SERACH RESULTS FOR" Manufacturing "
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.
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
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)
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 Cell Line DevelopmentJun 21, 2022 WHITE PAPER Fundamental Considerations for Bispecific ntibody-based Cell Line Development Seahee Kim Head of Cell Line Development The innovative dual specificity of bPostersSamsung Biologics Bispecific Antibody PlatformMay 26, 2022 Bispecific Antibody Platform A Novel Asymmetrical Structure for Therapeutic Antibodies An emerging class of next-generation antibody therapy, bispecific antibWebinarsAccelerated High-performing Platform Process of Monoclonal Antibody: Upstream Optimization Case StudyMay 17, 2021Selecting the right CDMO partner is critical for a
manufacturing which requires prolonged periods of cell culturing, mRNA drug substance production is a cell-free process that involves linearization of plasmid DNA(pDNA), mixing it with enzymes and nucleotides to allow for its transcription into mRNA, and mRNA capping, etc.※ Samsung Biologics will add mRNA vaccine DS production capability to its existing facility by the first half of 2022. Manufacturing Process mRNA production begins with in-vitro transcription, where the linearized pDNA is synthesized to form mRNA in a reactor. Then, the mRNA is purified in steps involving chromatography and ultrafiltration(UF)/diafiltration(DF) to prepare for the formulation stage. Finally, the purified mRNA is encapsulated into Lipid Nanoparticles (LNP) through precise pump mixing technology to prevent degradation and to allow for in vivo delivery. Storage Because a mRNA is susceptible to degradation upon changing temperatures, it is subject to strict storage conditions. Samsung Biologics is able to meet such challenges though its upright and walk-in storage systems with temperature as low as -70°C as needed How a mRNA vaccine is made DNA Enzymes + Buffers + Nucleotides = mRNA mRNA+LNP Drug product Why Samsung Biologics? As the global biologics market gets more competitive, clients' needs and market uncertainty is growing more than ever before. Samsung Biologics promises that your invaluable molecule will be delivered to the market safely and quickly. Whether you are looking for standalone services or a seamless, integrated manufacturing service from clinical to commercial, we are focused on providing an unsurpassed level of customer service dedicated to the needs of our individual customers. We believe and are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions and proven expertise. Fully IntegratedOne Stop Service Offering services from clinical to commercial manufacturing with dedicated QC lab and RA support Modernized Stateof the Art Facility Newly built facilities fully compliant with cGMP that guarantee you the best environment for your product PromptResponsiveness We value your time andpromise a prompt response Flexibility from1K to 15K With various different scales, we have a solution for you 1 / 4
manufacturing of drug substance in multiple scales and capacity. The downstream suites are equipped with chromatography skids, columns, UF/DF skids, virus filtration skids, and Grade A bulk filling capacity, as well as product pool vessel capacities from 200 liters to 15,000 liters to handle a wide range of pool volumes. Small Scale Equipped with a wide range of bioreactor sizes as well as new manufacturing technology, we offer multiple cGMP manufacturing facilities to deliver the production volumes required by our clients at any given time. Our small-scale manufacturing facility has the same best-in-class characteristics and equipment as our large-scale plants, featuring stainless steel and single-use bioreactors at 1,000 liter scale, and one purification suite with pre- and post-viral segregation. Multiples Scales, Multiple Capacities,to fit various processes for any production volume sCMO4,000L Plant 130,000L Plant 2150,000L Plant 3180,000L 1 * Plant 3 has Fed-batch with N-1 Perfusion Capability
ManufacturingQualityEngineeringManagement Support Content tab ManufacturingQualityEngineeringManagement Support Manufacturing Manufacturing Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial management and ValidationDistribution ManagementValidation Quality Quality Quality ControlQuality Assurance Quality ControlQuality Assurance Engineering Engineering Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Management Support Business 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.
