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(Samsung Biologics) 2022 1st Quarter Report
(Samsung Biologics) 2022 1st Quarter Report
※ Disclaimer
This document was disclosed voluntarily for foreign investors. The original Korean version of the
disclosure can be found on KIND(http://kind.krx.co.kr), DART(http://dart.fss.or.kr). If and when
there is any discrepancy between the English and Korean versions, the Korean text shall prevail.
Therefore, it is essential for the investors to consult the Korean text before making investment
decisions.
1. Company Overview
Listed - - - - -
Unlisted 1 - - 1 -
Total 1 - - 1 -
Subsidiary Reason
- -
Newly consolidated
- -
- -
No longer consolidated
- -
D. Establishment date
Samsung Biologics Co., Ltd. was established on April 22, 2011.
F. Status of SME
Samsung Biologics Co., Ltd. (hereinafter, Samsung Biologics or the Company) does not fall within small
and medium enterprises (SMEs) in accordance with Article 2 of the Framework Act of Small and Medium
Enterprises and Article 3 of the Enforcement Decree of the Framework Act on Small and Medium
Enterprises as of the date when the report is submitted.
G. Main business
The Company consists of two business segments: CMO (Contract Manufacturing Organization)
business that provides domestic and international biopharmaceutical companies with manufacture of
high-tech drugs on a contract basis; and CDO (Contract Development Organization) business that
serves development of cell line and manufacturing process. In the current period, revenue generated
from sales of products and services accounts for 91.6% and 8.4% of the total revenue respectively. By
region, the Company’s has generated the total revenue from the following regions: Europe – 55.9%,
North America – 23.2%, Korea – 10.5%, and Others – 10.4%.
Refer to「II. Business Overview」for more details about the business.
H. Credit rating
Rating Definition
AAA An ‘AAA’ rating indicates the highest likelihood of interest and principal payment.
An ‘AA’ rating indicates very high likelihood of interest and principal payment. The likelihood may,
A
nevertheless, be slightly lower than is the case for the highest rating category (AAA).
An ‘A’ rating indicates high likelihood of interest and principal payment. The likelihood may,
B nevertheless, be more susceptible to changes in circumstances and in economic conditions than
is the case for higher rating category (AA).
A ‘BBB’ rating indicates moderate likelihood of interest and principal payment, but changes in
BBB circumstances and in economic conditions are more likely to impair this likelihood than is the case
for higher rating category (A).
A ‘BB’ rating indicates some uncertainty over the likelihood of interest and principal payment and
BB
speculative elements.
A ‘B’ rating indicates substantial uncertainty over the likelihood of interest and principal payment
B
and is considered more speculative than higher rating category (BB).
A ‘CCC’ rating indicates high risk of default and questionable likelihood of interest and principal
CCC
payment.
A ‘CC’ rating indicates very high risk of default and extremely low likelihood of interest and principal
CC
payment.
A ‘C’ rating indicates extremely high risk of default and lack of likelihood of interest and principal
C
payment.
Rating Definition
AA Capacity for timely payment is very strong, but somewhat less than 'AAA'
A Capacity for timely payment is strong, but somewhat susceptible to external changes in the future.
Capacity for timely payment is adequate, but more likely to be weakened by future market
BBB
changes.
BB Capacity for timely payment faces no immediate problems, but speculative in its future stability.
I. Whether the Company is listed (or registered or designated) and matters related to special
listed companies
Listing Date listed Subject to regulations for
Special listed company
(or registered or designated) (or registered or designated) special exception companies
Changes in the place of principal office since the establishment of the Company are as follows :
Date Address Remarks
2011.04.22 104B, Pilot Plant, 7-50, Songdo-dong, Yeonsu-gu, Incheon, South Korea Establishment
Changed to
125, Cheomdan-daero, Yeonsu-gu, Incheon, South Korea road name-
2014.01.07
(Songdo-dong, Samsung Biologics Co., Ltd.) based
address
Changed to
300, Songdo Bio-daero, Yeonsu-gu, Incheon, South Korea road name-
2016.07.04
(Songdo-dong, Samsung Biologics Co., Ltd.) based
address
※ On December 16, 2020, Executive director John Rim was appointed as the new Chief Executive
Officer and Kim Taehan resigned from his position of Chief Executive Director during the 10 th board of
director’s meeting.
Type of Appointment
Date shareholder Expiry or Dismissal
meeting Initial Extension
Executive director
Kim Dongjoong
Annual
Independent director Independent director Independent director
2019.03.22 General
Heo Geunnyeong Jeong Seokwoo Yoon Byungchul
Meeting
Independent director
Kwon Soonjo
Executive director
Annual John Rim Executive director
2020.03.20 General -
Independent director Kim Taehan
Meeting
Eunice Kim
As of the reporting date, the Company's Board of Directors (BOD) consists of three Executive directors
(Kim Taehan, John Rim, and Kim Dongjoong) and four Independent directors (Heo Geunnyoung, Eunice
Kim, Lee Changwoo, and Bahk Jaewan).
C. Changes in the largest shareholder
E. Details and results in case the Company went through or currently goes through
compositions, reorganization proceedings, and other equivalents
- Not applicable
Biogen Therapeutics Inc. has a call option that allows it to purchase up to 50%-1 shares of Samsung
Bioepis under an agreement between shareholders on December 6, 2011.
On June 29, 2018, Biogen Therapeutics Inc. exercised the call option, and on November 7, 2018, the
transfer of shares and payments were completed.
Category Dates
Date Details
2011.04.22 Established Samsung Biologics Co., Ltd.
2011.04.28 Signed a lease agreement for the plant site in Songdo
2011.05.06 Started the construction of Songdo Plant 1
Date Details
2012.02.28 Established Samsung Bioepis Co., Ltd.
2013.07.18 Signed a contract with BMS regarding DS manufacturing
2013.09.23 Started the construction of Songdo Plant 2
2013.10.18 Signed a contract with Roche regarding DS manufacturing
Signed a contract with BMS regarding DS manufacturing enhancement and
2014.04.16
DP manufacturing
2014.06.23 Established a joint venture, Archigen Biotech Ltd.
Changed the largest shareholder’s company name
2014.07.04
(Samsung Everland Inc. → Cheil Industries Inc.)
Changed the largest shareholders (Before: Samsung Electronics Co., Ltd. 46.79%, Cheil
Industries Inc. 46.79%, Samsung C&T Corporation 4.25%
2015.09.02
→ After: Samsung C&T Corporation 51.04%, Samsung Electronics Co., Ltd. 46.79%)
2015.11.12 Started the construction of Songdo Plant 3
2015.11.30 Obtained an approval of Songdo Plant 1’s manufacturing license from FDA
(no observation)
2022.03.28 Signed an additional contract with Eli Lily Kinsale Limited regarding DS manufacturing
2022.03.29 Agreed to a Land Purchase Agreement for Second Bio Campus in Songdo Disctrict 11
2022.03.29 Invested in Samsung Life Science Fund, U.S. Cell and Gene Therapy Developer
3. Changes in Paid-in Capital
Type of 12th
Classification 11th 10th 9th 8th
share (1Q)
Number of
Issued 66,165,000 66,165,000 66,165,000 66,165,000 66,165,000
shares
Ordinary
share Par value
2,500 2,500 2,500 2,500 2,500
per share
Total equity 165,412,500,000 165,412,500,000 165,412,500,000 165,412,500,000 165,412,500,000
Number of
Issued -
shares
Preferred
share Par value
-
per share
Total equity -
Number of
Issued -
shares
Others Par value
-
per share
Total equity -
Total Total equity 165,412,500,000 165,412,500,000 165,412,500,000 165,412,500,000 165,412,500,000
4. Stock Information
Type of stocks
Classification Note
Common Preferred Total
1. Capital reduction - - - -
2. Cancellation - - - -
3. Redemption - - - -
4. Other - - - -
B. Treasury Shares
- Not applicable
5. Articles of Incorporation
Amendment record
1. Business Overview
The Company is organized into two segments consisting of CMO and CDO businesses. The CMO
business provides clients with the service of manufacturing biopharmaceuticals, and the CDO business
offers a wide range of services including the development of cell line, manufacturing process,
characterization, and analysis method for pipelines ranging from cell line development to early-stage
clinical phase. The Company achieved annual sales of 1.568 trillion won in 2021, and sales of
biopharmaceuticals were 1.442 trillion won in product sales and 126 billion won in service revenue.
From the total sales of 511.3 billion won in the first quarter of 2022, sales of goods, etc. were 468.3
billion won, and service sales were 43 billion won.
The Company operates commercial manufacturing capacity of 360,000L (Plant 1 – 30,000L, Plant 2 –
150,000L, Plant 3 – 180,000L) and clinical manufacturing capacity of 4,000L in Incheon Free Economy
Zone (Songdo region). This is the largest manufacturing capacity in the global CMO industry . The
Company established an overseas subsidiary, Samsung Biologics America, Inc. in the United States to
secure stable sales growth and overseas expansion. In addition, the Company achieved a fruitful
performance in both CDO and Drug Product(DP) businesses, remarked by its DP production of
Moderna’s mRNA vaccine. Meanwhile, the company’s subsidiary, Samsung Bioepis is a
biopharmaceuticals Research & Development firm that is working on the development and
commercialization of biosimilars.
In 2022, the global biopharmaceutical market is valued at USD 360 billion, which accounts for 39.3%
of the entire pharmaceutical market. The biopharmaceutical market is expected to increase with an
average growth rate of 10.3% by 2026. The rapid growth is expected to boost the expansion of the
overall pharmaceutical market. In addition, the recent trend shows the greater reliance on CMO
companies by global pharmaceutical companies (Evaluate Pharma, Apr 2021, McKinsey report). The
CDMO industry is expected to increase from USD 14.3 billion in 2022 to USD 20.3 billion in 2026 with
an average growth rate of 10.1%, based on the following factors (Frost&Sullivan, Jul 2021).
The Company is a contract manufacturer specializing in mammalian cell-based antibody drugs, which
is a major component of the biopharmaceutical market. The market is oligopolistic, dominated by a few
players with large-scale manufacturing facilities. As of 2022, there are three companies with a global
production capacity of over 300,000L production: Korea-based Samsung Biologics, Switzerland-based
Lonza, and Germany-based Boehringer Ingelheim. The Company runs 364,000L production facilities
as of now and plans to concrete its leading position as it completes the construction of Plant 4 with
256,000L capacity by 2023.
The Company is currently widening the scope of business to CDO services, mRNA, and cell/gene
therapy manufacturing to transform into a global biopharmaceutical company. The CDO business
provides cell line and process development and characterization services for small and medium-size
biotechs, which do not have their own development facilities. The Company launched a high-performing
cell line ‘S-CHOice’, which delivers high productivity and viability, and ‘S-Cellerate’, which is a platform
that innovatively shortens the development period through a standardized process for each
development stage. Furthermore, the Company opened its first global CDO R&D center in the renowned
San Francisco Biopharma Cluster in October 2020 and currently plans to widen the scope of the market
to Boston, Europe, and China.
