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  • Celltrion
    Celltrion to spotlight subcutaneous (SC) infliximab (Remsima™ SC) and broader IBD portfolio at UEG Week 2026

    Celltrion to showcase its broad IBD portfolio, including Remsima™ IV, Remsima™ SC, the newly launched Remsima™ IV Liquid formulation, Steqeyma™ and Yuflyma™Symposium and Meet the Experts sessions to highlight long-term clinical evidence and real-world experience with subcutaneous (SC) infliximab (Remsima™ SC) across different IBD patient scenarios INCHEON, SOUTH KOREA, OCTOBER 15 2026 – Celltrion, Inc. today announced its participation in United European Gastroenterology (UEG) Week 2026, taking place from October 17 to 20 in Barcelona, Spain, where it will highlight its inflammatory bowel disease (IBD) treatment portfolio, led by Remsima™ SC (subcutaneous infliximab). Celltrion will showcase its comprehensive infliximab portfolio, comprising Remsima™ intravenous (IV) and subcutaneous (SC) formulations, as well as the Remsima™ IV liquid formulation launched in Europe earlier this year. [1] In addition, the company will highlight its broader IBD portfolio, including SteQeyma™ (ustekinumab) and Yuflyma™ (adalimumab), reflecting its continued efforts to expand treatment options for patients with IBD. [2],[3] On October 18, Celltrion will host a symposium titled "Navigating the Treatment Journey with Subcutaneous Infliximab Across Clinical Scenarios." The symposium will be chaired by Professor Peter M. Irving of King's College London, UK, a leading expert in IBD.  Celltrion will also host two MTE sessions at its exhibition booth, featuring international IBD experts. In the first session, Professor Irina Blumenstein of University Hospital Frankfurt, Germany, will share clinical evidence and treatment considerations relating to Remsima™ SC monotherapy, drawing on real-world data and clinical experience. The second session will feature Dr. Gionata Fiorino of San Camillo-Forlanini Hospital in Rome, Italy, who will discuss the clinical considerations and potential value of early transition to SC infliximab following IV induction therapy in patients with complex Crohn's disease, as well as the potential role of Remsima™ SC in the management of perianal Crohn's disease. "UEG Week 2026 provides an opportunity to share clinical evidence and real-world experience with healthcare professionals, highlighting the role of Remsima™ SC in addressing different IBD treatment needs," said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. "We will continue to strengthen our position in the IBD market and establish ourselves as a trusted partner for healthcare professionals worldwide." [ENDS] Notes to Editors:About Remsima™ SC (CT-P13 SC, subcutaneous infliximab)CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5  About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. References [1] European Medicines Agency Summary of Product Characteristics (SmPC), Remsima. Available at link to SmPC [Last accessed October 2026].[2] European Medicines Agency Summary of Product Characteristics (SmPC), SteQeyma. Available at link to SmPC [Last accessed October 2026].[3] European Medicines Agency Summary of Product Characteristics (SmPC), Yuflyma. Available at link to SmPC [Last accessed October 2026].4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-23535 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287

  • Omlyclo
    Celltrion Expands Omlyclo® Portfolio in Europe with Launch of 300 mg Strength

    • Omlyclo® (omalizumab) 300 mg launched in key European markets including Germany, the UK and France, with rollout to expand across Europe by year-end• Omlyclo® 300 mg strength available in both pre-filled syringe (PFS) and autoinjector (AI) presentations• Multiple dose strengths and device options broaden treatment flexibility for healthcare professionals INCHEON, SOUTH KOREA – Celltrion (KRX: 068270) today announced the launch of the 300 mg strength of Omlyclo® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1 With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions. Following the European launch of Omlyclo® 75 mg and 150 mg late last year, Celltrion began rolling out the 300 mg strength in key markets including Germany, the UK and France in the middle of this year. Celltrion is gradually expanding supply to other European countries and plans to complete the rollout across Europe by the end of the year. Celltrion is offering Omlyclo® 300 mg in both pre-filled syringe (PFS) and autoinjector (AI) presentations, allowing patients and healthcare professionals a choice of device depending on the treatment setting and individual patient needs. This comprehensive portfolio provides greater flexibility in dose strengths and device options. Celltrion will continue to provide product information to healthcare professionals and institutions as part of its commercial activities across Europe. “The launch of Omlyclo® 300 mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Building on the first omalizumab biosimilar1 advantage and broad product portfolio, we will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo®’s strong growth momentum across Europe throughout the second half.” About OMLYCLO® (CT-P39, biosimilar omalizumab1) Omlyclo® is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo® is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). About Celltrion, Inc.Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. TrademarkXolair® is a registered trademark of Novartis AG. Reference1 European Medicines Agency. Summary of Product Characteristics (SmPC), Omlyclo. [Last Accessed August 2026] 