ManufacturingQualityEngineeringManagement Support Content tab ManufacturingQualityEngineeringManagement Support Manufacturing Manufacturing Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial Management and ValidationDistribution ManagementValidation Cell CulturePurificationFill & FinishManufacturing Science and TechnologyProject ManagementMaterial management and ValidationDistribution ManagementValidation Quality Quality Quality ControlQuality Assurance Quality ControlQuality Assurance Engineering Engineering Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Infra SupportEngineering TechnologyEngineering Project ManagementEngineering Validation Management Management Support Business 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.
manufacturing/production of commercial drugs, aseptic filling (DP) and analysis testing.- We introduce our service to clients. Dedicated project managers for each client are involved in entire process from product 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
Driven. For a Sustainable Life. Samsung Biologics aspires to lead the industry in protecting our planet for the health of future generations. In our mission to enrich human life while creating enduring and sustainable value, we are investing in practices and technologies to mitigate the risks of climate change in the greater areas we impact. As a global CDMO partner, we recognize the greater impact we can have by working together, and essential to our decarbonization is the cooperation and engagement with our suppliers to accelerate the net zero transition across our supply chains. A blossom of hope We are on a journey to help create a healthier adn sustainable future. Our path to changing the world is never ending. It touches everyone and everything. Together we are Driven. For a Sustainable Life. Driven. For Life. Samsung Biologics ESG Report We're committed to sharing oursustainable progress and goals.Learn more about our sustainability initiatives. Find out more Our InvolvementsWe are committed to global carbon neutrality SMI Sustainable Markets Initiative(SMI) A low-carbon transition engagement led by the British royal family,Samsung Biologics participated as a representative of the global CDMO industryto seek a net-zero supply chain plan Find out more on the SMI website The SMI was launched by HRH The Prince of Wales at the World Economic Forum in 2020. It aims to lead the transition to a sustainable future by convening leaders to bring economic value into alignment with social and environmental sustainability. In 2021, the SMI Health Systems Taskforce was formally launched at COP26 in Glasgow including 13 leaders from across the healthcare system with CEOs/equivalents from: AstraZeneca, GSK, Merck, Roche, Samsung Biologics, Sanofi, Novo Nordisk, the World Health Organization, UNICEF, NHS England, the Sustainable Healthcare Coalition, the Karolinska Institute and the University of Pavia. With its shared ambition to accelerate the delivery of net zero, sustainable healthcare to improve individual, societal and planetary health, the SMI Health Systems Taskforce is committed to delivering action in three priority areas through the establishment of Working Groups: Supply Chains (championed by John Rim, CEO Samsung Biologics). The Supply Chains Working Group is focused on accelerating the net zero transition across health systems supply chains. More specifically, the group aims to work with suppliers to decarbonize upstream product supply chains, with a focus on renewable energy, clean heat, green logistics and common supplier standards. Patient Care Pathways (championed by Paul Hudson, CEO Sanofi). The Patient Care Pathways Working Group focuses on identifying opportunities to deliver net zero patient care while improving health and societal outcomes. The group aims to demonstrate how interventions across the care pathway can drive emissions reductions by decarbonizing care settings, preventing and managing disease progression, and delivering lower-CO2 solutions. Digital Healthcare (championed by Belén Garijo, CEO Merck). The Digital Healthcare Working Group focuses on leveraging digital innovation and technology in order to drive the transition to net zero across health systems. The initial focus of the group is on demonstrating how digital solutions can support reducing emissions across clinical trials while improving patient outcomes and the patient experience. Frontier 1.5D The Frontier 1.5D project is a global collaborative effort to limit temperature rise to 1.5°C above pre-industrial levels.Business leaders from Korea have joined with the British Embassy, Ewha Woman’s University, Financial Supervisory Service, to analyze the financial impact of climate response policies in the effort to address uncertainties associated with climate change and collectively thrive for a net-zero future. As a business sector representative, Samsung Biologics wi