The Company has implemented mRNA production capacity within its existing manufacturing plant,
which is set to be cGMP ready by the 1H 2022. Additionally, the Company signed a land purchase
agreement for a new plant with production capacity for mRNA and cell/gene therapy products in
November 2021.
A. Major products
(Unit: KRW Bil)
The selling prices of products manufactured or to be manufactured by the Company can be adjusted
according to contract conditions, for instance being adjusted by the ratio calculated by reflecting the
annually-announced CPI (Customer Price index) in the initially-determined selling price or being
increased at the fixed rate determined by a contract.
3. Raw Materials
The major raw materials used in the pharmaceuticals are either confirmed by the customer for reasons
such as quality control or purchased through the vendor assigned by the customer. Pre- or post-
settlement (reimbursement) is made by the customer for the purchased raw materials and incidental
expenses. Due to these terms and conditions, the risks associated with the purchase of raw materials,
such as price fluctuations, are limited.
Meanwhile, the Company signs a long-term contract with raw material suppliers to obtain a stable
supply of raw materials, and applies the inflation rate (approx. 1~2%) level of raise to a price increase.
Therefore, risks relating to price fluctuation due to the limited contract terms.
The Company calculates operating rate by separating actual working time from non-working time of key
production facilities, where the annual production capability is calculated by considering the Slowdown
and Product Changeover period per Drug Substance production plant.
(Unit: batch)
Note 1) The Company is exempted from paying rental fees as the Company satisfied the requirements for rental fee exemption
in accordance with the Ordinance of Common Property Management of Incheon Metropolitan City by signing a lease
agreement with Incheon Metropolitan City.
※ Fair value is excluded as an objective estimation for major tangible assets is difficult.
(2) Investments
(Unit: KRW Bil)
New, extended,
2022.01~2022.03 Manufacturing facilities, etc. 1,967 -
supplemented, etc.
4. Sales
A. Sales performance
B. Sales channel
The most important thing for the Company’s sales activities is to sign contracts with customers since
the CMO business in which the Company is engaged is a contract-based industry. It usually takes 6~12
months to win an order (from the date when a customer’s request for proposal was received until the
date when a contract is concluded), and is implemented as follows :
[Order-winning process]
Category Details
• Inspect the status of customers (organization, number of products,
Discover a
Contact the clinical test progress, capacity, etc.)
potential
customer • Contact a customer when participating in exhibitions and introduce
customer
CMO services
Request for Meeting of • Email, telephone, visit and meeting, etc.
the persons in charge • Take the minutes of a meeting
customer’s Check the volume • Sign a confidential agreement, provide corporate profile data (incl.
CMO(RFP) to order capacity), attract to visit the Songdo site
• Review related divisions of each field
• Financial risk: review differentiated batch prices
Review risks
• Legal risk: existing products ordered, noncompetitive review with
Samsung Biologics’ products
Submit a
• Suggest contract terms in which the customer’s conditions for
proposal
manufacturing process are reflected
Review terms and
• Consider conditions including contract period, time available to
conditions
manufacture, price, scope of services, minimum volume
guaranteed, capacity reserve, etc.
Select candidate
• A customer selects 2~3 candidate CMOs
CMOs
Select a CMO
Select a preferred
• A customer selects a preferred CMO through final evaluation
CMO
• Review related divisions of each field
• Financial risk: minimum volume guaranteed/reserve volume,
Review risks
service sales item, etc.
• Legal risk: liability scope, noncompetitive clauses, etc.
Consult on
Consult on basic • Negotiate on and adjust major conditions
contract terms
contract terms • Prepare MOU and LOI
Consult on
detailed contract • Consult on conditions for master service agreement
terms
Exchange a final
Win a contract • Develop a final contract
contract
Following these procedures, the Company recognizes sales at the point of quality release (QR) by the
customer for the products manufactured, and delivers the customer’s inventory stored in the Company’s
warehouse to a location designated by the customer (generally a customer’s carrier) in accordance with
the contract. Meanwhile, the Company does not have separate sales channels or agencies.
C. Sales method and conditions
The sales method and conditions for biopharmaceutical manufactured by the Company are separately
determined by a contract with the customer. According to the contract, annual minimum volume of
production is determined, and the volume requested for PO by the customer is manufactured and
delivered to the designated location. Sales recognition and billing are implemented at the time when
the customer’s quality approval is obtained for the products manufactured, and the payment is collected
within 30~60 days after billing.
D. Sales strategy
The Company will make new contracts and expand existing contracts by constantly communicating
about the Company’s production capacity, facility expansion progress, and future plans and by
maintaining relationships with existing/potential customers. The Company also leads strategic sales
activities by actively participating in various inner circle meetings to identify demand for
biopharmaceutical production and competitors’ production plans.
In addition, we are expanding our customers from large pharmaceutical companies to small and
medium-sized biotech companies, and to increase orders, we continue to strengthen our marketing
capabilities and expand our global network. Besides, we are enhancing our potential customers'
confidence in our production and quality control capabilities through thorough track record management.
E. Sales condition
Amount
7,758 3,429 4,329
Minimum Take (USD Mil)
or Pay Production
~2031 33,622,000 15,172,000 18,450,000
Antibody (Liter)
2015 *Subject to
drugs each contract Amount
Expected demand 12,176 3,429 8,747
(USD Mil)
when the customers
develop the productsProduction
50,407,000 15,172,000 35,235,000
(Liter)
Note 1) Total contract amounts may also increase after the consultation depending on the increase in customers’ demands.
Note 2) Total contract amounts above exclude raw material revenue from raw materials and supplies that have been put into
production and service revenue from production process improvements and additional services such as quality analysis.
5. Financial Risk Management
The Company’s risk management policies are established to identify and analyze the risks faced by the
Company, to set appropriate risk limits and controls, and to monitor risks and adherence to limits. Risk
management policies and systems are reviewed regularly to reflect changes in market conditions and
the Company’s activities. The Company, through its training and management standards and
procedures, aims to maintain a disciplined and constructive control environment in which all employees
understand their roles and obligations. The Board of Directors oversees how management monitors
compliance with the Company’s risk management policies and procedures and reviews the adequacy
of the risk management framework in relation to the risks faced by the Company.
B. Credit Risk
Credit risk is the risk of financial loss to the Company if a customer or counterparty to a financial
instrument fails to meet its contractual obligations and arises principally from the Company’s receivables
from customers. The carrying amount of financial assets represents the maximum credit exposure. The
maximum exposures to credit risk at the end of 1Q 2022 and 2021 are as follows:
(Unit: KRW Thousand)
C. Liquidity Risk
Liquidity risk is the risk that the Company will encounter difficulty in meeting the obligations associated
with its financial liabilities which are settled by delivering cash or other financial assets. The Company’s
approach to managing liquidity is to ensure, as much as possible, that it will always have sufficient
liquidity to meet its liabilities when they are due, under both normal and stressed conditions, without
incurring unacceptable losses or risking damage to the Company’s reputation.The ultimate
responsibility for liquidity risk management remains with the Board of Directors, which establishes
fundamental policies to adequately manage short-term, medium- and long-term financing and liquidity
management regulations. To maintain adequate liquidity, the Company manages liquidity risk by
periodically forecasting and adjusting its capital balance.
Contractual maturity dates of financial liabilities as of the 1Q 2022 and 2021 are as follows. The amount
includes interest paid and excludes the impact of netting agreements. The Company does not anticipate
that the cash flow included in the maturity analysis could occur significantly earlier or at different
amounts.
(1) End of 1Q 2022
The Company is exposed to currency risk on sales, purchases, and borrowings. The currencies in which
these transactions primarily are denominated are USD and so forth. The Company establishes a plan
to manage currency risk through currency forwards and so forth, if considered necessary.
(1) Exposure to currency risk
The Company’s level of exposure to foreign currency risk is as follows :
(Unit: KRW Thousand)
Assets:
Short-term financial
36,324,000 - - - - - - --
instruments
Liability:
(*) Swap-covered borrowings are excluded as they are not exposed to currency risk.
1Q 2022 2021
Description
Average End Average End
USD 1,204.95 1,210.80 1,144.42 1,185.50
EUR 1,352.44 1,351.13 1,352.79 1,342.34
CHF 1,304.45 1,311.74 1,251.65 1,297.47
JPY(100¥) 1,035.74 992.74 1,041.45 1,030.24
GBP 1,616.62 1,590.81 1,573.96 1,600.25
The Company is exposed to interest rate risk because it raised funds with interest paid at a variable
rate. If the interest rate changes by 0.5% as of the current and previous quarters, the effect of the
change in the interest rate on the income before income tax is as follows :
(Unit: KRW Thousand)
Decrease(Increase) in
(466,027) 466,027 (330,411) 330,411
Interest expense
F. Capital Management
The Company’s capital management is for the purpose of maximizing the shareholders’ interest by
maintaining an optimal capital structure. To achieve optimal capital structure, the Company may improve
its financial structure by monitoring financial ratios, such as the debt-to-equity ratio.
(*) On January 28, 2022, the Board of Directors of the Company resolved to increase its capital for the
acquisition of construction-in-progress and securities of other entities. The Company recognized KRW
815,861 million of derivative liabilities related to 4,339,688 shares of stock warrants granted to existing
shareholders, which was recognized as a decrease in share premium. The debt ratio, excluding the
impact of the issuance of warrants for the current quarter, is as follows:
Description End of 1Q 2022 End of 2021
Liabilities (A) 2,860,541,014 2,978,908,646
Capital (B) 5,137,667,559 4,991,102,141
Debt ratio (A/B) 55.68% 59.68%
G. Derivative Instruments and Put-back Options
The Company has established contracts for financial derivatives for foreign currency borrowings for
the purpose of hedging exchange rate risk of foreign currency receivables/debts and interest rate, and
the details are listed below.
Currency
USD Libor(3M)
Trading interest Hana bank 2018.05.31 2023.05.31 USD KRW 1,080 3.70
30,000,000 + 1.70
swap
Currency
USD Libor(3M)
Trading interest Woori bank 2021.08.30 2024.08.30 USD KRW 1,164 2.15
30,000,000 + 1.20
swap
(*) The details have been prepared based on the date of borrowing.
Interest rate(%)
Financial Contract Contract Maturity
Classification Category
institution Amount Date Date
Received Paid
On January 28, 2022, the Board of Directors of the Company resolved to increase its capital for the
acquisition of construction-in-progress and securities of other entity. The Company recognized KRW
815,861 million of derivative liabilities related to 4,339,688 shares of stock warrants granted to existing
shareholders, which was recognized as a decrease in share premium.
