SERACH RESULTS FOR" Development "
development and manufacturing organization (CDMO), announced today that the company will commence the construction of a fifth plant as part of its strategic expansion in response to increased market demand.News BriefSamsung Biologics to attend DCAT Week, expand U.S. presence with New Jersey siteMarch 21, 2023Samsung Biologics is participating in DCAT Week 2023 from March 20 to 23. Kevin Sharp, VP and Head of Samsung Biologics America Sales, will talk about the company’s manufacturing capacity expansion plans in a speaking session during the Member Company Announcement Forum at the event. News BriefSamsung Biologics shares 2023 business plans at 41st Annual J.P. Morgan Healthcare ConferenceJanuary 12, 2023Samsung Biologics shared its 2023 business plans and vision at the 41st Annual J.P. Morgan Healthcare Conference, taking place between January 9-12 in San Francisco, California, USA. During the main track presentation today, John Rim, CEO and President of Samsung Biologics said the company will build on the strong growth momentum in 2022 with continued investments to further solidify its global position.Media Focus#CPHI22: As Samsung’s new plant comes online, it looks to expand in Korea and beyondDecember 2, 2022It is no secret that the CDMO arm of one of South Korea’s largest conglomerates has been expanding in 2022. In the middle of the year, Samsung Biologics was going to see a bump in funding from the Samsung group and now has committed to boosting its presence in South Korea and beyond.Press ReleasesSamsung Biologics unlocks additional capacity for production at its newest Plant 4October 11, 2022Incheon, S. Korea, October 11, 2022 – Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), announced today that its Plant 4 – the world’s largest single bio manufacturing plant – has commenced GMP operations this month.Media FocusFor $323M, Samsung Biologics buys land for a 2nd manufacturing campus in South KoreaAugust 5, 2022 Samsung’s expansion plan for its CDMO unit is an efficient, no-nonsense enterprise, marching on with no end in sight.Maybe that’s why, at its home base in South Korea, Samsung Biologics refers to its factories by number. Just 11 years into its existence, Samsung has Plants 1, 2 and 3 in operation, Plant 4 under construction and Plants 5 and 6 on the drawing board.Media FocusSamsung Biologics speeds $2B plant build forecast to boost capacity 70%August 10, 2022Samsung Biologics is pushing for early completion of its new $2 billion manufacturing facility in an effort to meet increased demand and boost the South Korean CMO giant’s profits.
development and manufacturing. Plant1 30KL, Plant2 154KL, Plant3 180Kl, Plant4 240KLMultiple scales, multiple capacities to fitvarious processes for any production volumeTotal Capacity604KLPlant 130,000L5KL x 6Plant 2154,000L15KL x 101KL x 2 (Stainless Steel)1KL x 2 (Single-Use)Plant 3180,000L15KL x 12Plant 4240,000L15KL x 1210KL x 6TechnologiesN-1 perfusionHigh cell density continuous production with both TFF and ATF systems100% WFI dual supplyEliminates risk of production disruption due to water supplySimultaneous operationAccelerates manufacturing to satisfy large product demandFeaturesData integrity ensured via Pharma4.0 enabled technologiesSolar power generator installed on roof areasMultiple operation modes for production efficiency
development and manufacturing of biopharmaceutical products. We offer a fully integrated service at a single site - a seamless solution that accelerates your discovery from early development through clinical and commercial manufacturing.Bio Campus I 604KL - moreBio Campus I 604KL - factoryBio Campus II*720KL - moreBio Campus II*720KL - factoryBio Campus I 604KLPlant 130,000LPlant 2154,000LPlant 3180,000LPlant 4240,000LBio Campus II*720KL* to be completed by 2032Technologies & FeaturesAccessibilityFull in-house capabilities at a single siteMulti-scale manufacturingReal-time client accessEfficiencyEnd-to-end offeringSimultaneous operationMultiple operation modesSustainabilityCarbon neutralSolar power generatorReusable water treatment systemDigitalizationDigitally optimized smart labReal-time data sharingEnterprise Quality Unified Information System (EQUIS)
