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Korea Herald
15-05-2025
- Business
- Korea Herald
Celltrion unfazed by US policy shifts: chair
Seo sees US pricing overhaul leveling playing field for biosimilars, affirms W5tr target revenue Celltrion Group Chair and founder Seo Jung-jin downplayed concerns over potential fallout from recent US policy and tariff changes, saying the South Korean drugmaker remains on track to meet its annual revenue target of 5 trillion won ($3.58 billion) this year. 'Concerns about the impact of recent US policy and tariff changes have been excessively amplified,' Seo said during an online briefing Thursday. 'We see no effect on our business this year, and even next year, it could be an opportunity rather than a risk.' His remarks come amid mounting investor unease over Washington's efforts to cut drug prices and adopt broader protectionist trade measures. Celltrion shares have fallen 16 percent this year, reflecting wider uncertainty across the sector. In a briefing aimed at addressing those concerns directly, Seo emphasized the company's preparedness to navigate shifting regulatory and trade dynamics. He said that Celltrion faces no immediate fallout from potential sector-specific tariffs, at least through next year. 'Celltrion has already secured inventory covering 15 to 21 months of US-bound supply,' he said. 'Whatever tariff measures are introduced, they won't affect us until the end of next year.' The company manufactures active pharmaceutical ingredients in Korea, while finished products are produced through contract manufacturing organizations in Europe and the US. Its US-bound biosimilars — including Remsima, Herzuma and Truxima — are sold via local partners such as Pfizer. Seo added that Celltrion has secured US-based contract manufacturing capacity for up to 3 million vials, with options to expand to 6 million if needed, providing flexibility to absorb potential tariff shocks. Still, he voiced caution over building an active pharmaceutical ingredients plant in the US. Constructing a 100,000 liter facility would cost about 1.3 trillion won in Korea, but is nearly 2 trillion won in the US, he said. 'We'll make a careful decision on US infrastructure investment once tariff policy becomes clearer, likely by year-end,' Seo said. Seo also said the US push to cut drug prices could ultimately benefit Celltrion. 'US drug prices are undeniably high compared to other countries, but that mainly applies to originator biologics,' he said. 'Celltrion focuses on biosimilars, so we're largely unaffected by pricing pressure.' He blamed inflated drug prices on the complex distribution chain of the US, where pharmacy benefit managers, insurers and wholesalers eat into the margin, creating inefficiencies. Although biosimilars are already sold at discounts of up to 90 percent compared to branded biologics, market penetration remains limited due to entrenched profit-driven intermediaries, he added. 'If the Trump administration simplifies the intermediary distribution system, it would create a more competitive market, one where Celltrion could thrive,' said Seo. While apologizing for the setback from the delayed launch of its new drug Zymfentra, Celltrion's key treatment for autoimmune diseases, in the US, Seo characterized the impact as minor and offset by other product sales. According to Seo, the company aims to expand its portfolio by launching 18 new biosimilar products by 2038, bringing the total to 40, while staying on course to begin clinical trials for 13 new drug candidates — including antibody-drug conjugates and bispecific antibodies — by 2035. Seo reaffirmed the group's full-year target remains intact. 'We're projecting between 4.6 trillion and 5 trillion won,' he said, expressing confidence earnings will rise quarter by quarter, charting a steady upward trajectory. Celltrion reached its target of 3.5 trillion won in revenue last year. Alongside earnings growth, Seo also pledged to boost shareholder returns and investor confidence. 'We will continue to repurchase and cancel treasury shares, with all newly acquired shares to be canceled,' he said, noting the company has already bought and canceled 450 billion won worth this year and plans to purchase up to 700 billion won more if needed. Toward the end, the chairman made a personal appeal to investors, reaffirming his long-term commitment to the company amid challenging times. 'I will do everything in my power to ensure stable and sustainable growth for as long as I live,' said the 67-year-old founder. 'I have no intention of selling this company or any part of my stake and plan to grow it and pass it on to my successors. I have about seven years left, and I intend to devote them entirely to Celltrion.'


