CEO MESSAGE Driven. For Life.
SAMSUNG BIOLOGICS
2025.7
Announcement
Dear Valued Investors and Shareholders, We extend our sincere appreciation for your unwavering trust and support - an enduring foundation for our sustained growth and continued success.
Key Highlights
Q2 Financial Performance
• Rev. +11%, OP +9% YoY on expanded operations at Plant 4
- Consolidated: (KRW) Rev. 1,290B, OP 476B (OPM: 36.9%)
- Biologics: (KRW) Rev. 1,014B, OP. 477B (OPM: 47.0%)
- Bioepis: (KRW) Rev. 401B, OP. 90B (OPM: 22.4%)
• FY guidance raised following robust ramp-up at Plant 4 *+20~25%+25-30% YoY
CDMO
• 1H CDMO Rev. surpassed KRW 2T for the first time
• Strongest 1H order intake on record: KRW 3.4T - Mid-year order intake reached around 60% of FY '24 total
• 9 new CDO contract wins, including with global pharma
• Cumulative orders: USD 18.7B, CMO 104, CDO 146
Business Expansion
• Commencement of Plant 5 operations (Apr. 25)
• Expansion into CRO with 'Samsung Organoids' launch
• Equity spin-off announced to delineate CDMO & Biosimilar
- Pure-play CDMO transition to enhance client alignment
- Enabling optimized business execution to enhance growth
Biosimilar
• Strategic partnership with NIPRO Corporation (JP) for multiple biosimilar pipelines, including SB17 (bStelara)
• SB12 (bSoliris): Launched in the U.S. (Apr. '25)
• SB16 (bProlia, bXgeva): Approved by the Korean MFDS (Apr. 25) *Ministry of Food and Drug Safety
Today, Samsung Biologics announced our financial results for the second quarter of 2025.
In the second quarter, we maintained positive business momentum, driven by increased revenue contributions from Plant 4 and steady growth across our business portfolio. As a result, consolidated revenue reached KRW 1.3 trillion, representing an approximate 11% increase year-over-year (YoY). Excluding a one-off milestone revenue recognized in the biosimilar business during the same period last year, recurring revenue grew by 37%, underscoring the strength and resilience of our core operations. On a standalone basis, Samsung Biologics achieved first-half revenue exceeding KRW 2 trillion for the first time since our founding. We believe these results reflect our solid business fundamentals and the continued trust placed in us by our global partners.
Building on our solid performance - even amid persistent market volatility - and with the successful ramp-up of Plant 4 providing additional momentum, we are pleased to announce an upward revision of our annual revenue growth guidance, from +20~25% YoY to +25-30% YoY. This adjustment reflects not only the stability and resilience of our business, but also the confidence in our future trajectory and growth opportunities. Despite ongoing uncertainties in the broader market environment, we remain committed to disciplined execution and continuous enhancement of our competitiveness to drive sustained value creation.
Sustained Growth Anchored in Global Competitiveness and Trust
Delivering Results through Customer Focus and Operational Excellence
Our order performance has remained solid throughout 2025. Cumulative order volume for the first half reached a record-high level of approximately KRW 3.5 trillion (USD 2.4 billion), equivalent to about 60% of the full year total recorded in 2024. We are actively pursuing additional contracts through constructive discussions with a number of clients, and remain committed to strengthening collaborations with global partners and expanding our stable order base.
We also achieved meaningful progress across other business areas. We are steadily strengthening our CDO business, as evidenced by the signing of nine new contracts with clients spanning biotechs and big pharmas, while also demonstrating our capabilities in emerging modalities including ADC (Antibody-drug Conjugate), through a full-scope development and manufacturing agreement.
Fostering Long-Term Growth Through Strategic Transformation and Business Expansion
Reinforcing Business Stability Through Expansion and Strategic Realignment
Plant 5, operational since April, is stably ramping up, with contract discussions well underway with global pharmaceutical companies. With automation and digitalization at its core, Plant 5 is setting new standards for operational efficiency and quality performance - breakthrough innovations that are expected to contribute positively to long-term profitability.
