SERACH RESULTS FOR" Manufacturing "
manufacturing contract of their COVID-19 vaccine. Subsequently we also announced our plan to add an mRNA vaccine drug substance facility by 2022 in order to provide a full end-toend service for mRNA vaccine production from drug substance manufacturing to aseptic fill and finish with labeling, packaging, and cold storage. We hope that with this expansion of our services portfolio, Samsung Biologics will provide an even greater contribution to the rapid supply of high-quality vaccines worldwide. We will also continue to study new technologies such as cell and gene therapies in addition to mRNA to secure new platforms for growth and business momentum. Plant 4 Expansion Currently Plant 4 is on track to begin partial GMP operations by the end of 2022. As global biopharmaceutical companies broaden and diversify their SCM strategy with new antibody drugs continuously under development, the demand for CDMOs is steadily increasing. This need for additional capacity is not only reflected in our Plant 4 pre-sales activity, but is also driving us to closely review the investment and construction of a second bio-campus in Songdo, Incheon. 3-Dimensional Expansion : Capacity / Geography / Portfolio Earlier this yera, we shared our '3-Dimensional Expansion' strategy to becoming a fully integrated global top-tier biopharmaceutical company, and I am proud to confirm we are keeping that promise even at this moment. In addition, Samsung Biologics will be proactive in fulfilling our commitment and responsibility to a better planet and social environment as signaled by the issuance of our first annual sustainability report during this past quarter. We will also continue to stay ahead of and respond to evolving market dynamics and client needs to maximize corporate and shareholder value. Thank you for your continued support. Sincerely, John Rim President and CEO, Samsung Biologics
manufacturing services according to our strict COVID-19 controls and management systems. Our supply chain management war room monitored and managed availability of critical materials around the clock, while our preemptive development of our Live Virtual Tour platform ensured our ability ot perform client due diligence and regulatory inspections amid worldwide travel restrictions, enabling us to sign additional CMO contracts for a total of 47 cumulative by the end of 2020. Our achievements in 2020 not only demonstrated innovation in the CDMO market but also strengthened our business competitiveness despite the COVID-19 pandemic. Samsung Biologics, I ask for your continued warm attention and support. Sincerely, also established a stable growth foundation by securing full contracts in Plants 1, 2, John Rim President and CEO, Samsung Biologicsand near-full contracts in plant 3. We also made a decisive investment to expand Plant 4 to respond to the accelerated supply/demand situation within the industry. Plant 4 will be the word's most productive facility, with a total of 256,000L, which is 76,000L larger than plant 3. in the CDO (contract Development) business, we successfully launched our proprietary cell line, "S-CHOice" in August. In october, we announced the opening of our R&D center in San Francisco, US. We will continue to evaluate expanding DP (fill finish) facilities to ensure client satisfaction by providing competitive end-to-end services. 2021 - The beginning of a new decade for Samsung Biologics, I ask for your continued warm attention and support. Sincerely, John Rim President and CEO, Samsung Biologics As announced at this year's JP Mogan conference, we are planning to expand our business in 3 aspects : capacity expansion, geography expansion, and scope expansion over the next 10 years: Capacity Expansion By acquiring Bio-campus Ⅱ and plant 4 expansion in Songdo play as game changer beyond CDMO champion Geography Expansion Expansion of CMO and CDO capacity oustide of Korea to maximize customer satisfaction and expand prospects. Scope Expansion Study from mAb based biologics to new potential growth momentum(eg. Cell/gene therapy, vaccine etc.) For the Next Decade 3-Dimensional Expansion - Business Expansion & Portfolio Diversification Source : JP Morgan Healthcare Conference 2021 Samsung Biologics will always advance forward and deliver on ever challenging goals as a CDMO Champion. As we celebrate our 10 year anniversary this year, we will not be complacent with our achievements, but instead commit ourselves even more to continuously innovating our process for superior client satisfaction. Through this, we will strive to increase both customer value while maximizing shareholder value. And we will continue to actively communicate with investors to inform on our business performance. In this new decade of Samsung Biologics, I ask for your continued warm attention and support. Sincerely, John Rim President and CEO, Samsung Biologics
manufacturing, offering fully integrated, one-stop services. for additional information regarding Plant 4, please visit our newly opened "Plant 4 Virtual Showroom", where you can also track its ongoing construction progress. Bio CMO/CDO/CRO Champing 2030 As a CDMO service provider, Samsung Biologics attained the largest total capacity within the shortest amount of time while ensuring top-notch quality services. We will continue to strengthen our competitive edge through technological innovation and new business development. We will also strive to ensure maximum client satisfaction, optimize shareholder value, and most importantly advance the industry in improving assessibility to healthcare and quality of life. We ask for your continued encouragement and support in buliding a better future with Samsung Biologics. Thank you, Tae Han Kim President & CEO, Samsung Biologics December 3rd, 2020