development experts help you expedite development journey.S-DUAL™DEVELOPICK™Content TabS-DUAL™DEVELOPICK™The choice for your next dual-specificity therapeutics The choice for your next dual-specificity therapeuticsS-DUAL™ is an advanced, high-yield bispecific antibody platform designed to meet your needs and generate perfect pairing every time. The innovative dual-specificity of bispecific antibodies opens up a wide range of applications, enabling clients to reach commercialization much more efficiently.Asymmetrical StructureClear separation of initial impuritiesEasy in-process control during manufacturingLow Immunogenicity RiskSimilar structure to typical bispecific antibodiesAntibody-derived protein onlyCorrectly Paired bsAb Knob-into-Hole CH3 dimer applied on an additional domain in one Fab arm>95% purityStreamlined Access Favorable contract terms with competitive pricingOnly Parental antibody sequences needed to develop BsAbClick for more informationLate Discovery1 Month (including vector construction)S-DUALTMProprietary Bispecific Antibody PlatformAsymmetric IgC-like structureLow immunogenicity riskCorrect HC & LC pairingStreamlined Access1 Month Small scale Ab productionSmall scale Ab productionSmall scale Ab production with transient expressionAdditional material can be produced for supplemental studies1 Month Developability AssessmentDEVELOPICKTMDevelopability assessmentThermo-stabilityAggregationPurity ProfileConcentrationIND / BLA ApprovalTime & cost for drug developmentoptimized with DEVELOPICKTMEnsure success from an early stageTimely EvaluationReceives results in just 1 monthEfficient AssessmentRequires 20mg of material onlySystematic Scoring SystemGuides you to the optimal decision Samsung Biologics’ DEVELOPICK™ provides early insight and selection guidance to your time and cost to maximize efficiency.Our proprietary platform ensures your path to development success by implementing systematic approach to predict candidates with the best potential for advancement.DEVELOPICK ™Small scale Ab production1 Month Small scale Ab productionAsymmetric IgC-like structureLow immunogenicity riskCorrect HC & LC pairingStreamlined AccessDEVELOPICK ™Developability assessment1 Month Developability AssessmentThermo-stabilityAggregationPurity ProfileConcentrationCell line development to CommercializationTime & cost for drug development optimized with DEVELOPICKTMUse of S-CHOice® cell line for a stable cell line developmentIND / BLA ApprovalAccelerate your journey withKnowing the right candidate with the highest possibility for success is critical for continuing your journey to IND, BLA, and beyond.1 Material production with transient expression / bulk pool material (optional)2 Developability assessmentLeverage our expertise to enable clear and informed decisions for your development candidates with DEVELOPICK™3 Go/No-Go decision for cell line development4 Samsung Biologics’ CDMO service (CLD to IND)Developability Assessment WorkflowMaterial supplyBasic Characteristic Analysis(DSF* & DLS**)Heat Stress TreatmentLow pHTreatmentSEC-HPLECE-SDS (NR)Data Summarization& Evaluation*DSF : Differential Scanning Fluorimetry**DLS : Dynamic Light ScatteringRelated ContentsWebinarsNew Approaches in Bispecific Antibody DevelopmentFeb 20, 2023In this webinar in collaboration with Contract Pharma, Jina Kim, our Senior Scientist at our Bio R&D Center, shares insights about new approaches in bispecific antibody development while introduciSamsung BIO InsightExploring Samsung Biologics’ CDO capabilities | Bispecific antibodiesNov 29, 2022 Driven by advances in biotechnology, biopharmaceuticals are among the most sophisticated achievements of modern science and have become central to the industry. Antibody therapies, making up the largPostersSamsung Biologics Developability Assessment Plaform: DEVELOPICK™ for Rapid and Accurate Evaluation of Thermal and Chemical StabilitySep 16, 2022 WhitepapersFundamental Considerations for Bispecific Antibody-based
Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes.Analytical Testing CapabilitiesAcross the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release, and stability.Our QC team is capable of performing analytical test method transfers from client laboratories, method validation, qualification, and verification in accordance to ICH Q2 (R1) guidelines, FDA, EMA, and PMDA requirements.Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of:Chemical Testing1. Impurity / Purity by HPLC2. Identification by FT-IR3. Water content4. Osmolality, Protein Content (A280), Appearance, pHBiochemical Testing1. Polymerase Chain Reaction (PCR)2. Enzyme-Linked Immunosorbent Assay (ELISA)3. Electrophoresis (gel-based / capillary electrophoresis)4. Cell-Based AssaysMicrobiological Testing1. Sterility2. Microbial Limit (Bioburden)3. Microbial Identification4. EndotoxinStability Program CapabilitiesWe maintain controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and accelerated conditions (with temperature and/or light).Environmental and Clean Utility MonitoringThrough our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that our controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable air particles and surfaces. Clean Utilities Monitoring includes the testing of water, compress gases, and clean steam for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.
