18. Company's Board of Directors decided to distribute RMB 8.9266 cash dividend for every 10 shares (30% payout ratio, RMB2,644 million cash dividend in total). 2022 Business Operation Highlights - We continued to expand our customer base globally. In 2022, demand for our services was very strong and we grew our customer base to more than 5,950 active accounts by adding over 1,400 new customers. We continued to optimize our cross-platform synergies to better serve our customers worldwide, strengthen our unique competitive advantage as a fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) and Contract Testing, Development and Manufacturing Organization (CTDMO) platform, and provide one-stop services for our clients from discovery to development and manufacturing. Revenue growth was demonstrated across our expanding global customer base: Revenue from US-based customers grew 113% to RMB25,884 million; revenue from Europe-based customers grew 19% to RMB4,432 million; revenue from China-based customers grew 30% to RMB7,526 million; and revenue from other regions grew 23% to RMB1,512 million. We remain focused on delivering high quality services with great efficiency to retain loyal customers for the long term. During the Reporting Period, revenue from existing clients grew 77% to RMB37,781 million and new clients contributed RMB1,573 million in revenue. During the Reporting Period, revenue from the top 20 global pharmaceutical companies grew 174% to RMB18,421 million; revenue generated from all other customers grew 30% to RMB20,934 million. Our unique positioning across the pharmaceutical development value chain drove our "follow-the-customer" and "follow-the-molecule" strategies and enhanced synergies across our business segments. Customers using services from multiple business units contributed RMB36,736 million in revenue, growing 87% year-over-year. - WuXi Chemistry: CRDMO integrated business model drove revenue doubled Revenue grew 104.8% to RMB28,850 million and adjusted non-IFRS gross profit grew 106.6% to RMB11,882 million, with a gross margin of 41.2%. Excluding COVID-19 commercial projects, WuXi Chemistry revenue grew strongly by 39.7%. Revenue from new modalities-related services (TIDES) grew 158.3% to RMB2,037 million. Revenue from discovery chemistry services ("R") grew 31.3% to RMB7,213 million. i. Our industry-leading small molecule drug discovery platform delivered more than 400,000 custom synthesized new compounds to our clients in the past twelve months. Through our small molecule discovery services, we enabled our customers to accelerate their research while generating opportunities for our downstream business units. As part of our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our global customers, supporting the rapid and sustainable growth of our CRDMO business. ii. We continued executing our "long-tail" strategy. Demand from "long-tail" customers in small molecule and new modality-related discovery services continued to grow. Revenue from development and manufacturing (D&M) services grew 151.8% to RMB21,637 million. i. During the Reporting Period, we won 973 new molecules to our D&M pipeline, including 1 new molecule at the commercial stage. To date, our D&M pipeline consists of 2,341 molecules, including 50 in commercial stage, 57 in phase III, 293 in phase II and 1,941 in phase I and pre-clinical stages. ii. D&M services for new modalities is gaining strong momentum. During the Reporting Period, the number of TIDES (mainly oligo and peptides) D&M clients increased 81% to 103 customers, and the number of TIDES molecules increased 91% to 189 molecules. Revenue from TIDES D&M business grew 337% to RMB1,578 million. Our TIDES business has a unique end to end CRDMO platform, enabling R&D and production of multiple complex conjugates. By Feb. 2023, we have in total 27 oligo production lines, over 10,000 liter peptide solid-phase synthesizers, and an R&D team of over 1,000 people. Our late-stage and commercial project delivery capabilities are favored by customers, supporting large scale production with industry leading speed. Furthermore, our integrated API plus DP platform have completed 16 CMC projects in 2022. We continued our capacity expansion to meet customer demands. During the Reporting Period, we began operations in Changzhou Phase 3 facility, Changshu facility and our Wuhan campus, which further enhanced our global integrated CRDMO platform capabilities and capacities. We continued the design and construction of facilities in Changzhou and Wuxi city in China, Delaware in the U.S. and Tuas in Singapore, aiming to better serve our global customers' future needs. Three sites located in Changzhou, Shanghai Waigaoqiao and Wuxi city were awarded "Silver" sustainability ratings by EcoVadis with excellent results, representing a leading position in the industry. - WuXi Testing: strong growth driven by lab testing services Revenue from WuXi Testing grew 