CN-201

October 1, 2024 6:45 am ET Addition of CN201, a next generation CD3xCD19 bispecific antibody with potential applications in B-cell malignancies and autoimmune diseases, broadens and fortifies Merck’s pipeline RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases. “By actively depleting B-cells, CN201 offers applications spanning both B-cell malignancies and autoimmune diseases. We look forward to building upon the foundational work started by the Curon team,” said Dr. Dean Y. Li, president, Merck Research Laboratories. CN201 is currently being investigated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, potentially leading to significant and sustained reductions in B-cell populations. Transaction details Under the agreement, Merck, through a subsidiary, has acquired full global rights to CN201. As previously disclosed, the transaction is being accounted for as an asset acquisition. Merck is recording a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, which will be included in third-quarter non-GAAP results and was not included in Merck’s full-year financial outlook issued on July 30. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results on October 31. About CN201 CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Media Contacts: Robert Josephson (203) 914-2372 Carly Myar (917) 227-5957 Investor Contacts: Peter Dannenbaum (732) 594-1579 Damini Chokshi (732) 594-1577 Source: Merck & Co., Inc.

Revenue increased by 1.0% YoY to RMB 8,574.2 million Non-COVID revenue grew by 7.7% YoY, with non-COVID late-phase & commercial manufacturing YoY growth of 11.7% Added 61 new integrated projects, including 4 from late-phase and commercial stage Client's molecule recently acquired by MNC, highlighting a potential best-in-class CD3 asset utilizing three of our proprietary technology platforms Total integrated projects of 742, one of the largest portfolios of complex biologics Successful EMA inspections of 13 products and FDA inspections of 2 products in 1H24 HONG KONG, Aug. 21, 2024 /PRNewswire/ -- WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) service company offering end-to-end solutions for biologics discovery, development and manufacturing, is pleased to announce its unaudited interim results for the first half of 2024 ("Reporting Period"). Financial Highlights Revenue: The Group's revenue for the Reporting Period matches that of the first half of 2023, totaling RMB 8,574.2 million, with a year-on-year (YoY) increase of 1.0%. Excluding the COVID sales in the same period last year, the non-COVID revenue grew by 7.7%, and the non-COVID late-phase & commercial manufacturing revenue grew by 11.7% YoY. Key drivers supporting our base revenue growth include: (i) the successful execution of the Group's "Follow and Win the Molecule" strategies, combined with our leading technology platforms, best-in-industry timeline and excellent execution track records; (ii) an expanded spectrum of services offered to the biologics industry, including fast-growing technology platforms such as antibody-drug conjugates (ADCs) and bispecific & multi-specifics; (iii) robust growth in pre-IND revenue, which more than offset the impact of significant Discovery Services deals in 1H 2023; and (iv) the utilization of newly expanded capacities, including the ramp-up of manufacturing sites in Europe and the U.S. Gross Profit and Gross Profit Margin: IFRS gross profit was RMB3,350.0 million compared to RMB3,560.6 million in the same period last year. Adjusted gross profit was RMB3,811.2 million compared to RMB3,993.1 million in the same period last year. IFRS gross profit margin was 39.1% and adjusted gross profit margin was 44.4%. The decrease of gross profit margin was mainly due to the margin mix impact from the significant Discovery Services deals in 1H 2023, the slightly lower capacity utilization in China due to the COVID volume in the same period last year, the continued impact of the ramp-up of new manufacturing facilities in Ireland, Germany, and the U.S., all of which were partially offset by the efficiencies achieved from the WBS and other continuous improvement initiatives. EBITDA and EBITDA Margin: EBITDA was RMB2,805.9 million compared to RMB3,230.6 million in the same period last year. Adjusted EBITDA was RMB3,570.4 million compared to RMB3,818.3 million in the same period last year. EBITDA margin was 32.7% and adjusted EBITDA margin was 41.6%. Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit and net profit attributable to owners of the Company was RMB1,780.3 million and RMB1,499.1 million, respectively, representing a YoY decline of 23.9% and 33.9%. The decline was due to, among other factors, (i) an increase in selling, marketing and administrative expenses ("SG&A") as the Group continues to invest in its geographic footprint, (ii) an increase in SG&A for WuXi XDC Cayman Inc., a non-wholly owned subsidiary of the Company, as a standalone listed company on the Main Board of The Stock Exchange of Hong Kong Limited (stock code: 2268), and (iii) an unmaterialized foreign exchange translation loss as a result of the depreciation of Euro against RMB year-to-date. Adjusted Net Profit: Adjusted net profit was RMB2,544.8 million, down 13.0% YoY from a record-high base in 1H 2023. Basic earnings per share (EPS): Basic EPS and adjusted basic EPS were RMB0.37 and RMB0.55, respectively. Business Highlights Amid a dynamic geopolitical landscape, the Group added 61 new integrated projects in 1H 2024, demonstrating the Company's resilience and its ability to maintain growth. This, compared to 46 new projects added in 1H 2023, is one of our best 6-month periods for new project adds to date. Among the 61 newly added projects, 52 were from pre-IND, 5 from early-phase, 3 from late-phase, and 1 was from the commercial manufacturing phase. We believe that our robust business activities in the pre-IND stage signal early signs of a biotech funding recovery. During the Reporting Period, the Group continued to execute its "Win-the-Molecule" strategy, adding 9 post-IND projects, among which 4 are in the late-phase and commercial manufacturing stages. Since 2018, the Group has won 78 projects under the "Win-the-Molecule" initiative, with the winning formula centered on quality, speed, and advanced technological platforms. The number of late-phase projects increased to 56, laying a strong foundation for future commercial manufacturing. The number of commercial manufacturing projects was 16, as we removed 8 COVID and 1 non-COVID dormant projects. The total number of integrated projects was 742, representing one of the largest portfolios of complex biologics, including bispecifics & multispecifics (123), ADCs (167), fusion proteins (76) and vaccines (23). Among the 123 bispecifics & multispecifics projects, WuXiBody™ and SDArBody™ accounted for nearly half, as both proprietary platforms continue to gain worldwide recognition. As of June 30, 2024, total backlog reached US$20.1 billion, the same level as the first half of last year, including US$13.0 billion service backlog and US$7.1 billion upcoming potential milestone backlog. Backlog within 3 years exceeded US$3.6 billion, providing high visibility for near-term revenue opportunities. The Group offers end-to-end CRDMO services through our global network. Our Ireland site is making great progress overall and is seeing significant commercial manufacturing demands from 2024 and onwards, with 2025 almost fully booked. MFG6.1 successfully completed its first PPQ campaign in 1H 2024, and MFG6.2 expansion is on track to be completed in the 4Q of 2024. MFG7 commenced commercial manufacturing, though there has been a slight delay in the ramp-up due to an operational issue during an engineering run. The site remains on track to reach its steady-state in 2026, serving a critical role in our "Global Dual Sourcing" network. For our Singapore site, construction work has commenced, initially to support XDC's operation readiness in 2026. Design-work for WuXi Biologics facilities is still ongoing. The Group's unified and consistent quality system has been pivotal in driving our clients' success and remains one of our key competitive advantages. A total of 21 inspections from the EMA and FDA were completed, with a 100% success rate in passing pre-approval inspections (PAIs). In 1Q 2024, EMA inspection of 13 products was successfully completed. In 2Q 2024, FDA inspection of 2 products was successfully completed. Our industry-leading technology platforms span from discovery to development and manufacturing. Examples of discovery technologies include WuXiBody™ (for Bi-/Multi-specific antibody), T cell engager (TCE) platform, tumor associated antigens (TAA) mAb discovery, and single B cell technology. Examples of development technologies include WuXia™ (cell line development), WuXiDAR4™ (drug antibody ratio technology), and WuXiHigh™ (customized formulation strategies for high concentration drug products). Examples of manufacturing technologies include WuXiUI™ (ultra-intensified fed-batch manufacturing) and WuXiUP™ (ultra-high productivity continuous processing). WuXiUI™ is our next-gen manufacturing process that can increase titer by 3-6x with culture time comparable to traditional fed-batch processes, and is currently undergoing pilot runs. WuXiUP™ can increase titer by 5-15x, and resolve various quality issues, making it an ideal technology for unstable molecules, molecules that clients wish to increase titer of significantly, or molecules experiencing quality issues. Recently, our client, Curon Biopharmaceutical's investigational B-cell depletion therapy CN201 was acquired by Merck & Co., Inc. CN201 utilizes 3 aforementioned proprietary technology platforms: WuXiBody™, TCE platform and WuXiUP™. Our people are key assets of WuXi Biologics. As of June 30, 2024, the Group's total staff comprised 12,435 employees, including approximately 4,200 scientists, and the total retention rate was approximately 94%. During 1H 2024, we announced the planned retirements of Dr. Weichang Zhou (former CTO), Mr. Peter Shen (CMO), and Dr. Jerry Xu (former CQO). We deeply appreciate their contributions to WuXi Biologics. The transition was seamless, with Dr. Sherry Gu (CTO), Dr. Wei Guo (Head of Global Manufacturing, effective August 2024), and Mr. Ing Hou Loh (Head of Global Quality) assuming