Development Finishing Fully Automated Visual Inspection Secondary Bulk Packaging Storage& Shipping 2-8 ℃ to -70 ℃ Storage Options Passive and Active Shipping Options Regulatory Support Approved in over 20 Global Markets Type V DMFFull CMC end-to- end support 1 / 5 Client Satisfaction We are committed to Re-inventing the Client Experience in the DP CMO world. From the first point of contact,we are committed to ensuring you have the most pleasant experience possible. We know Tech Transfers, Clinical Trials and Commercial Operations can be very difficult and daunting; we are here to help you simplify and succeed in your program objectives. We’ll make it easy on you and your team just the way it should be. Speed to Market We live in an industry where mere days can make the difference between a blockbustersuccess or a complete program implosion. We are confident that you’ll find our expertise in development, tech transfer and commercialization to be the missing link to achieving your goals. Our entire facility is designed around the intention to get your product to market faster and better.On Time, In Full; every time, all the time. Adaptability Whether you are moving your product from the benchtop or from another facility around the world, don’t worry.We can help. Our facility and systems have been designed to be able to adapt to the many nuances and requirements of our strict industry. Our staff of seasoned experts and well appointed facilities are ready and able to take on nearly every challenge keeping you awake at night. If we don’t have it, we’ll work with you to design the system or purchase the equipment to ensure your success. We are here to serve you and your patients. pause
Development Business DevelopmentBD Planning Corporate Business Operation PlanningProcurementLegal & CompliancePR Corporate management FinanceInformation TechnologyHuman resources Business DevelopmentBusiness DevelopmentBD Planning Corporate Business OperationPlanningProcurementLegal & CompliancePR Corporate managementFinanceInformation TechnologyHuman resources Application Method Register your CV in our Talent Pool system and we will contact you if and when your preferred position or a position that matches your previous career experiences becomes available. Eemail@example.com Passing of the application procedures and employment may be cancelled if the contents of the application form are found to be false.※ Download Application Form Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
Development Business DevelopmentBD Planning Corporate Business Operation PlanningProcurementLegal & CompliancePR Corporate management FinanceInformation TechnologyHuman resources Business DevelopmentBusiness DevelopmentBD Planning Corporate Business OperationPlanningProcurementLegal & CompliancePR Corporate managementFinanceInformation TechnologyHuman resources Application Method Register your CV in our Talent Pool system and we will contact you if and when your preferred position or a position that matches your previous career experiences becomes available. Efirstname.lastname@example.org Passing of the application procedures and employment may be cancelled if the contents of the application form are found to be false. Register in talent pool Registered applications of candidates in talent pool are primarily reviewed for positions on demand.
