Infliximab-dyyb (Celltrion)

- 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 Revenue Second-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 Growth The 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 Growth Celltrion'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 Drivers Building 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 Guidance Celltrion 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