these roles. With a deep bench of industry veterans who possess extensive domain expertise and proven leadership records, the Group is well-positioned to continue building a strong and sustainable organization for many decades to come. WBS (WuXi Biologics Business System) is our lean operation and management system launched in 2021. During 1H 2024, by implementing approximately 60 Kaizen projects and events, the Group delivered Gross Profit Margin enhancement of roughly 100 basis points, along with significant business growth, inventory reduction, labor hour savings, and quality improvements to combat operation headwinds. Additionally, ESG Kaizen projects contributed to the Group's ESG initiatives by achieving remarkable carbon emission reduction, material savings, waste reductions and more recycling, and water savings. We will continue to promote WBS as our lean culture to drive continuous improvements across all facets of our operations, to create better value for our clients, employees and partners The Group has incorporated ESG as an essential part of its sustainable growth strategy. The Group's ESG performance has been widely recognized by the industry and has been awarded an AAA rating from MSCI ESG Ratings, a Platinum Medal from EcoVadis, and was named an ESG Industry Top-Rated Company and an APAC Regional Top-Rated Company by Sustainalytics. In 2024, WuXi Biologics was included in S&P Global's Sustainability Yearbook 2024 with a Top 1% S&P Global Corporate Sustainability Assessment (CSA) ranking and was named an Industry Mover. The Group has always been committed to serving and contributing to the global healthcare community while adhering to the highest standards of regulatory compliance and operational excellence. The Group noted the introduction of the BIOSECURE Act in the U.S. Congress and subsequent amendments to it, including a proposed "grandfather" clause with transition period. The contents of the draft legislation remain subject to further review and modification as it moves through the legislative process and the legislative route also involves uncertainty. As a global biologics CRDMO platform, the Group does not have a human genomics business, nor does it collect human genomic data in any of its businesses around the world. The Group firmly believes that it has not, does not, and will not pose a security risk to the United States or any other countries. The Group will continue to closely monitor this process and remains committed to supporting its clients globally and to operating in accordance with the applicable laws and regulations of all jurisdictions where it has business operations. Management Comment Dr. Chris Chen, CEO of WuXi Biologics, stated, "Amid a dynamic macroeconomic and geopolitical environment, our business has demonstrated strong resilience. This is attributed to our unique CRDMO business model which we believe is the most efficient for our industry, as well as the successful implementation of our 'Follow and Win the Molecule' strategies. In the first half of 2024, we added 61 new integrated projects, including 4 from late-phase and commercial stages. This is a strong testament to our clients' endorsement of our exceptional execution and our technological leadership. Our client Curon's molecule was recently acquired by Merck & Co., Inc., highlighting a potential best-in-class CD3 asset (CN201), which was discovered, developed, and manufactured using 3 of our proprietary technology platforms, WuXiBody™, TCE platform and WuXiUP™." Dr. Chris Chen added, "Our business fundamentals remain strong. The Company's unified and consistent quality systems, proprietary technology platforms, global talent pool - led by a seasoned management team and includes a strong technical team with over 4,200 scientists - and exceptional execution distinguish WuXi Biologics in our industry. We remain firmly committed to serving our global clients in the healthcare community and benefiting patients worldwide." Dr. Ge Li, Chairman of WuXi Biologics, concluded, "WuXi Biologics delivered solid business performance in the first half of 2024 despite an uncertain external environment and challenging comparisons year over year. Looking ahead, we will continue to adhere to our end-to-end CRDMO business model, expand our global presence and further improve our execution. We will continue to enhance our R&D and manufacturing efficiencies, deliver superior value to our partners, and benefit patients worldwide as an end-to-end, one-stop service provider for the biopharmaceutical industry. We remain dedicated to delivering groundbreaking therapies to patients and fulfilling our vision that 'every drug can be made and every disease can be treated'." Key Financial Ratios (For the Six Months Ended June 30) ~ End ~ About WuXi Biologics WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of June 30, 2024, WuXi Biologics is supporting 742 integrated client projects, including 16 in commercial manufacturing (excluding 8 COVID CMO projects and 1 non-COVID dormant CMO project). 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: 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. SOURCE WuXi Biologics