development to product manufacturing. R&D More Close - We develop and optimize extensible and stable process to supply drugs for commercial and clinical use in stable and constant manner.- Our service includes cell culture / development of downstream process, analysis methods and dosage form.- SBL develops an integrated process by reflecting all aspects of development into clinical and commercial manufacturing. Quality More Close - We guarantee high quality process and facility management that are engaged in our business plan.- Quality experts comply with regulation standards and promote a culture of quality compliance. Manufacturing More Close - We develop safe and trustworthy clinical and commercial biopharmaceuticals, and provide manufacturing service within cutting-edge production facilities that comply with strict cGMP standard- All processes are conducted in compliance with cGMP standard and high standards required by authorities. Manufacturing Support More Close - SBL provides an end-to-end service for clients who want CMO or CDO services- Our manufacturing process starts from equipment validation to process development. EPCV More Close - We support entire teams so that SBL becomes the largest biopharmaceutical manufacturing facility in the world. SCM More Close - We make sure important raw materials for drug manufacturing are stably supplied and manufactured products are well delivered to clients. Business Administration More Close - We support our teams from back office. Our roles include HR, finance, legal and etc. with which we help to deliver value to clients based on outstanding cGMP expertise and quality assurance system. Please select your interests. Please select your interests.Sales & Marketing, R&D, Quality, Manufacturing Support, EPCV, Supply Chain, Business Administration Sales & Marketing PR Sales Support Project Management R&D CDO Quality Quality Control Quality Assurance Manufacturing Cell Culture Purification Fill & Finish Manufacturing Support Process Development Manufacturing Technology Validation EPCV Equipment Technology Engineering Technology Engineering Project Management Supply Chain Procurement Material Management Business Administration Business Strategy Information Security Legal & Compliance IR Finance IT Human Resources Safety Health Environment Management
Development Procurement, Roche (2014-2018)VP, CFO Global Product Development, Roche (2010-2013) Senior Vice President & Managing DirectorDong Joong Kim Senior Vice President & Managing Director, Business Resources Innovation Center, Samsung Biologics (2014-Present)Head of Planning Support Team, Production Technology Institute, Samsung Electronics(2013-2014) Independent directorSeok Woo Jeong Independent Director, Samsung Biologics (2016-Present)Professor, Department of Business Administration, Korea University Business School (1997-Present)Non-standing Member, Korea Accounting Institute (2016-2019) Independent directorSoon Jo Kwon Independent Director, Samsung Biologics(2016-Present)Professor, Department of BioLogical Engineering, Inha University(2013-Present)Chairman, International Cooperation Committee, Institute of Biological Engineering (IBE)(2011-2013) Independent DirectorKun Nyoung Huh Independent Director, Samsung Biologics(2019-Present)Advisor, Pyeong An Lawfirm(2019-Present)Presiding Judge, Seoul Central District Court (2004-2007) Independent Director Eunice Kyunghee Kim Watch the Interview Independent Director, Samsung Biologics (2020-Present)Professor at Law School of Ewha Women's University (2010-Present)Vice president of International Association of Korean Lawyers (IAKL) (2008-Present)Compliance officer of executive vice president & Head of Legal Affairs at Hana Financial Group, Inc. (2008-2010) Appointment of DirectorsMembers of the board of directors are elected through a resolution of the general meeting of shareholders under the company’s articles of incorporation. Incumbent members may be reelected after the expiration of their terms. Samsung Biologics shall have at least three but no more than ten directors and such directors shall be appointed at the general meeting of shareholders; provided, however, that at least three independent directors shall be appointed and the number of the independent directors shall account for at last a majority of the total number of directors.A resolution for the election of directors shall be adopted by the affirmative votes of a majority of the shareholders present at the meeting, which shall also be at least 1/4 of the total number of issued and outstanding shares.Any vacancy in the office of directors shall be filled at a general meeting of shareholders; provided, however, that if the number of directors does not fall below the number prescribed in Paragraph 1 of Article 29 in the Articles of Incorporation and there is no difficulty in the administration of business, the foregoing shall not be applicable. Term of Office of DirectorThe term of office of directors shall end at the close of the ordinary general meeting of shareholders convened in respect to the last fiscal year within three years from their appointment. ChairpersonThe chairperson of the board of directors shall be appointed among the directors by a resolution of the board of directors. Resolution of the BODThe