  • CI
    Celltrion Reports Q2 2026 Revenue of KRW 1.3937Tn and Operating Profit of KRW 451.8Bn; Record Quarterly Revenue as New Product Growth and Cost Improvements Boost Profitability

    - Revenue up 45% and operating profit up 86.3% YoY, with a 32.4% operating margin demonstrating solid growth.- High-margin new products grew 76% YoY, accounting for 65% of total biologics revenue.- COGS ratio improved by 5.4 percentage points YoY, reflecting continued improvement in profitability.- Operating margin above 30% was achieved despite continued investment in R&D for future growth.- The company aims to exceed its annual guidance, supported by major market tenders and continued expansion of newly launched products in the second half. INCHEON, South Korea – Celltrion today announced that it recorded consolidated revenue of KRW 1.3937 trillion and operating profit of KRW 451.8 billion for the second quarter of 2026. The results represent year-over-year (YoY) increases of 45% in revenue and 86.3% in operating profit. Following a record quarterly revenue performance in the first quarter, the company also achieved its highest-ever quarterly revenue in the second quarter. Operating margin improved by 7.2 percentage points from a year earlier to 32.4%, demonstrating both strong top-line growth and enhanced profitability. Compared with the preliminary earnings announced on July 3, revenue increased by KRW 93.7 billion and operating profit rose by KRW 21.8 billion. The latest results reflect more than just revenue growth, highlighting qualitative growth driven by a portfolio shift toward new products and improved manufacturing efficiency. Stable sales of key products, strong global sales growth of newly launched high-margin products, and faster-than-expected cost structure improvements contributed to the performance. The results also demonstrated a virtuous business cycle in which profits from commercialized products provide stable financial support for research and development investments to fuel future growth. ▲ High-Margin New Products Continue Strong Growth Across Major Markets, Accounting for 65% of Biologics RevenueSecond-quarter growth was driven by the rapid expansion of high-margin new products[1], while key products including Remsima, Truxima, and Herzuma maintained solid market positions. Truxima ranked No. 1 in market share in the United States, supported by expanded long-term supply agreements, while Remsima maintained its leading position across key markets. Herzuma achieved a record-high market share of 78% in Japan and exceeded 30% market share in Europe. Revenue from new products increased 76% YoY, expanding their contribution to total biologics revenue to 65%. By product, Remsima SC surpassed a 32% market share across the EU5[2] markets, while Zymfentra, the U.S. brand of Remsima SC, has continued to see steady uptake since launch. Yuflyma maintained its leading position in the European adalimumab market and continued to gain market share in the United States through expanded supply capabilities and distribution networks. Vegzelma maintained its leadership position in Europe and strengthened its U.S. growth foundation through formulary listings by two major pharmacy benefit managers (PBMs). Combined quarterly revenue from five newly launched products — Eydenzelt, Avtozma, Omlyclo, Stoboclo and Osenvelt, and Steqeyma — whose global rollout accelerated last year, exceeded KRW 300 billion, up 49% from the previous quarter. Celltrion plans to increase the share of biologics revenue generated by new products to approximately 70% in the second half of the year by continuing to expand launches into additional markets and broaden approved indications. ▲ COGS Ratio Improves to 38%; Product Mix and Manufacturing Efficiency Accelerate Profit GrowthThe cost of sales ratio improved to 38%, down 5.4 percentage points YoY and 2.1 percentage points from the previous quarter. The improvement was driven by a more favorable product mix resulting from the growing contribution of high-margin new products, as well as enhanced cost competitiveness through the depletion of high-cost inventory, higher production yields, and process optimization. This led to the emergence of operating leverage, with operating profit growth significantly exceeding revenue growth. The company expects profitability improvement to accelerate further in the second half as continued top-line