Celltrion

- Celltrion will proactively amend its Articles of Incorporation to reflect the intent of the pending Commercial Act revision and submit a proposal for the cancellation and utilization of treasury shares at the upcoming AGM.- The Company plans to cancel 65% of its treasury shares, excluding those reserved for employee compensation, while the remaining 35% will be utilized to secure future growth drivers.- The planned cancellation of 6.11 million shares exceeds the volume of treasury shares repurchased in 2024–2025, demonstrating the Company’s commitment to responsible shareholder returns.- Celltrion will also adopt cumulative voting, an independent director system, an expanded number of separately elected outside directors, and electronic shareholders’ meetings in advance to strengthen shareholder rights protection. INCHEON, South Korea - Celltrion announced today that it will submit agenda items to its upcoming Annual General Meeting of Shareholders (AGM) to manage the cancellation, retention, and utilization of treasury shares under a structured framework, as part of its effort to strengthen corporate competitiveness and enhance shareholder value. In its notice of convocation, the company disclosed that it will hold its 35th Annual General Meeting of Shareholders on March 24 and submit agenda items including approval of the treasury share cancellation and disposal plan, partial amendments to the Articles of Incorporation, appointment of directors, and approval of the financial statements including a cash dividend of KRW 750 per share. Celltrion plans to revise its Articles of Incorporation and obtain shareholder approval to clarify the legal basis for treasury share cancellation and disposal. The Company also aims to eliminate potential market uncertainty and maintain a transparent disclosure framework. In addition, the amendments will proactively incorporate the intent of the government-proposed Commercial Act revision by introducing an independent director system, mandatory cumulative voting, an increased number of separately elected outside directors, and electronic shareholders’ meetings, thereby strengthening shareholder rights protection. Celltrion intends to retain approximately 3 million shares out of its current treasury holdings of approximately 12.34 million shares for employee compensation purposes, including stock options already granted. This measure reflects shareholders’ requests to utilize treasury shares instead of issuing new shares for stock option exercises. Excluding the portion retained for stock option purposes, approximately 6.11 million shares, representing 65% of the Company’s treasury share holdings, will be cancelled, while the remaining approximately 3.23 million shares (35%) will be utilized to secure future growth drivers. After announcing that it would cancel all treasury shares acquired in 2025, Celltrion has already cancelled approximately 1.96 million shares. If the additional cancellation of 6.11 million shares is finalized, the total will exceed the entire amount repurchased in 2024 (2.39 million shares) and the remaining 2025 repurchases (2.98 million shares), and will also include shares acquired prior to 2023. The additional 6.11 million shares scheduled for cancellation correspond to approximately KRW 1.4633 trillion based on the closing price as of February 11. Funds secured through monetization will be utilized to strengthen capabilities necessary for Celltrion’s future growth, including development and acquisition of new technologies and investment in manufacturing facilities. Given the nature of the biopharmaceutical industry, where new drug development significantly impacts corporate value, the Company plans to deploy these resources as strategic investments to enhance mid- to long-term competitiveness. “This treasury share proposal reflects our commitment to embracing the intent of the Commercial Act revision currently under discussion in the National Assembly, establishing a transparent treasury share management framework, and prioritizing shareholder value,” a Celltrion official said. “We will remain committed to shareholders while securing future growth drivers and advancing toward becoming a global biopharmaceutical leader.” 

