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Celltrion unfazed by US policy shifts: chair
Celltrion unfazed by US policy shifts: chair

Korea Herald

time15-05-2025

  • 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.'

South Korea's Celltrion expects minimal impact from Trump's drug pricing order
South Korea's Celltrion expects minimal impact from Trump's drug pricing order

Hans India

time15-05-2025

  • 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.

Celltrion secures direct sales of cancer treatment in Spain
Celltrion secures direct sales of cancer treatment in Spain

Korea Herald

time14-05-2025

  • 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.'

Celltrion unveils value-up program to boost growth, shareholder returns
Celltrion unveils value-up program to boost growth, shareholder returns

Korea Herald

time18-03-2025

  • Business
  • Korea Herald

Celltrion unveils value-up program to boost growth, shareholder returns

Korean pharmaceutical giant Celltrion on Tuesday pledged to achieve an annual growth rate of 30 percent and a return on equity of at least 7 percent by 2027, as part of its long-term initiative aimed at enhancing corporate value and boosting shareholder returns. For the next three years, the firm added it would maintain an average shareholder return rate of 40 percent. This year, Celltrion has set a revenue target of 5 trillion won ($3.45 billion), following record-high revenue of 3.56 trillion won in 2024. The company plans to accelerate growth by strengthening its market position in biosimilars, including Remsima and Truxima, while expanding its young portfolios, which saw its sales figures rise from 26.1 percent to 38.4 percent last year. The company also expects a significant reduction in the costs of goods sold, which declined from 63 percent in 2023 to approximately 45 percent within a year and aims to reach the 20 percent range by 2027. To enhance shareholder value, Celltrion will increase dividends, repurchase shares and cancel treasury stocks, targeting a 40 percent shareholder return ratio. The company will issue a record-high dividend of 750 won in cash and 0.05 shares per common share this year. 'With strong sales and portfolio expansion, we have introduced this program to reinforce our corporate vision and commitment to shareholders,' said a Celltrion official. 'We aim to become a global top-tier pharmaceutical company while ensuring shared growth with investors.'

Celltrion secures approval for new drug product plant in Songdo
Celltrion secures approval for new drug product plant in Songdo

Korea Herald

time14-02-2025

  • Business
  • Korea Herald

Celltrion secures approval for new drug product plant in Songdo

Celltrion announced on Friday that it has received construction approval to build a new drug product (DP) manufacturing plant in Songdo, Incheon. The new facility, permitted by the Incheon Free Economic Zone Authority, will be located near the company's existing Plant 1 and have an annual production capacity of around 8 million liquid vials. Celltrion plans to complete construction in the first half of 2026 to begin full-scale commercial production in 2027. The plant will manufacture existing biosimilar products such as Truxima and Vegzelma, along with newly approved liquid vial treatments like Idencelt, Stekyma and Aptozuma. Pharmaceutical products are generally categorized into drug substances (DS), produced through processes such as cell culture and purification, and drug products, the finished form of the drug formulated for patient administration. With the expansion of its DP manufacturing capacity, the company anticipates a 30 percent reduction in production costs per product compared to current contract manufacturing organization expenses, strengthening its competitiveness in international bidding markets. The new DP plant will feature isolators to prevent exposure to hazardous substances, reducing contamination risks while enhancing operational efficiency through advanced manufacturing equipment and process automation. By integrating the new facility with the existing DP production line at Plant 2, the company aims to shorten product shipment timelines, improve workforce efficiency and enhance overall production capabilities. The increased in-house DP manufacturing capacity will also allow greater flexibility in global supply strategies. With expanded options for DS and DP supply, Celltrion can better adapt to country-specific market conditions and export requirements. Meanwhile, the company plans to adopt a flexible production strategy in the US by leveraging local CMO partnerships to mitigate potential tariff risks. This two-track approach is expected to enhance market responsiveness in line with global economic conditions. To meet the growing global demand for pharmaceuticals and expand its product portfolio, Celltrion has been strengthening its production capabilities. The company has secured a total DS production capacity of 250,000 liters, consisting of its 100,000-liter Plant 1, 90,000-liter Plant 2 and the recently operational 60,000-liter Plant 3. For DP production, the company currently manufactures 4 million liquid vials annually at Plant 2. With the additional 8 million vials from the new facility, Celltrion's total annual DP production capacity will increase to 12 million vials. "With the DP plant expansion, we can proactively respond to rising global demand and new product launches, ensuring a stable supply of high-quality pharmaceuticals," a Celltrion official said. "By strengthening our production capacity and cost competitiveness, we aim to accelerate global market expansion and drive company growth."

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