Samsung Collaboration

9 Months Ended

Sep. 30, 2025

Revenue from Contract with Customer [Abstract]

The Company has an agreement with Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) to develop and commercialize multiple pre-specified biosimilar candidates, which have since launched and are part of the Company's product portfolio. Under the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration of product candidates, and the Company has an exclusive license for worldwide commercialization with certain geographic exceptions specified on a product-by-product basis. The Company's access rights to each product under the agreement last for 10 years from each product's launch date on a market-by-market basis. Gross profits are shared equally in all markets with the exception of certain markets in Brazil where gross profits are shared 65% to Samsung Bioepis and 35% to the Company. Since the Company is the principal on sales transactions with third parties, the Company recognizes sales, cost of sales and selling, general and administrative expenses on a gross basis. Generally, profit sharing adjustments are recorded either to Cost of sales (after commercialization) or Selling, general and administrative expenses (prior to commercialization).

Samsung Bioepis is eligible for additional payments associated with pre-specified clinical and regulatory milestones. As of September 30, 2025, one potential remaining $25 million milestone remains unpaid.

Summarized information related to this collaboration is as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2025		2024		2025		2024
Sales	$	190	$	164	$	501	$	499
Cost of sales	120		112		312		329
Selling, general and administrative	17		18		55		60


($ in millions)	September 30, 2025		December 31, 2024
Receivables from Samsung included in Other current assets	$	37	$	30
Payables to Samsung included in Trade accounts payable	165		143

Organon & Co. 10-Q