High Hopes for High-concentration Drug Yuflyma
The author is an analyst of KB Securities. He can be reached at kimtaehee@kbfg.com. -- Ed.
Outstanding efficacy and safety data for Remsima SC showcased at EULAR 2022
Celltrion showcased outstanding efficacy and safety data for Remsima SC at EULAR 2022 (Jun 1-4). According to data presented, patients who received a 120mg dose of Remsima SC via subcutaneous injection at two-week intervals displayed better therapeutic progress than those receiving 3mg/kg of the original intravenous formulation of the infliximab biosimilar, while also showing better results in terms of immunogenicity (i.e., antibody response, development of neutralizing antibodies). We see accelerated market penetration for Remsima SC, given: (1) strong efficacy and safety, as affirmed by a wide range of clinical trials; (2) improved dosing convenience for patients; and (3) increased treatment options for physicians.
High hopes for high-concentration drug Yuflyma
Among the array of drug candidates slated for release in the U.S. market in 2023, the most highly anticipated is Yuflyma, a Humira biosimilar. Humira, used to treat autoimmune diseases, is the world’s best-selling drug; in 2021, the drug generated USD20.7bn in sales worldwide, with sales in the U.S. accounting for 83.7% (USD17.3bn). While the market for Humira in the U.S. can be divided into high-concentration (85%) and low-concentration (15%) formulations, only three of the 10 or so biosimilars slated for release are of high-concentration (including Yuflyma). The fact that the company has already been engaged in the sales of another TNF-α inhibitor (Remsima IV) also bodes well for Yuflyma.
Maintain BUY and TP of KRW200,000
We maintain BUY and TP of KRW200,000 for Celltrion. Investment points include: (1) the company will begin booking revenue for Yuflyma, Remsima SC, the Stelara biosimilar, and the Eylea biosimlar in 2H22; (2) Remsima IV’s U.S. market share is on a rapid rise; (3) product mix should improve on a boost in high-margin products heading deeper into the year; and (4) given that projects for yield improvements have been completed, commercial production of Truxima is imminent.