IR Notice
CEO IR NEWSLETTER Driven. For Life.
SAMSUNG BIOLOGICS 2025.04
Dear valued investors and shareholders, This is John Rim from Samsung Biologics. We extend our sincere appreciation for your unwavering trust and support, which remain the cornerstone of our company's growth and success.
Key Highlights
- Q1 Financial Performance
- . Robust earnings driven by Plant 4 and FX tailwinds - Consolidated: Rev. 1,298B, OP. 487B (OPM: 37.5%) - Biologics : Rev. 1,000B, OP. 430B (OPM: 43.0%) - Bioepis : Rev. 401B, OP. 128B (OPM: 31.9%) . Annual sales growth guidance maintained at +20-25% * Consolidated basis
- CDMO
- . Signed a record-breaking $1.4B CMO contract *EU-based big pharma . CDO business expansion with global pharma demand . Won CDMO Leadership Awards for 12 consecutive years . Continued order intake: $17.8B cum. contract volume - Total 102 CMO Products and 137 CDO Products
- Business Expansion
- . Commenced operations at ADC facility . Completed Plant 5 construction (Operational since Apr. '25) . Investment in C2N Diagnostics through Life Science Fund . Opened a sales office in Tokyo, Japan
- Biosimilar
- · SB17 (bStelara) : US launch (Feb. '25) · SB12 (bSoliris) : US partnership with Teva (Jan. '25) *Marketing & Commercialization . Product launched in Apr. '25 · SB16 (bProlia, bXgeva) : EC & US FDA Approval (Feb. '25)
Today, Samsung Biologics released our financial results for the first quarter of 2025. Amid a persistently challenging business environment shaped by geopolitical tensions, macroeconomic uncertainty, and policy volatility, we achieved strong results, driven by resilient operational execution and a disciplined commitment to operational excellence. On a consolidated basis, revenue reached KRW 1.3 trillion, primarily driven by the steady operational stabilization of Plant 4, increased sales of biosimilar products, and FX tailwinds. In light of potential currency fluctuations and the broader uncertainty surrounding the global macroeconomic landscape, we continue to expect that our full-year performance will be in line with the guidance communicated earlier this year. As always, should external developments warrant a refined perspective on our outlook, we will engage with the market in a timely and transparent manner. Amid ongoing signals of potential tariff actions on pharmaceuticals by the U.S. administration, we are closely monitoring prospective policy shifts and associated risks. We acknowledge the possible ramifications for our clients and ultimately, for patients, and will be working closely with our clients to develop countermeasures that can be implemented swiftly and effectively. We remain committed to delivering reliable and sustainable results grounded in our resilient business model and robust operational capabilities.
Demonstration of Global CDMO Leadership through Strong Order Intake and Proven Client Satisfaction Global Competitiveness Underpinned by Enduring Client Trust and Operational Excellence Building on our commitment to exceptional quality and client-centric execution, we continue to solidify our market leadership by achieving significant business milestones. In January, we entered into a landmark CMO agreement valued at approximately USD 1.4 billion (KRW 2 trillion) with a leading European pharmaceutical company - marking the largest single order in our history, accounting for nearly 40% of our total annual order volume for 2024. Since then, we have been actively engaged in discussions with both existing and prospective clients for additional orders, further reinforcing our growth trajectory. Our CDO business also continues to advance steadily, supported by ongoing advancement of our platform technologies and service capabilities. While sustaining stable collaborations with existing partners, we are broadening our client portfolio, thereby strengthening our position as a fully integrated CDMO through enhanced synergy between our CMO and CDO operations. We are honored to have once again been recognized with the CDMO Leadership Awards by Outsourced Pharma, marking our twelfth consecutive year of distinction. This year, we were named a winner in the "Biologics- Global" category and additionally received the "Best Facility" award, affirming the strength of our manufacturing infrastructure, uncompromising quality standards, and technological expertise. Selected based on direct feedback from global biopharmaceutical clients, this award underscores the trust we have built through consistently delivering high-quality biomedicines and fostering long-term partnerships grounded in reliability and performance. We will continue to strive for excellence by delivering exceptional value to our clients and further strengthening our leadership as a trusted global CDMO.