A. License-Out Contracts
- Not applicable
B. License-In Contracts
- Not applicable
C. Sales Contracts
(Unit: USD Mil)
Biopharm Eli Lilly Kinsale Limited CMO 2022.03.28 2029.12.31 92.0 Cash -
D. Other Contracts
E. R&D Activities
Category Details
F. R&D Expenses
(Unit: KRW Bil, %)
1Q 2022 2021 2020
Raw material expenses 25 164 193
Labor expenses 113 444 357
Type of Depreciation expenses 47 160 105
expenses Outsourcing expenses - - -
Others 38 151 131
Total R&D expenses 223 919 786
SG & A expenses 10 34 51
Manufacturing expenses 213 885 735
Accounting
classification Development expenses
- - -
(Intangible Assets)
Total R&D expenses 223 919 786
R&D expenses/ Sales Ratio
4.4% 5.9% 6.7%
[Total R&D expenses / Sales*100]
Note 1) Consolidated basis in accordance with K-IFRS.
Note 2) The Company is not applicable to government subsidies.
G. R&D Performance
7. Other Information
Pharmaceutical manufacturer is under strict government regulation throughout all phases (pre-clinical
phase, clinical phase, IND approval, production and distribution, etc.) due to their nature of providing
products which bring significant impact on human lives.
Laws Details
Unfair Competition
and Prevention and
- Regulate the act of unjustifiably using or disclosing trade secrets of clients
Trade Secret
Protection Act
Act on the
Registration and - Regulate the registration, evaluation, and management of chemical substances that are
Evaluation, Etc. of not controlled as drug and quasi-drug by the Pharmaceutical Affairs Act
Chemical Substances, - Registration and evaluation requires cost and time to import the drug substances that fall
Toxic Chemicals under chemical substances subject to the Act
Control Act
Transboundary
Movement, Etc. of - Inspect the risks posed by living modified organisms
Living Modified - Regulate the import of living modified organisms and registration of the research facility
Organisms Act
- Regulate unfair trading practices and unfair collective practices across the entire business
area including winning an order for CDMO project, building manufacturing facilities, and
Fair Trade Act
purchasing materials
- Impose corrective measures, penalty, fine, etc. if related matters are violated
B. Business-related Important Intellectual Property Rights
During the first half of 2020, the Company launched its proprietary cell line development platform S-
CHOice. As of the end of 2021, The brand name S-CHOice has officially obtained its trademarks in six
countries (Korea, US, EU, UK, China, and Japan). In addition, S-Cellerate, a CDO platform brand that
compiles our accumulated know-how, expertise, and innovative technology across all areas of
consignment development service, was completed the registration of domestic trademarks in December
2021. The Company completed the trademark registration of the slogan Driven. For Life. in South Korea
and Madrid as of the end of 2021. In addition, the Company strives to secure intellectual property/
trademark rights, including related patent and trademark rights, through continuous research
development related to biopharmaceutical manufacturing.
C. Environmental Regulations
With an environmental policy placing environmental contaminant reduction and green values at the top
of its priorities, the Company commits itself to do all it can to prevent undesired environmental events
and make utmost efforts to lead the sustainable future.
To put this into practice, the Company strives to achieve compliance with environmental regulations and
reduce contaminant generation in addition to actively being engaged in chemical accident prevention
by implementing a life cycle management system for all chemicals handled in its business sites. In
addition, the Company follows regulatory requirements for contaminant emission standards, reports the
amount of greenhouse-gas emission and energy usage and transparently discloses relevant
information to its stakeholders in order to meet the government’s low-carbon growth policies and
responses to climate change.
(Business site management, compliance with environmental regulations and contaminant reduction)
The Company has installed and is operating various facilities for water pollution prevention, air pollution
prevention, waste storage, noise control, etc. to minimize emission of contaminants generated from
biomedicine manufacturing processes so that impact on the surrounding social environment can be
minimized. For business site environment management, regular self-inspections in addition to
management and supervision of relevant authorities have been carried out. As such, the Company’s
excellent environment control capability was acknowledged by being selected as the Best Company for
Environment Management by the City of Incheon three times, in 2015, 2018 and 2021.
The Company discloses transparent information on environmental emission performance and operational
status each year and is making efforts for regulatory compliance and contaminant reduction through
continued investment.
Integrated Chemical
- The Company is making efforts to prevent chemical accidents across the
Substance
Company by managing the lifecycle (entire process) of chemical
Management
substances using the chemical substance management system.
System
Greenhouse-gas emission and energy consumption for the recent five years are as follows :
※ The subjects are our plant, shuttle bus, rental building, etc.
※ The data provided above is submitted to the “National Greenhouse Gas Management System.”
※ Emissions and energy consumption may change depending on the verification results of external verification agencies.
※ Refer to H. Green management in 4. Subsequent events under XI. Other Information for details.
D. Industry Overview
Blockbuster biopharmaceuticals released around the year 2000 (immunosuppressant drugs, anticancer
drugs, antidiabetic drugs, etc.) still show a high level of sales growth, and new promising antibody drugs
for hyperlipidemia, Alzheimer’s disease, and atopic dermatitis along with immune checkpoint inhibitors
continue to be released.
Pharmaceutical companies are expanding the areas of production outsourcing to specialized CMOs
where massive capital investments are required to minimize the uncertainty in marketing authorization
and sales forecasting of drugs. This market change gives a new opportunity to CMOs.
Global CDMO companies are aiming for a one-stop shop model that can provide end-to-end services
to reduce pharmaceutical companies' development to production, clinical development to
commercialization needs, and complexity of a single project.
Recently, regulatory authorities across the world have strongly recommended pharmaceutical
companies to secure a source for stable drug production. The U.S. Food and Drug Administration (FDA)
requested pharmaceutical companies to establish a contingency plan, believing that supply stability
cannot be guaranteed in case the drug is manufactured in a single site. Accordingly, pharmaceutical
companies are making use of CMOs to run multiple manufacturers for a single drug.
In 2022, the global biopharmaceutical market is valued at USD 360 billion, which accounts for 39.3%
of the entire pharmaceutical market. The market is expected to increase with an average growth rate of
10.3% in 2026, boosting the growth of the overall pharmaceutical industry.
Biopharmaceutical Market Size
Source: EvaluatePharma, Apr 2021 and Mckinsey report
The global bio-CDMO market is valued at USD 14.3 billion in 2022 and is forecasted to reach USD 20.3
billion by 2026 at an average growth rate of 10.1% for the next five years.
E. Competition Status
The Company has emerged as a global bio CMO based on production facilities by securing a total
capacity of 364,000 liters with 360,000L (Plant 1 – 30,000L, Plant 2 – 150,000L, Plant 3 – 180,000L) of
commercial production facilities and 4,000L of clinical production facilities in Songdo Free Economic
Zone (Songdo District) in Incheon. As of 2022, competitors with similar capacity of more than 300,000
liters include Switzerland-based Lonza and Germany -based Boehringer Ingelheim. In addition, China-
based Wuxi Biologics and US-based Fujifilm Diosynth are aggressively expanding capacity both
domestically and internationally.
F. Competitiveness
The Company is currently widening the scope of business to CDO services, mRNA and cell/gene
therapy to transform into global biopharmaceutical company. The CDO business provides cell line and
process development and characterization services for small and medium-size Biotechs, which do not
have own development facilities. The Company launched high-performing cell line ‘S-CHOice’, which
delivers high productivity and viability, and ‘S-Cellerate’, which is a platform that innovatively shortens
the development period through a standardized process for each development stage. Furthermore, the
Company opened its first global CDO R&D center in the renowned San Francisco Biopharma Cluster
in October 2020 and currently plans to widen the scope of the market including Boston, Europe, and
China.
The Company has implemented mRNA production capacity within its existing manufacturing plant,
which is set to be cGMP ready by the first half of 2022. In November 2021, the company signed a land
purchase agreement for a new plant with production capacity for mRNA and cell/gene therapy products.
III. Financial Affairs
1. Financial Statements
Refer to Audited Financial Statements published on the Company’s Website.
6. Dividends
In accordance with the Articles of Incorporation, the Company can pay out dividends of profits in cash
or shares, with the approval granted by the Board of Directors. For shareholders’ value enhancement,
dividends will be determined, considering the Company’s investment plan, financial status, and
dividends sustainability. We plan to review whether to pay cash dividends within 10% of free cash flow
(FCF) for the year after 2025.
The Company’s articles of incorporation regarding dividends are provided in the Articles 48 and 49.
Article Content
Common - - -
Cash dividend yield (%)
Preferred - -
Common - -
Share dividend yield (%)
Preferred - -
Common - -
Cash dividend per share
(KRW)
Preferred - -
Common - -
Stock dividend per share
(share)
Preferred - -
C. Dividend History
- - - -
※ The Company has no dividend payout history in the past five years.
7. Matters About Financial Through the Issuance of Securities
7-1. Financing Through the Issuance of Securities
[Issuance of Equity Securities]
- - - - - - - - - -
- - - - - - - - - -
Total - - - - - - - - -
B. Commercial Paper Balance
Under Above 10 days Above 30 days Above 90 days Above 180 days Above 1 year Above 2 years
Issuing company Above 3 years Total
10 days /under 30 days /under 90 days /under 180 days /under 1 year /under 2 years /under 3 years
Public - - - - - - - - -
Balance Private - - - - - - - - -
Total - - - - - - - - -
Under Above 10 days Above 30 days Above 90 days Above 180 days
Issuing company Total Issue limit Balance limit
10 days /under 30 days /under 90 days /under 180 days /under 1 year
Public - - - - - - - -
Balance Private - - - - - - - -
Total - - - - - - - -
D. Corporate Bond Unredeemed Balance
Under Above 1 year Above 2 years Above 3 years Above 4 years Above 5 years
Issuing company Above 10 years Total
1 year /under 2 years /under 3 years /under 4 years /under 5 years /under 10 years
Unredeemed
Private - 40,000 - - - - - 40,000
Balance
Under Above 1 year Above 5 years Above 10 years Above 15 years Above 20 years
Issuing company Above 30 years Total
1 year /under 5 years /under 10 years /under 15 years /under 20 years /under 30 years
Public - - - - - - - -
Unredeemed
Private - - - - - - - -
Balance
Total - - - - - - - -
F. Contingent Convertible Bond Outstanding Balance
Above 1 year Above 2 years Above 3 years Above 4 years Above 5 years Above 10 years Above 20 years Above
Issuing company Under 1year Total
/under 2 years /under 3 years /under 4 years /under 5 years /under 10 year / under 20 years / under 30 years 30 years
Public - - - - - - - -
Balance Private - - - - - - - -
Total - - - - - - - -
Contract details Total collateral value remains under 200% of consolidated equity
Constraint on collateral
Implementation status Fulfilled (0%)
Constraint on disposal of assets Contract details Total restricted value remains under 80% of consolidated assets
(excl. financial assets and inventories)
Implementation status Fulfilled (No disposal of assets exceeding KRW 6.1 trillion)
Plan Actual
Classification Name of bond Date of issuance Reason for difference
Purpose Amount raised Purpose Amount used
7-1 Public Investment in Investment in
Corporate bond 2021.09.03 380,000 380,000 -
non-guaranteed bond manufacturing plant manufacturing plant
7-2 Public Investment in Investment in Currently reviewing the
Corporate bond 2021.09.03 120,000 78,556
non-guaranteed bond manufacturing plant manufacturing plant investment plan
Plan Actual
Classification Name of bond Date of issuance Reason for difference
Purpose Amount raised Purpose Amount used
- - - - - - - -
C. Unused Funds Management Report
(As of March 31, 2022) (Unit: KRW Mil)
Type of financial instrument Name of financial instrument Amount Contract period Investment term
Total 41,444 -
8. Other Financial Information
- Other matters requiring attention in relation to the use of the financial statements
(2) Ruling of the securities and Futures Commission in relation to the accounting for investment
in Samsung Bioepis Co., Ltd., the related administrative lawsuit and the indictment
Refer to Note 25 in Notes to Consolidated Financial Statements, published on the Company’s website
for detailed information about the litigation.
