Organon & Co. and its partner Shanghai Henlius Biotech announced that the U.S. Food and Drug Administration approved POHERDY, the first pertuzumab biosimilar to receive U.S. approval. The approval allows POHERDY to be marketed for all indications of the reference product, Perjeta, and positions Organon as a new entrant in the high‑value HER2‑positive breast‑cancer market.
In its most recent quarterly report, Organon posted revenue of $1.602 billion, a 1% increase on a reported basis but a 1% decline when adjusted for foreign‑exchange effects, compared with $1.582 billion in the same quarter last year. Non‑GAAP adjusted diluted earnings per share rose to $1.01, beating consensus estimates of $0.93 by $0.08. The company’s adjusted EBITDA margin expanded to 32.3% from 29.0% in Q3 2024, driven by a 14% reduction in operating expenses and a favorable mix shift toward higher‑margin biosimilar products.
Segment analysis shows that the Biosimilars division grew 19% in Q3 2025, largely due to the launch of new products such as Hadlima and Ontruzant. In contrast, the Women’s Health segment declined 3% on a reported basis, reflecting slower demand for its established brands. The decline in Women’s Health revenue offsets the strong biosimilar growth, resulting in a modest overall revenue increase.
CEO Kevin Ali highlighted the company’s disciplined cost management, noting that the 2024 year delivered a third consecutive year of constant‑currency revenue growth and an expansion of adjusted EBITDA margin ex‑IPR&D. He emphasized that the 2025 guidance reflects confidence in maintaining margin strength despite the loss of exclusivity for Atozet. Jon Martin, Organon’s U.S. commercial lead for biosimilars, underscored the strategic importance of POHERDY, stating that the approval “builds on Organon’s momentum in women’s health and oncology and expands access to a critical therapy for HER2‑positive breast cancer.” Dr. Jason Zhu of Henlius added that the approval validates Henlius’ global R&D capabilities and supports its long‑term strategy.
Analysts have responded cautiously to the approval, citing ongoing financial headwinds such as declining margins and a high debt‑to‑equity ratio. The company’s Altman Z‑Score of 1.17 places it in the distress zone, raising concerns about its ability to sustain profitability. In addition, a patent infringement lawsuit filed by Genentech in August 2025 could delay POHERDY’s commercial launch, adding uncertainty to the expected revenue upside.
Strategically, the POHERDY approval expands Organon’s oncology biosimilar portfolio and strengthens its competitive position against larger reference product manufacturers. The company’s guidance for 2025 remains conservative, with a revenue outlook of $6.20 billion to $6.25 billion and an adjusted EBITDA margin target of approximately 31.0%. The approval is a milestone that could unlock new revenue streams, but the company must navigate regulatory, competitive, and financial challenges to fully capitalize on the opportunity.
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