Celltrion

- Completed formulary listings with ESI’s public and private insurance plans and Optum’s public insurance plan, securing reimbursement coverage across 35% of the total U.S. insurance market- Vegzelma recorded 10.6% market share in the U.S. bevacizumab sector in May, with rapid growth expected through expanded reimbursement access- High-margin follow-up products including Omlyclo are scheduled to launch in the U.S. in H2, building on the performance of Celltrion’s existing portfolio [July 7, 2026, KST] Celltrion today announced that Vegzelma (bevacizumab), its treatment for metastatic colorectal cancer and breast cancer, has successfully secured formulary listings with two major pharmacy benefit managers (PBMs) in the United States, establishing a foundation for reimbursement coverage. As Vegzelma has already achieved a market share of over 10% through ‘open market’-focused sales activities, this latest achievement is expected to further accelerate its market share expansion.Vegzelma has recently been listed as a preferred drug on the government and commercial insurance formularies of Express Scripts (ESI), one of the top three PBMs in the United States, as well as on the government insurance formulary of Optum, another major PBM. Reimbursement coverage for ESI government plans and Optum has already taken effect from July 1, while reimbursement coverage for ESI commercial plans is scheduled to begin in January next year.In the U.S. pharmaceutical market, the top three PBMs hold significant influence, accounting for approximately 80% of the total insurance market. If a drug is not listed on formularies managed by PBMs, patients are required to purchase the product at its full price without reimbursement, making access to high-cost treatments practically difficult. Through these PBM formulary listings, Vegzelma has secured reimbursement coverage across more than 35% of the U.S. insurance market, establishing a stable foundation for prescription growth.According to IQVIA, Vegzelma recorded approximately 10.6% market share in the U.S. bevacizumab sector as of May, surpassing double-digit market share for the first time since launch and continuing its growth momentum. This result was achieved through Celltrion USA’s focused strategy targeting the U.S. bevacizumab open market and is considered particularly meaningful as Vegzelma delivered strong performance despite entering the market as a latecomer in a highly competitive environment.The open market is a channel supported by the U.S. government that directly connects healthcare institutions and pharmaceutical companies, where a company’s sales capabilities and product competitiveness serve as key factors for market penetration. With these formulary listings, Vegzelma is expected to further accelerate its market share growth by adding new reimbursement access from insurers to the existing growth momentum generated in the open market. Celltrion plans to continue pursuing formulary listing negotiations with other major PBMs to further strengthen Vegzelma’s growth trajectory.In addition to Vegzelma, Celltrion’s other key products, including SteQeyma (ustekinumab) and Yuflyma (adalimumab), are also continuing to perform well in the U.S. market. The two products recorded market shares of 13.3% and 8.1%, respectively, in the U.S. in May, demonstrating stable prescription growth. Also, SteQeyma ranked second in prescription volume among ustekinumab biosimilars despite intense competition following the launch of seven biosimilar products, underscoring the direct sales competitiveness of Celltrion USA.Alongside the performance of its existing products, Celltrion’s U.S. revenue growth is expected to continue as high-margin follow-up products are launched. In the second half of the year, the subcutaneous (SC) formulation of Avtozma (tocilizumab), a treatment for autoimmune diseases, and Omlyclo (omalizumab) are scheduled to be newly launched in the U.S., further strengthening the company’s portfolio. Also, Omlyclo is expected to launch in the U.S. as a first-mover omalizumab biosimilar, positioning it to rapidly capture the market based on its competitive advantage.“Vegzelma has secured a reimbursement foundation in the U.S. by being listed as a preferred drug on the formularies of major PBMs with significant market influence, and we expect this to further accelerate prescription growth,” said an official from Celltrion. “We will continue to pursue formulary listing negotiations with other major PBMs to build on Vegzelma’s achievements, while strengthening the sales performance of Celltrion’s broader portfolio and expanding our market influence in the United States.” 