resolution of the board of directors shall be adopted in the attendance of a majority of the directors in the office and by the affirmative votes of a majority of the directors present at the meeting; provided, however, that a resolution of the board of directors on matters stipulated under Article 397-2 (Prohibition of Use of Corporate Opportunities and Assets) and Article 398 (Self-Dealing between Directors, etc. and the Company) of the Commercial Code shall be adopted by the affirmative votes of at least 2/3 of the directors in office. Independence of Independent DirectorsThe Independent Director Candidate Nomination Committee shall nominate the candidates for the independent directors among persons who meet qualification requirements stipulated in the relevant laws and regulations, including the Commercial Code, etc. An independent director shall be one with professional knowledge or sufficient experience in management, e
development relating to pharmaceutical products, subcontracting, advisory service;6.Education service and business service;7.Research service and investment business;8.Bioengineering and bio-pharmaceutical product research;9.Health and medical research;10.Joint research with domestic or international institutions;11.Technical research service for other domestic or international institutions;12.Plant design, purchasing agency, manufacture, construction, validation and supervision service;13.Real estate sale and purchase and leasing business;14.Transportation business;15.Parking lot business;16.Warehousing business;17.Businesses related to, necessary for, or incidental to any of the foregoing. Article 3 (Location of Head Office and Establishment of Branch, etc.) The Company shall have its head office in Incheon City and, if necessary, may establish branches, representative offices, business offices, sales offices, or local subsidiaries by a resolution of the Board of Directors (BOD) or of such a committee as authorized by the BOD. Article 4 (Method of Public Notices) The Company’s public notices shall be published in the Company’s website (http://samsungbiologics.com); provided, however, that in the event the public notices cannot be posted electronically due to computer system error or other unavoidable circumstances, the public notices shall be published in the JoongAng Ilbo, a daily newspaper of general circulation published in Seoul. Chapter 2.Shares Article 5 (Total Number of Shares Authorized to be Issued) The total number of shares that the Company is authorized to issue shall be Five Hundred Million (500,000,000) shares. Article 6 (Par Value per Share) The par value of each share to be issued by the Company shall be Two Thousand Five Hundred (2,500) won. Article 7 (Total Number of Shares to be Issued upon Incorporation) The total number of shares to be issued at the time of incorporation of the Company shall be One Million Five Hundred Thousand (1,500,000) shares. Article 8 (Classes of Shares and Share Certificates) ①The classes of shares to be issued by the Company shall be common shares and preferred shares, each of which shall be in registered form.②Preferred shares to be issued by the Company shall be preferred shares concerning dividends with non-voting rights, and the number of the preferred shares shall not be more than Fifty Million (50,000,000) shares.③Dividends on the preferred shares shall be first paid in cash at such dividend rate as determined by the BOD or such a committee as authorized by the BOD at the time of issuance based on the par value of the preferred shares.④In the event that the dividend rate of the common shares exceeds that of the preferred shares under Paragraph 3, any excess amount available for distribution after payment of dividends on the preferred shares and the common shares at the same ividend rate as that for the preferred shares shall be equally distributed to both common and preferred shareholders in proportion to their shareholding.⑤In the event that preferred dividends are not fully distributed on the preferred shares for any given fiscal year, any accumulated undistributed dividends shall be preferentially distributed first at the time of distribution of dividends in the immediately following fiscal year.⑥In case of rights issues, bonus issues or stock dividends, common shareholders shall be entitled to common shares, and preferred shareholders shall be entitled to preferred shares, in proportion to their respective shareholding; provided, however, that in case of rights issues, bonus issues or stock dividends, the Company may, if necessary, issue only one class of shares, where all the shareholders shall be entitled to such class of shares to be issued. Article 8-2(Electronic Registration of Rights to be Indicated on Shares and Stock Warrant Certificates) The Company shall electronically register rights to be indicated on shares and stock warrant certificates i
