Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio, Market Reach

Celltrion announced it plans to commercialize 22 biosimilars by 2030, championing its efforts to increase development of biosimilars and novel drugs. The projection was shared in the company’s investor relations report for September and October 2024.¹

Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that allows for the subcutaneous administration of its infliximab biosimilar (Inflectra, Remsima). In international markets, Zymfentra is marketed as a biosimilar under the name Remsima SC.² By 2030, Celltrion said that it plans to have 12 immunology products, 7 oncology offerings, and 3 products for other therapeutic areas.

Regarding the state of the industry, of the 65 companies that have developed and conducted global clinical trials on the same biosimilars as Celltrion, 15 succeeded launching their products in Europe and the US, with only 4 achieving over $1 billion in annual biosimilars sales.

For the second quarter of 2024 (Q2 2024), Celltrion saw a 66.9% jump in sales from the previous year, reaching about $635.6 million. The growth was driven by sales in both the existing core as well as the US introduction of Celltrion products in 2023.

Operating profit temporarily decreased due to the company’s ongoing merger between Celltrion and Celltrion Healthcare. The cost of goods sold ratio slightly improved quarter over quarter (QoQ) due to the absorption of inventory previously held by Celltrion Healthcare. This ratio is expected to improve more quickly, driven by sales growth in the second half of 2024 (2H24). Operating profit is anticipated to increase starting in 2H24 as the amortization of sales rights was completed this quarter, following a temporary decrease in the second quarter of 2024 (2Q24) due to the amortization of intangible assets acquired through the purchase price allocation process post-merger.

Sales for biopharmaceuticals increased 5.7% year over year with balanced growth observed across novel and biosimilar agents. Biosimilar sales went up 77.4%, which Celltrion called an emerging growth driver going forward. Nonbiopharmaceutical sales increased 17.9% QoQ.

By individual products, Remsima (infliximab biosimilar), Remsima SC, Yuflyma (adalimumab biosimilar), and Vegzelma (bevacizumab biosimilar) achieved record-high quarterly sales. Intravenous (IV) Remsima sales reached the approximately $225 million to $250 million, while Remsima SC stabilized $75 million in sales. Yuflyma and Vegzelma sales grew rapidly due to successful bids in major European countries, and Zymfentra began generating revenue. New biosimilars contributed significantly to growth, with their sales mix rising from 26.5% in 2Q23 to 30.2% in 2Q24. In Europe, direct sales drove notable growth, especially for Remsima IV/SC and Yuflyma, while North American growth was fueled by increased Inflectra sales. With expanded capacity to meet demand, Inflectra and Zymfentra are expected to drive further sales growth in the US.

In other accomplishments, Celltrion established a direct sales system in the European Union in 2019 and in the United States in 2023. The company is also positioning itself as a top-tier global pharmaceutical leader with capabilities for biosimilars and novel drugs. Celltrion has a production capacity of 250,000 L for drug substances at its facility in Songdo, Republic of Korea, and can manufacture approximately 18 million syringes annually through Celltrion Pharm.

References

1. Celltrion. Celltrion IR presentation. September 9, 2024. Accessed November 4, 2024. https://www.celltrion.com/en-us/investment/ir/presentations

2. Jeremias S. FDA approved first subcutaneous infliximab product. The Center for Biosimilars^®. October 23, 2023. Accessed November 4, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-subcutaneous-infliximab