Stoboclo listed as a preferred product on the CVS Caremark formulary, with originator products excluded, supporting accelerated uptakeOsenvelt, previously listed on CVS Caremark, secures a competitive advantage as the only biosimilar designated as a preferred productListings secured with three major PBMs within seven months of launch, achieving over 60% reimbursement coverage in the U.S.Celltrion remains focused on accelerating sales through a field-based direct sales strategy and strong product competitiveness INCHEON, South Korea-  Celltrion announced today that Stoboclo (denosumab), its biosimilar treatment for bone-related diseases, has been listed as a preferred product on the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States. With this listing, Celltrion has successfully completed preferred formulary placement on CVS Caremark for both biosimilars referencing Prolia and XGEVA. As a result of its preferred status, patient reimbursement for Stoboclo will commence on April 1 (local time), providing a solid foundation for expanding market share in the U.S. In particular, the listing of Stoboclo has been accompanied by the exclusion of the originator products from the CVS Caremark formulary, which is expected to further accelerate prescribing. The decision reflects CVS Caremark’s assessment of Stoboclo’s product competitiveness and is expected to have a positive impact on ongoing formulary discussions with other PBMs and insurers. Meanwhile, Osenvelt, which was listed on the CVS Caremark formulary ahead of Stoboclo, has been designated as the sole biosimilar preferred product, securing a clear competitive advantage. As the only reimbursed biosimilar for CVS Caremark members in its oncology indication, Osenvelt is expected to further strengthen its market position and drive prescription growth. With both Stoboclo and Osenvelt listed on CVS Caremark, Celltrion expects favorable prescribing conditions to extend across healthcare services under CVS Health, the parent company of CVS Caremark. CVS Health is one of the leading integrated healthcare companies in the U.S., operating across PBMs, pharmacy networks, health insurance, and healthcare services, and holds significant influence across the healthcare value chain. Through this achievement, Stoboclo and Osenvelt have been listed as preferred products on formularies managed by three major PBMs, including two of the three largest PBMs in the U.S. and another large PBM ranked among the top five by market share. This milestone was achieved within approximately seven months of their launch in July 2025, and is estimated to have secured reimbursement coverage exceeding 60% of the U.S. market. The outcome is largely attributable to Celltrion USA’s field-oriented commercial strategy, which focused on targeted engagement with PBMs, healthcare professionals, and key institutions from the early stages of launch. In parallel, Celltrion plans to continue expanding its presence in the U.S. open market, which accounts for approximately 30% of the total denosumab market. The open market primarily comprises healthcare institutions supported by U.S. government programs, where pharmaceutical companies’ sales capabilities and product value play a decisive role. Building on its experience from the successful direct sales of its oncology biosimilar Vegzelma (bevacizumab), Celltrion intends to actively leverage its accumulated commercial expertise to support the uptake of Stoboclo and Osenvelt. “The preferred formulary listing of Stoboclo and Osenvelt with CVS Caremark has established a stable prescribing foundation that supports sales expansion. As Celltrion continues to receive positive evaluations from multiple major U.S. PBMs, we will actively leverage the local commercial networks built through our existing product portfolio to strengthen the early market positioning of Stoboclo and Osenvelt.”said an official at Celltrion. Meanwhile, Stoboclo and Osenvelt received FDA approval in March 2025 for all approved indications (full label), consistent with those of the reference products. The originator products recorded combined global sales of approximately USD 6.6 billion in 2024, of which approximately USD 4.4 billion, or 67%, was generated in the U.S. market. 

Celltrion's 4Q revenue increased by 25% YoY, while operating profit surged by 142%, with both figures exceeding prior guidance.Biopharmaceutical sales grew by 24% YoY, driven by strong growth in high-margin new products, which accounted for 54% of sales.The OP Margin lifted to 35.8% as merger-related effects have fully normalized, contributing to enhanced profitability amid continued top-line expansion.Five newly launched products are expected to drive full-year sales in 2026, with the company setting a sales guidance of KRW 5.3Tn.With a steadily expanding biosimilar portfolio and accelerated investment in novel drug development, Celltrion is poised to enter a new phase of high-growth trajectory. INCHEON, South Korea - Celltrion announced on February 5 that it recorded consolidated revenue of KRW 4.1625 trillion and operating profit of KRW 1.1685 trillion in FY2025. This marks a 17% and 137.5% year-over-year (YoY) increase, respectively, achieving the company’s record-high performance and surpassing the KRW 4 trillion annual revenue and KRW 1 trillion operating profit milestones for the first time. The full-year operating margin rose 14.3 percentage points (pp) YoY to 28.1%. Revenue for Q4 2025 reached KRW 1.3302 trillion, up 25.1% YoY, while operating profit surged 142% YoY to KRW 475.2 billion — both outperforming previous guidance (KRW 1.2839 trillion revenue, KRW 472.2 billion operating profit). The final figures surpassed the conservative guidance, which had reflected market volatility, thereby meeting overall market expectations. Revenue contribution from newer portfolio surpasses 50% as new high‑margin products gain traction Celltrion’s strong 2025 performance was driven by continued stable growth of legacy products, along with accelerated revenue generation from newly launched high-margin assets in the newer portfolio. While Remsima, Truxima, and Herzuma maintained stable