We have also broadened our service portfolio by launching 'Samsung Organoids', a new drug screening platform utilizing organoids - three-dimensional mini-organ models derived from stem or tissue cells that closely mimic human organs - marking our entry into the CRO business. Our drug screening service utilizes patient-derived tumor organoids to deliver higher patient relevance and greater cost-effectiveness than traditional cell-based or animal models testing. We believe this approach enables more precise and rapid assessment of drug candidates for our clients. By engaging clients from the earliest stages of drug candidate discovery, we aim to achieve early lock-in and establish enduring partnerships, while helping clients reduce development risks and accelerate R&D.
Meanwhile, our Board of Directors approved an equity spin-off in May. With this spin-off, the CDMO business unit will remain within the existing company, Samsung Biologics, while a newly established holding company, Samsung Episholdings, will be formed to assume 100% ownership of Samsung Bioepis, which is dedicated to development and commercialization of biosimilar products.
This strategic separation is intended to proactively address potential concerns about conflicts of interest that could be raised by CDMO clients, while also strengthening our organizational stability and agility in light of evolving policy and regulatory uncertainties. By clearly delineating two businesses with distinct revenue structures and growth strategies, we aim to help investors make more precise valuation and selective investment decisions.
Following the spin-off, each entity will independently pursue growth opportunities tailored to its distinct business characteristics and strategic direction. Samsung Biologics will solidify our identity as a 'pure-play CDMO', aiming to enhance shareholder value by expanding global partnerships and strengthening the high-margin
business portfolio. Samsung Episholdings will serve as an
investment holding company, providing strategic oversight of its subsidiaries while actively investing in new business opportunities to establish a solid foundation for long-term growth. Samsung Bioepis will further cement its position as a global top-tier
player in biosimilar business through ongoing product innovation and continuous advancement of its technological capabilities.
Advancing Market Leadership in Biosimilar Business Through Continuous Product Launches and Partnership Expansion Driving Global Influence through Market Expansion
In the second quarter, Samsung Bioepis continued to solidify its
standing in the biosimilar market through product launches, regulatory approvals, and new partnerships.
Samsung Bioepis launched SB12, a biosimilar to Soliris (eculizumab),
in the U.S. in April through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases.
SB16 was approved by the Korean Ministry of Food and Drug
Safety (MFDS) as a biosimilar to Prolia (denosumab) and Xgeva (denosumab) in April and May respectively, following approvals by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February.
Also, Samsung Bioepis entered into a license, development, and commercialization partnership with NIPRO Corporation, paving the way for multiple biosimilar candidates - including SB17 - to enter the Japanese market. This partnership will play a crucial role in expanding Samsung Bioepis' presence in Japan, where biosimilars have a great potential to bring cost savings and widen access to
treatments.
Samsung Bioepis will continue to advance its biosimilar pipeline
covering a wide spectrum of therapeutic areas and will remain committed to ensuring high-quality and reliable supply of medicines
to improve access for patients around the world.
Continued ESG Efforts
for Long-Term Value Creation
Advancing Global Well-being and Sustainability through ESG Leadership
Samsung Biologics places ESG at the core of the corporate ethos
and continually strives to deliver meaningful, measurable results.
We published our latest ESG report in May which demonstrates
enhanced alignment with global regulations and guidelines. Environmental disclosures include comprehensive assessment of risk and opportunities based on the TNFD LEAP framework. Social metrics highlight expanded supply chain assessments, broader scope of human rights evaluations, and targeted mitigation efforts for high-risk issues. Governance reporting covers the board and independent director evaluations systems, as well as the operation of advanced quality management systems. These disclosures are
structured to meet with the standards of major ESG benchmarks, including MSCI, DJSI, and EcoVadis.
