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Research and Development in the US and Europe.Mr. Rim has also held senior leadership roles with Astellas Pharmaceuticals in General Management, Sales & Marketing, Technical Operations, Customer Service, Business Development, and Strategic Planning.Mr. Rim has over 30 years’ experience in the biopharmaceutical industry and began his career as a management consultant with Booz, Allen & Hamilton consulting to pharmaceutical companies in the US and Europe.Mr. Rim holds a bachelor’s degree from Columbia University, a master’s degree from Stanford University, and an MBA from the Kellogg School of Management at Northwestern University.Read a message from the CEOJames ParkExecutive Vice President & CBOJames Park is Executive Vice President and Managing Director of the Global Sales Center.Prior to joining Samsung Biologics in 2015, Mr. Park held various technical and operational positions, as well as business development management leadership positions in biopharmaceutical companies in the U.S.Mr. Park began his career in 1989 with ALZA Corporation, a subsidiary of J & J, as a chemical engineer where he participated and led process and product development, technology transfer, validation and commercialization of several OROS products. Mr. Park then worked in Technical & Alliance Management at Watson Pharmaceuticals. Transitioning to Merck as a Change Agent/Six Sigma Project Manager, Mr. Park then managed the Operational Excellence projects related to process improvements, cost savings and quality initiatives.From 2004 to 2015, Mr. Park participated in and directed 100+ CMC due diligences on assets ranging from pre-clinical to commercial products, and managed Global Manufacturing & Supply BD activities including Licensing, Outsourcing and M&A at Bristol-Myers Squibb.Mr. Park has over 25 years of experience in the biopharmaceutical and pharmaceutical industries.Pierre CatignolExecutive Vice PresidentPierre Catignol is Executive Vice President and Head of Manufacturing center at Samsung Biologics.Mr. Catignol has over 25 years of experience in the biopharmaceutical and pharmaceutical industry.Prior to joining Samsung Biologics, Mr. Catignol began his career at Sanofi-Pasteur in 1995, and extended his career in StALLERGENES AND VIRBAC as Head of Operations & Supply site and Operations & Quality respectively.His recent leadership role was at Lonza as Head of Portsmouth site.Mr. Catignol holds a master's degree for General Engineering at ECAM university.Kun Lo, Ph.D.Executive Vice PresidentDr. Kun Lo is Executive Vice President and Head of EPCV center responsible for construction and operation of new plants.Prior to joining Samsung Biologics in 2020, Dr. Lo held various management positions in Engineering and New Business.Dr. Lo began his career with Samsung General Chemicals in 1992, then developed chemical products and managed manufacturing for 18 years in Samsung Total Petrochemical. In 2013, Dr. Lo advanced through Engineering expertise as a manager of Engineering Support Team and Process Design in Samsung Engineering.Dr. Lo assumed responsibilities for planning global business as a New Business Team Leader and Head of US corporation in Samsung Engineering.Dr. Lo holds a doctor’s degree from Seoul National University in Chemical Engineering.Sam MachourExecutive Vice President & CQOSam Machour is Executive Vice President and Chief Quality Officer in charge of Quality, Regulatory and Compliance at Samsung Biologics.Prior to joining Samsung Biologics in 2019, Mr. Machour spent more than 32 years supporting MedTech, bioscience and biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Regulatory, Operations and product commercialization.Mr. Machour served at several big pharma including Pfizer, GSK and J&J and held global leadership roles at Lonza as its Vice-President and Global Head for Quality and Regulatory and member of the Biologics Executive Com
Research and Development in the US and Europe. Mr. Rim has also held senior leadership roles with Astellas Pharmaceuticals in General Management, Sales & Marketing, Technical Operations, Customer Service, Business Development, and Strategic Planning. Mr. Rim has over 30 years’ experience in the biopharmaceutical industry and began his career as a management consultant with Booz, Allen & Hamilton consulting to pharmaceutical companies in the US and Europe. CEO Message Detail CEO Message For over a decade, Samsung Biologics has rapidly evolved into the world's largest and best-in-class CMO service provider, and now, we are continuously expanding our CDO and CRO business areas to make the next leap in biopharma. In this next decade, we will continue to build greater capabilities to meet new market demand as a top service provider in the biopharmaceutical industry while ensuring quality and stable supply of life-saving drugs. Since its launch, Samsung Biologics has not only expanded its manufacturing capacity but also established a solid track record of successful regulatory approvals and award-winning client satisfaction. In efforts to provide the highest level of customer-centric services, Samsung Biologics has implemented leading edge technologies and with great agility, demonstrated distinguished processes in terms of speed, price competitiveness, quality, and efficiency. We are facing a time of significant challenges and market dynamics. To respond proactively, we are making bold moves by adding Plant 4, with the largest and most flexible manufacturing scales, to our headquarters as well as carrying forward with global expansions with the CDO R&D Center. We expect synergies from collaborations between the new global locations and our manufacturing site in Songdo, a rising bio hub. With a steadfast vision and unrelenting drive to achieve better life for all, we embrace responsibility, expertise, and pride in our work, and will continue on our noble mission to enable improved accessibility of biomedicines and consequently the quality of life for people around the globe. We will challenge ourselves to improve in all facets of our business through innovation, dedication, and teamwork so that we can continue to add meaningful value to all of our clients, partners, and shareholders. Thank you for your continuous trust and support. John Rim President & CEO President & CEO, Samsung Biologics John Rim sign
Research and 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 c
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 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 inc
research on the harmful factors of musculoskeletal disorders and deliver a program for the prevention of musculoskeletal disorders to achieve a better working environment. Operation of Mental Health ClinicWe operate a variety of programs for mental health to prevent any mental health issues and mental health related accidents occurring for our valued employees. Industrial Hygiene Management Work Environment AssessmentWe continue to make the essential efforts to create healthy workplaces by measuring the exposure levels of harmful factors in the work environment in order to prevent any health problems and create a safe and pleasant working environment. Chemical Risk AssessmentWe assess the hazards of handling chemical substances and establish the relevant safety management measures to ensure that all our employees remain “chemically safe.” Hands-on Safety TrainingWe run hands-on training programs to enhance the safety and emergency response capabilities of all our employees.
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
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
research collaboration agreement to co-develop ADC toolbox technologies and a contract development agreement to support the development of AimedBio’s monoclonal antibody therapy for atopic dermatitis and dementia. These agreements reflect Samsung Biologics’ commitment to exploring and developing innovative technologies for next-generation biomedicines. The Company plans to expand its business portfolio to include ADCs and is currently building its own separate ADC 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.”
research firm Statista, Samsung Biologics ranked #2 in the Healthcare & Life Sciences industry category. The recognition reinforces the Company's unwavering commitment to excellence, quality, and the trust of its valued clients and partners. As a dependable CDMO partner, Samsung Biologics has focused on enhancing a corporate culture where employees act on integrity to earn the trust of clients each and every day. From an extensive survey of over 70,000 participants, companies were evaluated across different elements related to customer, investor, and employee trust. A total of 269,000 evaluations were submitted and the top 1,000 Most Trustworthy Companies across 23 industries were chosen based on a holistic approach to evaluating trust. Samsung Biologics will continue to innovate and uphold its vision of delivering life-saving treatments by providing high-quality products, industry-leading services, and an unwavering responsibility to the communities in which it operates.
research and diagnostics, but many organizations face inherent challenges. In this Whitepaper, we show how Samsung Biologics can overcome existing challenges through the ‘S-KiH platform,’ and how this innovative technology will be able to revolutionize the process of heterodimer formation.
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