Celltrion

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.”

Celltrion has successfully completed the pivotal regulatory clinical trial for Herzuma SC and plans to submit marketing authorization applications within the next three months, starting with Europe and Korea, its largest markets for SC formulation products.The trial demonstrated pharmacokinetic (PK) equivalence as well as comparable safety and immunogenicity to the reference product, and Herzuma SC is expected to reduce administration time to approximately five minutes.Celltrion plans to leverage its hyaluronidase-based SC formulation platform for subsequent pipeline candidates as well as for the development of novel drug programs.By establishing a full SC value chain spanning development, regulatory approval, manufacturing, and commercialization, Celltrion has secured differentiated competitiveness beyond simple technology out-licensing models.Building on its advanced SC formulation capabilities, Celltrion also aims to expand its business scope into formulation-change CMO services. INCHEON, South Korea- Celltrion announced today that it has successfully completed the regulatory clinical trial for ‘Herzuma SC(CT-P6 SC)’, the subcutaneous (SC) formulation of the breast cancer treatment ‘Herzuma (trastuzumab)’, plans to submit marketing authorization applications to regulatory authorities in Europe and Korea within the next three months. In the recently completed pivotal trial for CT-P6 SC, Celltrion directly compared CT-P6 SC with the reference product’s SC formulation and successfully demonstrated pharmacokinetic (PK) equivalence, the primary endpoint of the study. Furthermore, it confirmed equivalence to the originator product in safety and immunogenicity assessments. With this, Celltrion has once again demonstrated its unparalleled development capabilities. Following the successful development and commercialization of the biosimilar Herzuma, it has now successfully completed the regulatory clinical trial for an SC formulation biosimilar incorporating the enzyme hyaluronidase. The company has secured sufficient data on quality and PK equivalence compared to the original product. Accordingly, following prior consultations with regulatory authorities, it plans to apply for marketing authorization for Herzuma SC in Europe and domestically within three months without conducting additional clinical trials. Europe and Korea currently represent Celltrion’s largest markets for SC formulation products. Celltrion developed Herzuma SC by internalizing hyaluronidase-based SC formulation technology. This technology temporarily breaks down hyaluronic acid within subcutaneous tissue, enabling the SC administration of high-concentration, high-dose pharmaceuticals, which offers high safety and scalability. Additionally, Herzuma SC is expected to maximize patient convenience by reducing the administration time from approximately 90 minutes (including a 30-minute maintenance period) for the existing intravenous (IV) formulation to within about 5 minutes, while also broadening the options available to healthcare providers. Upon approval, Celltrion is expected to accelerate its expansion of global market share by securing a full product lineup encompassing both IV and SC formulations. According to IQVIA, the global trastuzumab market size reached approximately $3.561 billion as of 2024. Celltrion has completed its own integrated development platform spanning the entire SC formulation development lifecycle, establishing Korea's only full SC value chain encompassing development, approval, mass production, and global supply starting with this Herzuma SC. Unlike the license-out (L/O) approach, which transfers only partial technology externally, this structure enables direct control over the entire cycle from development to commercialization and sales. It is evaluated as securing a differentiated structural competitive advantage in terms of long-term profitability and strategic flexibility. It also holds significant strategic meaning in establishing a mid-to-long-term growth platform leveraging SC formulation technology, going beyond the success of a single product. Once the development of Herzuma SC is completed, Celltrion is expected to join the ranks of ‘first movers’ by being the first to apply hyaluronidase to a biosimilar, establishing itself as a leading example for biosimilars in this formulation. As this milestone is anticipated to secure a market advantage, the company expects to maximize both product competitiveness and profitability. Celltrion plans to actively consider applying the SC formulation to its own biosimilars as well as new drugs under development in the future, if necessary. Celltrion has already demonstrated its capability to commercialize SC formulations through Remsima SC (US product name: Zymfentra). Building on this, the company plans to expand into contract manufacturing (CMO) services for formulation changes, offering its SC formulation modification expertise to external clients as well. “Following the world’s first commercialization of infliximab SC, we have now secured hyaluronidase-based SC formulation technology, completing global-level SC formulation capabilities,” said an official at Celltrion. “Beyond this, we will accelerate global market share expansion and new business growth such as contract development and manufacturing (CDMO), based on our overwhelming competitive advantage of full-cycle SC formulation development internalization—from productization to manufacturing and supply.”