26.4% to RMB5,719 million and adjusted non-IFRS gross profit grew 37.3% to RMB2,101 million, with a gross margin of 36.7%. Revenue from lab testing services grew 36.1% year-over-year to RMB4,144 million. i. The Company provides a full range of laboratory testing services for our customers, including drug metabolism and pharmacokinetics (DMPK), toxicology, and bioanalysis for drug development testing as well as medical device testing. We provide customers with high-quality services, realize "one report for global submission," and enable customers to save time, reduce costs and increase efficiency. By maintaining close collaborative relationships with our customers based on our "follow-the-molecule" and "follow-the-customer" strategies, existing customers account for over 60% of our customer base. We leveraged our integrated WuXi AppTec Investigational New Drug (WIND) program to generate preclinical data package and prepare global regulatory submissions of investigational new drug (IND), expediting the IND application process for many customers worldwide. ii. Drug safety evaluation services achieved strong revenue growth of 46% year-over-year. We maintained our industry-leading position in Asia Pacific for drug safety evaluation services that meet global regulatory requirements. iii. Our largely US-based medical device testing business has turned around and grew 33% year-over-year. iv. On the capacity expansion side, 55,000 square meters laboratory are under construction in Suzhou and Qidong for 2023 delivery. Our clinical CRO & SMO (Site Management Organization) reached a revenue of RMB1,575 million, representing year-over-year growth of 6.4%, due in part to the impacts of COVID-19 pandemic in many cities across China in 2022. v. For clinical CRO, despite challenges in 2022, the Company provided services to approximately 200 projects, enabling our customers to obtain 15 IND approvals. vi. For SMO, the Company maintained No.1 leadership position in China and continued to grow. Our SMO business maintained strong growth amid multiple rounds of lockdown in 2022, and continued to gain market share in multiple therapeutic areas (lung cancer, breast cancer, dermatology, cardiovascular disease, ophthalmology, rheumatology, and nervous system etc.). As of the end of 2022, our SMO business maintained approximately 4,700 staff across around 150 cities in China, providing services at more than 1,000 hospitals. During the Reporting Period, revenue from our SMO business grew 23.5% and backlog grew 35.6%. In 2022, our SMO business supported 35 new drug approvals for clients. vii. Clinical CRO and SMO businesses leverage the strength of our Lab Testing platform to drive conversion. By leveraging our strong pre-clinical testing services, we have successfully converted 17 preclinical projects to clinical projects in 2022. - WuXi Biology: demand for our broad biology services drove growth with strong contribution from new modalities related services Revenue from WuXi Biology grew 24.7% to RMB2,475 million and adjusted non-IFRS gross profit grew 22.5% to RMB1,013 million, with a gross margin of 40.9%. Although revenue growth in the second quarter was temporarily impacted by the ongoing effects of the COVID-19 epidemic in Shanghai, business recovered in the second half due to the dedication of our employees. The Company has one of the largest discovery biology enabling platform, with more than 3,000 experienced scientists who provide comprehensive biology services covering all major stages and therapeutic areas of drug discovery. The Company has established 3 centers of excellence for non-alcoholic steatohepatitis (NASH), anti-viral, neuroscience and aging. Both our cancer discovery service and our rare and immune disease service continued to grow, providing customers with integrated high-quality services from target discovery to clinical biomarker detection. The Company has a leading DNA Encoded Library (DEL) and compound generation platform with over 90 billion compounds, 6,000 unique proprietary scaffolds and 35,000 building blocks, providing these services for more than 1,500 customers. A customer advanced a project into clinical stage in 2022 based on the hits generated using our DEL screening technology. This was the first reported clinical candidate from our DEL hits, which is also an important validation of our platform. The Company continues to build its biology capabilities for new modalities, including target protein degradation, nucleic acid-based and conjugated modalities, oncolytic virus, vector platform, and novel drug delivery vehicles. During the Reporting Period, WuXi Biology revenue from new modalities grew strongly by 90%. Its revenue contribution grew to 22.5% in 2022 from 14.6% in 2021, suggesting that new modalities-related biology services have become an increasingly important growth driver. - WuXi ATU: CTDMO business model drove growth Revenue from WuXi ATU grew 27.4% year over