performance, next-generation products such as Remsima SC, Yuflyma, Vegzelma, Zymfentra, Steqeyma, Omlyclo, and Stoboclo/Osenvelt demonstrated robust market uptake. As a result, global biopharmaceutical sales increased 24% YoY to KRW 3.8638 trillion, with new products accounting for 54% of total biopharma revenue — surpassing the halfway mark.By product, Remsima maintained market leadership with 59% share in Europe and 30% in the U.S. (marketed as Inflectra). Building on this stronghold, the company also launched a liquid formulation with improved preparation convenience and easier storage, which is expected to further accelerate prescription uptake. Truxima posted over 30% market share in both the U.S. and Europe, growing 17.1% YoY. Herzuma maintained the No. 1 position in Europe and captured a dominant 75% market share in Japan, growing 10.1% YoY. Yuflyma ranked No. 1 in Europe and recorded 44% YoY growth globally, supported by rising prescriptions in the U.S. Vegzelma sustained its top market position in Europe and expanded market share in the U.S., driven by channel diversification through open markets and online platforms — resulting in 66.8% YoY growth. Five new products — Steqeyma, Stoboclo/Osenvelt, Omlyclo, Avtozma, and Eydenzelt — were either launched in 2H25 or under pre-launch preparation in some markets but still delivered a combined annual revenue exceeding KRW 300 billion. The early success was mainly attributable to favorable formulary listings with U.S. pharmacy benefit managers (PBMs) and successful tender wins across European markets. These products are expected to achieve stronger full-year sales in 2026 as prescriptions ramp up throughout the year. Five new products — Steqeyma, Stoboclo/Osenvelt, Omlyclo, Avtozma, and Eydenzelt — were either launched in the second half of 2025 or were in pre-launch phases in select markets. Despite their late debut, the five products collectively generated KRW 360 billion in sales within the year. This early success was driven by favorable formulary inclusion with major U.S. pharmacy benefit managers(PBMs) and multiple tender wins across key European markets. As these five products transition into full-year sales cycles in 2026, revenue contribution is expected to scale significantly, supporting Celltrion’s overall top-line growth.Amid continued top-line growth, Celltrion delivered meaningful profitability improvement through structural cost optimization. COGS ratio improved to 35.8% in Q4 2025, down from 39% in Q3 and significantly below the 63% level in Q4 2023 immediately following the merger. This improvement was driven by clearance of high-cost inventory and completion of amortization of R&D expenses, officially resolving merger-related effects. 2026 Revenue Target Set at KRW 5.3 trillion — Continued Growth Expected from New Product Uptake and New Business Following a record year in 2025, Celltrion has entered a full-scale growth phase, targeting consolidated revenue of KRW 5.3 trillion in 2026. The company plans to strengthen its market position by continuing stable supply of 11 commercial biosimilars via its global manufacturing network and direct sales infrastructure, while executing country-specific strategies.  In 2026, Celltrion will implement a "select and focus" strategy, reducing reliance on high-COGS products and aggressively pursuing tenders for higher-margin newly launched products. The company expects the revenue contribution from these products to expand to 70% of total sales. In the CDMO business, the Branchburg manufacturing facility in New Jersey — acquired in late 2025 — will begin contributing revenue in 2026. Under a three-year supply agreement worth KRW 678.7 billion, Celltrion will produce biologics for Eli Lilly through 2029. The Branchburg site will also serve as a production base for Celltrion’s U.S.-bound products and expand capacity up to 132,000 liters to support future CDMO growth globally. Celltrion will continue to invest in pipeline expansion, targeting next-level growth in both biosimilars and novel drugs. The biosimilar portfolio is set to expand from 11 to 41 products by 2038, addressing a broader range of therapeutic areas. The addressable market is projected to exceed KRW 400 trillion — more than four times the size of current opportunities. In the autoimmune segment, a Phase 1 trial for Taltz biosimilar (CT‑P52) is ongoing, with two additional IND submissions (CT‑P45 and CT‑P68) planned. Phase 3 trials are in progress for Keytruda biosimilar (CT‑P51) and Darzalex biosimilar (CT‑P44). Herceptin SC formulation, which recently completed pivotal studies, is on track for regulatory submissions in Europe and Korea within three months. Celltrion also continues to advance its pipeline of novel drugs, including 16 assets in antibody-drug conjugates (ADC), multi-specific antibodies, FcRn inhibitors, and obesity treatments. Four candidates — ADCs CT‑P70, CT‑P71, CT‑P73 and multi-antibody CT‑P72 — have already entered clinical trials. Notably, CT‑P70 received Fast Track Designation from the U.S. FDA, enabling accelerated development. Additional novel antibody INDs are expected to enter the trials in 2026.  “Driven by post-merger synergies and successful market penetration of new products, we achieved record-breaking performance in 2025. With structural cost efficiencies now in place and continued momentum from our newly launched products, we expect to maintain high growth in 2026,” said an official at Celltrion. “By expanding our biosimilar pipeline and establishing new growth engines in novel drugs and CDMO business, we are committed to becoming a global biopharmaceutical leader.” “Fueled by post-merger synergies and the successful uptake of newly launched products, we delivered record-breaking performance in 2025,” said an official at Celltrion. “With structural cost improvements firmly in place and strong momentum from our next-generation portfolio, we expect to sustain high growth in 2026. Going forward, we will continue to expand our biosimilar pipeline and secure new growth drivers in novel drug development and the CDMO business, as we strive to become a leading global biopharmaceutical company.”