Manufacturing and Business Operations Samsung Biologics announced our 2020 Q3 Earnings today. Despite the ongoing COVID-19 pandemic, we maintained stable business operations including development and manufacturing according to our strict COVID-19 controls and management system. 2020 Q3 Revenue 2,746B KRW(QoQ 11% DOWN, YoY 49% UP) Operating Profit 565B KRW (QoQ 30% DOWN, YoY 139% UP) Profit Before Incom Tax 737B KRW (QoQ 9% UP, YoY 67% UP) Net Profit 561B KRW (QoQ 8% UP, YoY 27% UP) Manufacturing Contracts and Business Performance 4 additional contracts in Q3 11 cumulative contracts in 2020 thus far plant 4 Expansion(august) S-CHOiceTMLaunched(August) Continuing to Strengthen Business Competitiveness Towards Becoming a Super Value Company In August, we announced our Plant 4 expansion, which will have a capacity of 256,000L. With the Plant 4 expansion Samsung Biologics is proactively responding to changes in the global biopharmaceutical market and is strongly positioned as the global No.1 CMO based on production capacity. applying Super Value Company principles in the CDO(contract development)market, we continue to strengthen our competitive edge. Samsung Biologics successfully launched our own cell line, S-CHOiceTM, in August 2020. The S-CHOiceTM cell line results in shorter production times and price competitiveness for our clients. Additionally, to strengthen client satisfaction and bring our contract development services closer to global clients, we are launching a CDO R&D Center in San Francisco, California on October 29th(KST). I encourage you to attend the online grand opening ceremony of our CDO R&D Center. Please register through the link at the bottom of the letter. Samsung Biologics will contnue to innovate to provide qualiy services for clients to support them in their mission to advance life-saving therapies. Thank you, Tae Han Kim President & CEO, Samsung Biologics October 21, 2020 CEO IR Newsletter 2 뿐만 아니라 글로벌 거점과 고객사 확보 역량 강화를 위해 10월 29일 미국 San Francisco에 CDO R&D 센터를 오픈할 계획입니다. 온라인으로 진행되는 본 행사에 관심 있으신 투자자분들은 메일 하단의 '등록'을 통해 참석하실 수 있습니다. 삼성바이오로직스는 앞으로도 지속적인 혁신을 통해 빠른 속도로 양질의 서비스를 제공하며, 보다 높은 기업가치 창출을 위해 최선을 다하겠습니다. Super Value Company를 향한 삼성바이오로직스의 행보에 투자자 여러분들의 따뜻한 관심과 지속적인 성원을 부탁드립니다. 감사합니다. 2020년10월21일 삼성바이오로직스 대표이사 사장 김태한
manufacturing supply. At Samsung Biologics, innovation isn’t something we do in bursts or sporadically. It is a constant approach, and the biopharmaceutical industry has recognized this trait through our outstanding quality, cost competitiveness, and customer satisfaction over the years. Taking into consideration the market’s supply and demand and the trend of global pharmaceutical companies expanding their usage of CMPs, we see the Plant 4 expansion as our long-term strategy for resilience and growth not only for ourselves but for our clients as well. Plant 4 Super Pant Detail Capacity 256,000L CAPEX Amount 1.74 trillion Korean Won Targeted Construction Period Groundbreaking in September 2020 Mechanical completion by the end of 2022 Location & Size Songdo, Incheon (Next to Plant 3) Approximately 23.8 million square meters Plant 4 will have the world’s largest manufacturing capacity at a single site with top-notch quality and production efficiency – using Samsung Biologics’ cutting-edge plant design technology. Also in order to respond to our clients’ diverse requests with even more flexibility, we will leverage a variety of bioreactor sizes (2,000L, 10,000L, and 15,000L). Upon Plant 4’s completion, Samsung Biologics will have a total site capacity of 620,000 liters, setting us on track to be one of the world’s largest CDMO companies. We recognize that we’re entering into a new era for biomanufacturing that requires us to go beyond the standard: we need to innovate through technology and product construction to create this super gap between us and our competitors. In addition to our Plant 4 expansion, we are also reviewing the creation of a second bio complex in Songdo, Incheon. We’re investing in these advancements because our future and the future of healthcare depends on it. We promise to continue to deliver long-term growth and value for our shareholders, whose success and Samsung Biologics’ success are inextricably linked. Sincerely, Tae Han Kim President & CEO, Samsung Biologics August 11, 2020
manufacturing agreement with Vir Biotechnology -valued at 440 billion korean won-for a potential COVID-19 treatment. We also signed a 280 billion Korean won CMO contract with GSK in May to expand their innovative biopharmaceutical portfolio. This year to date, we have signed eight manufacturing contracts with clients, valued approximately at 1.8 trillion korean won. These achievements further articulate our continued commitment to continuous top line growth and client satisfaction through outstanding ution and innovation. As competition intensifies, several big pharmaceutical and CMO companies are increasing their manufacturing capacities as the demand for novel biologics continues to rise. Meanwhile, the number of pharma companies without in-house facilities is multiplying, and SCM strategies are moving towards increased dependence on CMOs amid COVID-19. Considering these dynamics in the supply and demand of biotherapeutics, we recognize an opportunity for expansion as our outstanding quality, cost competitiveness, and client satisfaction have laid the foundation for a more robust, long-term strategy. As a result, we are looking at expanding our manufacturing