Our de-carbonization efforts have yielded tangible results: by the
end of 2024, we reduced greenhouse gas emissions by about 24% compared to 2023, and transitioned about 29% of our total electricity consumption to renewable energy. In addition, we entered into an additional solar Power Purchase Agreement (PPA) to supply approximately 11% of our annual energy usage for 2026, further accelerating our transition to renewable energy.
We continue to deliver meaningful outcomes through collaborative
ESG initiatives. As a champion of the Supply Chains Working Group in the Sustainable Markets Initiative (SMI)'s Health Systems Task Force, we are leading global efforts toward de-carbonization across the supply chain in the biopharmaceutical sector. We hosted a forum for Chief Procurement Officers (CPOs) of leading global companies, providing a venue for discussion on the importance of carbon neutrality and effective supply chain management. In addition, we held webinars for our suppliers to highlight the
significance of carbon neutrality and to encourage their active
participation in our supply chain initiatives. This year, we are also participating in low-carbon plastics initiatives, with plans to replace plastics used and generated in raw material sourcing and product manufacturing with low-carbon alternatives.
Our consistent achievements have earned us recognition for three consecutive years as an outstanding company in the Pharmaceutical, Bio and Health Sector at the '2025 JoongAng ESG Awards, co-hosted by JoongAng Ilbo and Sustinvest. Most notably,
our MSCI ESG rating was recently upgraded from BB to BBB- our first time achieving BBB-reflecting increased external recognition of our governance and sustainability practices. Given that MSCI is
widely referenced by global investors, this improvement highlights the increasing confidence in our ESG practices. We will remain focused on pursuing sustainable management aligned with global standards and strive for even higher ESG performance.
As an industry leader, Samsung Biologics will continue to fulfill our social responsibilities and do our utmost to build a more sustainable future. We sincerely appreciate your unwavering trust and support,
and remain committed to growing together while creating even greater value in the years ahead.
July 23rd, 2025
John Rim
President & CEO, Samsung Biologics
CEO MESSAGE Driven. For Life.
SAMSUNG BIOLOGICS
2025.7
Announcement
Dear Valued Investors and Shareholders, We extend our sincere appreciation for your unwavering trust and support - an enduring foundation for our sustained growth and continued success.
Key Highlights
Q2 Financial Performance
• Rev. +11%, OP +9% YoY on expanded operations at Plant 4
- Consolidated: (KRW) Rev. 1,290B, OP 476B (OPM: 36.9%)
- Biologics: (KRW) Rev. 1,014B, OP. 477B (OPM: 47.0%)
- Bioepis: (KRW) Rev. 401B, OP. 90B (OPM: 22.4%)
• FY guidance raised following robust ramp-up at Plant 4 *+20~25%+25-30% YoY
CDMO
• 1H CDMO Rev. surpassed KRW 2T for the first time
• Strongest 1H order intake on record: KRW 3.4T - Mid-year order intake reached around 60% of FY '24 total
• 9 new CDO contract wins, including with global pharma
• Cumulative orders: USD 18.7B, CMO 104, CDO 146
Business Expansion
• Commencement of Plant 5 operations (Apr. 25)
• Expansion into CRO with 'Samsung Organoids' launch
• Equity spin-off announced to delineate CDMO & Biosimilar
- Pure-play CDMO transition to enhance client alignment
- Enabling optimized business execution to enhance growth
Biosimilar
• Strategic partnership with NIPRO Corporation (JP) for multiple biosimilar pipelines, including SB17 (bStelara)
• SB12 (bSoliris): Launched in the U.S. (Apr. '25)
• SB16 (bProlia, bXgeva): Approved by the Korean MFDS (Apr. 25) *Ministry of Food and Drug Safety
Today, Samsung Biologics announced our financial results for the second quarter of 2025.