Development- And others Communication Communicate to - Client- Staff- Regulatory Agency- Audit committee- Others BCMO The strategic teams,which focuses on strategic issues that impact the organization's core objectives, products and services, are led by top management.The crisis management team has primary responsibility for addressing any crisis impacting the organization.※ BCMO: Business Continuity Management Office The tactical teams,which manage and coordinate the continuity of the processes required to deliver the impacted products and services and ensure that the resources are allocated appropriately, are led by a team leader. Tactical level plans provide a framework to coordinate strategic goals and decisions with the operational response teams. The operational teams,which focus on the continuity of the activities that contribute to the processes that deliver the prioritized products and services, is led by each functional site matter expert. An operational response establishes the necessary capability required to continue delivering priotised products and services. The strategic teams,which focuses on strategic issues that impact the organization's core objectives, products and services, are led by top management.The crisis management team has primary responsibility for addressing any crisis impacting the organization.※ BCMO: Business Continuity Management Office The tactical teams,which manage and coordinate the continuity of the processes required to deliver the impacted products and services and ensure that the resources are allocated appropriately, are led by a team leader. Tactical level plans provide a framework to coordinate strategic goals and decisions with the operational response teams. The operational teams,which focus on the continuity of the activities that contribute to the processes that deliver the prioritized products and services, is led by each functional site matter expert. An operational response establishes the necessary capability required to continue delivering priotised products and services. Annual Operation Embedding BCMS is the ongoing cycle of activities of the business continuity management program, which builds organizational resilience, and is the professional practice that defines how to integrate business continuity awareness and practice into business as usual activities. Embedding BCMS Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Performing Risk and Threat Mitigation Measures Implementation - Implements the solutions agreed in the designed stage · Development of Tactical/Operational Business Continuity Strategy· Establishment of Business Continuity Plans & a response structure Validation - Confirms that the business continuity program meets the objectives set in the policy and the plans and procedures in place are effective. · Exercise Program: performing annual exercises with various types of scenario by each department as well as company-wide· Management Review to ensure it aligns with organizational objectives Analysis - Reviews and assesses an organization to identify our objectives, how it functions and the constrains of its operating environment · Look into environment to find unidentified risks in terms of location, supply chain society, politics and so on.· Internal/external stakeholders· Business Impact Analysis for product, process, activity Design - Identifies and selects appropriate solutions to determine how continuity can be achieved in the event of an incident · Pe
CEO MESSAGE Driven. For Life. SAMSUNG BIOLOGICS 2023. 04 IR Newsletter Dear Investors, This is John Rim, CEO of Samsung Biologics. I would like to begin by expressing my deep gratitude and appreciation for your continued interest and support in Samsung Biologics. Key Highlights Financial Performance (Consolidated) • Steady YoY Sales growth for 13 consecutive quarters since the outbreak of COVID 19 pandemic (Q1'20-Q1'23) CAGR at 52% (20~23) • Revenue: KRW 720.9B (YoY +41%) • Operating Profit: KRW 191.7B (YoY +9%) CMO/CDO • P5 investment in Bio Campus II announced (Mar.) • Strengthened Partnerships with Big Pharmas (CMO, CDO) • Won CDMO Leadership Awards in all 6 Categories (Feb.) • Cum. contract amount reached USD 9.9B Business Expansion • Opening of a regional sales office in New Jersey, US (Mar.) * Investment for ADC manufacturing facilities announced (Jan.) • Strategic investment in Araris Biotech via Life Science Fund Bioepis • Launching of Lucentis biosimilar (SB11) in GER, UK, CA (Mar.) • Positive CHMP Opinion received for Soliris biosimilar (SB12) • Upcoming US launching of Humira Biosimilar (SB5) (Compertitive edge gained by high & low-concentration, prefilled syringe and auto-injector, etc.) Samsung Biologics announced our first quarter financial results, and we are pleased to report quarterly financial performance with consolidated revenue of 720.9 billion won up by 41% YoY and an operating profit of 191.7 billion won up by 9% YoY. Since the beginning of the COVID19 pandemic, sales have increased year on year for 13 consecutive quarters, spurred by significant growth in the CMO business. Based on these solid financial results, we are revising our guidance for our annual revenue growth rate from 10-15%, which we announced this January, to 15%-20% for year 2023. Samsung Biologics has been operating its existing Plants 1 through 3 at full capacity while maximizing operational efficiency and maintaining steady and stable manufacturing output. As a result, we secured CMO contracts with global big pharmas including GSK, Pfizer, and Eli Lilly, to name a few, totaling roughly KRW 500 billion, bringing the total accumulated CMO contract amount to approximately USD 9.9 