facilities to fulfill the needs of the growing biopharmaceutical market. We have also adjusted to operating in a more virtual environment due to COVID-19 and the profound changes it has introduced. Videoconferencing, webinars, and virtual tours are investments in technology that allow us to communicate and serve our clients while also keeping their safety in mind. Our Virtual Exhibition Hall introduced the Samsung Biologics business portfolio to a global audience during BIO Digital 2020, and our Live Virtual Tour solution established a platform where through high definition virtual connectivity, our experts are having richer conversations with potential clients and regulatory authorities than ever before. This level of engagement in a rapidly changing business environment showcased our unique strengths, ultimately allowing us to sign numerous contracts in first half of this year. During this unprecedented crisis, our conviction in our purpose-to achieve a better life for humanity through biomedicines-is stronger than ever. We understand this comes with a great responsibility to support our clients and communities as they navigate the challenges they face. Communication with clients and shareholders on key business environment changes is top of mind in order to maintain trust and cooperation. At Samsung Biologics, we will be innovative in strengthening our cost competitiveness and agility for maximum client satisfaction to grow into a "Super Value Company" that is relentless in its pursuit of innovation. On behalf of Samsung Biologics, I ask for your continued trust and support as we move forward with resilience and fortitude in these uncertain times, and focus on the well-being, health, and safety of all our stakeholders-our clients, shareholders, employees, and communities. Thank you, Tae Han Kim President & CEO, Samsung Biologics July 21, 2020
Dear Shareholders of Samsung Biologics: On November 14, the Securities and Futures Commission (“SFC”) announced the final result of its audit on our accounting in respect of our associate, Samsung Bioepis (“Bioepis”). In this regard, we will explain the progress of this issue and our position on the result of the measure taken by the SFC. ?Samsung Biologics (the “Company”) has been audited by the Financial Supervisory Service (“FSS”) since April 2017 as to whether the accounting was properly treated in the Company’s financial statements in respect of Bioepis, a joint venture between the Company and Biogen in the U.S., and the FSS disclosed the result of the audit to the media in early May. ? After numerous meetings of the audit committee and the SFC, the SFC announced the following results of the measure on July 12, 2018: among the alleged accounting violations of the Company, (i) “gross negligence” for failure to record notes regarding call options granted to Biogen in respect of shares in Bioepis to the auditors’ report for 2012 and 2013; (ii) “willful misconduct” for insufficient record of notes to the auditors’ report for 2014; and (iii) order for re-audit by the FSS with respect to the discretionary evaluation of the investment in shares through an inappropriate change of the accounting standards for 2015. ?In its announcement of the decision on re-audit on November 14, the SFC concluded that the Company’s treatment of Bioepis as a consolidated subsidiary as opposed to an associate under the equity method from 2012 to 2014, which was not deemed a violation in July, was to be deemed “negligence” for 2012 to 2013 and “gross negligence” for 2014. It also announced that the Company’s unjust discretionary evaluation of investment in shares for 2015 and failure to retroactively apply the amended accounting standards to the financial statements after 2012 would be deemed “willful misconduct.” ? Accordingly, the following measures were taken against the Company: i) prosecution against the Company and its representative director; ii) recommendation of dismissal of the Company’s representative director (CEO) and the responsible officer (CFO); iii) compulsory designation of external auditors for 3 years; iv) an order of a corrective measure (retrospective restatement of financial statements); and v) imposition of an administrative fine worth KRW 8 billion for “willful misconduct.” ?According to the KOSPI Listing Regulation, in case of any prosecution for violations of the accounting standards in the amount equal to or greater than 2.5% of the shareholders’ equity (for a large-scale corporation), a listing maintenance review event is triggered and such review must be conducted immediately after suspension of trading activities. Therefore, the trading of the Company’s shares has been suspended since the SFC’s announcement on its resolution after market closing on November 14. ?We deeply regret the findings of the SFC as we are confident that our accounting treatment has been proper under the K-IFRS. As such, we filed an administrative lawsuit against the SFC on October 8 regarding the 1st audit result and another administrative lawsuit against the SFC on November 27 regarding the 2nd audit result. Through these lawsuits, the Company aims to have the legality of its accounting treatment recognized. To prevent the administrative dispositions from taking effect, the Company applied for an order to stay the dispositions on restatement of financial statements, recommendation of dismissal of CEO and CFO, designati
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Samsung Biologics Confirms 'No Impact' of COVID-19 with Business Continuity Plan in EffectFebruary 25, 2020
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