In the second quarter, we maintained positive business momentum, driven by increased revenue contributions from Plant 4 and steady growth across our business portfolio. As a result, consolidated revenue reached KRW 1.3 trillion, representing an approximate 11% increase year-over-year (YoY). Excluding a one-off milestone revenue recognized in the biosimilar business during the same period last year, recurring revenue grew by 37%, underscoring the strength and resilience of our core operations. On a standalone basis, Samsung Biologics achieved first-half revenue exceeding KRW 2 trillion for the first time since our founding. We believe these results reflect our solid business fundamentals and the continued trust placed in us by our global partners.
Building on our solid performance - even amid persistent market volatility - and with the successful ramp-up of Plant 4 providing additional momentum, we are pleased to announce an upward revision of our annual revenue growth guidance, from +20~25% YoY to +25-30% YoY. This adjustment reflects not only the stability and resilience of our business, but also the confidence in our future trajectory and growth opportunities. Despite ongoing uncertainties in the broader market environment, we remain committed to disciplined execution and continuous enhancement of our competitiveness to drive sustained value creation.
Sustained Growth Anchored in Global Competitiveness and Trust
Delivering Results through Customer Focus and Operational Excellence
Our order performance has remained solid throughout 2025. Cumulative order volume for the first half reached a record-high level of approximately KRW 3.5 trillion (USD 2.4 billion), equivalent to about 60% of the full year total recorded in 2024. We are actively pursuing additional contracts through constructive discussions with a number of clients, and remain committed to strengthening collaborations with global partners and expanding our stable order base.
We also achieved meaningful progress across other business areas. We are steadily strengthening our CDO business, as evidenced by the signing of nine new contracts with clients spanning biotechs and big pharmas, while also demonstrating our capabilities in emerging modalities including ADC (Antibody-drug Conjugate), through a full-scope development and manufacturing agreement.
Fostering Long-Term Growth Through Strategic Transformation and Business Expansion
Reinforcing Business Stability Through Expansion and Strategic Realignment
Plant 5, operational since April, is stably ramping up, with contract discussions well underway with global pharmaceutical companies. With automation and digitalization at its core, Plant 5 is setting new standards for operational efficiency and quality performance - breakthrough innovations that are expected to contribute positively to long-term profitability.
We have also broadened our service portfolio by launching 'Samsung Organoids', a new drug screening platform utilizing organoids - three-dimensional mini-organ models derived from stem or tissue cells that closely mimic human organs - marking our entry into the CRO business. Our drug screening service utilizes patient-derived tumor organoids to deliver higher patient relevance and greater cost-effectiveness than traditional cell-based or animal models testing. We believe this approach enables more precise and rapid assessment of drug candidates for our clients. By engaging clients from the earliest stages of drug candidate discovery, we aim to achieve early lock-in and establish enduring partnerships, while helping clients reduce development risks and accelerate R&D.
Meanwhile, our Board of Directors approved an equity spin-off in May. With this spin-off, the CDMO business unit will remain within the existing company, Samsung Biologics, while a newly established holding company, Samsung Episholdings, will be formed to assume 100% ownership of Samsung Bioepis, which is dedicated to development and commercialization of biosimilar products.
This strategic separation is intended to proactively address potential concerns about conflicts of interest that could be raised by CDMO clients, while also strengthening our organizational stability and agility in light of evolving policy and regulatory uncertainties. By clearly delineating two businesses with distinct revenue structures and growth strategies, we aim to help investors make more precise valuation and selective investment decisions.
Following the spin-off, each entity will independently pursue growth opportunities tailored to its distinct business characteristics and strategic direction. Samsung Biologics will solidify our identity as a 'pure-play CDMO', aiming to enhance shareholder value by expanding global partnerships and strengthening the high-margin
business portfolio. Samsung Episholdings will serve as an
investment holding company, providing strategic oversight of its subsidiaries while actively investing in new business opportunities to establish a solid foundation for long-term growth. Samsung Bioepis will further cement its position as a global top-tier
player in biosimilar business through ongoing product innovation and continuous advancement of its technological capabilities.