growth generates greater economies of scale, alongside more efficient SG&A spending. The profitability improvement reflects a structural change driven by a shift in revenue mix toward new products and enhanced manufacturing competitiveness, rather than one-off factors. As the contribution of new products continues to increase, the foundation for stable earnings growth is expected to strengthen further. ▲ Operating Margin Exceeds 30% After Recognizing R&D Expenses for Future GrowthCelltrion's second-quarter performance was particularly noteworthy compared with previous quarters, as the company achieved a 32.4% operating margin despite recognizing R&D expenses related to future growth. Celltrion continues to invest in R&D—from the discovery of follow-on biosimilars and novel drug candidates to preclinical and clinical studies, regulatory approval, and commercialization—and recognizes the related costs in current-period earnings. Unlike manufacturing-focused business models, this structure entails maintaining the profitability of current products while simultaneously bearing the investment burden required for future pipeline development. Yet Celltrion delivered an operating margin exceeding 30%, demonstrating that the cash-generating capability and the competitiveness of its business provide strong support for continued R&D investment. Celltrion continues to strengthen a business model in which commercial success supports investment in the development of follow-on biosimilars and novel drug candidates, driving new product launches and revenue growth. This has led to growing recognition that the company's value should be assessed not only on its current profitability, but also on the value of its pipeline and long-term growth prospects supported by sustained R&D investment. ▲ Expanding Biosimilar and Novel Drug Pipeline to Strengthen Future Growth DriversBuilding on the launch of 11 biosimilars globally as of last year, Celltrion is accelerating development of its next-generation pipeline. The company plans to build a portfolio of 18 products by 2030, including biosimilars referencing autoimmune disease treatments such as Ocrevus, Cosentyx, and Taltz, as well as oncology therapies such as Keytruda and Darzalex. Supported by the ongoing trend toward relaxed clinical requirements among regulatory authorities, certain follow-on products are expected to benefit from reduced patient enrollment requirements, shorter development timelines, and lower R&D costs.  In novel drug development, the company continues to expand its novel drug portfolio through both in-house R&D and open innovation initiatives, with programs spanning antibody-drug conjugates (ADCs), multispecific antibodies, and obesity treatments. Leveraging the stable cash flows generated by its biosimilar business, Celltrion aims to accelerate its transformation into a global biopharmaceutical company by delivering tangible R&D outcomes from its novel drug pipeline. ▲ Stronger Second-Half Growth Expected; Company Aims to Exceed Full-Year GuidanceCelltrion expects second-half growth to exceed first-half performance as supplies under major tender contracts increase and newly launched products continue to gain market share across key markets. Driven by new product expansion into additional markets, U.S. PBM formulary coverage, deliveries under European public tenders, and year-end inventory stocking by distributors, the company aims to exceed its full-year targets of KRW 5.3 trillion in revenue and KRW 1.8 trillion in operating profit. A Celltrion official said, “Our second-quarter results demonstrated Celltrion’s cash-generating capability and business competitiveness, as we achieved an operating margin exceeding 30% while continuing to invest in R&D for future growth.” The official added, “We will continue to reinvest the stable cash flows generated by our biosimilar business into follow-on products and novel drug development, with the goal of exceeding our full-year performance targets and enhancing long-term corporate value.”[1] New products: Remsima SC (marketed as Zymfentra in the U.S.), Yuflyma, Vegzelma, Steqeyma, Stoboclo·Osenvelt, Avtozma, Omlyclo, and Eydenzelt[2] EU5: Germany, Spain, the United Kingdom, Italy, France

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Celltrion

Celltrion to spotlight subcutaneous (SC) infliximab (Remsima™ SC) and broader IBD portfolio at UEG Week 2026