Celltrion Revenue increased 35.2% YoY and operating profit surged 77.3%, marking the highest second-quarter performance in the company's history.High-margin newer portfolio exceeded 60% of total revenue, driving improved product mix and operating margin expansion to approximately 33%.Continued growth across the U.S. and Europe, supported by manufacturing expansion and pipeline advancement, further strengthens long-term growth foundation.Second consecutive quarter of outperforming market expectations, with further growth anticipated during the industry’s peak season in the second half. INCHEON, South Korea – Celltrion today announced that it recorded preliminary consolidated revenue of KRW 1.3 trillion and operating profit of KRW 430 billion for the second quarter of 2026. The results represent the strongest second-quarter performance in the company's history, with revenue increasing 35.2% year over year (YoY) and operating profit rising 77.3% YoY. Operating margin also improved significantly from 25% in the prior-year period to approximately 33%, demonstrating both continued top-line growth and improved profitability. The quarter was particularly meaningful as it reflected not only higher sales but also qualitative grwoth driven by a greater contribution from high-margin products and structurally improved cost base. Following its strong first-quarter performance, Celltrion once again exceeded market expectations in the second quarter, underscoring the growing commercial impact of its business competitiveness. The company also surpassed its previously announced second-quarter operating profit target of KRW 400 billion, which had been presented in its business outlook and management plan disclosed earlier this year, further strengthening confidence in the execution of its annual business plan. Furthermore, considering the seasonal characteristics of the biosimilar industry, in which supply volumes for major national tenders and year-end inventory stocking demand are concentrated in the second half of the year, sales growth is expected to accelerate further during the remainder of the year. As a result, expectations are increasing that the company will exceed its full-year performance targets. Transition toward High-Margin Young Portfolio Accelerates Structural Profitability Improvement The strong performance was driven by the rapid growth of newly launched high-margin products in addition to solid sales of the company’s existing flagship products, accelerating the transformation of its product portfolio toward higher-value offerings. Newer products including Remsima SC(marketed as Zymfentra in the U.S.), Yuflyma, and Steqeyma continued to deliver strong growth across major global markets, with the newer portfolio accounting for more than 60% of total revenue.Zymfentra continued to achieve record-high prescription volumes in the United States, while Steqeyma rapidly expanded its market share and established itself among the leading competitors in the U.S. market. Avtozma and Stoboclo/Osenvelt also successfully gained market traction and are emerging as new growth drivers. In Europe, Omlyclo continued to benefit from its first-mover advantage, while Vegzelma maintained its leading market position despite being a later entrant. Avtozma, Yuflyma, and Stoboclo/Osenvelt have also entered a phase of accelerated sales growth and are expected to become key contributors to second-half performance. Profitability is also improving structurally. As most one-off costs associated with the merger have been resolved, the completion of high-cost inventory clearance, the end of R&D amortization, and improved manufacturing yield(Titer Improvement) collectively enhanced the company's cost competitiveness. Celltrion believes these profitability improvements are structural rather than temporary, supported by a higher-margin product mix and improved manufacturing efficiency, providing a solid foundation for sustainable earnings growth. Strengthening Biosimilars, Novel Drug Pipeline, and Manufacturing Capacity to Support Long-Term Growth Beyond its strong financial performance, Celltrion continues to strengthen its long-term growth platform. CT-P55, a biosimilar referencing Cosentyx for autoimmune diseases, is currently undergoing regulatory review in Korea, North America, and other key markets, while regulatory submissions for Herzuma SC are progressing sequentially across major global markets. Development of follow-on biosimilars referencing Keytruda and Darzalex is also progressing as planned. The company plans to expand its biosimilar portfolio to 18 products by 2030 and 41 products by 2038. Novel drug development is also advancing steadily. CT-P70 and CT-P71 have both received U.S. FDA Fast Track Designation, accelerating their clinical development. Celltrion continues to expand R&D investment with the goal of securing a portfolio of 20 novel drug candidates by next year. To support its expanding product portfolio, Celltrion is simultaneously strengthening its global manufacturing network. In Korea, the company is constructing Plants 4 and 5, adding 180,000 liters of drug substance (DS) manufacturing capacity to its existing 250,000-liter production base. In the United States, Celltrion recently announced a 75,000-liter expansion of its Branchburg manufacturing facility in New Jersey, increasing total U.S. capacity to 141,000 liters. The expansion of its U.S. manufacturing site is expected to structurally mitigate tariff and supply chain risks while establishing a stronger foundation for the company's global contract manufacturing (CMO) business, ultimately supporting the company's long-term growth and enterprise value. A Celltrion official said, "Our second-quarter performance demonstrates that our strategy of expanding the newer product portfolio while improving profitability has begun to deliver meaningful results." The official added, "We continue to strengthen our sustainable growth foundation by simultaneously expanding our product portfolio, enhancing manufacturing capabilities, and accelerating novel drug development. As major tender opportunities and continued momentum from newly launched products are expected to support stronger performance in the second half, we remain confident in delivering results that surpass those of the first half while further strengthening our competitiveness as a global biopharmaceutical leader.".