B. Allowance for Bad Debt
(1) Allowance for bad debt by account for the past 3 years
(Unit: KRW Mil, %)
Write off - - -
(3) The guideline for bad debt allowance for account receivables
- Calculation of bad debt allowance
Calculation of bad debt allowance by applying the expected credit loss model that considers the
expected bad debt in the future to the balance of trade and other receivables as of the reporting date.
- Calculation basis of write-off experience rate and future expected bad debt
1. Write off experience rate is calculated using credit loss rate of all account receivables for all
historical period
2. Future expected bad debt is determined taking into consideration cases of debtor bankruptcy,
compulsory execution, death, disappearance, credit information of debtor and forward-looking
information.
(4) The outstanding period of account receivables
(As of March 31, 2022) (Unit: KRW Mil)
C. Inventory
Material in
184,14 0,898 192,475,049 147,250,544
transit
① Inspection date
• External auditors join and observe the inspection once a year near year-end (Late Dec. -
Early Jan.). In accordance with the internal regulation, internal inspection is carried out once
a month.
• For the difference in inventories between the inspection date and the end of the year, the
Company checks using warehouse record to confirm the inventories as the date of financial
statements.
② Inspection methodology
• All items for monthly internal inspection.
• External auditors join and observe the inspection and carry out sample test to check the
existence and completeness of inventory.
③ Obsolete Inventory
• If the net realizable value of inventories falls below the acquisition cost, the valuation loss
allowance is recognized to determine the value of the inventory assets in the statement of
financial position;
• The evaluation details of inventories as of March 31, 2022 are as follows.
Inventory Ending
Classification Acquisition cost Gross inventory
write-down Balance
Trade receivables and debt securities issued are initially recognized when they are issued. Other
financial instruments or liabilities are recognized only when the company becomes a party to the
contractual provisions of the instrument.
Except for trade receivables which do not contain a significant financing component, financial assets or
liabilities are measured at their fair value at initial recognition, and transaction cost directly attributable
to the acquisition of the financial assets or issuance of the financial liabilities is added to or subtracted
from the fair value if they are not financial assets or liabilities measured at fair value through profit or
loss. Trade receivables without a significant financing component are measured at their initial
transaction price.
Financial assets are not reclassified after the initial recognition unless the company changes its
business model for managing financial assets in which case all affected financial assets are reclassified
on the first day of the first reporting period following the change in the business model.
A financial asset that meets the following two conditions is measured at amortized cost unless the asset
is designated to be measured at FVTPL.
- The financial asset is held within a business model whose objective is to hold assets in order to collect
contractual cash flows
- The contractual terms of the financial asset give rise to cash flows that are solely payments of principal
and interest (SPPI) on the principal amount outstanding on specified dates
A debt instrument that meets the following two conditions is measured at FVOCI unless the asset is
designated to be measured at FVTPL.
- The financial asset is held within a business model whose objective is achieved by both collecting
contractual cash flows and selling financial assets.
- The contractual terms of the financial asset give rise to cash flows that are SPPI on specified dates
At initial recognition of an equity instrument that is not held for short-term trading, the company has the
irrevocable option to present subsequent changes in investment assets’ fair value in other
comprehensive income (OCI). This decision is made by investment assets.
All financial assets are measured at FVTPL unless they are measured at the aforementioned amortized
cost or FVOCI. This includes all financial derivatives. At initial recognition, the company has the
irrevocable option to designate financial assets to be measured at FVTPL, which are measured at
amortized cost or FVOCI, if doing so eliminates or significantly reduces an accounting mismatch.
However, the decision cannot be canceled afterwards.
- The stated policies and objectives for the portfolio and the operation of those policies in practice which
include management’s strategy focused on earning contractual interest income, maintaining a particular
interest rate, matching the duration of the financial assets to the duration of the liabilities that are funding
those assets, and expected cash outflows or realizing cash flows through the sale of the assets
- How the performance of the financial assets held in the business model is evaluated and reported to
the management
- The risks that affect the performance of the business model (and the financial assets held within that
business model) and how those risks are managed
- How members of the management are compensated (e.g., whether compensation is based on the fair
value of the assets managed or based on the contractual cash flows collected); and
- The frequency, amount, and timing of sales of financial assets in prior periods, reasons for such sales
and expectations about future sales activity.
Transfers of financial assets to third parties in transactions that do not qualify for derecognition are not
considered sales for this purpose.
A portfolio of financial assets whose performance is evaluated on a fair value-basis or that is held for
short-term trading is measured at FVTPL.
2) Financial assets: Assessment of whether contractual cash flows are solely payments of principal and
interest (SPPI). Principal is defined as the fair value of the financial asset on initial recognition. Interest
is defined as compensation for the time value of money, credit risk associated with the principal amount
outstanding during a particular period, and other basic lending risks and costs (e.g., liquidity risk,
administrative costs), as well as a profit margin.
In assessing whether contractual cash flows are SPPI, the company considers the contractual terms of
the instrument. If the financial asset contains a contractual term that could change the timing or amount
of contractual cash flows, which may give rise to the cash flows over the life of a financial instrument,
the company should assess whether the contractual cash flows are SPPI.
Additionally, for the financial asset acquired at a significant discount or premium to the contractual par
-amount, a prepayment amount that substantially represents the contractual par-amount and accrued
contractual interest (but unpaid), (which may include reasonable additional compensation for early
termination of the contract), is assessed as consistent with this criterion if the fair value of the
prepayment feature is insignificant at initial recognition.
③ Derecognition
The company derecognizes its financial assets, when the contractual rights to the cash flow from the
financial assets expire, when the company transfers its contractual rights to receive the cash flows from
the assets in a transaction in which substantially all of the risks and rewards of ownership of the financial
asset are transferred, or when the company neither transfers nor retains substantially all of the risks
and rewards of ownership and does not retain control of the financial asset.
Conversely, the company continues to recognize the assets if it retains substantially all the risks and
rewards of ownership of the transferred assets after transferring the assets recognized in the company’s
statement of financial position.
④ Offsetting
Financial assets and financial liabilities are offset and the net amount is presented in the statement of
financial position only when the company has a current and legally enforceable right to set-off all the
recognized financial assets and liabilities, and when the company has an intention to settle them on a
net basis or to realize the asset and settle the liability simultaneously.
Non-derivative financial liabilities, not classified as at FVTPL, are classified as other financial liabilities.
At initial recognition, other financial liabilities are measured at fair value after deducting transaction
costs that are directly attributable to the issue of the financial liability. At subsequent recognition, other
financial liabilities are measured at amortized cost using the effective interest method and interest costs
are recognized using the effective interest method as well.
The company derecognizes financial liabilities only when the obligation specified in the contract is
discharged, canceled, or expires. The company derecognizes original financial liabilities when there are
changes in cash flows under new terms of financial liabilities in the contract and recognizes new
financial liabilities at fair value based on the new terms.
When financial liabilities are derecognized, the difference between the carrying amount and the
consideration paid (including any non-cash assets transferred or liabilities assumed) is recognized in
profit or loss.
(3) Derivatives
If embedded derivatives' host contract is not financial asset and meets certain criteria, such embedded
derivatives are separately accounted from host contract.
Derivatives are measured initially at fair value. Subsequent to initial recognition, derivatives are
measured at fair value, and changes therein are generally recognized in profit or loss.
At the initiation of hedging relationships, the company documents the risk management objective and
strategy for undertaking the hedge. The company documents the economic relationship between the
hedging instrument and the hedged item, including the extent to which changes in cash flows of the
hedging instrument offset changes in cash flows of the hedged item.
If derivatives are designated as cash flow hedging instruments, the effective portion of changes in the
fair value of the derivatives is recognized in OCI and accumulated in the hedging reserve. The effective
portion of changes in the fair value of the derivatives recognized in OCI, from inception of the hedge, is
limited to the amount of cumulative changes in the fair value of the hedged item determined on a present
value basis. The ineffective portion of changes in the fair value of the derivatives is immediately
recognized in profit or loss.
For the hedged forecast transaction which results in the recognition of a non-financial item (such as
inventory), the accumulated amount in the hedge reserve and the cost of hedging is directly included in
the initial cost of non-financial assets when the non-financial assets are recognized. For all other hedged
forecast transactions, the accumulated amount in the hedge reserve and the cost of hedging is
reclassified to profit or loss in the same period or periods during which the hedged expected future cash
flows affect profit or loss.
The company has a free choice to prospectively discontinue hedge accounting if the hedging
relationship no longer complies with the qualifying criteria or if the hedging instrument expired or has
been sold, terminated, exercised.
For hedges of a transaction which results in the recognition of a non-financial item, when cash flow
hedge accounting is discontinued, the accumulated hedge reserve and the cost of hedging should be
held in equity until the non-financial item is initially recognized and included in the cost of non-financial
item. For other cash flow hedges, the amounts are reclassified to profit or loss in periods during which
the hedged expected future cash flows affect profit or loss as a reclassification adjustment, that includes
the cash flow hedge reserve and the cost of hedging reclassified to profit or loss.
If a hedged future cash flow is no longer expected to occur, the amounts are immediately reclassified
from the accumulated cash flow hedge reserve and the cost of hedging to profit or loss as a
reclassification adjustment.
The amount recognized in OCI is reclassified to profit or loss as a reclassification adjustment when a
foreign operation that was hedged is disposed of.
