Trastuzumab-PKRB(Celltrion)

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.”