billion (KRW 13 trillion). We have also been able to enter into a partnership with a large pharmaceutical company in our CDO business and continued to build on our solid track record. Samsung Bioepis, a wholly owned subsidiary of ours since April 2022, has also contributed to our swift top-line growth by broadening revenue streams from the expansion of Lucentis biosimilar (SB11) sales in the United States, and other newly launched markets such as Germany, UK and Canada. Simultaneously, in line with the company's three-dimensional growth strategy, Samsung Biologics continues to augment our differentiated "Super Gap" CDMO competitive edge through expansions in our capacity, geographic presence, and business portfolio. Capacity Expansion | Announcement of investment in Bio Campus II, with the construction of Plant 5 Plant 4 construction has been fully on track, with its 60,000L portion going operational in October last year, and the remaining 180,000L to go live in June of this year. We have already sealed a number of large-scale manufacturing contracts with Plant 4, signing 9 clients on 12 products, and are actively negotiating with 29 additional clients on 44 products. The robust demand seen for outsourced biopharmaceutical manufacturing convinced us that the time has come to proac- tively make this investment as part of our expansion strategy in order to further expand our global CMO market leadership. In this regard, we have decided to invest 1.98 trillion won ($1.51 billion) in the construction of our fifth
development and proactively purchased a plot of land 30% larger than the existing Bio Campus I to lay the groundwork for a large-scale bio complex for future growth. Plant 4 began partial operations in Oct. 2022, and we have secured 11 large-scale manufacturing contracts with 8 global biopharmaceutical companies and are actively negotiating an additional 34 contracts with 26 global major pharmaceutical companies. Based on such strong demand on the horizon, we decided to build our fifth facility even before Plant 4 was fully operational in order to meet our clients' needs in a timely manner. Plant 5 will be the first plant to be housed in Bio Campus II, with a capacity of 180KL, identical to Plant 4's phase 2 large scale design. Bio Campus II - conceptual rendering Plant 5 Construction Plan • Location: Bio Campus II in Songdo, Incheon (Approx. 35.7 million square meters) • Capacity: 180KL (Approx. 9.5 million square meters) • Construction Period (Target): Groundbreaking in Mar. 2023; CGMP ready by Sep. 2025 Expected CAPEX: Approx. KRW 1.98 trillion (incl. production support and utility facilities) With Plant 5, we will integrate simplified and standardized design and processes of our existing plants to save construction time and cost, in addition to optimizing operations. Simultaneously, we aim to introduce even greater competitive advantage and service perfection by incorporating cutting-edge technologies including automated equipment and systems and energy efficiency, while leveraging our deep expertise and know-how gained from the operation of our Bio Campus I plants 1, 2, 3, and 4. Using Plant 5 as a starting point, Samsung Biologics will invest approximately KRW 7 trillion in the development of Bio Campus II, which will include the construction of three additional large-scale mAb manufacturing facilities as well as an Open Innovation center to promote and foster innovative biotechnologies. Furthermore, we will continue to implement various inorganic strategies and pursue portfolio and geographic expansion in order to keep our commitment to being a top-tier biopharmaceutical company. As always, your continuous faith and support in us is greatly appreciated. Sincerely, March 17, 2023 President & CEO John Rim
Dear Investors, This is John Rim, CEO of Samsung Biologics. First and foremost, I would like to express my sincere gratitude and appreciation towards your continued interest and ongoing trust in Samsung Biologics over the past year. In 2022, Samsung Biologics achieved all of its annual targets in existing business divisions and successfully expanded its business scope for long-term, sustainable growth of the company. 2022 Financial Results (Consolidated) Cumulative revenue surpassed KRW 3T *the first and only company among Korean Pharma Revenue: KRW 3,001.3B (YoY +91%) *SBL(separated): KRW 2,437.3B Operating profit: KRW 983.6B (YoY +83%) CMO/CDO Plant 4 partial operations within 23 months of groundbreaking Launched "S-DUALTM and 'DEVELOPICKTM' * Bispecific antibody platform * Drug candidates developability platform Continued orders momentum: Cum. contract amount $9.5B Business Expansion Completion of KRW 3.2T rights offering (Apr.) Full acquisition of Samsung Bioepis (Apr.) Purchase of land for Biocampus II (Jul.) Investments in biotechs via Life Science Fund * Jaguar Gene Therapy (Mar.) and Senda Biosciences (Aug) Biosimilar Business US launch of Lucentis Biosimilar (SB11) (Jun.) FDA approval of high-conc. Humira Biosimilar (SB5) (Aug.) R&D expertise synergizing top-line growth of CDMO biz [A phenomenal fiscal year marked by unprecedented financial performance, with consolidated annual revenue exceeding KRW 3 trillion and an operating profit of around KRW 1 trillion, to be the first and only Korean