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Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved our targets for the first quarter of 2024. For the full year, the Company expects to deliver revenue of RMB 38.3-40.5 billion and free cash flow of RMB 4-5 billion, while adjusted non-IFRS NPM is expected to remain at a similar level as last year."

"Since its founding in 2000, WuXi AppTec has dedicated itself to serving as a highly efficient enabler to the industry, creating value for our customers and benefiting patients globally. Over the past two decades, the Company has remained fully committed to the highest quality and compliance standards, prioritizing our customers' needs, protecting their intellectual property (IP), and abiding by the laws and regulations in the countries in which we operate. Thanks to the trust and support from our customers globally, the Company continues to support the industry and enable our customers with continuously enhanced capabilities and capacity. With constantly emerging scientific innovations, including the rapid development of artificial intelligence (AI), the industry's demand for CRO, CDMO, CRDMO and CTDMO services will continue to grow – and this is the inevitable trend of the industry. Although the recently proposed U.S. legislation may create short-term uncertainty for the Company, our customers and the global pharmaceutical and life sciences industry, WuXi AppTec remains steadfast in 'doing the right thing and doing it right' and in supporting our customers' efforts to bring groundbreaking therapies to patients around the world."

Business Performance by Segments

• WuXi Chemistry: Integrated CRDMO Business Model Drives Steady Growth, with Continued Expansion in New Modalities (WuXi TIDES)

• • Revenue from WuXi Chemistry reached RMB5.56 billion; excluding COVID-19 commercial projects, revenue down 0.6%. Adjusted non-IFRS gross profit margin was 43.3%.

  • Drug discovery services ("R") continued to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 430,000 new compounds to customers, which grew 3% year-over-year. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business.

  • Development and manufacturing (D&M) services delivered sustained growth.
            i.        D&M services revenue^[2] reached RMB4.00 billion; excluding COVID-19 commercial projects, D&M services revenue grew 1.2% year-over-year.
            ii.        In the Reporting Period, we added 337 new molecules to our D&M pipeline. As of March 31, 2024, our D&M pipeline reached 3,286 molecules, including 64 commercial projects, 74 in phase III, 345 in phase II and 2,803 in phase I and pre-clinical stages, among which 11 commercial and phase III projects were added during the Reporting Period.

  • Specifically, TIDES business (mainly oligo and peptides) continued to expand.
             i.        In the Reporting Period, TIDES revenue grew strongly by 43.1% year-over-year to RMB0.78 billion. As of March, 31, 2024, backlog of TIDES grew significantly by 110% year-over-year.
             ii.        In the Reporting Period, the number of TIDES D&M customers increased 30% year-over-year to 146, and the number of TIDES molecules increased 43% year-over-year to 276.
             iii.        In January 2024, the total reactor volume of solid phase peptide synthesizers increased to 32,000L.

• WuXi Testing: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leadership Position and Drive Steady Growth

• • Revenue from WuXi Testing reached RMB1.49 billion. Adjusted non-IFRS gross profit margin was 35.6%.

  • Revenue from lab testing services down 0.6% year-over-year to RMB1.05 billion. Among which, revenue from drug safety evaluation services grew 3.7% year-over-year. We maintained our industry-leading position in the Asia-Pacific region.

  • In the first quarter, the Chengdu facility received National Medical Products Administration (NMPA) GLP qualification; the Qidong facility received Organization for Economic Co-operation and Development (OECD) and NMPA GLP qualifications in March and April. An additional 22,000m² of facilities were GLP-qualified in the first quarter.

  • Revenue from clinical CRO & SMO grew 11.0% year-over-year to RMB0.44 billion. SMO revenue grew 26.4% year-over-year, maintaining an industry leading position in China. In the Reporting Period, SMO supported 10 new drug approvals for customers. Clinical CRO enabled our customers to obtain 7 IND approvals.