Hans India
15-05-2025
- Business
- Hans India
South Korea's Celltrion expects minimal impact from Trump's drug pricing order
Seoul: Celltrion, a leading South Korean biopharmaceutical company, on Thursday said its business will remain largely unaffected by US President Donald Trump's executive order aimed at lowering drug prices to match those in other countries. The order seeks to address a drug pricing system in which the United States pays significantly more for prescription medicines than other developed nations, Yonhap news agency reported. "High US drug prices are not due to pharmaceutical companies, but rather the result of issues in the middle distribution process," said Celltrion Chairman Seo Jung-jin, in an online press conference. Trump's pricing proposal primarily targets intermediaries, such as pharmacy benefit managers (PBMs) and private-sector insurers, that drive up costs for US patients, he noted. Under the US PBM system, original biologic drugs are typically listed first in formularies, followed by the addition of two to three biosimilars through competitive processes. But the prices of biosimilars are often priced similarly to original drugs when prescribed in hospitals due to rebate issues involving intermediaries. "If the intermediary distribution structure that includes PBMs is overhauled, biosimilar manufacturers would be able to negotiate drug prices directly with the government instead of going through intermediaries," he said. "For Celltrion, this would generate more opportunities." Seo said the executive order will not likely affect the company's business, as its biosimilars are already sold at deeply discounted prices in the US market compared with original drugs. Regarding planned tariffs on pharmaceutical imports, the chairman also projected little impact on sales, noting that the company's flagship biosimilars -- Remsima, Herzuma and Truxima -- are not subject to import tariffs. The products are sold through Pfizer in the US market, and Celltrion holds sufficient inventories to supply the market for up to 21 months. The Trump administration plans to announce item-by-item tariffs on pharmaceutical imports within two weeks. "For continued growth, the company will also decide on whether to build a manufacturing facility in the US by the end of this year. We have already completed studies on 48 potential sites in eight US states for the project," Seo said, without elaborating. He forecast Celltrion will post between 4.6 trillion won ($3.29 billion) to 4.7 trillion won in sales this year, up from 3.56 trillion won last year. The company has significantly expanded its global biosimilar lineup, increasing the number of approved products from six to 11. It aims to commercialise 23 biosimilars by 2030 and 40 by 2038, while planning to put 13 original drugs under clinical trials by 2035. Celltrion currently sells its sole original drug, Zymfentra, in the US market for the treatment of self-immune diseases. The global market for its planned 23 biosimilars is expected to nearly double to 261 trillion won by 2030 from 138 trillion won this year, according to the company.


Korea Herald
14-05-2025
- Business
- Korea Herald
Celltrion secures direct sales of cancer treatment in Spain
Korean biopharmaceutical company Celltrion has initiated direct sales operations in Spain, completing its transition to locally led sales across all major European markets, the company announced Wednesday. Following the conclusion of its partnership with former distributor Kern Pharma, Celltrion's Spanish subsidiary will now manage local operations independently, directly distributing three oncology drugs: Truxima (rituximab), Herzuma (trastuzumab), and Vegzelma (bevacizumab). This strategic move follows a successful tender win from CSC, a major procurement consortium serving 25 public hospitals in Catalonia. Under the agreement, Celltrion will supply Truxima and Herzuma to CSC from 2025 through 2029. Building on its local market experience since 2018, Celltrion has reinforced its distribution network and built strong stakeholder relationships to support this transition. According to health care analytics firm IQVIA, Truxima and Herzuma achieved market shares of 23 percent and 22 percent, respectively, ranking among the top prescribed treatments in the third quarter of 2024 in Spain. In Portugal, Celltrion has also completed its direct sales transition, launching Stekima and securing a national tender covering approximately 60 percent of the market in its first year. 'By this initiative, Celltrion has proven its ability to operate independently and competitively in Europe,' said Kang Seok-hoon, head of Celltrion Spain and Portugal. 'We will continue leveraging our expertise to strengthen our position and accelerate growth across key European markets.'


Korea Herald
05-02-2025
- Business
- Korea Herald
Celltrion's Vegzelma becomes Europe's top prescribed bevacizumab
Celltrion announced Wednesday that its metastatic colorectal and breast cancer drug, Vegzelma, has become the most prescribed bevacizumab in Europe, demonstrating strong growth in its market share. According to market research firm IQVIA, Vegzelma accounted for 29 percent of bevacizumab-adcd prescriptions in Europe as of the third quarter of 2024. This marks a 9 percentage point increase from the previous quarter after its market debut in October 2022. Despite entering the market later than some competitors, Celltrion said its European subsidiary has driven rapid growth through direct distribution. Since 2020, the company has shifted to a direct sales strategy for its portfolio, including Remsima, Herzuma and Truxima, which were previously sold through distributors. Celltrion's overseas branches have strengthened relationships with local bidding organizations and prescribers to expand market reach. As part of these efforts, the company secured a contract in June 2024 with UniHA, France's largest drug procurement agency, allowing it to supply Vegzelma until 2027. Additionally, Celltrion has continued to grow steadily in the autoimmune disease sector. In five major European markets -- Germany, Spain, the UK, Italy and France -- Remsima SC achieved a 25 percent market share, marking a year-on-year increase of 1 percentage point. To bolster its presence in Europe, the company has been gradually rolling out its product, Steqeyma, across various regions. 'With our existing products achieving remarkable success in Europe, the strong sales of our newer treatments further solidify our market leadership,' said a Celltrion official. 'Building on this momentum, we aim to deliver outstanding results with our expanding portfolio.'