(4) Financial Instruments by Category
Currency
USD Libor(3M)
Trading interest Hana bank 2018.05.31 2023.05.31 USD KRW 1,080.00 3.70
30,000,000 + 1.70
swap
Currency
USD Libor(3M)
Trading interest Woori bank 2021.08.30 2024.08.30 USD KRW 1,164.00 2.15
30,000,000 + 1.20
swap
Interest rate(%)
Financial Contract Contract Maturity
Classification Category
institution Amount Date Date
Received Paid
Financial Financial
liabilities at Other liabilities Total liabilities at Other liabilities Total
amortized cost amortized cost
Current
liabilities
Trade and
other 232,956,191 - 232,956,191 342,930,338 - 342,930,338
payables(*)
Short-term
50,000,000 - 50,000,000 50,000,000 - 50,000,000
borrowings
Current
portion of
110,108,000 - 110,108,000 109,855,000 - 109,855,000
long-term
borrowings
Derivative
instrument - 815,861,344 815,861,344 - - -
liabilities
Lease
7,196,238 7,196,238 - 7,537,132 7,537,132
liabilities
Subtotal 393,064,191 823,057,582 1,216,121,773 502,785,338 7,537,132 510,322,470
Non-current
liabilities
Trade and
other 1,324,248 - 1,324,248 2,648,496 - 2,648,496
payables(*)
Debentures 538,691,065 - 538,691,065 538,553,996 - 538,553,996
Long-term
577,648,000 - 577,648,000 576,130,000 - 576,130,000
borrowings
Lease
- 9,521,612 9,521,612 - 10,671,166 10,671,166
liabilities
Subtotal 1,117,663,313 9,521,612 1,127,184,925 1,117,332,492 10,671,166 1,128,003,658
Total 1,510,727,504 832,579,194 2,343,306,698 1,620,117,830 18,208,298 1,638,326,128
(*) Annual allowances and performance bonuses to be paid to employees are excluded.
Carrying amount and fair value of financial assets as of the end of 1Q 2022 and 2021 are as follows :
(Unit: KRW Thousand)
① End of 1Q 2022
(Unit: KRW Thousand)
Level 1 Level 2 Level 3 Total
Financial assets :
Financial assets at
fair value through - 450,017,884 - 450,017,884
profit or loss
Derivative financial
- 7,055,818 - 7,055,818
instrument assets
Financial liabilities :
Derivative financial
- 815,861,344 - 815,861,344
instrument liabilities
② End of 2021
Valuation techniques and significant inputs used in measuring the fair value of financial instruments
classified as level 2 of the fair value hierarchy, are as follows :
Net gains or losses on each category of financial instruments as of the end of 1Q 2022 and 2021, are
as follows :
(Unit: KRW Thousand)
Interest income
Gain on valuation Other income (*) Net income (loss)
(expenses)
2022 2022 2022 2022
2021 2021 2021 2021
1Q 1Q 1Q 1Q
Financial
assets at
5,133,630 2,390,085 - - (201,033) 7,452,557 4,932,597 9,842,642
amortized
cost
Financial
assets at
fair value
- - 20,350 10,162 127,107 49,894 147,457 60,056
through
profit or
loss
Derivative
- - 2,963,847 1,842,454 - - 2,963,8474 1,842,454
assets
Financial
liabilities
at (2,857,976) (3,904,087) - - 3,439,478 (331,740) 581,502 (4,235,827)
amortized
cost
Other
(59,809) (217,487) - - - - (59,809) (217,487)
liabilities
Total 2,215,845 (1,731,489) 2,984,197 1,852,616 3,365,552 7,170,711 8,565,594 7,291,838
(*) Other income and expenses include gain (loss) on foreign currency translations and transactions,
and gain (loss) on disposal of financial assets at fair value through profit or loss.
(5) Re-measurement details of fixed assets
No re-measurement of fixed assets was carried out during the reporting period.
IV. Directors’ Management Discussion & Analysis
Pursuant to the reporting guidelines set forth by the Financial Supervisory Service of the Republic of
Korea, the Management Discussion and Analysis section, reported in annual report, is not included in
the quarterly and half year reports.
V. Auditor’s Report
Business
Auditor Auditor’s opinion Emphasis, etc. Key Audit Matters
year
(*) A review of the quarterly financial statements was conducted and all matters were presented fairly, in all material respects.
※ Auditor’s opinion for 1Q 2022, 2021, and 2020 is on both separate and consolidated financial statements.
※ The schedule above is for the audit and review of separate and consolidated financial statements.
B. Audit service contract
(Unit: KRW Thousand, hour)
Contract Actual
Business
Auditor Details
year Audit Audit Audit Audit
fee hour fee hour
- Review of the interim separate/consolidated financial statements
2022 Samil
- Audit of separate/consolidated financial statements 1,480,000 9,828 280,000 1,421
1Q PwC
- Audit of Internal Control over Financial Reporting (ICFR)
C. Status of signing audit services related to the investee under the equity method with auditors
(Unit: KRW Thousand, hour)
Business year Contract date Service details Service period Service fee Remarks
Business year Contract date Service details Service period Service fee Remarks
2022
- - - - -
1Q
On July 12, 2018 and November 14, 2018, the Company was notified of the designation of auditors for
3 years as a result of actions by the Securities and Futures Commission, and concluded an audit
contract with Samjong KPMG LLC and the external auditor of the 7th and 8th business years, while
signing a new contract with the designated auditor, Hanyoung EY. The Company has appointed Samil
PwC as an external auditor for three consecutive business years since 2019 in line with the Audit
committee's evaluation process in accordance with the Audit committee's operational regulations, as
the application to suspend the ruling of a request to withdraw the measure recommended by the
Securities & Futures Commission has been cited.
In accordance with Article 10 (4) of the Act on external audits of corporations and others and Article 12
(1) of the Enforcement Decree of the Same Act, the audit committee held a face-to-face meeting on
November 19, 2021 to appoint Samil Accounting Firm as the external auditor for 2022 and three
consecutive business years. Accordingly, the Company signed the audit contract to appoint Samil
Accounting Firm as the 12th~14th external auditor.
Business
Auditor Audit opinions Remarks
year
2022 Samil
- -
1Q PwC
※ Resolution Items: Approved For For For For For For For - -
1. Approval of meeting and objectives of
general meetings of shareholders.
1. Nomination of Board of Director's Approved For For For - - For For For For
6th ’22.03.29
committee members
1. Participation in paid-in capital increase by Approved For For For - - For For For For
related parties
th
7 ‘22.03.29 2. Review of compensation limit for directors Approved For For For - - For For For For
3. Signed contract to purchase 2nd Approved For For For - - For For For For
4. Approved For For For - - For For For For
※ From 11th Board of Directors meeting held on March 29, 2022, independent directors Kwon Soonjo and Jeong Seokwoo
resigned, and Lee Changwoo and Bahk Jaewan were newly appointed as independent directors.
※ Jan 24, 2022 (1st round), Details of “Approval of transactions with related parties”
※ Jan 28, 2022 (4th round), Details of “Approval of stock purchase agreement resolution”
※ Mar 29, 2022 (7th round), Details of “Participation of paid-in capital with related parties”
(1) Committees
Committee
Composition Name Purpose & authority Remarks
Name
[Purpose]
To deliberate the matters entrusted by the BOD out of
the Company’s material management information,
matters often entrusted by the BOD, and matters
(Chairperson) entrusted by the BOD as other material management
Management information
2 Executive John Rim
committee -
directors
(‘11.04.22) [Main authorities]
Kim Dongjoong
① General management
② Matters regarding finance
③ Other related matters
Committee
Composition Name Purpose & authority Remarks
Name
[Purpose]
To secure objectivity and transparency in determining
director compensation
[Main authorities]
(Chairperson)
3 Independent Bahk Jaewan ① Matters regarding the compensation limit of
Compensation
directors registered directors
committee -
1 Executive Heo Geunnyung
(‘16.08.10) ② Matters regarding performance evaluation criteria
director Eunice Kim
Kim Dongjoong of registered directors
③ Matters regarding the compensation system of
registered directors
④ Matters entrusted by the Board of Directors
regarding director compensation
[Purpose]
To deliberate large-scale related party transactions in
order to strength internal control over related party
transactions and external control over shareholders
and to enhance the efficiency of supervision over
illegal support
Related party (Chairperson)
transaction 3 Independent Heo Geunnyung
[Main authorities] -
committee directors
(‘16.08.10) Lee Changwoo ① To approve related party transactions
② To listen to the report of related party transactions
③ To order an ex-offcio investigation of related party
transactions
④ To suggest a corrective action against related
party transactions
[Purpose]
To deliberate policies regarding Environmental,
Social, and Corporate Governance issues including
Corporate Social Responsibilities, shareholder value
(Chairperson) enhancement, customer value enhancement and
Eunice Kim shareholding structure.
ESG
4 Independent
Committee -
directors Heo Geunnyung
(‘21.02.26) [Main authorities]
Lee Changwoo
Bahk Jaewan
① Matters regarding ESG strategy and policy
Director
(Attendance rate)
Date Details of agendas Result
John Rim Kim Dongjoong
(-%) (-%)
- - - - -
② Compensation committee
Director
(Attendance rate)
Kwon Heo Eunice Kim
Date Details of agendas Result
Soonjo Geun Kim Dong
nyung joong
(100%) (100%) (100%) (100%)
1. Assignment of employee stock ownership Approved For For For For
2. Review of 2022 individual annual income Approved For For For For
‘22.02.25 of executive directors
3. Review of 2022 compensation limit for Approved For For For For
registered directors
Director
(Attendance rate)
Date Details of agendas Result Heo Lee Bahk
Geunnyung Changwoo Jaewan
(100%) (100%) (100%)
1. Appointment of chair of related party Approved For For For
transaction committee
‘22.03.29
2. Participation in paid-in capital increase by Approved For For For
related parties
※ Details of March 29, 2022 agendas
④ ESG committee
Director
(Attendance rate)
Eunice Jeong Kwon Heo
Date Details of agendas Result
Kim Seok Soonjo Geun
woo nyung
(100%) (100%) (100%) (100%)
[Bill]
‘22.01.24 1. Approval of charitable contribution of idle Approved For For For For
raw materials
※ The ESG committee was newly established on February 26, 2021.
D. Independence of Directors
Relationship
Consecutive
Term with the
Name terms Appointment background Nominator Responsibility
expiration largest/major
(No.)
shareholder
- Contributed to the
transplantation of advanced
company management system
to the Company based on past
experience of working for
Samsung Electronics
Executive
Kim ‘25 O Board of Affiliate
- Expected to contribute to the Director
Dongjoong AGM (2) Directors Executive
Company's continued growth by CFO
overseeing HR, IT, Finance,
Business planning and Business
Innovation departments, which
are the company's key
management functions.