year to RMB1,308 million and adjusted non-IFRS gross profit was RMB-77 million, with a gross margin of -5.9%. Revenue from our Testing service grew 36%, and revenue from our Development service grew 43%. Gross profit declined largely due to under-utilized capacity at the newly built Shanghai Lingang site. During the Reporting Period, the Company focused on improving our CTDMO integrated enabling platform and strengthened capabilities and capacities. We provided development and manufacturing services for 68 projects, including 50 pre-clinical and Phase I projects, 10 Phase II projects, and 8 Phase III projects (2 projects have filed BLA, and 2 projects are in BLA preparation stage). For the 2 projects filed for BLA, one is a TIL product for a US client, which is the world's first innovative TIL-based therapy to be approved by FDA, and the other one is LVV used in a CAR-T product in China for a Chinese client. If they proceed as planned, we expect to have commercial stage projects in the second half of 2023. Our unique CTDMO platform has driven us to capture significant business opportunities. In 2022, we signed a tech transfer agreement to manufacture a blockbuster commercial CAR-T product. In August, we announced Licensing Agreement with Janssen for TESSA™. - WuXi DDSU: business continues evolving in 2022 to better provide innovative drug discovery services to customers Revenue from WuXi DDSU declined 22.5% to RMB970 million and adjusted non-IFRS gross profit declined 48.7% to RMB293 million, with a gross margin of 30.2%. DDSU's revenue decline was mainly due to our business transition to focus on fewer but more innovative projects to meet customers' demand for novel drug candidates. The future revenue growth will gradually come from royalty income. In 2022, our success-based drug discovery service unit filed INDs for 28 drug candidates and obtained 34 Clinical Trial Approvals (CTAs). As of the end of 2022, we have cumulatively submitted 172 new chemical entity IND filings with the National Medical Products Administration (NMPA) and obtained 144 CTAs, with 1 project in NDA review stage, 7 projects in Phase III, 24 projects in Phase II, and 75 projects in Phase I. And by Mar 20, 2023, we have 2 projects in NDA review stage. We will begin receiving royalty income once our customers launch these products in the market. We expect to start receiving royalty income from approved products beginning 2023, which is estimated to grow with about 50% CAGR over the next 10 years as more and more products commercialized by DDSU customers. Currently, we support 15 pre-clinical projects for customers in new modalities that include Peptide/Peptide-Drug-Conjugation (PDC), protein degraders and oligo. Several of these projects have filed IND in 2022, and multiple other projects are expected to file IND in early 2023. - The unique CRDMO and CTDMO business model of the Company continues to successfully drive record high financial performance. Our business continued its healthy growth while large scale commercial production projects generated strong cash flow in 2022. Our operating cash flow in 2022 represented an accelerated year-over-year growth of 133.6%. Free cash flow turned positive in 2022. 2023 Outlook On top of an exceptionally strong year of 2022, we expect revenue growth of 5-7% in 2023. Excluding COVID-19 commercial revenues, WuXi Chemistry expects to grow 36-38%, and TIDES (new modalities business in WuXi Chemistry) expects to grow as twice the speed of overall WuXi Chemistry. Other business segments (WuXi Testing, WuXi Biology, WuXi ATU) expect to grow 20-23%. WuXi DDSU will continue business transition, and expect to be down more than 20%. The Company will focus on continuous improvement of operating efficiency in 2023 to drive profitability and free cash flow growth. Adjusted non-IFRS Gross Profit expects to increase 12-14% year-over-year, with further improved operating efficiency, which will be conducive to the growth of Adjusted non-IFRS Net Income. Free cash flow will continue to be positive in 2023, and expect to increase by 600-800%. Capex spending expects to be RMB 8-9 billion, resulting from better asset utilization and efficiency improvement, with no impact on long-term growth. We will continue to invest in new capabilities and capacities to better serve global customer demands, and promote future growth of the Company. Our commitment to ESG As an enabler of innovation, a trusted partner, and a contributor to the global healthcare industry, the Company is committed to environmental protection and sustainability, and to being a good global corporate citizenship. Our outstanding ESG performance has been recognized by major global ESG rating agencies. In 2022, the Company received an "AA" rating from MSCI for a second consecutive year, and ranked in the top 2% for ESG ratings by Sustainalytics in the global pharmaceutical industry. Meanwhile, the Company was named to the 2022 