2026.10.15

Celltrion to showcase its broad IBD portfolio, including Remsima™ IV, Remsima™ SC, the newly launched Remsima™ IV Liquid formulation, Steqeyma™ and Yuflyma™Symposium and Meet the Experts sessions to highlight long-term clinical evidence and real-world experience with subcutaneous (SC) infliximab (Remsima™ SC) across different IBD patient scenarios INCHEON, SOUTH KOREA, OCTOBER 15 2026 – Celltrion, Inc. today announced its participation in United European Gastroenterology (UEG) Week 2026, taking place from October 17 to 20 in Barcelona, Spain, where it will highlight its inflammatory bowel disease (IBD) treatment portfolio, led by Remsima™ SC (subcutaneous infliximab). Celltrion will showcase its comprehensive infliximab portfolio, comprising Remsima™ intravenous (IV) and subcutaneous (SC) formulations, as well as the Remsima™ IV liquid formulation launched in Europe earlier this year. [1] In addition, the company will highlight its broader IBD portfolio, including SteQeyma™ (ustekinumab) and Yuflyma™ (adalimumab), reflecting its continued efforts to expand treatment options for patients with IBD. [2],[3] On October 18, Celltrion will host a symposium titled "Navigating the Treatment Journey with Subcutaneous Infliximab Across Clinical Scenarios." The symposium will be chaired by Professor Peter M. Irving of King's College London, UK, a leading expert in IBD.  Celltrion will also host two MTE sessions at its exhibition booth, featuring international IBD experts. In the first session, Professor Irina Blumenstein of University Hospital Frankfurt, Germany, will share clinical evidence and treatment considerations relating to Remsima™ SC monotherapy, drawing on real-world data and clinical experience. The second session will feature Dr. Gionata Fiorino of San Camillo-Forlanini Hospital in Rome, Italy, who will discuss the clinical considerations and potential value of early transition to SC infliximab following IV induction therapy in patients with complex Crohn's disease, as well as the potential role of Remsima™ SC in the management of perianal Crohn's disease. "UEG Week 2026 provides an opportunity to share clinical evidence and real-world experience with healthcare professionals, highlighting the role of Remsima™ SC in addressing different IBD treatment needs," said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. "We will continue to strengthen our position in the IBD market and establish ourselves as a trusted partner for healthcare professionals worldwide." [ENDS] Notes to Editors:About Remsima™ SC (CT-P13 SC, subcutaneous infliximab)CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5  About CelltrionCelltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. References [1] European Medicines Agency Summary of Product Characteristics (SmPC), Remsima. Available at link to SmPC [Last accessed October 2026].[2] European Medicines Agency Summary of Product Characteristics (SmPC), SteQeyma. Available at link to SmPC [Last accessed October 2026].[3] European Medicines Agency Summary of Product Characteristics (SmPC), Yuflyma. Available at link to SmPC [Last accessed October 2026].4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-23535 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287

Omlyclo

Celltrion Expands Omlyclo® Portfolio in Europe with Launch of 300 mg Strength

2026.08.25

• Omlyclo® (omalizumab) 300 mg launched in key European markets including Germany, the UK and France, with rollout to expand across Europe by year-end• Omlyclo® 300 mg strength available in both pre-filled syringe (PFS) and autoinjector (AI) presentations• Multiple dose strengths and device options broaden treatment flexibility for healthcare professionals INCHEON, SOUTH KOREA – Celltrion (KRX: 068270) today announced the launch of the 300 mg strength of Omlyclo® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1 With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions. Following the European launch of Omlyclo® 75 mg and 150 mg late last year, Celltrion began rolling out the 300 mg strength in key markets including Germany, the UK and France in the middle of this year. Celltrion is gradually expanding supply to other European countries and plans to complete the rollout across Europe by the end of the year. Celltrion is offering Omlyclo® 300 mg in both pre-filled syringe (PFS) and autoinjector (AI) presentations, allowing patients and healthcare professionals a choice of device depending on the treatment setting and individual patient needs. This comprehensive portfolio provides greater flexibility in dose strengths and device options. Celltrion will continue to provide product information to healthcare professionals and institutions as part of its commercial activities across Europe. “The launch of Omlyclo® 300 mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Building on the first omalizumab biosimilar1 advantage and broad product portfolio, we will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo®’s strong growth momentum across Europe throughout the second half.” About OMLYCLO® (CT-P39, biosimilar omalizumab1) Omlyclo® is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). In the EU, Omlyclo® is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). About Celltrion, Inc.Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. FORWARD-LOOKING STATEMENTCertain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", “anticipates”, the negative of these words or such other variations thereon or comparable terminology.In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. TrademarkXolair® is a registered trademark of Novartis AG. Reference1 European Medicines Agency. Summary of Product Characteristics (SmPC), Omlyclo. [Last Accessed August 2026] 