Relationship
Consecutive
Term with the
Name terms Appointment background Nominator Responsibility
expiration largest/major
(No.)
shareholder
※ From 11th Board of Directors meeting held on March 29, 2022, executive director Kim Dongjoong and independent director
Heo Geunnyung were re-appointed, and audit committee member Lee Changwoo and independent director Bahk Jaewan
were newly appointed.
The Company operates the Board of Directors Secretariat consisting of 6 full-time staff, to support
independent directors perform their professional duties. The staff provide the directors with reference
materials corresponding to the meeting agendas well in advance the meeting. This enables directors
study and review each agenda discussed during the Board of Directors/Committee meetings. If
necessary, the Directors are provided with separate information sessions on any agenda and they are
also frequently provided updates on other key management issues.
(1) Secretariat for Independent directors
Name Number Department/Position Task
Jeong Seokwoo
2020.01.13 JP Morgan Kwon Soonjo - - JP Morgan Healthcare conference
Heo Geunnyung
Jeong Seokwoo
Korea Health Industry Kwon Soonjo
2020.05.18 - - BIO KOREA 2020 (Online)(~05.23)
Development Institute Heo Geunnyung
Eunice Kim
2. Audit System
※ On March 29, 2022, the audit committee member Jeong Seokwoo and independent director Kwon Soonjo's terms expired.
※ On March 29, 2022, independent director Heo Geunnyung was re-appointed as an audit committee member, and Lee
Changwoo and Eunice Kim were newly appointed as independent directors.
B. Independence of Audit Committee Members
Relationship
Relationship
Appointment Reappointment with the
Name Recommendation Term with the
Background (No.) largest/major
Company
shareholder
- An accounting
expert (KICPA
and AICPA)
and doctorate
of Business
Administration.
he served as a
he has high
level of
understanding
in corporation
from multiple
independent
director
experiences.
- Expects Independent Affiliate
Lee contribution to director Executive
Chang enhancement 2022.03~2025.03 X -
Recommendation (SBL)
woo of Committee
competitivenes
s and
increasing the
rights and
interests of
stakeholders,
including
shareholders,
by performing
objective
management
supervisory
roles based on
expertise and
active board
activities
- As an expert in
legal field
(lawyer), He
served as
presiding judge
at the Seoul
Central District
Court and a
professor at the
Judicial
Research and
Training
institute Independent Affiliate
Heo
director O Executive
Geun - With 2022.03~2025.03 -
Recommendation (1) (SBL)
nyung considerable Committee
experience in
legal practice
and academic
fields, he will
play a crucial
role in
inspection and
reinforcement
of the
Company’s
legal system
Relationship
Relationship
Appointment Reappointment with the
Name Recommendation Term with the
Background (No.) largest/major
Company
shareholder
- Successfully
performed
various
positions such
as compliance
attorney at the
global
company,
independent
director, and
professor.
- Expects high
contribution in
inspection and
reinforcement Independent Affiliate
Eunice of the director Executive
2022.03~2023.03 X -
Kim Company’s Recommendation (SBL)
compliance Committee
monitoring
system and
practice of
ethical
management
system.
Expects
diverse and
strengthened
internal control
system as a
first female
independent
director.
The Company’s Audit committee is formed in accordance with Article 542-11 of the Commercial Act,
and three independent directors who constitute the Audit committee as stated above meet eligibility
requirements for both Independent directors and Audit committee members.
Details Qualifications Remarks
Qualified
More than 2/3 of independent directors Article 415-2
(All independent directors)
Qualified
Representative of Audit committee must
(Independent director: Article 542-11
be an independent director
Lee Changwoo)
Other qualification
(Related parties of the largest Qualified Article 542-11
shareholders, etc)
Meanwhile, the Audit committee is eligible to request reports on business performance and financial
status from Directors and requests additional reviews and supplementation of data as needed.
C. Activities of Audit Committee
Director
(Attendance rate)
Date Details of agendas Result
Jeong Kwon Heo Lee Eunice
Seokwoo Soonjo Geunnyung Changwoo Kim
(100%) (100%) (100%) (100%) (100%)
※ Reported Items:
1. 2021 financial statements and annual - - - -
‘22.01.24
business report
2. Audit activities by external auditor - - - -
※ Reported Items:
1. 2nd interim report from 3rd Assessment - - - -
committee
2. Audit activities by external auditor - - - -
3. Results of internal accounting - - - -
performance evaluation by the CEO
‘22.02.04 4. Performance and independence of - - - -
the Audit committee
5. Assessment result of the internal audit - - - -
department
6. Report on audit results of 1H 2021 - - - -
7. Report on the progress of major
issues - - - -
※ Reported Items:
‘22.02.15 1. 2nd Report on the progress of major - - - - Not Not
issues Applicable Applicable
(Newly (Newly
※ Reported Items: appointed) appointed)
1. 2nd Report on the results of internal - - -
-
accounting performance evaluation by
the CEO
2. 2nd Report on performance and - - -
‘22.02.21 -
independence of the Audit committee
3. 2nd Report on assessment result of - - -
-
the internal audit department
4. 3rd Report on the progress of major - - -
-
issues
※ Reported Items:
1. Operation status of internal - - - -
accounting control system
2. Progress of the assessment on - - - -
‘22.02.25 internal accounting control system by
PA
3. Progress of the end-of-year audit - - - -
※ Resolution Items:
1. Approval of agenda for the 11th AGM Approved For For For
※ Reported Items:
1. Entry education for newly appointed - - - -
auditors
2. Annual operation plan of the Audit - Not Not - - -
committee Applicable Applicable
‘22.03.29 - -
3. Annual plan of Internal accounting - (End of (End of -
management system term) term)
※ Resolution Items:
1. Appointment of chairman of audit Approved For For For
committee
D. Education Plan & Status of Audit Committee
Education plan
Reasons for
Date Educator Attendant Education contents
absence
※ In order to enhance the Audit committee's understanding of internal accounting and business through communication with the
Audit committee, the Company has been delivering various information to the auditors in the form of newsletter, including
biweekly work, trends related to internal accounting, and the status of the Company and pharmaceutical industry.
F. Compliance Officer
Name Career Qualification
- Master degree in Laws, Seoul National University (1996),
Moon 45th bar exam. Qualified
Hyung - Lawyer, Law firm KIM CHANG & LEE (2006~2017) (Article 542-13 Clause 5
Woo - Team leader, Legal Compliance Team, No. 1 of Commercial Act)
Samsung Biologics Co., Ltd. (2017~present)
A. Voting System
(As of March 31, 2022)
10th (2021)
Implementation - -
Annual General Meeting
D. Voting Shares
The Company has 66,165,000 shares of common stock outstanding, which account for 13.23% of the
total number of authorized shares (500 million shares). The number of shares available for exercising
the voting right is 66,113,694 shares excluding 51,306 shares in a special account of Samsung Life
Insurance, the Company’s financial affiliate company.
Number of
Classification Remarks
shares
Common stock 66,165,000 -
Number of outstanding shares (A)
Preferred stock - -
Common stock - -
Number of shares with revived voting
rights(E) Preferred stock - -
E. Stock affairs
Article 11 (Issuance and allocation of shares)
① The Company may issue new shares with a resolution of the BOD by:
1. Granting the shareholders opportunities to subscribe for new shares in proportion to their
respective shareholding;
2. Granting specific persons (including the shareholders of the Company) opportunities to
subscribe for new shares to the extent of not exceeding 30/100 of the total number of
issued and outstanding shares (the total number of issued and outstanding shares herein
shall include new shares to be issued under this Sub-Paragraph) by a method other than
that under Sub-Paragraph 1 (i.e. private placement) for managerial purpose of the
Company such as improvement of financial structure, introduction of new technology,
strategic partnership, etc.;
3. Granting general public (including the shareholders of the Company) opportunities to
subscribe for new shares and allocating new shares to those who subscribe for such
shares to the extent of not exceeding 50/100 of the total number of issued and
outstanding shares (the total number of issued and outstanding shares herein shall
include new shares to be issued under this Sub-Paragraph) by a method other than that
under Sub-Paragraph 1.
② When allocating new shares under Sub-Paragraph 3 of Paragraph 1 above, the Company
shall allocate new shares with a resolution of the BOD by::
Details of stock 1. Allocating new shares to unspecified subscribers without differentiating the types of
warrants in the persons who are granted opportunities to subscribe for new shares;
articles of 2. Allocating new shares to the members of the Employee Stock Ownership Association
incorporation pursuant to applicable laws and granting general public opportunities to subscribe for new
shares, including unsubscribed shares;
3. Granting the shareholders opportunities to subscribe for new shares first and, if there are
any unsubscribed shares, then to general public opportunities to be allocated;
4. Granting specific types of persons opportunities to subscribe for new shares in accordance
with reasonable standards stipulated in applicable statutory provisions, such as demands
forecast to be made by investment trader or investment broker as underwriter or arranger.
③ When new shares are allocated under Sub-Paragraph 2 or 3 of Paragraph 1 above, the
items set forth in Section 416 (1), (2), (2-2), (3) and (4) of the Commercial Code shall be
notified to shareholders by way of individual or public notices no later than two (2) weeks
prior to the date of payment of the subscription price; provided, however, that such an
individual notice and public notice may be substituted by publishing a Report of Major Items
to the Financial Services Commission and the stock exchange under Article 165-9 of the
Financial Investment Services and Capital Markets Act.
④ The class, number, and issuance price of the new shares that are to be issued under any of
the provisions in Paragraph 1 shall be determined by a resolution of the BOD.
⑤ Any of the new shares that are not subscribed for or paid therefor by applicable payment
date shall be handled by a resolution of the BOD in accordance with applicable laws and
regulations.
⑥ Disposal of fractional shares created in the course of allocation of new shares shall be
determined by a resolution of the BOD.
⑦ In case of allocation of new shares under Sub-Paragraph 1 of Paragraph 1 above, the
Company shall issue the certificates of preemptive rights to the shareholders.
General Shareholders’ Within 3 months after the
Closing date December 31
Meeting business year ends
Closing date of
December 31
stockholders’ list
Closure of
From January 1 to January 31
stockholders’ list
Type of share
-
certificates
Transfer agent Korea Securities Depository
Privileges of
Not Applicable
shareholders
Homepage (https://www.samsungbiologics.com)
Public notice
In unavoidable circumstances, related information is published on Joongang Daily
※ With Act on Electronic Registration of Stocks, Bonds, etc. (“Electronic Securities Act”) taking effect Sep 16, 2019, rights
specified on stocks and subscription warrants are subject to mandatory electronic registration, therefore, “Stock types” are no
longer applicable.