Dow Jones Sustainability Index (both World and Emerging Markets) and was included in the S&P Global Sustainability Yearbook 2023 for the first time with an "Industry Mover" award. In addition, the Company received recognitions in various ESG ratings, such as a leadership level of "A-" in the CDP Climate Change rating. In EcoVadis assessment on suppliers' responsibility, the Company was awarded a "Bronze" rating, and three sites in Changzhou, Shanghai Waigaoqiao and Wuxi city received "Silver" ratings. In 2022, our carbon emission intensity, energy consumption intensity and water use intensity reduced by 17.3%, 19.0%, and 23.4%, respectively, compared to the baseline of 2021. Management Comment Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved record growth for 2022. Our revenue increased 71.8% year-over-year and our adjusted non-IFRS net profit attributable to owners of the company increased 83.2% year-over-year. Our third-quarter revenue reached the milestone of over RMB 10 Billion for the first time in our history. WuXi AppTec's performance during 2022 demonstrated that the Company's unique CRDMO and CTDMO business models allow us to better meet growing demands from customers worldwide and continue to drive rapid growth for the Company." "In 2022, while COVID-19 continued to create uncertainty for many around the world, we effectively implemented our business continuity plan and leveraged our robust supply chain network to support our customers' lifesaving work. We remain committed to prioritizing our customers' needs. The Company will further enhance our capacity and capabilities and continuously improve our operating efficiency, to support our partners in their efforts to bring groundbreaking therapies to patients around the world. Driven by CRDMO and CTDMO business models, the Company is full of confidence to continue to grow and maintain our leading position as a global pharmaceutical R&D service platform." "In 2022, we continued to integrate ESG into every aspect of our business operations and achieved excellent results. The Company remains steadfast in 'doing the right thing and doing it right.' We will keep prioritizing our ESG commitments while enabling our customers' discovery, development and manufacturing of innovative medical solutions for those in need." About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI in 2022 and its open-access platform is enabling more than 5,950 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." Please visit: Forward-Looking Statements This press release may contain certain "forward-looking statements" which are not historical facts, but instead are predictions about future events based on our beliefs 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, our ability to protect our clients' intellectual property, unforeseeable international tension, competition, the impact of emergencies and other force majeure. Our forward-looking statements in this press release 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. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law. Use of Non-IFRS and Adjusted Non-IFRS Financial Measures We provide non-IFRS gross profit and non-IFRS net profit attributable to owners of the Company, which exclude share-based compensation expenses, issuance expenses of convertible bonds, fair value gain or loss from derivative component of convertible bonds, foreign exchange-related gains or losses, amortization of intangible assets acquired in business combinations, goodwill impairment, etc. We also provide adjusted non-IFRS net profit attributable to owners of the Company and earnings per share, which further exclude realized and unrealized gains or losses from our venture capital investments and joint ventures. Neither is required by, or presented in accordance with IFRS. We believe that the adjusted financial measures used in this press release are useful for understanding and assessing our core business performance and operating trends, and we believe that management and investors may benefit from referring to these adjusted financial measures in assessing our financial performance by eliminating the impact of certain unusual, non-recurring, non-cash and non-operating items that we do not consider indicative of the performance of our core business. Such adjusted non-IFRS net profit attributable to owners of the Company, the management of the Company believes, is widely accepted and adopted in the industry the Company is operating in. However, the presentation of these adjusted 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 IFRS. You should not view adjusted results on a stand-alone basis or as a substitute for results under IFRS, or as being comparable to results reported or forecasted by other companies. For more information, please contact: Ms. Ruijia Tang (for investors) IR Director Email: [email protected] Mr. Davy Wu (for media) PR Director Email: [email protected] SOURCE WuXi AppTec