Laying the Groundwork for Future Growth with Sustained Investment and Execution Excellence Strengthening Sustainable Global Leadership through a Three-Pillar Growth Strategy Our antibody-drug conjugate (ADC) facility commenced operations in the first quarter and is running smoothly in line with our plans. By integrating this new capability with our existing antibody manufacturing infrastructure, we are now better positioned to offer more comprehensive solutions to global clients engaged in ADC therapeutics. The construction of our fill & finish line is also progressing as scheduled. This April, we initiated operations at Plant 5, designed to elevate efficiency and operational stability through advanced automation and digital transformation. As part of our broader digital transformation initiatives, we implemented and internalized a state-of-the-art Manufacturing Execution System (MES) within Plant 5, replacing previously manual workflows with a more advanced digital manufacturing infrastructure. Also, we implemented various advanced automated systems to enhance operational efficiency and workplace safety. These enhancements are expected to boost productivity and quality, supporting long-term profitability. Looking ahead, we will focus on ensuring a stable and timely ramp-up of Plant 5, supported by favorable contract discussions currently underway with global pharmas. In alignment with our long-term strategic growth plan for ensuring capacity expansion in a measured and sustainable manner, we are also in the final stages of internal review and approval for investment in our next manufacturing facility, Plant 6. Samsung Life Science Fund - jointly established with Samsung C&T and Samsung Bioepis - recently decided to invest in C2N Diagnostics, a U.S .- based specialty diagnostics company recognized for its strong competitive edge in blood-based biomarker testing. C2N is committed to advancing early detection of Alzheimer's disease and related dementias, with the aim of broadening global patient access and improving health outcomes. This decision reflects our ongoing commitment to identifying forward-looking opportunities that align with long-term value creation in the life sciences domain. In tandem, we are advancing the expansion of our international commercial footprint. Following the successful operation of our sales offices in the United States, we opened a new sales office in Tokyo, Japan, earlier this year to strengthen client engagement across the Asian market. This regional presence is expected to support our efforts to diversify our client portfolio beyond the global top 20 pharmaceutical companies and to accelerate outreach to global top 40. We will continue to be dedicated to advancing our technological capabilities, scaling our manufacturing capacities, and deepening our global network to establish a resilient foundation for sustainable growth.
Expanding Global Market Presence through Competitive Biosimilar Products Reinforcing Competitive Positioning with Tangible Progress In the first quarter, Samsung Bioepis made notable progress in strengthening its position in the global biosimilar market, driven by key product launches and regulatory approvals. SB17, a biosimilar to Stelara (ustekinumab), was introduced in the U.S. in February through its commercialization partner, Sandoz. Also, Samsung Bioepis signed a commercialization agreement with Teva Pharmaceuticals for SB12, a biosimilar to Soliris (eculizumab), in January and launched the product in the U.S. in April. Lastly, SB16, a biosimilar to Prolia / Xgeva (denosumab), gained regulatory approvals from the U.S. Food and Drug Administration and the European Commission in February, and Korea's Ministry of Food and Drug Safety in April. Samsung Bioepis will continue to advance the development of a robust pipeline of high-quality biosimilars across diverse therapeutic areas, expanding global treatment options and contributing meaningfully to the long-term sustainability of the healthcare ecosystem.
ESG Achievements Driving Sustainable Growth Through ESG Leadership and Social Responsibility As a leading CDMO, sustainable management has become an integral component of our corporate strategy. Samsung Biologics is continuously striving to respond proactively and responsibly to the expectations and demands of diverse stakeholders. To enhance transparency and reinforce trust with our stakeholders, we released Engagement Report ahead of the issuance of our official 2025 ESG Report. Also, as an active participant in the Sustainable Markets Initiative (SMI), founded by His Majesty King Charles III, we continue to play a leading role as the Champion of the Supply Chains Working Group in the SMI Health Systems Task Force. Lastly, we received a "Low Risk" rating from Sustainalytics for the second consecutive year and were designated as an "Industry Top Rated" company for outstanding ESG risk management. Additionally, we achieved "Leadership" status with an "A-" rating in water security from Carbon Disclosure Project (CDP), reflecting our dedication to efficient water resource management. Samsung Biologics is committed to responsible environmental and social governance as we support the sustainable growth of the global biopharmaceutical industry. We kindly invite your continued interest and support as we remain steadfast in our journey toward a more sustainable and equitable future. Sincerely, April 23rd, 2025 John Rim President & CEO, Samsung Biologics
CEO IR NEWSLETTER Driven. For Life.