• WuXi Biology: New Modalities Business Drives Growth; WuXi Biology Platform Continues to Generate Downstream Opportunities

• • Revenue from WuXi Biology reached RMB0.56 billion. Adjusted non-IFRS gross profit margin was 38.5%.

  • The Company focused on improving capabilities related to new modalities. In the Reporting Period, WuXi Biology revenue from new modalities grew 12.2% year-over-year, contributing 29.2% of WuXi Biology revenue.

  • The Company further integrated resources of its in vivo pharmacology platform and continued to improve platform capabilities and efficiency.

  • The Company commenced operations at the Suzhou Guoxiang research platform by the end of March 2024, strengthening new capabilities of in vitro biology and in vivo pharmacology.

  • In the Reporting Period, WuXi Biology continued to generate downstream opportunities and contributed more than 20% of the Company's new customers.

• WuXi ATU: Commercial Projects Gradually Approved, Driving Future Growth

• • Revenue from WuXi ATU reached RMB0.28 billion. Adjusted non-IFRS gross profit margin was (32.8)%. Mainly due to: the completion of high-margin projects in 2023; the approval of the new TIL product in late February 2024, with an increase in costs associated with talents reserved for commercial manufacturing in advance; and the under-utilization of capacity for other projects.

  • The Company focused on improving our CTDMO integrated enabling platform and strengthening capabilities and capacity. As of March 31, 2024, we provided development, testing and manufacturing services for 65 projects, including 2 commercial projects, 5 Phase III projects (2 projects in BLA preparation stage), 9 Phase II projects and 49 pre-clinical and Phase I projects, among which, the world's first innovative TIL-based therapy was approved by FDA in the first quarter.

  • We are preparing for BLA filing to manufacture the LVV used in a commercial CAR-T product. We completed process performance qualification (PPQ) and started post-PPQ manufacturing, expect to file pre-approval submission (PAS) to FDA in the second half of 2024. Moreover, we expect to complete PPQ and file PAS to FDA in the second half of 2024 for a blockbuster commercial CAR-T product.

• WuXi DDSU^[3]: Supporting Customers to Continue Advancing Pipeline Projects

• • Revenue from WuXi DDSU reached RMB0.08 billion. Adjusted non-IFRS gross profit margin was 26.9%.

  • As of March 31, 2024, 3 new drugs developed for our customers obtained NMPA approvals, including 2 for COVID-19 infection treatments and 1 for tumor treatment. We continued to receive royalty income of the approved new drugs from customers. Moreover, 2 new drug candidates are in the NDA review stage.

  • In the Reporting Period, we supported customers to file INDs for 6 drug candidates and obtain 6 Clinical Trial Approvals (CTAs). Cumulatively, we have submitted 196 new chemical entity IND filings and obtained 175 CTAs for customers, among which 3 projects have obtained NDA approvals, 2 projects are in the NDA review stage, 4 projects are in Phase III, 35 projects are in Phase II, and 71 projects are in Phase I, covering multiple therapeutic areas.

  • Demand declined significantly, and thus fewer new projects were signed as expected.

This release provides a summary of the results and is not intended to be a comprehensive report. For additional information, please refer to the WuXi AppTec 2024 First Quarterly Results Presentation and 2024 First Quarterly Report disclosed on the Company's official website, as well as the 2024 First Quarterly Report and other relevant announcements published on the websites of the Shanghai Stock Exchange (www.sse.com.cn) and the Stock Exchange of Hong Kong (www.hkexnews.hk), 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 2024 First Quarterly Report of the Company has not been audited.

First Quarter 2024 Results by Segments

Unit: RMB million

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 life sciences 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, advanced 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 for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 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: http://www.wuxiapptec.com

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 customers' 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 the 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, non-financial assets impairment, talent incentive and retention expenses funded by cash donation from shareholders, etc. We also provide adjusted non-IFRS net profit attributable to the 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 the 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.

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SOURCE WuXi AppTec