CI

Celltrion Reports Q2 2026 Revenue of KRW 1.3937Tn and Operating Profit of KRW 451.8Bn; Record Quarterly Revenue as New Product Growth and Cost Improvements Boost Profitability

2026.07.27

- Revenue up 45% and operating profit up 86.3% YoY, with a 32.4% operating margin demonstrating solid growth.- High-margin new products grew 76% YoY, accounting for 65% of total biologics revenue.- COGS ratio improved by 5.4 percentage points YoY, reflecting continued improvement in profitability.- Operating margin above 30% was achieved despite continued investment in R&D for future growth.- The company aims to exceed its annual guidance, supported by major market tenders and continued expansion of newly launched products in the second half. INCHEON, South Korea – Celltrion today announced that it recorded consolidated revenue of KRW 1.3937 trillion and operating profit of KRW 451.8 billion for the second quarter of 2026. The results represent year-over-year (YoY) increases of 45% in revenue and 86.3% in operating profit. Following a record quarterly revenue performance in the first quarter, the company also achieved its highest-ever quarterly revenue in the second quarter. Operating margin improved by 7.2 percentage points from a year earlier to 32.4%, demonstrating both strong top-line growth and enhanced profitability. Compared with the preliminary earnings announced on July 3, revenue increased by KRW 93.7 billion and operating profit rose by KRW 21.8 billion. The latest results reflect more than just revenue growth, highlighting qualitative growth driven by a portfolio shift toward new products and improved manufacturing efficiency. Stable sales of key products, strong global sales growth of newly launched high-margin products, and faster-than-expected cost structure improvements contributed to the performance. The results also demonstrated a virtuous business cycle in which profits from commercialized products provide stable financial support for research and development investments to fuel future growth. ▲ High-Margin New Products Continue Strong Growth Across Major Markets, Accounting for 65% of Biologics RevenueSecond-quarter growth was driven by the rapid expansion of high-margin new products[1], while key products including Remsima, Truxima, and Herzuma maintained solid market positions. Truxima ranked No. 1 in market share in the United States, supported by expanded long-term supply agreements, while Remsima maintained its leading position across key markets. Herzuma achieved a record-high market share of 78% in Japan and exceeded 30% market share in Europe. Revenue from new products increased 76% YoY, expanding their contribution to total biologics revenue to 65%. By product, Remsima SC surpassed a 32% market share across the EU5[2] markets, while Zymfentra, the U.S. brand of Remsima SC, has continued to see steady uptake since launch. Yuflyma maintained its leading position in the European adalimumab market and continued to gain market share in the United States through expanded supply capabilities and distribution networks. Vegzelma maintained its leadership position in Europe and strengthened its U.S. growth foundation through formulary listings by two major pharmacy benefit managers (PBMs). Combined quarterly revenue from five newly launched products — Eydenzelt, Avtozma, Omlyclo, Stoboclo and Osenvelt, and Steqeyma — whose global rollout accelerated last year, exceeded KRW 300 billion, up 49% from the previous quarter. Celltrion plans to increase the share of biologics revenue generated by new products to approximately 70% in the second half of the year by continuing to expand launches into additional markets and broaden approved indications. ▲ COGS Ratio Improves to 38%; Product Mix and Manufacturing Efficiency Accelerate Profit GrowthThe cost of sales ratio improved to 38%, down 5.4 percentage points YoY and 2.1 percentage points from the previous quarter. The improvement was driven by a more favorable product mix resulting from the growing contribution of high-margin new products, as well as enhanced cost competitiveness through the depletion of high-cost inventory, higher production yields, and process optimization. This led to the emergence of operating leverage, with operating profit growth significantly exceeding revenue growth. The company expects