manufacturing partner to ensure a stable supply of life-saving drugs, especially in light of the current pandemic. ISO22301 is especially meaningful given our critical mission to the biopharma industry to providing patients with a stable supply of life-saving therapies under any circumstances OverviewOperating system Content Tab OverviewOperating system Overview Business Continuity Management System (BCMS, ISO22301) Samsung Biologics’ holistic management process that identifies potential threats to an organization and the impacts to business operations from such threats; and provides a framework for building organizational resilience with the capability of an effective response that safeguards the interests of its key stakeholders, reputation, brand and value-creating activities. Purpose of BCMS Samsung Biologics is operating Business Continuity Management System (BCMS) to protect the assets of our company and clients from risks and to stably deliver key products and services to patients. Leadership for BCMS Operation Samsung Biologics hereby pledges to protect the assets of our company and clients from risk and to stably deliver key products and services to patients to comply with our Business Continuity Management policy. We strive to identify and evaluate the risk of disruption to Samsung Biologics' activities in order to be a global leading company by implementing processes to prevent and mitigate the impact of disruption through continuous improvement. We establish a dedicated organization to routinely manage and continually improve suitability, adequacy, and effectiveness throughout the entire whole business continuity management process. We pledge to be a reliable company for our clients and shareholders by actively participating in BCM activities to stably deliver key products and services. Samsung Biologics President & CEOJohn Rim ISO22301 ISO22301 is a comprehensive standard published by the International Organization for Standardization (ISO) that represents the highest level of commitment to business continuity and disaster preparedness. Samsung Biologics became the first Korean pharmaceutical company to achieve ISO22301 certificate in 2018, and has continuously expanded the scope of certification for ensuring systemic BCMS management. Operating system BCMS Steering Group Samsung Biologics has three levels of teams in the response structure. The strategic, tactical, and operational teams in a response structure undertake different activities as follows: Crisis Management Committee Emergency Response - Evacuation- Initial Site response- First aid- Restoration- And others Business Support - Supply Chain- HR- Finance- Quality- And others Manufacturing - Drug Substance- Drug Product- Research- 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 strateg
CEO IR NEWSLETTER Driven. For Life. SAMSUNG BIOLOGICS 2023. 07 IR Newsletter Dear investors, This is John Rim from Samsung Biologics. First of all, thank you for your continuous interest and support in Samsung Biologics. Key Highlights Financial Performance (Quarterly Semi-annual) • Continued strong growth momentum: Rev. +41%, OP +46% * Q2 CAGR over three years ('20~23), consolidated • 2Q Consolidated: Rev. KRW 866B, OP KRW 253B (OPM: 29.3%) (+33% YoY) (+49% YoY) • 2Q Separate: Rev. KRW 637B, OP KRW 254B (OPM: 39.9%) (+27% YoY) (+48% YoY) • 1H Consolidated: Rev. KRW 1,587B, OP KRW 445B (OPM 28.0%) (+36% YOY) (+29% YoY) CDMO • Full operation of P4 240KL with Phase II initiation (Jun) *Blo Campus 1:604KL • Continued orders from Global Pharmas *Pfizer $1,080M, Novartis $391M, US Pharma $113M, EU Pharma $81M • 13 out of top 20 Big Pharmas as clients *Count Before COVID-19:3→ After COVID-19:13 • Cumulative contracts amount of USD 11.3B by Jul. **20: $6.1B → '21:$7.5B '22: $9.58 → 23 2Q: 10.5B Business Expansion • NJ sales office launched: Client support in closer proximity (Mar) • ADC investment, commercial operation to begin in '24 • Early operation of P5: Sep '25 → Apr 25 (reduced by 5 months) • Further technology improvement in S-DUAL and mRNA platform Bioepis • Lucentis Biosimilar (SB11): Geographic expansion of product launch • Soliris Biosimilar (SB12): EMA approved and launched in EU in Jul. • Humira Biosimilar (SB5): Launched in US in Jul. Samsung Biologics today announced second-quarter 2023 consolidated revenue of KRW 866B and consolidated operating profit of KRW 253B, representing a 33% and 49% increase