Samsung Common
Related party 20,836,832 31.49 20,836,832 31.49 -
Electronics stock
Samsung Life
Common Open market
Insurance Related party 56,026 0.08 51,306 0.08
stock transaction
(special account)
Common Open market
Kim Taehan Related party 16,400 0.02 15,100 0.02
stock transactions
Common
Kim Dongjoong Related party 4,300 0.01 4,300 0.01 -
stock
Common
49,656,024 75.04 49,650,004 75.04 -
stock
Total
Preferred
- - - - -
stock
※ The number of investors above is the number of common stock shareholders of Samsung C&T Corporation recorded up to
the latest shareholder list closure date which is December 31, 2021. The shares of Chief Executive Officer, Business
Executive, and Largest Shareholder are recorded up to the disclosure date December 31, 2022.
Details of changes in Chief Executive Officer, Business Executive, and Largest Shareholder
Samsung C&T Corporation, the largest shareholder of Samsung Biologics Co., Ltd., is located in 26,
Sangil-ro 6-gil, Gangdong-gu, Seoul, Republic of Korea, and engages mainly in business areas at home
and abroad: the engineering & construction sector including building, civil infrastructure, plant, and
housing; the trading & investment sector including natural resources, steel, chemical & industrial
materials, and living industrial; the fashion sector including apparel products manufacturing, sales
business and textile processing; the resort sector including landscaping and Everland (drier park),
Caribbean Bay (water park), golf club, and catering (Samsung Welstory) and the biopharmaceutical
outsourcing & biosimilar sector.
※ For more details regarding largest shareholders, please refer to the "1Q 2022 report" by Samsung &T Corporation disclosed
Changes of the largest shareholder during the time period subject to disclosure are as follows:
3. Distribution of Shares
A. Shareholders with over 5% ownership and stocks held by the employee stock
ownership association
(As of March 31, 2022) (Unit: share)
Number of shares
Classification Name of shareholders Share ratio Remarks
owned
Samsung C&T Corporation 28,742,466 43.44% -
Shareholders with
Samsung Electronics 20,836,832 31.49% -
over 5% ownership
National Pension Service 4,011,752 6.06% -
B. Minority shareholders
(As of March 31, 2022) (Unit: share)
Shareholders Shares owned
Category No. of No. of Remarks
No. of total No. of total
Minority Ratio Minority Ratio
shareholders shares
shareholders shares
Shareholders
Minority holding stocks
120,604 120,625 99.99 13,341,555 66,165,000 20.18
shareholders below 1/100 of total
stocks issued
4. Share Price and Stock Transactions
(Unit: KRW, share)
Class '22.03 '22.02 '22.01 ‘21.12 ‘21.11 ‘21.10
Share
Lowest 764,000 740,000 712,000 872,000 819,000 791,000
price
Average 808,905 766,833 823,200 903,955 857,318 856,526
Common
stock Highest
84,286 171,625 170,082 285,399 119,393 170,809
(day)
Trading Lowest
31,750 33,131 37,566 39,525 24,821 30,213
volume (day)
Monthly
1,019 1,077 1,503 1,992 1,311 1,267
(thousand)
※ The Company was listed on the stock market as of November 10, 2016.
VIII. Matters Regarding Executives and Employees
A. Registered executives
(As of March 31, 2022) (Unit: share)
※ From 11th Board of Directors meeting held on March 29, 2022, Lee Changwoo and Bahk Jaewan were newly appointed as independent directors, and independent directors Kwon Soonjo and
Jeong Seokwoo resigned due to end of term.
※ Shares with no voting rights only include preferred shares. For current updates on certificate of preemptive right to new stocks from a paid-in capital increase, please refer to the ownership
report of executives and major shareholders posted on March 16th ~23rd.
※ Number of shares held by executives as of March 31, 2022. For subsequent changes, please refer to the ownership report of executives and major shareholders at the DART (Data Analysis,
Retrieval and Transfer System
B. Unregistered executives
(As of March 31, 2022) (Unit: share)
No. of shares
owned
Date of Registration Employment Term of
Name Gender Position Responsibility Career With Without
birth status status service
voting voting
rights rights
- Head of Office, New Business Project Office,
Executive EPCV Center Samsung Engineering 1 year
Lo Kun M 1963.01 Unregistered Full-time - -
Vice President Leader - Doctor of Chemical Engineering, Seoul National 4 months
University
- CEO, Lumebio
Kang
W 1972.09 Vice President Unregistered Full-time CDO Team Leader - Master of Medicine, Sookmyung Women’s 5 months
Jahoon
University
※ Number of shares held by executives is as of March 31, 2022. For subsequent changes, refer to the ownership report of executives and major shareholders at the DART (Data Analysis, Retrieval
and Transfer System)
※ Shares with no voting rights only include preferred shares. For current updates on certificate of preemptive right to new stocks from a paid-in capital increase, please refer to the ownership
report of executives and major shareholders posted on March 16th ~23rd.
C. Registered executives with concurrent positions
Interlocking executive Interlocking company
E. Employees
(As of March 31, 2022) (Unit: KRW Mil)
Employee Non-Employee
No. of employees
Per
Regular Average Gross Remarks
Business Fixed-term workers capita
Gender workers Total length of annual M W Total
unit average
(Part-time (Part-time service salary
All All salary
worker) worker)
Manufacturing M 1,306 - 90 - 1,396 3.1 - -
Manufacturing F 623 - 46 - 669 2.7 - -
Research M 552 - 53 - 605 3.7 - -
Research F 733 - 31 - 764 3.5 - -
Support M 513 - 19 - 532 3.7 - - 418 239 657
Support F 282 - 12 - 294 3.6 - -
Total no. of M 2,371 - 162 - 2,533 3.3 44,264 18
employees F 1,638 - 89 - 1,727 3.2 26,983 16
Total 4,009 - 251 - 4,260 3.3 71,247 17 -
※ Gross annual salary is based on gross salary in the statement of earned income payments to be submitted to a competent tax
office in accordance with Article 20 of the Income Tax Act.
※ The number of employees above is based on headquarters and registered executives (7 members) are excluded.
The number of employees includes those on leave of absence.
※ The average salary per person was calculated based on the annual average number of employees of 4,213 (male: 2,505,
female: 1,708).
※ In the case of unregistered executives who were elected in the current year, only the compensation paid after the date of
election was calculated.
2. Executive Compensation
<Compensation of Directors and auditors>
Total 7 15,000 -
※ The approval amount at the shareholders’ general meeting is compensation limit for directors approved through the
resolution by the shareholders’ general meeting on March 29, 2022 in accordance with Article 388 of the Commercial Act
and the articles of incorporation.
Independent directors 1 21 21 -
Members of Audit
3 63 21 -
committee
Auditors - - - -
A. Overview of Affiliates(Summary)
B. Collateral provided
- Not applicable
C. Debt guarantee
- Not applicable
◦ Overview
Entering into - Contract name : Outsourced drug manufacturing
‘18.02.22 Single Sales or - Contract amount : USD 50,313,000 In progress
Supply Contract - Counterpart : Pharmaceutical company in US
- Contract period : 2018. 2. 21 ~ 2026. 12. 31
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 449,425,200
‘18.04.30 Single Sales or - Counterpart : Pharmaceutical company in Swiss In progress
Supply Contract - Contract period : 2018. 4. 30 ~ 2025. 12. 31
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 15,097,201
‘18.06.01 Single Sales or - Counterpart : Ichnos Sciences In progress
Supply Contract - Contract period : 2017. 9. 5 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 127,555,800
‘18.08.14 Single Sales or - Counterpart : Pharmaceutical company in Asia In progress
Supply Contract - Contract period : 2018. 8. 14 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
Entering into - Contract name : Outsourced drug manufacturing
‘18.09.12 Single Sales or - Contract amount : USD 266,454,000 In progress
Supply Contract - Counterpart : Gilead Sciences, Inc.
- Contract period : 2018. 9. 11 ~ 2025. 12. 31
◦ Overview
Entering into - Contract name : Outsourced drug manufacturing
‘19.04.01 Single Sales or - Contract amount : USD 50,224,225 In progress
Supply Contract - Counterpart : Cytodyn Inc.
- Contract period: 2019. 4. 1 ~ 2027.12.31
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 31,985,200
‘19.04.26 Single Sales or - Counterpart : Pharmaceutical company in Asia In progress
Supply Contract - Contract period : 2019. 4. 26 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 17,142,200
‘19.04.26 Single Sales or - Counterpart : Pharmaceutical company in Asia In progress
Supply Contract - Contract period : 2019. 4. 26 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 29,769,800
‘19.05.14 Single Sales or - Counterpart : Pharmaceutical company in Asia In progress
Supply Contract - Contract period : 2019. 5. 14 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name: Outsourced drug manufacturing
Entering into - Contract amount : USD 33,829,763
‘19.05.17 Single Sales or - Counterpart : UCB In progress
Supply Contract - Contract period : 2019. 5. 17 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
Entering into
- Contract name : Outsourced drug manufacturing
‘19.11.28 Single Sales or In progress
- Contract amount : USD 19,129,700
Supply Contract
- Counterpart : Pharmaceutical company in Asia
- Contract period : 2019. 11. 28 ~ Contract end date
※ The disclosure of the confidential details of contract end
date is reserved.
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 58,198,800
‘19.12.03 Single Sales or - Counterpart : Pharmaceutical company in US In progress
Supply Contract - Contract period : 2019. 12. 3 ~ Contract end date
※ The disclosure of the confidential details of contract
end date is reserved.
◦ Overview
Entering into - Contract name : Outsourced drug manufacturing
‘20.05.22 Single Sales or - Contract amount : USD 505,198,800 In progress
Supply Contract - Counterpart : GlaxoSmithKline Trading Services Limited
- Contract period : 2020. 5. 21 ~ 2028. 12 31
◦ Overview
- Contract name : Outsourced drug manufacturing
Entering into - Contract amount : USD 27,870,586
‘20.07.20 Single Sales or - Counterpart : H. Lundbeck A/S In progress
Supply Contract - Contract period : 2019. 9. 27 ~ Contract end date
※ The disclosure of the confidential details of counterpart &
contract end date is reserved.
