[비즈한국] The U.S. market performance of new drugs from Yuhan Corporation000100, GC Biopharma006280, and Celltrion068270 has shown mixed results in the first half of the year. Yuhan’s non-small cell lung cancer treatment 'Lazcluze' (domestic brand name: Leclaza) is showing a rosy outlook, recording a growth rate more than double that of its competitor, AstraZeneca's 'Tagrisso.' GC Biopharma’s immunoglobulin blood product 'Alyglo' is also assessed to be growing steadily in line with company expectations. However, Celltrion’s autoimmune disease treatment 'Zymfentra' has underperformed expectations, leading to continuous downward adjustments in its annual revenue forecasts.
According to industry sources on the 12th, global pharmaceutical giant Johnson & Johnson (J&J) reported $179 million (248.8 billion KRW) in revenue for the second quarter from Lazcluze and the immuno-oncology drug 'Rybrevant.' This represents a 27% increase over the first quarter ($141 million, 196 billion KRW). During the same period, this growth rate was more than double that of Tagrisso’s domestic U.S. growth rate (12.2%), indicating that the drug is establishing itself in the market quickly.
According to J&J, the progression-free survival (PFS) for patients receiving the combination therapy of Lazcluze and Rybrevant was 23.7 months, which is over 7 months longer on average than patients treated with Tagrisso (16.6 months), and the duration of response (DOR) was also analyzed to be 25.8 months, 9 months longer.
However, for Yuhan, the royalty income received from J&J is not yet satisfactory. The company received 2 billion KRW in royalties in the first quarter and 3.4 billion KRW in the second. Yuhan originally acquired Lazcluze from Genosco, a subsidiary of Oscotec039200, in 2015, and later licensed the global rights to J&J’s subsidiary, Janssen, in 2018, entitling Yuhan to double-digit royalties on global net sales of Lazcluze. Because J&J’s discounts, marketing, and legal rebates in the U.S. are excluded from net sales, the revenue used to calculate royalties is inevitably lower than actual gross sales. Furthermore, 40% of the received royalties must be shared with Oscotec and Genosco.
Nevertheless, Lazcluze is expected to serve as a long-term cash cow for Yuhan. J&J projects that annual revenue from the combination therapy of Lazcluze and Rybrevant will exceed $5 billion (6.9495 trillion KRW). As the combination therapy of Rybrevant and Lazcluze in both IV (intravenous) and SC (subcutaneous) formulations is expected to receive FDA approval within the year, the revenue scale of the combination therapy is likely to expand further. Additionally, there remains $725 million (1.0077 trillion KRW) in milestone payments to be received from the technology export contract with J&J.
Lee Hee-young, an analyst at Daishin Securities, noted, "Physician prescriptions for the Lazcluze combination therapy are increasing, with the combination now being selected for approximately 25% of first-line treatment patients," adding, "Upcoming momentum in the second half includes the announcement of final mOS (median overall survival) results for the combination therapy and its inclusion as a preferred first-line therapy in the National Comprehensive Cancer Network (NCCN) guidelines."
GC Biopharma’s immunoglobulin blood product 'Alyglo,' which was launched in the U.S. last July, is assessed to be entering the market smoothly.
Alyglo's revenue last year was 45 billion KRW, failing to reach the first-year target of $60 million (83.4 billion KRW), leading to concerns that it might not be establishing a solid footing. However, with 55 billion KRW in revenue achieved in the first half of this year, expectations are rising that the annual revenue target of $100 million (139.1 billion KRW) set at the time of its launch will be met.
The U.S. is experiencing a deepening supply shortage of blood products. When the U.S. Food and Drug Administration (FDA) approved Alyglo, it even noted that the launch of diverse products would serve the public interest given the local situation. Immunoglobulin preparations are designated as orphan drugs and essential medicines in the U.S.
A GC Biopharma official stated, "As growth is expected every quarter, achieving the $100 million in annual revenue announced as guidance to the outside market will not be a major problem."
Unlike Yuhan and GC Biopharma, Celltrion’s situation with its new drug is not easy. This is because sales of 'Zymfentra,' an autoimmune disease treatment launched in the U.S. last March, have not grown as quickly as expected.
Celltrion Chairman Seo Jung-jin initially expressed confidence, aiming for 250 billion KRW in revenue in the first year of Zymfentra's launch, 1 trillion KRW this year, and eventually reaching 5 trillion KRW. He even personally visited the U.S. to conduct sales activities for Zymfentra targeting local doctors.
However, the annual revenue target has been continuously lowered to 700 billion KRW (suggested in January) and 350 billion KRW (suggested in March). The total cumulative revenue for Zymfentra is 72 billion KRW, with 36 billion KRW—half the total—earned in the first half of this year.
Chairman Seo attributed the poor sales of Zymfentra to a misjudgment of the drug distribution process in the U.S., which differs from that of biosimilar products. Unlike other biosimilars that are registered with public and private insurance as soon as they are listed with Pharmacy Benefit Managers (PBMs), Zymfentra took about a year, making market expansion difficult. Although Zymfentra was launched in the U.S. as a new drug by emphasizing that it is the first SC formulation of the infliximab ingredient, it is a 'biobetter' product based on J&J’s 'Remicade.' It is currently competing against three biosimilar products while Remicade holds over 50% of the market share.
Shareholders who believed in Chairman Seo’s aspirations have strong complaints about Zymfentra's slump. With Zymfentra’s revenue guidance being lowered repeatedly, there are voices saying that Celltrion’s outlook cannot be trusted. Some shareholders have reacted by saying, "We were deceived by the company," "The executives who caused massive external distrust and negatively impacted the stock price should take responsibility," and "They need to reflect on why they have been shunned by foreigners and turned into an ugly duckling in the market."
The securities industry generally expects Zymfentra to generate 120 billion to 170 billion KRW in annual revenue, making it difficult to reach 200 billion KRW. Nevertheless, now that excessive expectations have been lowered, there are voices expecting a gradual upward trend in sales moving forward.
Jeong Jae-won, an analyst at iM Securities, cautiously predicted, "There is no problem with the product itself, so we can expect a switching effect from IV to SC formulations by highlighting the benefits of the SC formulation," adding, "While marketing performance appears to be the key to Zymfentra's sales growth in the second half, we can also confirm an upward trend in weekly prescription volume through IQVIA, a pharmaceutical market research firm."