respectively from the second quarter of 2022. On a separated basis, Samsung Biologics recorded KRW 637B (+ 27% YoY) in revenue and KRW 254B (+48% YoY) in operating profit. We continued to achieve solid YoY revenue growth over 14 consecutive quarters since the COVID outbreak in 2020 and are proud to announce that our business is progressing well in line with the annual revenue guidance of 15-20% growth for 2023, demonstrating our top-notch management execution, successful business performance, and our competitive advantage as a world class CDMO. I am also pleased to share that thanks to our robust sales activities, 13 of the top 20 global pharmas are now Samsung Biologics' clients, resulting in Plants 1, 2, and 3 all running at full capacity and Plant 4's 240kL capacity being fully operational since June 1. Our total cumulative CMO contracts now surpass USD 10B, and we continue to expand partnerships with global pharmas leveraging our CDO capabilities and platforms. Also, our subsidiary Samsung Bioepis has been contributing to top-line growth with the launch of EPYSQLITM (SB12), a biosimilar of Soliris, in the EU market after obtaining the final approval from European Commission, and a biosimilar of Humira named HADLIMATM (SB5), in the US in July. Full operation of Plant 4 dubbed the 'SUPER PLANT', and acceleration of Plant 5's construction timeline by 5 months We began operation of the 60KL portion of Plant 4 last October and unlocked the remaining 180KL portion this June (240KL in total). Our total capacity of 604kL across Bio Campus I is now fully available to support clients at multiple scales and on schedule as we had planned from the very beginning. Our sales activities targeted for P4 have led us to the execution of supply contracts for 16 products with 10 clients, and on-going contract negotiations with 30 clients for 46 products. Based on robust demand from clients, we announced in March the construction of Plant 5 which will be operationally ready by April 2025, about 24 months from groundbreaking and 5 months earlier than the original plan. Succe
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 facility in Bio Campus II, which will be located on a 96,000-square-meter plot. This new Plant 5, with a capacity of 180,000L, will break ground in the first half of this year and expected to complete construction and commence operations in September 2025. Plant 5 will maximize Samsung Biologics' operational efficiency by adopting the company's standardized facility design, allowing the company to leverage existing capabilities, expertise, and know-how acquired through experience at Plants 1 through 4, while introducing advanced digitalization and automation technologies. With Plant 5 construction, Samsung Biologics will further accelerate our capacity growth and leadership with Bio Campus II. Geographic Expansion | Regional sales office opening in New Jersey, USA In keeping with the company's ambitions for global expansion, Samsung Biologics has been strengthening our footprint in the United States by establishing a presence in major cit
manufacturing facilities at 604KL. With all three plants operating at full capacity, Samsung Biologics recognized the need for additional capacity 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
manufacturing of a Bristol Myers Squibb commercial antibody cancer drug substance. Bristol Myers Squibb and Samsung Biologics have an existing manufacturing agreement for a commercial antibody cancer drug and have expanded the strategic relationship over time. Under the terms of the new agreement, Samsung Biologics will provide drug substance manufacturing for an antibody cancer drug substance at the company’s latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea. “Our relationship with Bristol Myers Squibb spans over a decade, and we are proud and excited to help bring important medicines to patients around the world,” said John Rim, President and CEO of Samsung Biologics. “This collaboration with Bristol Myers Squibb underscores our commitment to expediting the delivery and ensuring the continuous supply of client pipelines, enabled by our commitment to manufacturing quality, innovation, and capacity.”
manufacturing facility with the goal to complete construction in 2024. “We are pleased to support AimedBio for their pipeline of innovative candidates towards the clinic,” said John Rim, President and CEO of Samsung Biologics. “As part of our continued efforts in fostering next-generation technologies, we hope this investment paves the way for future collaborations on the development and manufacturing of new drugs.”
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