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.07.28 Single Sales or - Contract amount: USD 268,349,994 In progress
Supply Contract - Counterpart: Eli Lilly and Company
- Contract period: 2020. 7. 21 ~ 2026.08.30
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.08.04 Single Sales or - Contract amount: USD 43,497,915 In progress
Supply Contract - Counterpart: Immunovant Sciences GmbH
- Contract period: 2018. 12. 18 ~ 2029. 12. 31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.08.05 Single Sales or - Contract amount: USD 226,866,568 In progress
Supply Contract - Counterpart: GlaxoSmithKline Trading Services Limited
- Contract period: 2020. 4. 9 ~ 2023. 12. 31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.09.22 Single Sales or - Contract amount: USD 377,542,300 In progress
Supply Contract - Counterpart: AstraZeneca AB
- Contract period: 2020. 6. 23 ~ 2028.12.31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.09.22 Single Sales or - Contract amount: USD 16,018,000 In progress
Supply Contract - Counterpart: AstraZeneca UK Ltd.,
- Contract period: 2020. 9. 21 ~ 2023.12.31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.10.06 Single Sales or - Contract amount: USD 19,713,000 In progress
Supply Contract - Counterpart: Checkpoint Therapeutics, Inc.,
- Contract period: 2020. 10. 02 ~ 2030. 10. 02
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.11.03 Single Sales or - Contract amount: USD 16,110,700 In progress
Supply Contract - Counterpart: Pharmaceutical company in US
- Contract period: 2020. 10. 28 ~ 2030.12.31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘20.11.09 Single Sales or - Contract amount: USD 51,458,000 In progress
Supply Contract - Counterpart: FibroGen, Inc.
- Contract period: 2020. 9. 18 ~ 2022.12.31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘21.01.15 Single Sales or - Contract amount: USD 202,261,032 In progress
Supply Contract - Counterpart: F.Hoffmann-La Roche Ltd
- Contract period: 2020. 6. 1 ~ 2024.12.31
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
‘21.01.15 Single Sales or - Contract amount: USD 550,150,000 In progress
Supply Contract - Counterpart: F.Hoffmann-La Roche Ltd
- Contract period: 2020. 6. 1 ~ 2024.12.31
◦ Overview
Important - Contract name: Outsourced drug manufacturing LOI
‘21.09.29 management - Contract amount: USD 41,510,000 In progress
matters - Counterpart: MSD International Business GmbH
- Contract period: 2021. 9.29 ~ Contract date
◦ Overview
- Contract name: Outsourced drug manufacturing LOI
Important - Contract amount: USD 56,581,000
‘21.12.23 management - Counterpart: Pharmaceutical company in Europe In progress
matters - Contract period: 2021.09.29 ~ 2022. 06.30
※ The disclosure of the confidential details of counterpart &
contract end date is reserved.
◦ Overview
Entering into - Contract name: Outsourced drug manufacturing
'22.03.28 Single Sales or - Contract amount: USD 92,041,300 In progress
Supply Contract - Counterpart: Eli Lilly Kinsale Limited
- Contract period: 2019.12.20 ~ 2029.12.31
2. Contingent Liability
A. Litigations
- In December 2020, Biogen Therapeutics Inc. has filed an arbitration with the International Chamber of Commerce (ICC)
against the Company in connection with the interpretation of some of the terms of the Samsung Bioepis Co., Ltd. joint venture
agreement with the Company, but was suspended the current arbitration process in accordance with the agreement of both
companies in February 2022. In April 2022, Biogen and the Company agreed to terminate the arbitration procedure.
If the Company does not comply with the commitments below, financial institutions may require an early
redemption of long-term borrowings.
Period
Lease terms are for a total of 50 years. The initial lease period is for 20 years from the land lease
contract date of April 28, 2011, and the Company can extend the contract by 10 years.
Exemption requirement
The Company whose foreign investment amounts to more than USD 20 million for 5 years since the
land lease contract date is subject to the exemption from Article 32 of Common Property Management
Ordinance of Incheon. Afterwards, the Company, including foreign invested enterprises that meet the
average daily employee count of above 300, is subject to exemption.
A. Sanctions
Regarding violations of Financial Investment Services and Capital Markets Act, Act on External Audit of
Stock Companies, Act on the Aggravated Punishment, etc. of Specific Economic Crimes and
Destruction of Evidence, the Prosecutor’s Office has investigated the Company’s Chief Executive
Officer and Chief Financial Officer. Following the investigation, with regards to Act on External Audit of
Stock Companies, Act on the Aggravated Punishment, etc. of Specific Economic Crimes and
Destruction of Evidence, the Prosecutor’s Office has filed an indictment of the Company’s Chief
Executive Officer and Chief Financial Officer, and the first trial is currently in progress.
Currently, there is no case settled by the Investigation agency and Jurisdiction.
Securities &
- External auditor designation by the
2018.11.14 Futures -.
regulator
Commission Act on External
- Recommendation to dismiss the Inappropriate
Samsung Audit of Stock
CEO and director in charge consolidation
Biologics Companies
- Correction of financial statements accounting
Financial Article 13
- Prosecution charges KRW
2018.11.21 Services
(Company and CEO) 8 billion
Commission
- On July 12, 2018, the Securities & Futures Commission(“SFC”) imposed the first administrative
measures in accordance with the Act on External Audit of Stock Companies against the Company for
alleged failure to disclose sufficient information in the Company’s Financial Statement from 2012 to
2015 regarding the Company’s joint venture agreement with Biogen Therapeutics Inc. The measures
(“First measures”) included external auditor designation by the regulator, recommendation of
dismissal of the Company’s directors in charge, and referral of the case against the Company and its
representative director (CEO) to the Prosecutors’ Office. On October 10, 2018, in order to prove
unfairness of the decisions and actions taken by the SFC, the company filed a lawsuit for cancellation
of aforementioned measures. (Seoul Administrative Court)
On September 24, 2020, the Court ruled to cancel the First measures imposed to the Company by
SFC and decided to suspend the First measures until the decision of the appeal trail is made. The
SFC appealed the Court’s first trial and the litigation is in progress at the Seoul High Court.
- On November 14, 2018, SFC determined a second measure, in accordance with the Act on External
Audit of Stock Companies against the Company for violation of accounting standards by
inappropriately applying separate method regarding investments in Samsung Bioepis from 2012 to
2018. The measures (“Second measures”) included imposition of administrative fine of KRW 8 billion,
external auditor designation by the regulator, recommendation of dismissal of the Company’s
representative director (CEO) and directors in charge, retrospective restatement of financial
statements, and referral of the case against the Company and its representative director (CEO) to the
Prosecutors’ Office. On November 21, 2018, following the procedure, the Financial Service
Commission(“FSC”) imposed a penalty of KRW 8 billion on the Company. On November 27, 2018, to
prove justification of the accounting treatment, the Company filed a lawsuit for cancellation of the
measures by the SFC and the FSC. (Seoul Administrative Court)
4. Subsequent Events
(1) On January 28, 2022, the Board of Directors of Samsung Biologics has approved the stock trade
contract to acquire Biogen Therapeutics Inc.’s stake of 10,341,852 shares in Samsung Bioepis to
diversify its business portfolio and strengthen the market competitiveness as the
biopharmaceutical company. The transaction payment consists of contract payment of USD
2,250,000,000 and conditional payment of USD 50,000,000 for the total consideration of USD
2,300,000,000. Payments will be made in three installments (payment of USD 1,000,000,000 on
the transaction closing date, payment of USD 812,500,000 within one year from the closing date,
payment of USD 437,500,000 within two years from the closing date) and the conditional payment
will be paid in full by January 2027 when conditions are met. On April 20, 2022, the Company paid
USD 1,000,000,000 and wholly acquired 10,341,852 shares.
(2) On January 28, 2022, the Board of Directors resolved to increase its capital for the acquisition of
construction-in-progress and securities of other entity. The capital increase amounts to KRW
3,200,751 million (5,009,000 registered ordinary shares), and the listing date of new shares is April
28, 2022.
(3) In December 2020, Biogen Therapeutics Inc. (“Biogen”) requested for arbitration in the Court of
International Chamber of Commerce against the Company regarding interpretation of certain
provision in joint venture agreement by and between Biogen and the Company; however, the
arbitration procedure has been suspended according to the agreement made between the two
parties in February 2022. In April 2022, Biogen and the Company agreed to terminate the
arbitration procedure.
(4) The Board of Directors resolved to purchase the land for the 2nd Bio Campus at an acquisition
price of approximately KRW 426 billion. The Company has been selected as a preferred bidder by
the Incheon Free Economic Zone Authority (IFEZ) and the negotiation is in progress to enter into a
contract.
C. Green management
The Company is making efforts to meet the government’s green growth policy through greenhouse-
gas/energy reduction activities, water reuse, waste resource circulation, environmental performance
evaluation, and management to establish a green management system and take full responsibility as
an eco-friendly company. The Company is also doing its best to preserve the environment through
continued management of environmental management indicators and disclose relevant information to
its stakeholders in a transparent manner.
The Company’s management indicators by each environmental area for the last 3 years are listed below.
※ The current management indicators may change depending on the results of the performance report
[Contaminant Management]
- Related laws: Article 255-2 of the「Customs Act」, Article 259-2 and Article 259-3 of the Enforcement
Decree of the Customs Act
- Related laws: Article 56 of the Framework Act on Environmental Policy (Environmental management
1. Consolidated Subsidiaries
(Unit : KRW mil)
Basis of a
Total asset of
Name of Established Main dominant- Major
Address the last
Company Date business subordinate Subsidiary
business years
relationship
Majority
Samsung
California, Biologics ownership of
Biologics 2020.01 16,129 X
U.S. R&D voting rights
America, Inc.
(K-IFRS 1110)
2. Affiliates
This section was excluded in the Quarterly Report according to Corporate Disclosure Guidelines set
forth by the Financial Supervisory Service Authority of the Republic of Korea. For details, please refer
to the 2021 Annual Report submitted on March 21, 2022.
3. Investments in Other Companies
(As of March 31, 2022) (Unit: KRW Mil, Thousand shares, %)
Financial status in
Beginning balance Increase(decrease) Ending balance
recent business year
Name of Acquisition Purpose of Acquisition Acquisition (disposal) Gain
company date Investment cost Share Book Share Book Total Net profit
Volume (loss) on Volume
ratio value Volume Amount ratio value assets (loss)
valuation
Samsung
Management
Bioepis Co., 2012.02.28 139,995 10,342 50.00 517,100 - - - 10,342 50.00 517,100 2,783,971 151,992
Participation
Ltd.
Archigen Management
2014.06.23 71,372 131,000 50.00 - - - 3,814 131,000 50.00 3,814 4,227 2,584
Biotech Ltd. Participation
Samsung
Biologics Management
2020.03.09 11,914 10 100.00 11,914 - - - 10 100.00 11,914 16,129 404
America, Participation
Inc.
SVIC 54
New
Management
Technology 2021.08.13 12,375 - 33.00 12,375 - - - - 33.00 12,375 37,136 -1,313
Participation
Investment
Association
(*1) In March 2022, the Board of Directors of the Company and AstraZeneca have agreed to the liquidation of Archigen Biotech Limited, a joint venture,
and its book amount was changed according to the expected receipt of liquidation payment.
[Confirmation by Expert]
1. Confirmation by Expert
- Not applicable
2. Expert’s Relations
- Not applicable