Advancing Market Leadership in Biosimilar Business Through Continuous Product Launches and Partnership Expansion Driving Global Influence through Market Expansion
In the second quarter, Samsung Bioepis continued to solidify its
standing in the biosimilar market through product launches, regulatory approvals, and new partnerships.
Samsung Bioepis launched SB12, a biosimilar to Soliris (eculizumab),
in the U.S. in April through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases.
SB16 was approved by the Korean Ministry of Food and Drug
Safety (MFDS) as a biosimilar to Prolia (denosumab) and Xgeva (denosumab) in April and May respectively, following approvals by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February.
Also, Samsung Bioepis entered into a license, development, and commercialization partnership with NIPRO Corporation, paving the way for multiple biosimilar candidates - including SB17 - to enter the Japanese market. This partnership will play a crucial role in expanding Samsung Bioepis' presence in Japan, where biosimilars have a great potential to bring cost savings and widen access to
treatments.
Samsung Bioepis will continue to advance its biosimilar pipeline
covering a wide spectrum of therapeutic areas and will remain committed to ensuring high-quality and reliable supply of medicines
to improve access for patients around the world.
Continued ESG Efforts
for Long-Term Value Creation
Advancing Global Well-being and Sustainability through ESG Leadership
Samsung Biologics places ESG at the core of the corporate ethos
and continually strives to deliver meaningful, measurable results.
We published our latest ESG report in May which demonstrates
enhanced alignment with global regulations and guidelines. Environmental disclosures include comprehensive assessment of risk and opportunities based on the TNFD LEAP framework. Social metrics highlight expanded supply chain assessments, broader scope of human rights evaluations, and targeted mitigation efforts for high-risk issues. Governance reporting covers the board and independent director evaluations systems, as well as the operation of advanced quality management systems. These disclosures are
structured to meet with the standards of major ESG benchmarks, including MSCI, DJSI, and EcoVadis.
Our de-carbonization efforts have yielded tangible results: by the
end of 2024, we reduced greenhouse gas emissions by about 24% compared to 2023, and transitioned about 29% of our total electricity consumption to renewable energy. In addition, we entered into an additional solar Power Purchase Agreement (PPA) to supply approximately 11% of our annual energy usage for 2026, further accelerating our transition to renewable energy.
We continue to deliver meaningful outcomes through collaborative
ESG initiatives. As a champion of the Supply Chains Working Group in the Sustainable Markets Initiative (SMI)'s Health Systems Task Force, we are leading global efforts toward de-carbonization across the supply chain in the biopharmaceutical sector. We hosted a forum for Chief Procurement Officers (CPOs) of leading global companies, providing a venue for discussion on the importance of carbon neutrality and effective supply chain management. In addition, we held webinars for our suppliers to highlight the
significance of carbon neutrality and to encourage their active
participation in our supply chain initiatives. This year, we are also participating in low-carbon plastics initiatives, with plans to replace plastics used and generated in raw material sourcing and product manufacturing with low-carbon alternatives.
Our consistent achievements have earned us recognition for three consecutive years as an outstanding company in the Pharmaceutical, Bio and Health Sector at the '2025 JoongAng ESG Awards, co-hosted by JoongAng Ilbo and Sustinvest. Most notably,
our MSCI ESG rating was recently upgraded from BB to BBB- our first time achieving BBB-reflecting increased external recognition of our governance and sustainability practices. Given that MSCI is
widely referenced by global investors, this improvement highlights the increasing confidence in our ESG practices. We will remain focused on pursuing sustainable management aligned with global standards and strive for even higher ESG performance.
As an industry leader, Samsung Biologics will continue to fulfill our social responsibilities and do our utmost to build a more sustainable future. We sincerely appreciate your unwavering trust and support,
and remain committed to growing together while creating even greater value in the years ahead.
July 23rd, 2025
John Rim
President & CEO, Samsung Biologics
- CDO
- CGMP
- ADC
- Bio Campus
- IR
- CMO