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WuXi AppTec Achieved First Quarter 2024 Target Despite External Challenges, Maintaining Stable Operations

Revenue Reached RMB7,982 Million; Excluding COVID-19 Commercial Projects, Down 1.8% Net Profit Attributable to the Owners of the Company Reached RMB1,942 Million; Diluted Earnings per Share (EPS) Reached RMB0.66 Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company Reached RMB1,913 Million; Adjusted Non-IFRS Diluted EPS Reached RMB0.65[1] Free Cash Flow Remained Positive and Reached RMB1,326 Million SHANGHAI, April 29, 2024 /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 and life sciences industry, today announced its financial results for the first quarter ending March 31, 2024 ("Reporting Period"):  Revenue reached RMB7,982 million; excluding COVID-19 commercial projects, revenue down 1.8%. Adjusted non-IFRS gross profit reached RMB3,090 million. Adjusted non-IFRS gross profit margin was 38.7%. Net profit attributable to the owners of the Company reached RMB1,942 million; diluted EPS reached RMB0.66. Adjusted non-IFRS net profit attributable to the owners of the Company reached RMB1,913 million; adjusted diluted non-IFRS EPS reached RMB0.65. Free cash flow remained positive and reached RMB1,326 million. In the first quarter of 2024, we added over 300 new customers, and in total we served more than 6,000 active customers over the past 12 months. Demand from customers across regions globally continued to grow. During the Reporting Period, revenue from the top 20 global pharmaceutical companies reached RMB2.70 billion, which grew 4.2% year-over-year excluding COVID-19 commercial projects. The sustained and steady business growth is attributed to our unique fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. WuXi Chemistry's D&M pipeline has maintained rapid growth, with a total of 337 new molecules added in the Reporting Period. As of March 31, 2024, our D&M pipeline reached 3,286 molecules, among which 11 commercial and phase III projects were added during the Reporting Period. As an enabler of innovation and a trusted partner and contributor to the global pharmaceutical and life sciences industry, the Company is committed to environmental sustainability efforts. The Company was named to the S&P Global Sustainability Yearbook and recognized as an Industry and Regional "Top-Rated" company by Sustainalytics consecutively in 2023 and 2024. Our outstanding ESG performance has also been widely acknowledged by major global ESG rating agencies, including MSCI, CDP, EcoVadis and FTSE Russell. The Company adheres to the unwavering commitment to customers' IP protection and the highest quality & compliance standards. In 2023, the Company has received a total of 748 quality audits and inspections conducted by global customers, regulatory authorities and independent third parties, and achieved 100% pass rate with no critical findings. The Company also received 83 information security audits conducted by global customers, with no critical findings. In addition, 24 of our main operating sites are ISO/IEC 27001 certified, including all the main operating sites in China. [1] In 2023 Q1 and 2024 Q1, WuXi AppTec had a fully-diluted weighted average share count of 2,948,890,231 and 2,925,052,346 ordinary shares, respectively. 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. [2] To further strengthen the CRDMO business integration, business units have been adjusted accordingly, and so have the R and D&M revenue splits (similar to 2023 baseline). 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. [3] WuXi DDSU will not be shown separately in the subsequent earnings presentation, as its revenue currently accounts for only ~1% of the Company. 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 Segment Revenue Change Adjusted non-IFRS Gross Profit Change Adjusted non-IFRS Gross Profit Margin WuXi Chemistry 5,562.63 (13.5) % 2,409.05 (16.6) % 43.3 %