profitability improvement to accelerate further in the second half as continued top-line growth generates greater economies of scale, alongside more efficient SG&A spending. The profitability improvement reflects a structural change driven by a shift in revenue mix toward new products and enhanced manufacturing competitiveness, rather than one-off factors. As the contribution of new products continues to increase, the foundation for stable earnings growth is expected to strengthen further. ▲ Operating Margin Exceeds 30% After Recognizing R&D Expenses for Future GrowthCelltrion's second-quarter performance was particularly noteworthy compared with previous quarters, as the company achieved a 32.4% operating margin despite recognizing R&D expenses related to future growth. Celltrion continues to invest in R&D—from the discovery of follow-on biosimilars and novel drug candidates to preclinical and clinical studies, regulatory approval, and commercialization—and recognizes the related costs in current-period earnings. Unlike manufacturing-focused business models, this structure entails maintaining the profitability of current products while simultaneously bearing the investment burden required for future pipeline development. Yet Celltrion delivered an operating margin exceeding 30%, demonstrating that the cash-generating capability and the competitiveness of its business provide strong support for continued R&D investment. Celltrion continues to strengthen a business model in which commercial success supports investment in the development of follow-on biosimilars and novel drug candidates, driving new product launches and revenue growth. This has led to growing recognition that the company's value should be assessed not only on its current profitability, but also on the value of its pipeline and long-term growth prospects supported by sustained R&D investment. ▲ Expanding Biosimilar and Novel Drug Pipeline to Strengthen Future Growth DriversBuilding on the launch of 11 biosimilars globally as of last year, Celltrion is accelerating development of its next-generation pipeline. The company plans to build a portfolio of 18 products by 2030, including biosimilars referencing autoimmune disease treatments such as Ocrevus, Cosentyx, and Taltz, as well as oncology therapies such as Keytruda and Darzalex. Supported by the ongoing trend toward relaxed clinical requirements among regulatory authorities, certain follow-on products are expected to benefit from reduced patient enrollment requirements, shorter development timelines, and lower R&D costs.  In novel drug development, the company continues to expand its novel drug portfolio through both in-house R&D and open innovation initiatives, with programs spanning antibody-drug conjugates (ADCs), multispecific antibodies, and obesity treatments. Leveraging the stable cash flows generated by its biosimilar business, Celltrion aims to accelerate its transformation into a global biopharmaceutical company by delivering tangible R&D outcomes from its novel drug pipeline. ▲ Stronger Second-Half Growth Expected; Company Aims to Exceed Full-Year GuidanceCelltrion expects second-half growth to exceed first-half performance as supplies under major tender contracts increase and newly launched products continue to gain market share across key markets. Driven by new product expansion into additional markets, U.S. PBM formulary coverage, deliveries under European public tenders, and year-end inventory stocking by distributors, the company aims to exceed its full-year targets of KRW 5.3 trillion in revenue and KRW 1.8 trillion in operating profit. A Celltrion official said, “Our second-quarter results demonstrated Celltrion’s cash-generating capability and business competitiveness, as we achieved an operating margin exceeding 30% while continuing to invest in R&D for future growth.” The official added, “We will continue to reinvest the stable cash flows generated by our biosimilar business into follow-on products and novel drug development, with the goal of exceeding our full-year performance targets and enhancing long-term corporate value.”[1] New products: Remsima SC (marketed as Zymfentra in the U.S.), Yuflyma, Vegzelma, Steqeyma, Stoboclo·Osenvelt, Avtozma, Omlyclo, and Eydenzelt[2] EU5: Germany, Spain, the United Kingdom, Italy, France