SAMSUNG BIOLOGICS 2025.04
Dear valued investors and shareholders, This is John Rim from Samsung Biologics. We extend our sincere appreciation for your unwavering trust and support, which remain the cornerstone of our company's growth and success.
Key Highlights
- Q1 Financial Performance
- . Robust earnings driven by Plant 4 and FX tailwinds - Consolidated: Rev. 1,298B, OP. 487B (OPM: 37.5%) - Biologics : Rev. 1,000B, OP. 430B (OPM: 43.0%) - Bioepis : Rev. 401B, OP. 128B (OPM: 31.9%) . Annual sales growth guidance maintained at +20-25% * Consolidated basis
- CDMO
- . Signed a record-breaking $1.4B CMO contract *EU-based big pharma . CDO business expansion with global pharma demand . Won CDMO Leadership Awards for 12 consecutive years . Continued order intake: $17.8B cum. contract volume - Total 102 CMO Products and 137 CDO Products
- Business Expansion
- . Commenced operations at ADC facility . Completed Plant 5 construction (Operational since Apr. '25) . Investment in C2N Diagnostics through Life Science Fund . Opened a sales office in Tokyo, Japan
- Biosimilar
- · SB17 (bStelara) : US launch (Feb. '25) · SB12 (bSoliris) : US partnership with Teva (Jan. '25) *Marketing & Commercialization . Product launched in Apr. '25 · SB16 (bProlia, bXgeva) : EC & US FDA Approval (Feb. '25)
Today, Samsung Biologics released our financial results for the first quarter of 2025. Amid a persistently challenging business environment shaped by geopolitical tensions, macroeconomic uncertainty, and policy volatility, we achieved strong results, driven by resilient operational execution and a disciplined commitment to operational excellence. On a consolidated basis, revenue reached KRW 1.3 trillion, primarily driven by the steady operational stabilization of Plant 4, increased sales of biosimilar products, and FX tailwinds. In light of potential currency fluctuations and the broader uncertainty surrounding the global macroeconomic landscape, we continue to expect that our full-year performance will be in line with the guidance communicated earlier this year. As always, should external developments warrant a refined perspective on our outlook, we will engage with the market in a timely and transparent manner. Amid ongoing signals of potential tariff actions on pharmaceuticals by the U.S. administration, we are closely monitoring prospective policy shifts and associated risks. We acknowledge the possible ramifications for our clients and ultimately, for patients, and will be working closely with our clients to develop countermeasures that can be implemented swiftly and effectively. We remain committed to delivering reliable and sustainable results grounded in our resilient business model and robust operational capabilities.
Demonstration of Global CDMO Leadership through Strong Order Intake and Proven Client Satisfaction Global Competitiveness Underpinned by Enduring Client Trust and Operational Excellence Building on our commitment to exceptional quality and client-centric execution, we continue to solidify our market leadership by achieving significant business milestones. In January, we entered into a landmark CMO agreement valued at approximately USD 1.4 billion (KRW 2 trillion) with a leading European pharmaceutical company - marking the largest single order in our history, accounting for nearly 40% of our total annual order volume for 2024. Since then, we have been actively engaged in discussions with both existing and prospective clients for additional orders, further reinforcing our growth trajectory. Our CDO business also continues to advance steadily, supported by ongoing advancement of our platform technologies and service capabilities. While sustaining stable collaborations with existing partners, we are broadening our client portfolio, thereby strengthening our position as a fully integrated CDMO through enhanced synergy between our CMO and CDO operations. We are honored to have once again been recognized with the CDMO Leadership Awards by Outsourced Pharma, marking our twelfth consecutive year of distinction. This year, we were named a winner in the "Biologics- Global" category and additionally received the "Best Facility" award, affirming the strength of our manufacturing infrastructure, uncompromising quality standards, and technological expertise. Selected based on direct feedback from global biopharmaceutical clients, this award underscores the trust we have built through consistently delivering high-quality biomedicines and fostering long-term partnerships grounded in reliability and performance. We will continue to strive for excellence by delivering exceptional value to our clients and further strengthening our leadership as a trusted global CDMO.