Designed to address limitations of current GLP-1 therapies by maximizing weight reduction while supporting preservation of muscle mass.Comprehensive toxicology studies, including primate studies, are underway as the program enters the final preclinical stage ahead of global clinical development.Positioned as a next-generation platform candidate with potential applicability across obesity, diabetes, and broader metabolic disease indications.Strategic collaboration with Japan-based Scohia Pharma supports development, with Celltrion expected to lead global development and commercialization.Expands Celltrion’s innovative pipeline beyond biosimilars into obesity, ADCs, and other novel therapeutics, reinforcing mid- to long-term growth drivers. INCHEON, South Korea – Celltrion today announced the initiation of primate toxicology studies for its next-generation obesity drug candidate, CT-G32, representing the final preclinical step prior to global clinical development. The company is advancing the program toward submission of an Investigational New Drug (IND) application in the first half of next year.CT-G32 is a next-generation obesity candidate designed to simultaneously engage four targets, including GLP-1 (glucagon-like peptide-1), and is being advanced by Celltrion as a potential first-in-class therapeutic. The candidate is intended to address key limitations observed in the current GLP-1 treatment landscape, including variability in patient response, muscle loss, and treatment durability, while enhancing overall weight reduction efficacy.As the global obesity therapeutics market is projected to exceed USD 100 billion, competition to secure next-generation multi-agonist mechanisms continues to intensify across the pharmaceutical industry. Celltrion aims to position CT-G32 beyond a conventional weight-loss therapy and develop it as a broader metabolic disease platform capable of regulating fat, muscle, and overall energy metabolism.Under the current toxicology program, Celltrion will assess the safety and toxicity profile of CT-G32 in 252 rats and 48 monkeys. The study is expected to provide critical data to support dose selection and safety evaluation for future clinical trials. In parallel, the company plans to further characterize the candidate’s pharmacokinetic (PK) and pharmacodynamic (PD) profile.In earlier preclinical studies, CT-G32 demonstrated superior weight reduction at equivalent doses relative to a benchmark candidate previously under development, while also showing preservation of lean body mass, including muscle.Based on these preclinical findings, Celltrion intends to submit an IND application in the first half of next year and subsequently advance CT-G32 into global clinical development. The company is also evaluating the potential to expand the candidate beyond obesity into additional metabolic disease indications, including diabetes and metabolic dysfunction-associated steatohepatitis (MASH).To support this program, Celltrion has established a strategic collaboration framework with Japan-based Scohia Pharma and is jointly advancing development activities. Celltrion expects to play a leading role across the full value chain, including preclinical and clinical development as well as global commercialization, in order to strengthen its long-term competitiveness in the global market.In parallel with its quadruple-action injectable program, Celltrion is also developing a multi-action oral obesity candidate. Through differentiated treatment options across stages of care, the company seeks to maximize portfolio synergies and build a broader presence in the obesity therapeutics market. Research is currently underway to improve stability and bioavailability, with IND submission for the oral candidate targeted for the second half of 2028.A Celltrion official said, “CT-G32 is being developed as a next-generation candidate intended to address the limitations of current GLP-1-based therapies while extending Celltrion’s reach beyond obesity into broader metabolic disease areas.” The official added, “Leveraging the global development and manufacturing capabilities established through our biosimilar business, Celltrion will continue to expand its innovative pipeline in areas including obesity and ADCs in support of sustainable mid- to long-term growth.”