pharma company to surpass KRW 3 trillion mark in annual sales] Significant and unpredictable volatility from macroeconomic and geopolitical factors has dominated the business environment in 2022. Interest rates were on an upward march, inflation was reaching what appeared at the time to be the generational highs, and exchange rates rose sharply. Despite such an unfavorable business environment, we were able to keep all three plants running at full capacity and maintain industry-leading batch success rates while minimizing product changeover (PCO) based on our operational excellence. As a result, for the first time in a half-year period, we surpassed KRW 1 trillion in revenue and have since broken our own record every quarter. In this regard, we are pleased to announce that we became the first and only Korean pharma company to surpass KRW 3 trillion mark in consolidated annual sales, with an operating profit of around KRW 1 trillion. [Plant 4, the world's largest plant, is on track to be completed within the first half of this year, with active presales activities rapidly locking in capacity.] Last October, Samsung Biologics began partial operations of Plant 4 (60,000 liters), the world's largest bio manufacturing site with a capacity of 240,000 liters, within 23 months after the groundbreaking, which was 6 months faster than the original 29-month timeline. It will be fully operational by the first half of this year, and presales activities have successfully locked in capacity. Prior to the plant's full ramp-up, we signed large-scale manufacturing contract agreements for 11 products with 8 global biopharmaceutical companies, and we are actively communicating with 26 other major clients on approximately 34 products. Based on our key competitive advantages of "speed" and "execution," we will strive to complete Plant 4 construction without a hitch and demonstrate our commitment to meeting client needs in a timely manner in order to solidify our trust-based partnership with our clients. [Taking the leap to become a fully integrated global biopharmaceutical company through active investments and portfolio diversification] In response to rising biopharmaceutical CMO demand, Samsung Biol
developments that have helped reduce production process timelines, with the industry striving to standardize and simplify manufacturing processes. By developing comprehensive strategies that include deep knowledge of the regulatory arena, specialized contract development and manufacturing organizations (CDMOs) can streamline workflows, reduce production costs, and increase efficiency.Read more
development and manufacturing organization (CDMO), today hosted its inaugural Suppliers ESG Day, both at its Songdo headquarters and online, to share environmental, social, and governance (ESG) strategies and drive collective action to decarbonize. The company invited supplier companies and external ESG specialists to discuss ESG-related requirements and recommendations as well as share successful case studies. “Since a majority of healthcare emissions are created in the manufacturing supply chains, it is critical for us to work together at every level to become greener and more circular,” said John Rim, CEO and President of Samsung Biologics. “By connecting our suppliers with resources to help them assess their performance and opportunities to go beyond carbon emissions reductions, we are building a more transparent and responsible value chain.” Samsung Biologics has been conducting ESG assessments with its suppliers to minimize potential social and ethical risks, build a stable network, and establish green strategies towards decarbonization. Earlier this year, the company and members of the Sustainable Markets Initiative’s Health Systems Task Force—a public-private partnership launched at COP26 to accelerate the decarbonization of health systems—called on suppliers to commit to joint, minimum climate and sustainability targets, which aim to address emissions across the value chain and reduce the complexity of multiple asks. The company today also released its second report aligned to the recommendations of the Task Force on Climate-Related Financial Disclosures (TCFD). The report serves the company’s commitment to providing transparency on its approach to managing climate-related risks and opportunities across the business. “We are pleased to share our progress towards our emissions reduction targets and the responsible business practices we are implementing to mitigate climate change risks,” said Rim. “We will continue to amplify our efforts to achieve our carbon ambition, while continuing to support our clients to deliver therapies to millions of patients worldwide.” Highlights from the 2023 report include:· Establishing new milestones to achieve net zero by 2050 and engaging suppliers to reduce their direct emissions · Prioritizing Samsung Biologics’ sustainable leadership as an active member of the Sustainable Markets Initiative and champion for the Supply Chains Working Group; First CDMO to receive the SMI’s Terra Carta Seal· Joining the Sustainable Aviation Buyers Alliance to help reduce emissions through investment in Sustainable Aviation Fuel The full text of the report is available here.
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