Laying the Groundwork for Future Growth with Sustained Investment and Execution Excellence Strengthening Sustainable Global Leadership through a Three-Pillar Growth Strategy Our antibody-drug conjugate (ADC) facility commenced operations in the first quarter and is running smoothly in line with our plans. By integrating this new capability with our existing antibody manufacturing infrastructure, we are now better positioned to offer more comprehensive solutions to global clients engaged in ADC therapeutics. The construction of our fill & finish line is also progressing as scheduled. This April, we initiated operations at Plant 5, designed to elevate efficiency and operational stability through advanced automation and digital transformation. As part of our broader digital transformation initiatives, we implemented and internalized a state-of-the-art Manufacturing Execution System (MES) within Plant 5, replacing previously manual workflows with a more advanced digital manufacturing infrastructure. Also, we implemented various advanced automated systems to enhance operational efficiency and workplace safety. These enhancements are expected to boost productivity and quality, supporting long-term profitability. Looking ahead, we will focus on ensuring a stable and timely ramp-up of Plant 5, supported by favorable contract discussions currently underway with global pharmas. In alignment with our long-term strategic growth plan for ensuring capacity expansion in a measured and sustainable manner, we are also in the final stages of internal review and approval for investment in our next manufacturing facility, Plant 6. Samsung Life Science Fund - jointly established with Samsung C&T and Samsung Bioepis - recently decided to invest in C2N Diagnostics, a U.S .- based specialty diagnostics company recognized for its strong competitive edge in blood-based biomarker testing. C2N is committed to advancing early detection of Alzheimer's disease and related dementias, with the aim of broadening global patient access and improving health outcomes. This decision reflects our ongoing commitment to identifying forward-looking opportunities that align with long-term value creation in the life sciences domain. In tandem, we are advancing the expansion of our international commercial footprint. Following the successful operation of our sales offices in the United States, we opened a new sales office in Tokyo, Japan, earlier this year to strengthen client engagement across the Asian market. This regional presence is expected to support our efforts to diversify our client portfolio beyond the global top 20 pharmaceutical companies and to accelerate outreach to global top 40. We will continue to be dedicated to advancing our technological capabilities, scaling our manufacturing capacities, and deepening our global network to establish a resilient foundation for sustainable growth.
Expanding Global Market Presence through Competitive Biosimilar Products Reinforcing Competitive Positioning with Tangible Progress In the first quarter, Samsung Bioepis made notable progress in strengthening its position in the global biosimilar market, driven by key product launches and regulatory approvals. SB17, a biosimilar to Stelara (ustekinumab), was introduced in the U.S. in February through its commercialization partner, Sandoz. Also, Samsung Bioepis signed a commercialization agreement with Teva Pharmaceuticals for SB12, a biosimilar to Soliris (eculizumab), in January and launched the product in the U.S. in April. Lastly, SB16, a biosimilar to Prolia / Xgeva (denosumab), gained regulatory approvals from the U.S. Food and Drug Administration and the European Commission in February, and Korea's Ministry of Food and Drug Safety in April. Samsung Bioepis will continue to advance the development of a robust pipeline of high-quality biosimilars across diverse therapeutic areas, expanding global treatment options and contributing meaningfully to the long-term sustainability of the healthcare ecosystem.
ESG Achievements Driving Sustainable Growth Through ESG Leadership and Social Responsibility As a leading CDMO, sustainable management has become an integral component of our corporate strategy. Samsung Biologics is continuously striving to respond proactively and responsibly to the expectations and demands of diverse stakeholders. To enhance transparency and reinforce trust with our stakeholders, we released Engagement Report ahead of the issuance of our official 2025 ESG Report. Also, as an active participant in the Sustainable Markets Initiative (SMI), founded by His Majesty King Charles III, we continue to play a leading role as the Champion of the Supply Chains Working Group in the SMI Health Systems Task Force. Lastly, we received a "Low Risk" rating from Sustainalytics for the second consecutive year and were designated as an "Industry Top Rated" company for outstanding ESG risk management. Additionally, we achieved "Leadership" status with an "A-" rating in water security from Carbon Disclosure Project (CDP), reflecting our dedication to efficient water resource management. Samsung Biologics is committed to responsible environmental and social governance as we support the sustainable growth of the global biopharmaceutical industry. We kindly invite your continued interest and support as we remain steadfast in our journey toward a more sustainable and equitable future. Sincerely, April 23rd, 2025 John Rim President & CEO, Samsung Biologics